WO2004050107A1 - A drop pill of treating and preventing from cardio-cerebral diseases and the process of producing thereof - Google Patents

A drop pill of treating and preventing from cardio-cerebral diseases and the process of producing thereof Download PDF

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WO2004050107A1
WO2004050107A1 PCT/CN2003/001014 CN0301014W WO2004050107A1 WO 2004050107 A1 WO2004050107 A1 WO 2004050107A1 CN 0301014 W CN0301014 W CN 0301014W WO 2004050107 A1 WO2004050107 A1 WO 2004050107A1
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parts
ginkgo
extract
ginkgo biloba
matrix
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PCT/CN2003/001014
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Chinese (zh)
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Yong Zhang
Meiling Wang
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Yong Zhang
Meiling Wang
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Publication of WO2004050107A1 publication Critical patent/WO2004050107A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/16—Ginkgophyta, e.g. Ginkgoaceae (Ginkgo family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • the present invention relates to a medicament for the prevention and treatment of cardiovascular and cerebrovascular diseases, in particular to a drip pill-type traditional Chinese medicine preparation containing ginkgo biloba extract as a main active ingredient.
  • Ginkgo flavonoids and ginkgolides in Ginkgo biloba extract have an arterial vasodilation effect, and are used to treat coronary insufficiency caused by arteriosclerotic hypertension, angina pectoris, myocardial infarction, cerebral embolism, cerebral vasospasm and arterial blood vessels.
  • salvia miltiorrhiza extract has protective effect on myocardial ischemia and is an effective drug for treating cardiovascular diseases.
  • the traditional Chinese medicine types made of Ginkgo biloba extract are injections, tablets and oral liquids, but there are no drip pills. The aforementioned dosage forms are absorbed by the human body at a slower rate, so the effect after the application is not ideal. Summary of the Invention
  • the object of the present invention is to provide a pill-type drug with better absorption and faster onset of cardiovascular and cerebrovascular expansion.
  • the present invention provides a ginkgo biloba drip pill for preventing and treating cardiovascular and cerebrovascular diseases, comprising 1 to 60 parts by weight of ginkgo biloba extract, 0 to 60 parts by weight of salvia miltiorrhiza extract and 20 to 80 parts of matrix.
  • the drip pill of the present invention contains 1 to 60% by weight of ginkgo flavonoids, 0.5 to 8% by weight of ginkgolides, and 0 to 60% by weight of tanshinone as active ingredients.
  • the matrix of the ginkgo dripping pills of the present invention may be selected from one or more of polyethylene glycol, sodium stearate, glycerol-gelatin, urea-citric acid, and glyceryl stearate.
  • the solution of the invention is based on the Chinese medicine's understanding of the pathogenesis of cardio-cerebral-vascular disease and its comorbidities and the principles of treatment, tracking modern pharmacological research inventions, and screening ginkgo biloba extracts that have an arterial blood vessel expansion effect from plant-based Chinese herbal medicines.
  • the salvia miltiorrhiza extract which has a protective effect on myocardial ischemia and has the function of promoting blood circulation and removing blood stasis, is matched with a matrix such as polyethylene glycol or sodium stearate, glycerol-gelatin, urea-citrate, glyceryl stearate, etc.
  • the dosage form is a drip pill which is particularly good for absorption.
  • the content of ginkgo flavonoids in the dripping pills of the present invention accounts for 116%, the content of ginkgolides accounts for 0.5-8%, and the content of tanshinone accounts for 0-60%.
  • the pharmacological effects of Ginkgo biloba pills are as follows: 1. Scavenging free radicals and inhibiting cell membrane lipid oxidation; 2. Preventing thrombus formation and anti-platelet aggregation; 3. Local ischemia in vitro and in vivo and hypertrophic heart myocardium Ischemia-induced cardiac dysfunction has a protective effect; 4. Enhance the deformability of red blood cells, reduce blood viscosity, 5. Reduce the production of peroxylipids, increase the SOD activity of red blood cells; 6. The blood circulation and brain cells of the brain Metabolism has better improvement and promoting effect.
  • Ginkgo biloba pills have a very good effect in preventing and treating coronary artery insufficiency, angina pectoris, myocardial infarction, cerebral embolism, and cerebral vasospasm caused by arteriosclerosis and hypertension.
