CN1903248A - Medicine for treating female climacterium syndrome and its prepn. method - Google Patents

本发明涉及中药制剂，具体涉及一种治疗女性更年期综合症的药物及制备方法，兼治骨质疏松、心血管病及提高免疫力。现有专利不含有黄芪等能抗衰老和提高身体免疫力的成分，致使其疗效也较为单一；或者成分繁多，制备过程相对复杂，且价格较贵。本发明药物成分：大豆异黄酮提取物2－5份，黄芪提取物3.5－7份，绞股蓝总皂甙1－3份，微晶纤维素4－8份，羧甲基淀粉钠或低取代羟丙基纤维素0.5－1.5份，硬脂酸镁0.05－0.15份。本发明的制作方法为：提取—制粒—压片，将辅料变化后也可制成胶囊。本发明选药严谨、诸药合用、相得益彰、功效显著。The invention relates to a traditional Chinese medicine preparation, in particular to a medicine for treating climacteric syndrome in women and a preparation method thereof, which can also treat osteoporosis, cardiovascular disease and improve immunity. The existing patents do not contain astragalus and other ingredients that can resist aging and improve body immunity, resulting in a relatively single curative effect; or there are many ingredients, the preparation process is relatively complicated, and the price is relatively expensive. The medicinal ingredients of the present invention: 2-5 parts of soybean isoflavone extract, 3.5-7 parts of astragalus extract, 1-3 parts of total saponins of Gynostemma pentaphyllum, 4-8 parts of microcrystalline cellulose, sodium carboxymethyl starch or low-substituted hydroxypropyl Base cellulose 0.5-1.5 parts, magnesium stearate 0.05-0.15 parts. The preparation method of the invention is as follows: extraction-granulation-tabletting, and capsules can also be made after changing auxiliary materials. The medicine of the present invention is rigorously selected, all medicines are used in combination, bring out the best in each other, and have remarkable efficacy.

一种治疗女性更年期综合症的药物及制备方法Medicament for treating climacteric syndrome in women and preparation method thereof

技术领域technical field

本发明涉及中药制剂，具体涉及一种以治疗女性更年期疾病为主，兼治骨质疏松、心血管病及提高免疫力的中药配方及制作方法。The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine formula and a preparation method mainly for treating women's climacteric diseases, and also for treating osteoporosis, cardiovascular diseases and improving immunity.

背景技术Background technique

随着年龄增长，社会竞争的加剧，加之家庭生活中的承重，女性的健康面临很大问题，例如常常出现潮热面红、自汗盗汗、心烦不宁、失眠多梦、头晕耳鸣等因雌激素水平下降所产生的临床症状，并伴随情绪低落、容易疲劳、免疫低下和注意力不集中等状态，长期症状为骨质疏松、心血管疾病及老年痴呆等。这些症状不仅严重威胁着妇女的身心健康，影响生活质量，同时也对社会和家庭带来不良影响。目前对于以上症状西医尚无良好的治疗方法，程度轻微者一般服用适量镇定剂等，只能缓解，治标不治本；症状严重者则采用雌激素替代疗法，但这一疗法的副作用较多，可导致子宫出血、乳腺肿胀等不适，也有增加乳腺癌和子宫内膜癌发病的危险性。另外传统中医方剂熬制过程复杂给患者带来诸多不便，近几年来虽有治疗此病的中药制剂配方，但也存在种种不足。With the growth of age, the intensification of social competition, coupled with the burden of family life, women's health is facing great problems, such as hot flushes, spontaneous sweating, restlessness, insomnia, dizziness and tinnitus, etc. The clinical symptoms caused by the decline of hormone levels are accompanied by depression, fatigue, low immunity and inattention. The long-term symptoms are osteoporosis, cardiovascular disease and senile dementia. These symptoms not only seriously threaten the physical and mental health of women and affect the quality of life, but also bring adverse effects on society and family. At present, there is no good treatment method for the above symptoms in Western medicine. Those with mild symptoms generally take appropriate amount of sedatives, etc., which can only alleviate the symptoms, not the root cause; those with severe symptoms can use estrogen replacement therapy, but this therapy has many side effects. It can cause discomfort such as uterine bleeding and breast swelling, and also increase the risk of breast cancer and endometrial cancer. In addition, the complexity of the traditional Chinese medicine prescription boiling process brings a lot of inconvenience to the patient. Although there is a Chinese medicine preparation formula for the treatment of this disease in recent years, there are various deficiencies.

公开号为CN 1401320、公开日为2003年3月12日的中国专利申请公开了“一种治疗妇女更年期综合症药物”的专利。该方法的有效成分为大豆异黄酮和枸杞提取物，大豆异黄酮能起到缓解更年期综合症的作用，如潮热面红、自汗盗汗、心烦不宁、失眠多梦、头晕耳鸣、腰膝酸软、手足心热等作用，但由于有效成分较单一，不含有黄芪等能抗衰老和提高身体免疫力的的成分，致使其疗效也较为单一。Publication number is CN 1401320, and the date of publication is that the Chinese patent application on March 12, 2003 discloses the patent of "a kind of medicine for the treatment of women's climacteric syndrome". The effective ingredients of this method are soy isoflavones and wolfberry extracts. Soy isoflavones can relieve menopausal symptoms, such as hot flashes, flushed face, spontaneous night sweats, restlessness, insomnia and dreaminess, dizziness, tinnitus, waist and knee pain. Soreness, heat in hands, feet, heart, etc., but because the active ingredients are relatively single, and it does not contain astragalus and other ingredients that can resist aging and improve the body's immunity, its curative effect is also relatively single.

公开号为CN 1401351、公开日为2003年3月12日的中国专利申请公开了“治疗妇女更年期综合症的药物”的专利。该药物由黄连、肉桂、枸杞子、山茱萸等十三味中药按比例配制而成。成分繁多，制备过程相对复杂，且价格较贵。Publication number is CN 1401351, and the date of publication is that the Chinese patent application on March 12, 2003 discloses the patent of " the medicine for the treatment of women's climacteric syndrome ". The medicine is prepared in proportion from thirteen traditional Chinese medicines such as coptis, cinnamon, medlar and dogwood. There are many ingredients, the preparation process is relatively complicated, and the price is relatively expensive.

发明内容Contents of the invention

本发明所要解决的技术问题是提供一种采用天然植物活性成分组成的、副反应少疗效显著的主治女性更年期综合症，兼治骨质疏松、心血管病、抗衰老及提高免疫力的的中药复方制剂。The technical problem to be solved by the present invention is to provide a traditional Chinese medicine compound which is composed of natural plant active ingredients, has few side effects and has significant curative effect, which is mainly used for treating climacteric syndrome in women, and also for treating osteoporosis, cardiovascular disease, anti-aging and improving immunity. preparation.