  • the drip pill can be administered orally or buccally.
  • the drip pill is small in size, and the drip pill is placed under the tongue for oral administration. The absorption is faster, and the highest blood concentration can be reached after 10 minutes.
  • Ginkgo biloba pills weigh 1 to 50 mg. 'Ginkgo biloba can be taken in a single dose or in several doses. It is preferred to take 3 times daily, 200-500mg each time.
  • the preparation method of the ginkgo biloba dripping pills is: according to the formula, ginkgo biloba extract and salvia miltiorrhiza extract are pulverized to a particle size of 80-100 meshes, and then mixed with the matrix, and heated to 80-100%.
  • the above drugs are in a molten state, stirred uniformly.
  • the medicine is dripped into the liquid paraffin at 15 ° C through a stainless steel mold hole by manual or mechanical means, and cooled and molded at room temperature.
  • the dissolution rate of the ginkgo biloba pills of the present invention and the existing ginkgo biloba tablets were compared to determine the dissolution rate: Take 1 ginkgo tablet, and Five pills were made with 500 mol of 0.01 mol / L hydrochloric acid as the dissolution medium, the rotation speed was 6 m / min, and the temperature was 37 ⁇ 0.5 V. 8ml was sampled at 3, 6, 9, 12, 15min at regular intervals, and immediately filtered through a 0.8 ⁇ m filter membrane, and then 8ml of 37 ° C, O.
  • the ginkgo biloba pills dissolve 100% at 12 minutes, while the gingko biloba tablets only dissolve 30.01%.
  • the gingko biloba pills dissolve 3 times faster than the ginkgo tablets.
  • Ai X X male, 66 years old. Coronary heart disease was complicated by angina pectoris many times. Ginkgo biloba pills were taken when the anterior heart area was painful. The angina pectoris disappeared after 10 minutes. After taking the medicine continuously for four weeks, the heart was normal.
  • Liu XX male, 70 years old, had a history of stroke after hypertension, left ventricular hypertrophy, systolic blood pressure higher than 21.3Kpa (160mmHg), reported self-reported dizziness, headache, tinnitus, and took medication for 22 days.
  • the blood pressure was stable at 18.6 I 12.0Kpa (140 / 90mmHg).
  • Ginkgo biloba extract 1 part, matrix polyethylene glycol 6000 20 parts.
  • Ginkgo biloba extract 1 part Salvia miltiorrhiza extract 30 parts, matrix polyethylene glycol 6000 20 parts.
  • Ginkgo biloba extract 1 part Salvia miltiorrhiza extract 40 parts, matrix polyethylene glycol 4000 50 parts.
  • Ginkgo biloba extract 30 parts of Ginkgo biloba extract, 2 parts of Salvia miltiorrhiza extract, 6000 50 parts of matrix polyethylene glycol.
  • Ginkgo biloba extract 30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 20 parts of matrix glycerin-gelatin.
  • Ginkgo biloba extract 30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 40 parts of matrix glycerin-gelatin.
  • Ginkgo biloba extract 30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 80 parts of matrix glycerin-gelatin.
  • Ginkgo biloba extract 25 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 20 parts of matrix polyethylene glycol 6000.
  • Ginkgo biloba extract 30 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
  • ginkgo biloba extract 60 parts of ginkgo biloba extract and 50 parts of glyceryl stearate.
  • Ginkgo biloba extract 60 parts of Ginkgo biloba extract, 25 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
  • Ginkgo biloba extract 50 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 40 parts of matrix urea monocitrate.
  • the production method of Ginkgo biloba is as follows:
  • Ginkgo biloba extract purchased from Shandong Yimeng Ginkgo Pharmaceutical Factory
  • salvia extract purchased from Xi'an Hongsheng Biotechnology Industrial Co., Ltd.

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Abstract

This invention discloses a drop pill of treating Cardio-Cerebral diseases. The pill comprises 1-60weight parts of extract of gingko biloba, 0-60 weight parts extract of red sage root, and 20-80 weight parts matrix, especially 1-60%(by weight) flavone of gingko biloba, 0.5-8%(by weight) of lactone of gingko biloba, and 0-60% tanshinone as these active ingredients. The highest level in blood can be attained at 10 minutes after the pill was administrated by sublingual. The pill can treat and prevent from coronary insufficiency caused by sclerosis and hypertension, angina pectoris, myocardial infarction, cerebral thrombosis, cerebral vasospasm and so on. The invention also discloses the process of producing the pill.