一种治疗女性更年期综合症的药物，其特征在于，包括以下质量份数的成分：大豆异黄酮提取物2-5份，黄芪提取物3.5-7份，绞股蓝总皂甙1-3份，微晶纤维素4-8份，羧甲基淀粉钠或低取代羟丙基纤维素0.5-1.5份，硬脂酸镁0.05-0.15份。A medicine for treating climacteric syndrome in women, characterized in that it comprises the following ingredients in parts by mass: 2-5 parts of soybean isoflavone extract, 3.5-7 parts of Astragalus extract, 1-3 parts of total gypenosides, microcrystalline 4-8 parts of cellulose, 0.5-1.5 parts of sodium carboxymethyl starch or low-substituted hydroxypropyl cellulose, and 0.05-0.15 parts of magnesium stearate.

本发明的制作方法为：提取-制粒-压片，制片时成品剂型为片剂。具体制作过程如下：The preparation method of the present invention is: extraction-granulation-tabletting, and the finished dosage form is a tablet during tablet making. The specific production process is as follows:

1、制备提取物1. Preparation of extract

大豆异黄酮提取物：提取过程见申请号为：200510008536.9的专利申请，请补充申请日申请名称，具体提取过程为：(此专利已申请，但还未公开，所以没有公开号)Soybean isoflavone extract: see the patent application with application number: 200510008536.9 for the extraction process. Please add the application name on the application date. The specific extraction process is: (This patent has been applied for, but it has not yet been published, so there is no publication number)

(1)将低温豆粕粉碎，过40～60目筛，得低温豆粕粉末；(1) Crush the low-temperature soybean meal and pass through a 40-60 mesh sieve to obtain low-temperature soybean meal powder;

(2)低温豆粕粉末与萃取剂50～90％乙醇水溶液于45～85℃下进行连续多级逆流浸提，低温豆粕粉末与萃取剂的质量体积比(kg/L)为1∶2～5，得到低温豆粕的乙醇浸取液减压蒸发，除去乙醇，得到大豆异黄酮浓缩水溶液；(2) Low-temperature soybean meal powder and extractant 50-90% ethanol aqueous solution are subjected to continuous multi-stage countercurrent leaching at 45-85 °C, and the mass-volume ratio (kg/L) of low-temperature soybean meal powder to extractant is 1:2-5 to obtain the ethanol extract of the low-temperature soybean meal, evaporate under reduced pressure, remove the ethanol, and obtain a concentrated aqueous solution of soybean isoflavones;

(3)在步骤(2)的大豆异黄酮浓缩水溶液中加入氢氧化钙调节pH值为8～12，絮凝，静置除去絮凝沉淀物后，用盐酸调节pH值至6～7，絮凝，静置除去絮凝物后，得到絮凝原料液；(3) Add calcium hydroxide to the concentrated aqueous solution of soybean isoflavones in step (2) to adjust the pH value to 8-12, flocculate, leave to stand to remove the flocculation sediment, adjust the pH value to 6-7 with hydrochloric acid, flocculate, and statically After the flocs are removed, the flocculation raw material solution is obtained;

(4)以乙酸乙酯为萃取剂，对步骤(3)的絮凝原料液进行萃取，减压浓缩，除去乙酸乙酯，得到纯度为40％左右的大豆异黄酮粗产品，萃取率95％以上；(4) Using ethyl acetate as the extraction agent, extract the flocculation raw material liquid in step (3), concentrate under reduced pressure, remove ethyl acetate, obtain a crude product of soybean isoflavones with a purity of about 40%, and an extraction rate of more than 95% ;

(5)步骤(4)的大豆异黄酮粗产品用石油醚进行重结晶，石油醚与大豆异黄酮粗产品的体积质量比(L/kg)为5～9∶1，可得到纯度95％以上的大豆异黄酮产品。(5) The crude product of soybean isoflavones in step (4) is recrystallized with petroleum ether, and the volume-to-mass ratio (L/kg) of petroleum ether to the crude product of soybean isoflavones is 5 to 9: 1, and a purity of more than 95% can be obtained. soy isoflavone products.

黄芪提取物：取原料药黄芪饮片，加8-12倍量水(质量份数)煎煮2次，每次1-3小时，煎煮液过滤后合并，得黄芪提取液；将黄芪提取液弃上清后对剩余物减压浓缩，条件为：70℃，真空度-0.1MPa，至相对密度为1.05～1.10(50℃)，加2-4倍量(体积份数)乙醇使沉淀，放置，倾出上清液；沉淀物加50℃-70℃的热水溶解，过滤，滤液再加乙醇使含醇量达70％-75％(质量份数)，放置，倾出上清液；沉淀物再加50℃-70℃的热水溶解，过滤，滤液再加乙醇使含醇量达80％-85％(质量份数)，放置，倾出上清液，得浸膏；将所得浸膏进行喷雾干燥，即得黄芪提取物。Radix Astragali extract: take raw material Radix Astragali decoction pieces, add 8-12 times the amount of water (number of parts by mass) to decoct twice, each time for 1-3 hours, and merge the decoction liquid after filtration to obtain Astragalus extract; After discarding the supernatant, concentrate the residue under reduced pressure. The conditions are: 70°C, vacuum degree -0.1MPa, until the relative density is 1.05-1.10 (50°C), add 2-4 times the amount (parts by volume) of ethanol to precipitate, Put it aside, pour out the supernatant; dissolve the precipitate with hot water at 50°C-70°C, filter, add ethanol to the filtrate to make the alcohol content reach 70%-75% (parts by mass), place it, pour out the supernatant The precipitate is dissolved in hot water at 50°C-70°C, filtered, and ethanol is added to the filtrate to make the alcohol content reach 80%-85% (parts by mass), placed, and the supernatant liquid is poured out to obtain an extract; The obtained extract is spray-dried to obtain the astragalus extract.