Description

一种防治心脑血管疾病的银杏滴丸  Ginkgo dropping pills for preventing and treating cardiovascular and cerebrovascular diseases
技术领域 Technical field
本发明涉及一种预防和治疗心脑血管疾病的药物， -特别是一种由银杏叶提取物 为主要有效成分的滴丸型中药制剂。 背景技术  The present invention relates to a medicament for the prevention and treatment of cardiovascular and cerebrovascular diseases, in particular to a drip pill-type traditional Chinese medicine preparation containing ginkgo biloba extract as a main active ingredient. Background technique
银杏叶提取物中的银杏黄酮和银杏内酯对动脉血管有扩张作用， 用于治疗动脉 硬化高血压病所致的冠状动脉供血不全、 心绞痛、 心肌梗塞、 脑栓塞、 脑血管痉挛 以及因动脉血管供血不良所引起的其他疾患， 丹参提取物对心肌缺血有保护作用， 是治疗心血管疾病的有效药物。 目前由银杏叶提取物制成的中药剂型有针剂、 片剂 和口服液， 但还没有滴丸制剂， 前述剂型被人体吸收的速率都较慢， 因而用药后起 效也不够理想。 发明内容  Ginkgo flavonoids and ginkgolides in Ginkgo biloba extract have an arterial vasodilation effect, and are used to treat coronary insufficiency caused by arteriosclerotic hypertension, angina pectoris, myocardial infarction, cerebral embolism, cerebral vasospasm and arterial blood vessels. For other diseases caused by poor blood supply, salvia miltiorrhiza extract has protective effect on myocardial ischemia and is an effective drug for treating cardiovascular diseases. At present, the traditional Chinese medicine types made of Ginkgo biloba extract are injections, tablets and oral liquids, but there are no drip pills. The aforementioned dosage forms are absorbed by the human body at a slower rate, so the effect after the application is not ideal. Summary of the Invention
本发明的目的在于提供一 吸收更好， 扩张心脑血管起效更快的滴丸型药物。 本发明提供了一种防治心脑血管疾病的银杏滴丸， 包括 1一 60重量份银杏叶提 取物、 0— 60重量份丹参提取物和 20— 80份基质。 本发明的滴丸含有 1一 60重量％ 的银杏黄酮、 0.5— 8 %重量％的银杏内酯和 0— 60重量％丹参酮作为有效成分。  The object of the present invention is to provide a pill-type drug with better absorption and faster onset of cardiovascular and cerebrovascular expansion. The present invention provides a ginkgo biloba drip pill for preventing and treating cardiovascular and cerebrovascular diseases, comprising 1 to 60 parts by weight of ginkgo biloba extract, 0 to 60 parts by weight of salvia miltiorrhiza extract and 20 to 80 parts of matrix. The drip pill of the present invention contains 1 to 60% by weight of ginkgo flavonoids, 0.5 to 8% by weight of ginkgolides, and 0 to 60% by weight of tanshinone as active ingredients.
本发明银杏滴丸的基质可以选自聚乙二醇、 硬脂酸钠、 甘油一明胶、 尿素一枸 橼酸、 硬脂酸甘油酯中的一种或多种。  The matrix of the ginkgo dripping pills of the present invention may be selected from one or more of polyethylene glycol, sodium stearate, glycerol-gelatin, urea-citric acid, and glyceryl stearate.
本发明的解决方案是基于中医学对心脑血管疾病及其合并症发病机理的认识及 治疗原则， 追踪现代药理研究发明， 从植物类中草药中筛选出对动脉血管有扩张作 用的银杏叶提取物， 对心肌缺血有保护作用具有活血化瘀功能的丹参提取物， 配以 聚乙二醇或硬脂酸钠、 甘油一明胶、 尿素一枸橼酸、 硬脂酸甘油酯等基质， 该药物 的剂型为特别利于吸收的滴丸。 本发明的滴丸中银杏黄酮的含量占 1一 60% , 银杏内 酯的含量占 0.5_8 %， 丹参酮的含量占 0—60%。  The solution of the invention is based on the Chinese medicine's understanding of the pathogenesis of cardio-cerebral-vascular disease and its comorbidities and the principles of treatment, tracking modern pharmacological research inventions, and screening ginkgo biloba extracts that have an arterial blood vessel expansion effect from plant-based Chinese herbal medicines. The salvia miltiorrhiza extract, which has a protective effect on myocardial ischemia and has the function of promoting blood circulation and removing blood stasis, is matched with a matrix such as polyethylene glycol or sodium stearate, glycerol-gelatin, urea-citrate, glyceryl stearate, etc. The dosage form is a drip pill which is particularly good for absorption. The content of ginkgo flavonoids in the dripping pills of the present invention accounts for 116%, the content of ginkgolides accounts for 0.5-8%, and the content of tanshinone accounts for 0-60%.
银杏滴丸的药理作用如下： 1 . 清除自由基， 抑制细胞膜脂质氧化反应； 2. 防 止血栓形成和抗血小板聚集； 3. 对离体及在体局部心肌缺血以及肥大心脏局部心肌 缺血引的心功能紊乱， 均有保护作用； 4. 增强红细胞的变形能力， 降低血液粘度， 5. 降低过氧脂质的产生， 提高红细胞 SOD活性； 6. 对脑部血液循环及脑细胞代谢 有较好的改善及促作用。 The pharmacological effects of Ginkgo biloba pills are as follows: 1. Scavenging free radicals and inhibiting cell membrane lipid oxidation; 2. Preventing thrombus formation and anti-platelet aggregation; 3. Local ischemia in vitro and in vivo and hypertrophic heart myocardium Ischemia-induced cardiac dysfunction has a protective effect; 4. Enhance the deformability of red blood cells, reduce blood viscosity, 5. Reduce the production of peroxylipids, increase the SOD activity of red blood cells; 6. The blood circulation and brain cells of the brain Metabolism has better improvement and promoting effect.
银杏滴丸对于防治动脉硬化及高血压所致的冠状动脉供血不全、 心绞痛、 心肌 梗塞、 脑栓塞、 脑血管痉挛等有很好的疗效。 该滴丸可以通过口服或含服给药。 该 滴丸颗粒细小， 将滴丸置于舌下含服， 吸收更快， 10分钟后即可达到血液最高浓度。  Ginkgo biloba pills have a very good effect in preventing and treating coronary artery insufficiency, angina pectoris, myocardial infarction, cerebral embolism, and cerebral vasospasm caused by arteriosclerosis and hypertension. The drip pill can be administered orally or buccally. The drip pill is small in size, and the drip pill is placed under the tongue for oral administration. The absorption is faster, and the highest blood concentration can be reached after 10 minutes.
银杏滴丸每丸重 1一 50mg。'银杏滴丸可以单剂量服用， 或分几个剂量服用。 优 选日服 3次， 每次 200—500mg。  Ginkgo biloba pills weigh 1 to 50 mg. 'Ginkgo biloba can be taken in a single dose or in several doses. It is preferred to take 3 times daily, 200-500mg each time.
该种银杏滴丸的制备方法是： 按配方取银杏叶提取物和丹参提取物粉碎至 80— 100 目粒度后， 与基质混匀， 加热至 80— 100Ό上述药物达到熔融状态， 搅拌均匀， 在 60— 80°C保温状态下采用手工或机械装置将药料经不锈钢模孔滴入至 15°C的液态 石蜡中， 在室温下冷却成型， 整形后脱模即得。  The preparation method of the ginkgo biloba dripping pills is: according to the formula, ginkgo biloba extract and salvia miltiorrhiza extract are pulverized to a particle size of 80-100 meshes, and then mixed with the matrix, and heated to 80-100%. The above drugs are in a molten state, stirred uniformly. At a temperature of 60-80 ° C, the medicine is dripped into the liquid paraffin at 15 ° C through a stainless steel mold hole by manual or mechanical means, and cooled and molded at room temperature.