2、制粒2. Granulation

分别将原辅料过80目筛，大豆异黄酮提取物2-5份，黄芪提取物3.5-7份，绞股兰提取物1-3份，微晶纤维素4-8份，羧甲基淀粉钠0.3-0.9份(内加)或低取代羟丙基纤维素0.5-1.5份，混合均匀，加70％乙醇水溶液适量，制成软材，过12-18目筛制粒，50℃鼓风干燥，过12-18目筛整粒。(均为质量份数)Pass the raw and auxiliary materials through a 80-mesh sieve, 2-5 parts of soybean isoflavone extract, 3.5-7 parts of Astragalus extract, 1-3 parts of Jiaogulan extract, 4-8 parts of microcrystalline cellulose, carboxymethyl starch 0.3-0.9 parts of sodium (internal addition) or 0.5-1.5 parts of low-substituted hydroxypropyl cellulose, mix well, add an appropriate amount of 70% ethanol aqueous solution to make a soft material, granulate through a 12-18 mesh sieve, and blast at 50 ° C Dry, pass through a 12-18 mesh sieve and granulate. (both parts by mass)

3、压片3. Tablet

干颗粒中加入0.2-0.6份羧甲基淀粉钠(外加)、硬脂酸镁0.05-0.15份，混合均匀，压制片剂。(均为质量份数)Add 0.2-0.6 parts of sodium carboxymethyl starch (external addition) and 0.05-0.15 parts of magnesium stearate to the dry granules, mix well, and compress into tablets. (both parts by mass)

方中大豆为豆科植物大豆的成熟种子，公元前2838年《神农本草经》首次记载了大豆及其药用价值，并列为“中品”，具有强身健体之功效，对女性慢性疾病有预防治疗作用。黄芪为豆科植物，性味甘温，归肺、脾经。作为传统中药，具有益卫固表、利水消肿、托毒生肌、补中益气、辛凉解表、宣肺通窍之功效；用于气虚乏力，食少便溏，中气下陷，表虚自汗，气虚水肿，久溃不敛，血虚萎黄，内热消渴。绞股蓝为葫芦科绞股蓝属植物，性味苦寒。具有消炎解毒，止渴祛痰之功效。Fangzhong soybean is the mature seed of the leguminous plant soybean. In 2838 BC, "Shen Nong's Herbal Classic" recorded soybean and its medicinal value for the first time, and listed it as "medium grade". preventive treatment. Astragalus is a leguminous plant with a sweet and warm nature, and returns to the lung and spleen channels. As a traditional Chinese medicine, it has the effects of benefiting the body and solidifying the exterior, diuresis and swelling, supporting toxin and promoting muscle growth, nourishing the middle and replenishing qi, relieving the exterior with pungent coolness, clearing the lung and clearing the orifices; Spontaneous perspiration due to deficiency, edema due to deficiency of vital energy, prolonged ulceration, chlorosis due to blood deficiency, internal heat and quenching thirst. Gynostemma is a plant of the genus Gynostemma of Cucurbitaceae, with a bitter and cold taste. It has the effects of anti-inflammatory and detoxification, quenching thirst and eliminating phlegm.

现代医学研究表明，大豆异黄酮是一类植物雌激素，主要有大豆苷原和染料木黄酮两种，其结构与雌激素相似，大豆异黄酮对而潮热面红、自汗盗汗、心烦不宁、失眠多梦、头晕耳鸣临床症状都有改善。绝经期妇女服用大豆异黄酮，血中激素水平到达一定数量，能改善更年期妇女性激素和临床症状，提高肌体的免疫功能。黄芪多糖是黄芪的主要活性成分之一，具有显著增强机体免疫、抗衰老等多种功能和药理功效。绞股蓝中有6种皂甙与人参皂甙结构相同，还有一些经水解可得到人参皂甙。绞股蓝皂甙对人体具有强壮、耐缺氧、耐高温、抗疲劳、增强免疫力等多方面作用。这些对提高人体的运动能力、促进疲劳恢复、调整机能状态非常有益。Modern medical research shows that soy isoflavones are a type of phytoestrogens, mainly including daidzein and genistein, whose structure is similar to estrogen. Ning, insomnia, dreaminess, dizziness and tinnitus clinical symptoms are all improved. Menopausal women take soy isoflavones, blood hormone levels reach a certain amount, can improve menopausal women's sex hormones and clinical symptoms, and improve the body's immune function. Astragalus polysaccharide is one of the main active components of Astragalus, which has various functions and pharmacological effects such as significantly enhancing the body's immunity and anti-aging. There are 6 kinds of saponins in Gynostemma pentaphyllum with the same structure as ginsenosides, and some of them can be hydrolyzed to obtain ginsenosides. Gypenosides have various effects on the human body such as strength, hypoxia resistance, high temperature resistance, fatigue resistance, and immunity enhancement. These are very beneficial to improving the exercise capacity of the human body, promoting fatigue recovery, and adjusting functional status.

纵观该方为一多味中药组成的复方，由于选药严谨、诸药合用、相得益彰、功效显著。从肺胃、脾肾四脏的生理特点入手，以治疗妇女更年期疾病为主，以调和一样、扶正祛邪为宗旨，具备了清肺和胃、补益脾肾，缓解妇女更年期之症状，改善骨质疏松，增强机体免疫力之功效。The prescription is a compound prescription composed of multiple traditional Chinese medicines. Due to the rigorous selection of medicines and the combination of various medicines, they complement each other and have remarkable effects. Starting from the physiological characteristics of the lung, stomach, spleen and kidney, it mainly treats women's climacteric diseases. Loose texture, enhance the body's immunity.

另外，本发明所述配方将辅料变化后也可制成胶囊，具体配方如下：大豆异黄酮提取物2-5份，黄芪提取物3.5-7份，绞股兰提取物1-3份，微晶纤维素或淀粉、或环糊精48份。(均为质量份数)In addition, the formula of the present invention can also be made into capsules after changing the auxiliary materials. The specific formula is as follows: 2-5 parts of soybean isoflavone extract, 3.5-7 parts of Astragalus extract, 1-3 parts of Jiaogulan extract, micro 48 parts of crystalline cellulose or starch, or cyclodextrin. (both parts by mass)

服用方法：每天1次，每次1片，温开水服用。Dosage: Take 1 tablet each time with warm water, once a day.

注意事项：服药期间禁忌酸辣、酒。Note: hot and sour, alcohol is contraindicated during the medication.

具体实施方式Detailed ways

实施例1Example 1

一种治疗女性更年期综合症的药物产品配方为：大豆异黄酮提取物0.1kg，黄芪提取物0.13kg，绞股兰提取物0.065kg，微晶纤维素0.17kg，羧甲基淀粉钠0.03kg，硬脂酸镁0.003kg。A drug product formula for treating climacteric syndrome in women is: 0.1kg of soybean isoflavone extract, 0.13kg of Astragalus extract, 0.065kg of Jiaogulan extract, 0.17kg of microcrystalline cellulose, 0.03kg of sodium carboxymethyl starch, Magnesium stearate 0.003kg.

其具体制备过程如下：Its specific preparation process is as follows:

1、制备提取物1. Preparation of extract

大豆异黄酮提取物：提取过程见已公开专利，申请号为：200510008536.9①将低温豆粕粉碎，过40～60目筛。②乙醇溶液浸提：在平转式浸出器中(采用的设备由浙江余姚粮机厂生产，型号为YJPT 5，处理量为5T/D)，低温豆粕2.5t与萃取剂85％乙醇水溶液7500L于50℃下进行连续16级逆流浸提，可得到高浓度的浸取液；减压浓缩除去浸取液中全部的乙醇，得到低温豆粕的浓缩水溶液。③氢氧化钙絮凝：在浓缩液中加入粉状氢氧化钙调pH值至10～12，进行絮凝，静置1h后过滤，得黄色淤泥状沉淀及黄色(稍浑浊)滤液；在滤液中加入浓度为20％的盐酸，调pH值至6～7，静置2h，取上清液，得絮凝原料液。④乙酸乙酯萃取：采用填料塔作为萃取塔，塔径为400mm，塔高6m，所用填料为规格25×25×3的瓷制拉西环；食品级乙酸乙酯作为连续相，进料方向由下向上，絮凝原料液作为分散相，进料方向由上向下。上下进料口由恒流泵控制，上下出料口由阀门控制。首先将塔身充满乙酸乙酯，然后上下口同时进料，絮凝原料液与萃余液流量均为1000L/h，萃取剂与萃取液流量均为4000L/h，待系统稳定后，收集萃取液和萃余液，乙酸乙酯蒸干得到大豆异黄酮粗产品11.2kg，纯度为41.5％，萃取率为97.8％。⑤石油醚萃取：用70L石油醚对41.5％的异黄酮粗产品进行重结晶，得到异黄酮产品4.6kg，纯度为97.8％，提取率为96.8％，总的提取率为90.0％。Soybean isoflavone extract: See the published patent for the extraction process, the application number is: 200510008536.9 ①Crush the low-temperature soybean meal and pass it through a 40-60 mesh sieve. ②Ethanol solution extraction: In a horizontal rotary extractor (the equipment used is produced by Zhejiang Yuyao Grain Machinery Factory, the model is YJPT 5, and the processing capacity is 5T/D), 2.5t of low-temperature soybean meal and 7500L of 85% ethanol aqueous solution of extraction agent Continuous 16-stage countercurrent leaching at 50°C can obtain a high-concentration leaching solution; vacuum concentration removes all ethanol in the leaching solution to obtain a concentrated aqueous solution of low-temperature soybean meal. ③Calcium hydroxide flocculation: add powdered calcium hydroxide to the concentrated solution to adjust the pH value to 10-12, carry out flocculation, let it stand for 1 hour and then filter to obtain a yellow sludge-like precipitate and a yellow (slightly turbid) filtrate; add With 20% hydrochloric acid, adjust the pH value to 6-7, let stand for 2 hours, and take the supernatant to obtain the flocculation raw material solution. ④ Ethyl acetate extraction: use a packed tower as the extraction tower, the diameter of the tower is 400mm, the height of the tower is 6m, and the packing used is porcelain Raschig rings with a specification of 25×25×3; food-grade ethyl acetate is used as the continuous phase, and the feeding direction is From bottom to top, the flocculation raw material liquid is used as the dispersed phase, and the feeding direction is from top to bottom. The upper and lower material inlets are controlled by constant flow pumps, and the upper and lower material outlets are controlled by valves. Firstly, the tower body is filled with ethyl acetate, and then the upper and lower ports are fed at the same time. The flow rate of flocculation raw material liquid and raffinate is 1000L/h, and the flow rate of extractant and extractant is 4000L/h. After the system is stable, collect the extract and raffinate, and evaporated to dryness with ethyl acetate to obtain 11.2 kg of soybean isoflavone crude product with a purity of 41.5% and an extraction rate of 97.8%. ⑤ Petroleum ether extraction: 41.5% crude isoflavones were recrystallized with 70L petroleum ether to obtain 4.6kg of isoflavones with a purity of 97.8%, an extraction rate of 96.8%, and a total extraction rate of 90.0%.

黄芪提取物：取原料药黄芪饮片，加10倍量水(质量份数)煎煮2次，每次1.5小时，煎煮液过滤后合并，得黄芪提取液；将黄芪提取液弃上清后对剩余物减压浓缩，条件为：70℃，真空度-0.1MPa，至相对密度1.05～1.10(50℃)，加3倍量乙醇(体积份数)使沉淀，放置，倾出上清液；沉淀物加50℃的热水溶解，过滤，滤液再加乙醇使含醇量达70％(质量份数)，放置，倾出上清液；沉淀物再加50℃的热水溶解，过滤，滤液再加乙醇使含醇量达80％(质量份数)，放置，倾出上清液，得浸膏；将所得浸膏进行喷雾干燥，即得黄芪提取物。Astragalus extract: take raw material Radix Astragali decoction pieces, add 10 times the amount of water (mass parts) and decoct twice for 1.5 hours each time, filter the decoction and combine to obtain Astragalus extract; discard the supernatant of Astragalus extract Concentrate the residue under reduced pressure, the conditions are: 70°C, vacuum degree -0.1MPa, to a relative density of 1.05-1.10 (50°C), add 3 times the amount of ethanol (parts by volume) to precipitate, place it, and pour out the supernatant Add 50 ℃ hot water to dissolve the precipitate, filter, add ethanol to the filtrate to make the alcohol content reach 70% (parts by mass), place it, pour out the supernatant; add 50 ℃ hot water to dissolve the precipitate, filter , and ethanol is added to the filtrate to make the alcohol content reach 80% (parts by mass), placed, and the supernatant liquid is poured out to obtain an extract; the obtained extract is spray-dried to obtain an extract of Radix Astragali.

绞股蓝提取物：市购(购于西安鸿生生物技术有限公司，绞股蓝总皂甙含量为98％)Gynostemma pentaphyllum extract: commercially available (purchased from Xi'an Hongsheng Biotechnology Co., Ltd., the total saponin content of Gynostemma pentaphyllum is 98%)

2、制粒2. Granulation

分别将原辅料过80目筛，取大豆异黄酮提取物0.1kg、黄芪提取物0.13kg、绞股兰提取物0.065kg、微晶纤维素0.17kg、羧甲基淀粉钠0.02kg(内加)，混合均匀，加70％乙醇水溶液适量，制成软材，过14目筛制粒，50℃鼓风干燥，过16目筛整粒。Pass raw and auxiliary materials through 80-mesh sieve respectively, and take 0.1kg of soybean isoflavone extract, 0.13kg of Astragalus extract, 0.065kg of Jiaogulan extract, 0.17kg of microcrystalline cellulose, and 0.02kg of sodium carboxymethyl starch (internal addition) , mix evenly, add an appropriate amount of 70% ethanol aqueous solution to make a soft material, pass through a 14-mesh sieve to granulate, blow dry at 50°C, and pass through a 16-mesh sieve for granulation.

3、压片3. Tablet

干颗粒中加入0.01kg羧甲基淀粉钠(外加)、硬脂酸镁0.003kg，混合均匀，压制片剂1000片，片重0.5g/片。Add 0.01kg sodium carboxymethyl starch (additional), 0.003kg of magnesium stearate to the dry granules, mix uniformly, and compress 1000 tablets, with a tablet weight of 0.5g/sheet.