按照中国药典 1990年版二部附录 60的桨法对本发明的银杏滴丸与现有的银杏 片 (银杏叶片， 江苏扬子江药业集团有限公司)溶出速率作对比测定： 取银杏片 1片， 银杏滴丸 5粒， 以 0.01mol / L盐酸 500ml作溶解介^， 转速 6m / min， 温度 37±0.5 V。 分别在 3， 6， 9， 12, 15min定时取样 8ml， 立即经 0.8μπι的滤膜过滤， 并随即 补加 37°C、 O.Olmol / L盐酸 8ml， 取滤液 5ml， 按试样富集方法处理后， 进样 10μ1， 进行高效液相色谱测定银杏黄酮含量。 以测得的两种剂型各时间点的溶出量， 计弇 片剂和滴丸的累积溶出百分比。 两种剂型的累积溶出百分比见下表：  According to the paddle method of Appendix 60 of the Chinese Pharmacopoeia 1990, the dissolution rate of the ginkgo biloba pills of the present invention and the existing ginkgo biloba tablets (Ginkgo biloba leaves, Jiangsu Yangzijiang Pharmaceutical Group Co., Ltd.) were compared to determine the dissolution rate: Take 1 ginkgo tablet, and Five pills were made with 500 mol of 0.01 mol / L hydrochloric acid as the dissolution medium, the rotation speed was 6 m / min, and the temperature was 37 ± 0.5 V. 8ml was sampled at 3, 6, 9, 12, 15min at regular intervals, and immediately filtered through a 0.8μm filter membrane, and then 8ml of 37 ° C, O. Olmol / L hydrochloric acid was added, and 5ml of the filtrate was taken. According to the sample enrichment method After the treatment, 10 μ1 was injected and the high-performance liquid chromatography was performed to determine the ginkgo flavonoid content. Based on the measured dissolution of the two dosage forms at each time point, calculate the cumulative dissolution percentage of the tablets and pills. The cumulative dissolution percentages of the two dosage forms are shown in the table below:
Figure imgf000003_0001
由上表可见银杏滴丸在 12分钟时已 100%的溶出， 而银杏片剂只溶出 30.01 % , 银杏滴丸比银杏片溶出速度快 3倍。
Figure imgf000003_0001
It can be seen from the above table that the ginkgo biloba pills dissolve 100% at 12 minutes, while the gingko biloba tablets only dissolve 30.01%. The gingko biloba pills dissolve 3 times faster than the ginkgo tablets.
该药物于 2000年投入临床试验， 据 890例患者的病历统计， 总有效率达 90%， 患者普遍反映银杏滴丸具有易吸收、 见效快、 疗效显著的特点。 下面提供了一些典 型的病例表明：  The drug was put into clinical trial in 2000. According to the medical record statistics of 890 patients, the total effective rate reached 90%. Patients generally reported that Ginkgo biloba pills are easy to absorb, have quick effects and have significant effects. Here are some typical case indications:
季 X X， 男， 52岁， 冠心病合并高血压， 收缩压高于 24.0Kpa ( 180mmHg), 自觉胸闷、 头昏、 颈部僵硬， 服用本药 2p天后， 胸闷明显减轻， 收缩压降至 18.8Kpa ( 141mmHg), 服药后无其他不适。 Season XX, male, 52 years old, coronary heart disease with hypertension, systolic blood pressure is higher than 24.0Kpa (180mmHg), Conscious chest tightness, dizziness, and stiff neck. After 2 days of taking this medicine, the chest tightness was significantly reduced, and the systolic blood pressure decreased to 18.8Kpa (141mmHg). There was no other discomfort after taking the medicine.
魏 X X， 女， 63岁， 高脂血症伴有糖尿病， 全身乏力， 肢体麻木， 服药 18天， 麻木感消失， 倦怠情况好转， 经血液化验低密度脂蛋白胆固醇降至 2.5mmol / L。  Wei X X, female, 63 years old, hyperlipidemia with diabetes, general weakness, numbness of the limbs, taking medicine for 18 days, numbness disappeared, burnout improved, and low-density lipoprotein cholesterol was reduced to 2.5mmol / L by blood tests.
艾 X X， 男， 66岁，.冠心病多次并发心绞痛， 心前区隐痛时服用银杏滴丸， 10 分钟心绞痛消失， 后连续服药四周， 心脏无异常。  Ai X X, male, 66 years old. Coronary heart disease was complicated by angina pectoris many times. Ginkgo biloba pills were taken when the anterior heart area was painful. The angina pectoris disappeared after 10 minutes. After taking the medicine continuously for four weeks, the heart was normal.
刘 X X， 男， 70岁， 高血压曾有脑中风史， 左心室肥厚， 收缩压高于 21.3Kpa ( 160mmHg)， 自诉头晕、 头痛、 耳鸣， 服药 22天， 上述不适明显减少， 睡眼转好， 血压稳定在 18.6 I 12.0Kpa ( 140 / 90mmHg)。 具体实施例  Liu XX, male, 70 years old, had a history of stroke after hypertension, left ventricular hypertrophy, systolic blood pressure higher than 21.3Kpa (160mmHg), reported self-reported dizziness, headache, tinnitus, and took medication for 22 days. The blood pressure was stable at 18.6 I 12.0Kpa (140 / 90mmHg). Specific embodiment
1. 按下述重量配比取原料：  1. Take raw materials according to the following weight ratio:
银杏叶提取物 1份， 基质聚乙二醇 6000 20份。  Ginkgo biloba extract 1 part, matrix polyethylene glycol 6000 20 parts.
2. 按下述重量配比取原料：  2. Take raw materials according to the following weight ratio:
银杏叶提取物 1份， 基质甘油一明胶 55份。  Ginkgo biloba extract 1 part, matrix glycerin-gelatin 55 parts.
3. 按下述重量配比取原料：  3. Take raw materials according to the following weight ratio:
银杏叶提取物 1份， 基质硬脂酸甘油酯 80份。  1 part of Ginkgo biloba extract and 80 parts of matrix glyceryl stearate.
4. 按下述重量配比取原料：  4. Take raw materials according to the following weight ratio:
银杏叶提取物 1份， 丹参提取物 30份， 基质聚乙二醇 6000 20份。  Ginkgo biloba extract 1 part, Salvia miltiorrhiza extract 30 parts, matrix polyethylene glycol 6000 20 parts.
5. 按下述重量配比取原料：  5. Take raw materials according to the following weight ratio:
银杏叶提取物 1份， 丹参提取物 40份， 基质聚乙二醇 4000 50份。  Ginkgo biloba extract 1 part, Salvia miltiorrhiza extract 40 parts, matrix polyethylene glycol 4000 50 parts.
6. 按下述重量配比取原料：  6. Take raw materials according to the following weight ratio:
银杏叶提取物 2份， 丹参提取物 30份， 基质硬脂酸钠 80份。  2 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, and 80 parts of sodium stearate.
7. 按下述重量配比取原料- 银杏叶提取物 2份， 丹参提取物 60份， 基质甘油一明胶 20份。  7. According to the following weight ratio, take 2 parts of raw materials-ginkgo biloba extract, 60 parts of salvia miltiorrhiza extract, and 20 parts of base glycerin-gelatin.
8. 按下述重量配比取原料：  8. Take raw materials according to the following weight ratio:
银杏叶提取物 3份， 丹参提取物 55份， 基质聚乙二醇 6000 45份。  3 parts of Ginkgo biloba extract, 55 parts of Salvia miltiorrhiza extract, and 45 parts of matrix polyethylene glycol 6000.
9. 按下述重量配比取原料：  9. Take raw materials according to the following weight ratio:
银杏叶提取物 4份， 丹参提取物 55份， 基质聚乙二醇 6000 80份。  4 parts of Ginkgo biloba extract, 55 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
10. 按下述重量配比取原料： 银杏叶提取物 30份， 基质甘油—明胶 20份。 10. Take raw materials according to the following weight ratio: 30 parts of Ginkgo biloba extract and 20 parts of matrix glycerin-gelatin.
11. 按下述重量配比取原料：  11. Take raw materials according to the following weight ratio:
银杏叶提取物 30份， 丹参提取物 2份， 基质聚乙二醇 6000 50份。30 parts of Ginkgo biloba extract, 2 parts of Salvia miltiorrhiza extract, 6000 50 parts of matrix polyethylene glycol.
12. 按下述重量配比取原料： 12. Take raw materials according to the following weight ratio:
银杏叶提取物 40份， 丹参提取物 3份， 基质聚乙二醇 6000 80份。40 parts of Ginkgo biloba extract, 3 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
13. 按下述重量配比取原料： 13. Take raw materials according to the following weight ratio:
银杏叶提取物 30份， 丹参提取物 30份， 基质甘油一明胶 20份。30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 20 parts of matrix glycerin-gelatin.