临床观察实验方法：Clinical Observation Experiment Method:

使用双盲、随机、安慰剂对照门诊病人观察的方法研究，30名受试者分为两组：药物组：每日服用一片药物，对照组服用淀粉制剂。在治疗期间禁止服用其它豆类食品或雌激素等制剂。Using a double-blind, randomized, placebo-controlled outpatient study, 30 subjects were divided into two groups: the drug group: taking one tablet of the drug every day, and the control group taking starch preparations. It is forbidden to take other soy foods or preparations such as estrogen during the treatment period.

整个观察期2个月，第一次为筛选病人，即称为第一日，之后每月两次共四次进行接诊。第一次给病人按8个症状进行分级打分(潮热面红、自汗盗汗、心烦不宁、失眠多梦、头晕耳鸣、情绪低落、容易疲劳、注意力不集中)，每一症状打分标准为1-3分：The entire observation period is 2 months. The first time is to screen patients, which is called the first day, and then twice a month for a total of four consultations. For the first time, the patient is graded and scored according to 8 symptoms (hot flushes, spontaneous sweating, restlessness, insomnia and dreaminess, dizziness, tinnitus, depression, easy fatigue, lack of concentration), and the scoring standard for each symptom For 1-3 points:

3分，症状中最严重者。其严重程度为患者不能忍受，不能坚持正常工作，影响到日常生活，必须去医院就医。3 points, the most severe symptoms. Its severity is that the patient can't bear it, can't insist on normal work, affects daily life, and must go to the hospital for medical treatment.

2分，症状中等程度。或者虽有较重症状，但还能忍受，坚持一般的日常工作。2 points, the symptoms are moderate. Or although there are severe symptoms, they can still tolerate it and stick to their normal daily work.

1分，症状中最轻者。症状相对比较轻，患者能进行一般工作。注意力转移时，症状相对较轻。1 point, the mildest symptom. Symptoms are relatively mild, and patients can perform general work. Symptoms are relatively mild when attention is diverted.

0分，没有任何症状。0 points, no symptoms.

以上八个主观症状，重度者总分为3×8＝24分，中度为16分，轻度为6分以下。For the above eight subjective symptoms, the total score is 3×8=24 points for severe cases, 16 points for moderate cases, and less than 6 points for mild cases.

受试纳入标准：所有参加观察者均为已婚健康妇女，并符合以下条件：Inclusion criteria: All participants and observers are married healthy women who meet the following conditions:

①有典型的更年期综合症，综合评分在6分以上。①Have typical menopausal syndrome, and the comprehensive score is above 6 points.

②血中雌激素水平下降，而促卵泡刺激素(FSH)和促卵泡刺激素(LH)水平增高。② The level of estrogen in the blood decreases, while the levels of follicle-stimulating hormone (FSH) and follicle-stimulating hormone (LH) increase.

③3个月内未服用过类固醇等激素。③ Have not taken steroids and other hormones within 3 months.

④无乳癌、子宫癌、妊娠、阴道出血、心血管病、肝病、过敏等既望病史。④ No history of breast cancer, uterine cancer, pregnancy, vaginal bleeding, cardiovascular disease, liver disease, allergies, etc.

将受试者随机分为2组，两组患者均进行常规药物检查和实验室检查。The subjects were randomly divided into two groups, and patients in both groups underwent routine drug examination and laboratory examination.

疗效判定：Judgment of curative effect:

按8个症状治疗前后综合评分改变判定疗效，并经统计学处理。The curative effect was judged according to the change of comprehensive score of 8 symptoms before and after treatment, and was processed statistically.

药物安全性分析采用定期血、尿、肝、肾功能常规检查。The drug safety analysis adopts regular blood, urine, liver and kidney function checks.

结果：result:

30例患者随机分为两组，药物组受试者平均年龄为51.8±4.62，更年期症状综合平均分为17.18±3.12，而安慰剂组患者平均年龄为50.53±4.59，更年期症状综合平均分数为16.86±3.04，详见下表。在服药前后两组资料无统计学差异。30 patients were randomly divided into two groups. The mean age of the subjects in the drug group was 51.8±4.62, and the mean score of menopausal symptoms was 17.18±3.12, while the mean age of the patients in the placebo group was 50.53±4.59, and the mean score of menopausal symptoms was 16.86. ±3.04, see the table below for details. There was no statistical difference in the data of the two groups before and after taking the medicine.

服用药物与安慰剂前后更年期症状综合评分比较( x±D)   服药组(n＝15)   安慰剂组(n＝15)   治疗前   治疗后   治疗前   治疗后   潮热面红   2.24±0.57   1.27±0.41^**##   2.17±0.47   2.16±0.53   自汗盗汗   2.01±0.50   1.21±0.46^**##   2.23±0.51   2.34±0.42   心烦不宁   1.97±0.56   1.23±0.51^**#   2.01±0.44   1.62±0.56   失眠多梦   2.18±0.51   1.54±0.62^*#   2.12±0.49   2.06±0.48   头晕耳鸣   1.93±0.59   1.19±0.37^**##   1.98±0.61   2.13±0.37   情绪低落   2.37±0.46   1.36±0.42^**##   2.46±0.54   2.19±0.31   容易疲劳   2.67±0.59   1.61±0.38^**#   2.22±0.48   1.97±0.27   注意力不集中   1.81±0.45   0.97±0.48^**##   1.67±0.41   1.63±0.33   综合计分   17.18±3.12   10.38±3.04^**##   16.86±3.07   16.28±2.42 Comparison of comprehensive score of menopausal symptoms before and after taking medicine and placebo (x±D) Medication group (n=15) Placebo group (n=15) Before treatment After treatment Before treatment After treatment hot flashes 2.24±0.57 1.27±0.41 ^** ## 2.17±0.47 2.16±0.53 Spontaneous sweating 2.01±0.50 1.21±0.46 ^** ## 2.23±0.51 2.34±0.42 upset 1.97±0.56 1.23±0.51 ^** # 2.01±0.44 1.62±0.56 insomnia 2.18±0.51 1.54±0.62 ^* # 2.12±0.49 2.06±0.48 dizziness tinnitus 1.93±0.59 1.19±0.37 ^** ## 1.98±0.61 2.13±0.37 Depression 2.37±0.46 1.36±0.42 ^** ## 2.46±0.54 2.19±0.31 Tired easily 2.67±0.59 1.61±0.38 ^** # 2.22±0.48 1.97±0.27 inattention 1.81±0.45 0.97±0.48 ^** ## 1.67±0.41 1.63±0.33 Comprehensive score 17.18±3.12 10.38±3.04 ^** ## 16.86±3.07 16.28±2.42

治疗前后相比^*P＜0.05；^**P＜0.01Compared before and after treatment ^* P <0.05; ^** P <0.01

药物组与安慰剂组相比#P＜0.05；##P＜0.01#P＜0.05 between drug group and placebo group; ##P＜0.01

药物组受试者服药2月后，更年期8项主要症状明显好转，症状总分下降为10.38±3.04与治疗前及安慰组治疗后相比均有显著性差异。而安慰组受试者治疗前后，更年期8项主要主观症状无明显好转，症状总分仍为16.28±2.42After taking the drug for 2 months, the 8 main symptoms of menopause improved significantly, and the total score of symptoms decreased to 10.38±3.04, which was significantly different from that before treatment and after treatment in the placebo group. Before and after treatment in the placebo group, the 8 main subjective symptoms of menopause did not improve significantly, and the total symptom score was still 16.28±2.42.