14. 按下述重量配比取原料： 14. Take raw materials according to the following weight ratio:
银杏叶提取物 30份， 丹参提取物 30份， 基质甘油一明胶 40份。30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 40 parts of matrix glycerin-gelatin.
15. 按下述重量配比取原料： 15. Take raw materials according to the following weight ratio:
银杏叶提取物 30份， 丹参提取物 30份， 基质甘油一明胶 80份。30 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 80 parts of matrix glycerin-gelatin.
16. 按下述重量配比取原料： 16. Take raw materials according to the following weight ratio:
银杏叶提取物 25份， 丹参提取物 60份， 基质聚乙二醇 6000 20份。25 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 20 parts of matrix polyethylene glycol 6000.
17. 按下述重量配比取原料- 银杏叶提取物 30份， -丹参提取物 60份， 基质聚乙二醇 6000 50份。17. Take the raw materials according to the following weight ratio: 30 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, 6000 50 parts of matrix polyethylene glycol.
18. 按下述重量配比取原料： 18. Take raw materials according to the following weight ratio:
银杏叶提取物 30份， 丹参提取物 60份， 基质聚乙二醇 6000 80份。30 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
19. 按下述重量配比取原料:. 19. Take raw materials according to the following weight ratio :.
银杏叶提取物 60份， 基质硬脂酸钠 20份。 60 parts of ginkgo biloba extract and 20 parts of sodium stearate.
20. 按下述重量配比取原料：  20. Take raw materials according to the following weight ratio:
银杏叶提取物 60份， 基质硬脂酸甘油酯 50份。 60 parts of ginkgo biloba extract and 50 parts of glyceryl stearate.
21. 按下述重量配比取原料 .·  21. Take raw materials according to the following weight ratio. ·
银杏叶提取物 60份， 基质硬脂酸甘油酯 80份。 60 parts of ginkgo biloba extract and 80 parts of matrix glyceryl stearate.
22. 按下述重量配比取原料：  22. Take raw materials according to the following weight ratio:
银杏叶提取物 60份， '丹参提取物 30份， 基质聚乙二醇 6000 20份。60 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 6000 parts of matrix polyethylene glycol 6000.
23. 按下述重量配比取原料： 23. Take raw materials according to the following weight ratio:
银杏叶提取物 60份， 丹参提取物 30份， 基质聚乙二醇 6000 50份。60 parts of Ginkgo biloba extract, 30 parts of Salvia miltiorrhiza extract, 6000 50 parts of matrix polyethylene glycol.
24. '按下述重量配比取原料： 24. 'Take raw materials according to the following weight ratio:
银杏叶提取物 60份， 丹参提取物 25份， 基质聚乙二醇 6000 80份。60 parts of Ginkgo biloba extract, 25 parts of Salvia miltiorrhiza extract, and 80 parts of matrix polyethylene glycol 6000.
25. 按下述重量配比取原料： 银杏叶提取物 50份， 丹参提取物 60份， 基质聚乙二醇 6000 20份。 25. Take raw materials according to the following weight ratio: 50 parts of ginkgo biloba extract, 60 parts of salvia miltiorrhiza extract, and 20 parts of matrix polyethylene glycol 6000.
26. 按下述重量配比取原料：  26. Take raw materials according to the following weight ratio:
银杏叶提取物 50份， 丹参提取物 60份， 基质聚乙二醇 6000 40份。  Ginkgo biloba extract 50 parts, salvia miltiorrhiza extract 60 parts, matrix polyethylene glycol 6000 40 parts.