两组受试者服药2月后，无一例检查发现血、尿、肝、肾功能异常。After the two groups of subjects took the medicine for 2 months, none of the blood, urine, liver, and kidney functions were found to be abnormal.

发明人采用随机、双盲和安慰剂方法观察了药物对更年期综合症的治疗作用。通过上述的临床实验观察，可以发现，此药物在治疗更年期综合症方面具有明显的疗效。结果表明：两组受试者在服药前各观察资料无统计学差异。药物组受试者服药2月后，更年期8项主要主观症状明显好转；而安慰组受试者治疗前后，更年期8项主要主观症状无明显好转，表明服用此药物对改善更年期症状是有益的。The inventor has observed the therapeutic effect of the medicine on menopausal syndrome by adopting random, double-blind and placebo methods. Through the above-mentioned clinical experiment observation, it can be found that this drug has obvious curative effect in the treatment of menopausal syndrome. The results showed that there was no statistical difference in the observation data of the two groups of subjects before taking the medicine. After taking the drug for 2 months, the 8 main subjective symptoms of menopause improved significantly for the subjects in the drug group; while the 8 main subjective symptoms of menopause did not improve significantly for the subjects in the placebo group before and after treatment, indicating that taking this drug is beneficial for improving menopausal symptoms.

实施例2Example 2

一种治疗女性更年期综合症的药物产品配方为：大豆异黄酮提取物0.08kg，黄芪提取物0.16kg，绞股兰提取物0.025kg，微晶纤维素0.17kg，低取代羟丙基纤维素0.025kg，硬脂酸镁0.0025kg。A drug product formula for treating female climacteric syndrome is: 0.08kg of soybean isoflavone extract, 0.16kg of Astragalus extract, 0.025kg of Jiaogulan extract, 0.17kg of microcrystalline cellulose, and 0.025kg of low-substituted hydroxypropyl cellulose kg, magnesium stearate 0.0025kg.

其具体制备过程如下：Its specific preparation process is as follows:

1、制备提取物1. Preparation of extract

大豆异黄酮提取物：提取过程见已公开专利，申请号为：200510008536.9①将低温豆粕粉碎，过40～60目筛。②乙醇溶液浸提：在平转式浸出器中(采用的设备由浙江余姚粮机厂生产，型号为YJPT 5，处理量为5T/D)，低温豆粕2.5t与萃取剂85％乙醇水溶液7500L于50℃下进行连续16级逆流浸提，可得到高浓度的浸取液；减压浓缩除去浸取液中全部的乙醇，得到低温豆粕的浓缩水溶液。③氢氧化钙絮凝：在浓缩液中加入粉状氢氧化钙调pH值至10～12，进行絮凝，静置1h后过滤，得黄色淤泥状沉淀及黄色(稍浑浊)滤液；在滤液中加入浓度为20％的盐酸，调pH值至6～7，静置2h，取上清液，得絮凝原料液。④乙酸乙酯萃取：采用填料塔作为萃取塔，塔径为400mm，塔高6m，所用填料为规格25×25×3的瓷制拉西环；食品级乙酸乙酯作为连续相，进料方向由下向上，絮凝原料液作为分散相，进料方向由上向下。上下进料口由恒流泵控制，上下出料口由阀门控制。首先将塔身充满乙酸乙酯，然后上下口同时进料，絮凝原料液与萃余液流量均为1000L/h，萃取剂与萃取液流量均为4000L/h，待系统稳定后，收集萃取液和萃余液，乙酸乙酯蒸干得到大豆异黄酮粗产品11.2kg，纯度为41.5％，萃取率为97.8％。⑤石油醚萃取：用70L石油醚对41.5％的异黄酮粗产品进行重结晶，得到异黄酮产品4.6kg，纯度为97.8％，提取率为96.8％，总的提取率为90.0％。Soybean isoflavone extract: See the published patent for the extraction process, the application number is: 200510008536.9 ①Crush the low-temperature soybean meal and pass it through a 40-60 mesh sieve. ②Ethanol solution extraction: In a horizontal rotary extractor (the equipment used is produced by Zhejiang Yuyao Grain Machinery Factory, the model is YJPT 5, and the processing capacity is 5T/D), 2.5t of low-temperature soybean meal and 7500L of 85% ethanol aqueous solution of extraction agent Continuous 16-stage countercurrent leaching at 50°C can obtain a high-concentration leaching solution; vacuum concentration removes all ethanol in the leaching solution to obtain a concentrated aqueous solution of low-temperature soybean meal. ③Calcium hydroxide flocculation: add powdered calcium hydroxide to the concentrated solution to adjust the pH value to 10-12, carry out flocculation, let it stand for 1 hour and then filter to obtain a yellow sludge-like precipitate and a yellow (slightly turbid) filtrate; add With 20% hydrochloric acid, adjust the pH value to 6-7, let stand for 2 hours, and take the supernatant to obtain the flocculation raw material solution. ④ Ethyl acetate extraction: use a packed tower as the extraction tower, the diameter of the tower is 400mm, the height of the tower is 6m, and the packing used is porcelain Raschig rings with a specification of 25×25×3; food-grade ethyl acetate is used as the continuous phase, and the feeding direction is From bottom to top, the flocculation raw material liquid is used as the dispersed phase, and the feeding direction is from top to bottom. The upper and lower material inlets are controlled by constant flow pumps, and the upper and lower material outlets are controlled by valves. Firstly, the tower body is filled with ethyl acetate, and then the upper and lower ports are fed at the same time. The flow rate of flocculation raw material liquid and raffinate is 1000L/h, and the flow rate of extractant and extractant is 4000L/h. After the system is stable, collect the extract and raffinate, and evaporated to dryness with ethyl acetate to obtain 11.2 kg of soybean isoflavone crude product with a purity of 41.5% and an extraction rate of 97.8%. ⑤ Petroleum ether extraction: 41.5% crude isoflavones were recrystallized with 70L petroleum ether to obtain 4.6kg of isoflavones with a purity of 97.8%, an extraction rate of 96.8%, and a total extraction rate of 90.0%.