27. 按下述重量配比取原料：  27. Take raw materials according to the following weight ratio:
银杏叶提取物 50份， 丹参提取物 60份， 基质聚乙二醇 6000 80份。 ·  Ginkgo biloba extract 50 parts, Salvia miltiorrhiza extract 60 parts, matrix polyethylene glycol 6000 80 parts. ·
28. 按下述重量配比取原料：  28. Take raw materials according to the following weight ratio:
银杏叶提取物 50份， 丹参提取物 60份， 基质尿素一枸橼酸 40份。 银杏滴丸的生产方法如下：  50 parts of Ginkgo biloba extract, 60 parts of Salvia miltiorrhiza extract, and 40 parts of matrix urea monocitrate. The production method of Ginkgo biloba is as follows:
银杏叶提取物 (从山东沂蒙银杏制药厂购买)和丹参提取物 (从西安鸿生生物科技 实业有限公司购买)均从市场上购得， 按配方取银杏叶提取物和丹参提取物粉碎至 80 一 100目粒度后， 与基质混匀， 加热至 80—100°C上述药物达到熔融状^， 搅拌均匀， 在 60— 80°C保温状态下采用手工或机械装置将药料经不锈钢模孔滴入到 15°C的液态 石蜡中， 在室温下冷却成型， 整形后脱模即得。  Ginkgo biloba extract (purchased from Shandong Yimeng Ginkgo Pharmaceutical Factory) and salvia extract (purchased from Xi'an Hongsheng Biotechnology Industrial Co., Ltd.) were both purchased from the market. After a 100-mesh particle size, mix with the matrix, heat it to 80-100 ° C to achieve a molten state ^, stir well, and use manual or mechanical devices to drip the medicine through the holes of the stainless steel mold under the heat preservation state of 60-80 ° C. Put it into liquid paraffin at 15 ° C, cool and mold at room temperature, and release it after shaping.

Claims

权利要求 Rights request
1. 一种防治心脑血管疾病的银杏滴丸，包括 1一 60重量份银杏叶提取物、 0— 60 重量份丹参提取物和 20— 80份基质。 1. A ginkgo biloba pill for preventing and treating cardiovascular and cerebrovascular diseases, comprising 1 to 60 parts by weight of ginkgo biloba extract, 0 to 60 parts by weight of salvia miltiorrhiza extract and 20 to 80 parts of matrix.
2. 根据权利要求 1所述的银杏滴丸， 其中所述滴丸含有 1一 60重量％的银杏黄 酮、 0.5— 8 %重量％的银杏内酯和 0— 60童量％丹参酮作为有效成分。  2. The ginkgo dropping pills according to claim 1, wherein the dropping pills contain 1 to 60% by weight of ginkgo flavonoids, 0.5 to 8% by weight of ginkgolides, and 0 to 60% by weight of tanshinone as active ingredients.
3. 根据权利要求 1所述的银杏滴丸， 其中所述基质为聚乙二醇。  3. The ginkgo dripping pills according to claim 1, wherein the matrix is polyethylene glycol.
4. 根据权利要求 1所述的银杏滴丸， 其中所述基质为硬脂酸钠。  4. The ginkgo dripping pills according to claim 1, wherein the base is sodium stearate.
5. 根据权利要求 1所述的银杏滴丸， 其中所述基质为甘油一明胶。  5. The ginkgo dropping pills according to claim 1, wherein the matrix is glycerin-gelatin.
6. 根据权利要求 1所述的银杏滴丸， 其中所述基质为尿素一枸橼酸。  6. The ginkgo biloba drip pill according to claim 1, wherein the matrix is urea-citric acid.
7. 根据权利要求 1所述的银杏滴丸， 其中所述基质为硬脂酸甘油酯。  7. The ginkgo dripping pills according to claim 1, wherein the base is glyceryl stearate.
8. 根据权利要求 1-10所述的银杏滴丸的制备方法， 包括将将银杏叶提取物和 丹参提取物粉碎， 与基质混匀， 加热至熔融状态， 在 60— 80Ό保温状态下滴入到 15 °0的液态石蜡中， 冷却成型， 整形后脱模即得。  8. The method for preparing ginkgo biloba pills according to claims 1-10, comprising pulverizing ginkgo biloba extract and salvia miltiorrhiza extract, mixing with a matrix, heating to a molten state, and instilling in a 60-80Ό incubation state After cooling to 15 ° 0 liquid paraffin, it will be formed after demolding.
PCT/CN2003/001014 2002-11-29 2003-11-28 A drop pill of treating and preventing from cardio-cerebral diseases and the process of producing thereof WO2004050107A1 (en)

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CN1872099B (en) * 2005-06-01 2010-09-29 天津天士力制药股份有限公司 Medication for treating cardiovascular diseases, and cerebrovascular disease
CN102058629B (en) * 2010-12-31 2015-09-02 浙江康恩贝制药股份有限公司 Be suitable for the method that tablets of Ginkgo biloba L produced by high speed tablet press
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CN107773545A (en) 2016-08-29 2018-03-09 烟台益诺依生物医药科技有限公司 The sublingual pharmaceutical composition of Edaravone and (+) 2 baras camphor
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