黄芪提取物：取原料药黄芪饮片，加8倍量水(质量份数)煎煮2次，每次1.3小时，煎煮液过滤后合并，得黄芪提取液；将黄芪提取液弃上清后对剩余物减压浓缩，条件为：70℃，真空度-0.1MPa，至相对密度1.05～1.10(50℃)，加3倍量乙醇(体积份数)使沉淀，放置，倾出上清液；沉淀物加70℃的热水溶解，过滤，滤液再加乙醇使含醇量达75％(质量份数)，放置，倾出上清液；沉淀物再加70℃的热水溶解，过滤，滤液再加乙醇使含醇量达85％(质量份数)，放置，倾出上清液，得浸膏；将所得浸膏进行喷雾干燥，即得黄芪提取物。Extract of Radix Astragali: take raw material Radix Astragali decoction pieces, add 8 times the amount of water (in parts by mass) and decoct twice for 1.3 hours each time, filter the decoction and combine to obtain Astragalus extract; discard the supernatant of Astragalus extract Concentrate the residue under reduced pressure, the conditions are: 70°C, vacuum degree -0.1MPa, to a relative density of 1.05-1.10 (50°C), add 3 times the amount of ethanol (parts by volume) to precipitate, place it, and pour out the supernatant Add 70°C hot water to dissolve the precipitate, filter, add ethanol to the filtrate to make the alcohol content reach 75% (parts by mass), place it, pour out the supernatant; add 70°C hot water to dissolve the precipitate, filter , and ethanol is added to the filtrate to make the alcohol content reach 85% (parts by mass), placed, and the supernatant liquid is poured out to obtain an extract; the obtained extract is spray-dried to obtain the Radix Astragali extract.

绞股蓝提取物：市购(购于西安鸿生生物技术有限公司，绞股蓝总皂甙含量为98％)Gynostemma pentaphyllum extract: commercially available (purchased from Xi'an Hongsheng Biotechnology Co., Ltd., the total saponin content of Gynostemma pentaphyllum is 98%)

2、制粒2. Granulation

分别将原辅料过80目筛，取大豆异黄酮提取物0.08kg，黄芪提取物0.16kg，绞股兰提取物0.025kg，微晶纤维素0.17kg，低取代羟丙基纤维素0.025kg，混合均匀，加70％乙醇水溶液适量，制成软材，过14目筛制粒，50℃鼓风干燥，过16目筛整粒。Pass the raw and auxiliary materials through a 80-mesh sieve respectively, take 0.08kg of soybean isoflavone extract, 0.16kg of astragalus extract, 0.025kg of Jiaogulan extract, 0.17kg of microcrystalline cellulose, and 0.025kg of low-substituted hydroxypropyl cellulose, and mix Evenly, add an appropriate amount of 70% ethanol aqueous solution to make a soft material, pass through a 14-mesh sieve to granulate, blow dry at 50°C, and pass through a 16-mesh sieve for granulation.

3、压片3. Tablet

干颗粒中加入硬脂酸镁0.0025kg，混合均匀，压制片剂1000片，片重0.46g/片。Add 0.0025kg of magnesium stearate to the dry granules, mix well, and compress 1000 tablets, with a tablet weight of 0.46g/sheet.

临床观察：Clinical Observation:

通过与实施例1相同的方法，对实施例2的药物进行临床观察，结果如下：By the same method as Example 1, the medicine of Example 2 is clinically observed, and the results are as follows:

药物组受试者服药2月后，更年期8项主要症状明显好转，症状总分下降为10.75±2.94，与治疗前(17.38±3.06)及安慰组治疗后相比均有显著性差异。而安慰组受试者治疗前后，更年期8项主要主观症状无明显好转，症状总分仍为16.35±2.56(安慰组受试者治疗前症状总分为17.01±3.16)。这表明服用此药物对改善更年期症状是有益的。After taking the drug for 2 months, the 8 main symptoms of menopause improved significantly, and the total symptom score decreased to 10.75±2.94, which was significantly different from that before treatment (17.38±3.06) and after treatment in the placebo group. Before and after treatment in the placebo group, the eight main subjective symptoms of menopause did not improve significantly, and the total symptom score was still 16.35±2.56 (the total symptom score of the placebo group before treatment was 17.01±3.16). This shows that taking this drug is beneficial for improving menopausal symptoms.

实施例3Example 3

一种治疗女性更年期综合症的药物产品配方为：大豆异黄酮提取物0.08kg，黄芪提取物0.15kg，绞股兰提取物0.05kg，微晶纤维素0.18kg，低取代羟丙基纤维素0.035kg，硬脂酸镁0.0027kg。A drug product formula for treating female climacteric syndrome is: 0.08kg of soybean isoflavone extract, 0.15kg of Astragalus extract, 0.05kg of Jiaogulan extract, 0.18kg of microcrystalline cellulose, and 0.035kg of low-substituted hydroxypropyl cellulose kg, magnesium stearate 0.0027kg.

其具体制备过程如下：Its specific preparation process is as follows:

1、制备提取物1. Preparation of extract

大豆异黄酮提取物：提取过程见已公开专利，申请号为：200510008536.9①将低温豆粕粉碎，过40～60目筛。②乙醇溶液浸提：在平转式浸出器中(采用的设备由浙江余姚粮机厂生产，型号为YJPT 5，处理量为5T/D)，低温豆粕2.5t与萃取剂85％乙醇水溶液7500L于50℃下进行连续16级逆流浸提，可得到高浓度的浸取液；减压浓缩除去浸取液中全部的乙醇，得到低温豆粕的浓缩水溶液。③氢氧化钙絮凝：在浓缩液中加入粉状氢氧化钙调pH值至10～12，进行絮凝，静置1h后过滤，得黄色淤泥状沉淀及黄色(稍浑浊)滤液；在滤液中加入浓度为20％的盐酸，调pH值至6～7，静置2h，取上清液，得絮凝原料液。④乙酸乙酯萃取：采用填料塔作为萃取塔，塔径为400mm，塔高6m，所用填料为规格25×25×3的瓷制拉西环；食品级乙酸乙酯作为连续相，进料方向由下向上，絮凝原料液作为分散相，进料方向由上向下。上下进料口由恒流泵控制，上下出料口由阀门控制。首先将塔身充满乙酸乙酯，然后上下口同时进料，絮凝原料液与萃余液流量均为1000L/h，萃取剂与萃取液流量均为4000L/h，待系统稳定后，收集萃取液和萃余液，乙酸乙酯蒸干得到大豆异黄酮粗产品11.2kg，纯度为41.5％，萃取率为97.8％。⑤石油醚萃取：用70L石油醚对41.5％的异黄酮粗产品进行重结晶，得到异黄酮产品4.6kg，纯度为97.8％，提取率为96.8％，总的提取率为90.0％。Soybean isoflavone extract: See the published patent for the extraction process, the application number is: 200510008536.9 ①Crush the low-temperature soybean meal and pass it through a 40-60 mesh sieve. ②Ethanol solution extraction: In a horizontal rotary extractor (the equipment used is produced by Zhejiang Yuyao Grain Machinery Factory, the model is YJPT 5, and the processing capacity is 5T/D), 2.5t of low-temperature soybean meal and 7500L of 85% ethanol aqueous solution of extraction agent Continuous 16-stage countercurrent leaching at 50°C can obtain a high-concentration leaching solution; vacuum concentration removes all ethanol in the leaching solution to obtain a concentrated aqueous solution of low-temperature soybean meal. ③Calcium hydroxide flocculation: add powdered calcium hydroxide to the concentrated solution to adjust the pH value to 10-12, carry out flocculation, let it stand for 1 hour and then filter to obtain a yellow sludge-like precipitate and a yellow (slightly turbid) filtrate; add With 20% hydrochloric acid, adjust the pH value to 6-7, let stand for 2 hours, and take the supernatant to obtain the flocculation raw material solution. ④ Ethyl acetate extraction: use a packed tower as the extraction tower, the diameter of the tower is 400mm, the height of the tower is 6m, and the packing used is porcelain Raschig rings with a specification of 25×25×3; food-grade ethyl acetate is used as the continuous phase, and the feeding direction is From bottom to top, the flocculation raw material liquid is used as the dispersed phase, and the feeding direction is from top to bottom. The upper and lower material inlets are controlled by constant flow pumps, and the upper and lower material outlets are controlled by valves. Firstly, the tower body is filled with ethyl acetate, and then the upper and lower ports are fed at the same time. The flow rate of flocculation raw material liquid and raffinate is 1000L/h, and the flow rate of extractant and extractant is 4000L/h. After the system is stable, collect the extract and raffinate, and evaporated to dryness with ethyl acetate to obtain 11.2 kg of soybean isoflavone crude product with a purity of 41.5% and an extraction rate of 97.8%. ⑤ Petroleum ether extraction: 41.5% crude isoflavones were recrystallized with 70L petroleum ether to obtain 4.6kg of isoflavones with a purity of 97.8%, an extraction rate of 96.8%, and a total extraction rate of 90.0%.

黄芪提取物：取原料药黄芪饮片，加12倍量水(质量份数)煎煮2次，每次3小时，煎煮液过滤后合并，得黄芪提取液；将黄芪提取液弃上清后对剩余物减压浓缩，条件为：70℃，真空度-0.1MPa，至相对密度1.05～1.10(50℃)，加4倍量乙醇(体积份数)使沉淀，放置，倾出上清液；沉淀物加60℃的热水溶解，过滤，滤液再加乙醇使含醇量达73％(质量份数)，放置，倾出上清液；沉淀物再加60℃的热水溶解，过滤，滤液再加乙醇使含醇量达83％(质量份数)，放置，倾出上清液，得浸膏；将所得浸膏进行喷雾干燥，即得黄芪提取物。Extract of Radix Astragali: Take the decoction pieces of Radix Astragali as the raw material, add 12 times the amount of water (in parts by mass) and decoct twice for 3 hours each time, filter the decoction and combine to obtain the extract of Astragalus membranaceus; discard the supernatant of the extract of Astragalus membranaceus Concentrate the residue under reduced pressure, the conditions are: 70°C, vacuum degree -0.1MPa, to a relative density of 1.05-1.10 (50°C), add 4 times the amount of ethanol (parts by volume) to precipitate, place it, and pour out the supernatant Add 60 ℃ hot water to dissolve the precipitate, filter, add ethanol to the filtrate to make the alcohol content reach 73% (mass fraction), place it, pour out the supernatant; add 60 ℃ hot water to dissolve the precipitate, filter , and ethanol is added to the filtrate to make the alcohol content reach 83% (parts by mass), placed, and the supernatant liquid is poured out to obtain an extract; the obtained extract is spray-dried to obtain the Radix Astragali extract.

绞股蓝提取物：市购(购于西安鸿生生物技术有限公司，绞股蓝总皂甙含量为98％)Gynostemma pentaphyllum extract: commercially available (purchased from Xi'an Hongsheng Biotechnology Co., Ltd., the total saponin content of Gynostemma pentaphyllum is 98%)

2、制粒2. Granulation

分别将原辅料过80目筛，取大豆异黄酮提取物0.08kg，黄芪提取物0.15kg，绞股兰提取物0.05kg，微晶纤维素0.18kg，低取代羟丙基纤维素0.025kg(内加)，混合均匀，加70％乙醇水溶液适量，制成软材，过14目筛制粒，50℃鼓风干燥，过16目筛整粒。The raw and auxiliary materials are passed through 80 mesh sieves respectively, and 0.08kg of soybean isoflavone extract, 0.15kg of Radix Astragali extract, 0.05kg of Jiaogulan extract, 0.18kg of microcrystalline cellulose, and 0.025kg of low-substituted hydroxypropyl cellulose (inner Add), mix evenly, add an appropriate amount of 70% ethanol aqueous solution to make a soft material, pass through a 14-mesh sieve to granulate, blow dry at 50°C, and pass through a 16-mesh sieve for granulation.

3、压片3. Tablet

干颗粒中加入0.01kg羧甲基淀粉钠(外加)、硬脂酸镁0.0027kg，混合均匀，压制片剂1000片，片重0.52g/片。Add 0.01kg sodium carboxymethyl starch (additional), 0.0027kg magnesium stearate to the dry granules, mix uniformly, compress 1000 tablets, and the tablet weighs 0.52g/sheet.

临床观察：Clinical Observation:

通过与实施例1相同的方法，对实施例3的药物进行临床观察，结果如下：By the same method as Example 1, the medicine of Example 3 is clinically observed, and the results are as follows:

药物组受试者服药2月后，更年期8项主要症状明显好转，症状总分下降为10.59±3.01，与治疗前(17.09±3.15)及安慰组治疗后相比均有显著性差异。而安慰组受试者治疗前后，更年期8项主要主观症状无明显好转，症状总分仍为16.49±2.63(安慰组受试者治疗前症状总分为17.20±3.21)。这表明服用此药物对改善更年期症状是有益的。After taking the drug for 2 months, the 8 main symptoms of menopause improved significantly, and the total score of symptoms decreased to 10.59±3.01, which was significantly different from that before treatment (17.09±3.15) and after treatment in the placebo group. Before and after treatment in the placebo group, the eight main subjective symptoms of menopause did not improve significantly, and the total symptom score was still 16.49±2.63 (the total symptom score of the placebo group before treatment was 17.20±3.21). This shows that taking this drug is beneficial for improving menopausal symptoms.