WO2004052382A1 - Medicament traditionnel chinois agissant efficacement contre l'hyperlipemie - Google Patents

Medicament traditionnel chinois agissant efficacement contre l'hyperlipemie Download PDF

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Publication number
WO2004052382A1
WO2004052382A1 PCT/CN2003/000128 CN0300128W WO2004052382A1 WO 2004052382 A1 WO2004052382 A1 WO 2004052382A1 CN 0300128 W CN0300128 W CN 0300128W WO 2004052382 A1 WO2004052382 A1 WO 2004052382A1
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parts
chinese medicine
traditional chinese
liver
treatment
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PCT/CN2003/000128
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English (en)
Chinese (zh)
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Wenquan Fang
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Titan Pharmaceuticals (Shenzhen) Ltd
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Priority to AU2003221274A priority Critical patent/AU2003221274A1/en
Publication of WO2004052382A1 publication Critical patent/WO2004052382A1/fr

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Classifications

    • 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)
    • A61K36/72—Rhamnaceae (Buckthorn family), e.g. buckthorn, chewstick or umbrella-tree
    • 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)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286—Carthamus (distaff thistle)
    • 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)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/482—Cassia, e.g. golden shower tree
    • 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)
    • A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605—Morus (mulberry)
    • 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)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734—Crataegus (hawthorn)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

Definitions

  • the invention relates to a medicine for treating hyperlipidemia, in particular to a traditional Chinese medicine compound medicine for nourishing yin and clearing liver, promoting blood circulation, and treating liver and kidney yin deficiency and blood stasis type hyperlipidemia.
  • Hyperlipidemia is a common disease in the clinic, and its incidence has increased significantly with age. Hyperlipidemia plays an important role in the pathogenesis of arteriosclerosis, coronary heart disease, and obesity, and has caused widespread concern. In China, the prevention and treatment of cardiovascular and cerebrovascular diseases have been incorporated into public health services, and they are treated the same as infectious diseases. .
  • Yunnan Huafen Tianqi Oral Liquid It consists of buckwheat pollen, Tiansanqi, and honey. It is used for blood stasis obstruction syndrome of hyperlipidemia.
  • New Qingning Tablets Composed of rhubarb. For hyperlipidemia syndrome.
  • Zhi Ke Qing It consists of loquat, scutellaria baicalensis, hawthorn, Alisma purpurea, rhubarb, and woody fragrance. Used for phlegm-dampness evidence of hyperlipidemia.
  • Shouwu film composed of Shouwu. For liver and kidney yin deficiency syndrome of hyperlipidemia.
  • Hawthorn essence lipid-lowering tablet Composed of northern hawthorn. For stasis syndrome due to hyperlipidemia.
  • Lipid-lowering fitness tablets Composed of Alisma. For hyperlipidemia of spleen deficiency and dampness.
  • Xinmaitong Pian It consists of Angelica sinensis, Cassia seed, Uncaria rhynchophylla, Achyranthes bidentata, Salvia miltiorrhiza, Kudzu root, Sophora japonicum, Mao Keqing, Xia orange grass, Panax notoginseng. For hyperlipidemia of blood stasis and obstruction.
  • Jiangzhiling tablet It consists of Shouwu, Cassia, Huangjing, Woody, Hawthorn, Golden Cherry, Mulberry and Alisma. For liver and kidney yin deficiency syndrome of hyperlipidemia.
  • Dantian Jiangzhi Pill It consists of Danshen, Shouwu, Ginseng, Polygonatum, Tianqi, Chuanxiong, Angelica, Alisma, Epimedium, Wujiapi, Cinnamon. For the syndrome of yin deficiency and stasis due to hyperlipidemia.
  • the invention provides a pure traditional Chinese medicine compound medicine with precise curative effect, safety and convenience, small side effects and low price.
  • the invention provides a pharmaceutical preparation for the prevention and treatment of hyperlipidemia, especially a traditional Chinese medicine compound medicine preparation for treating yin and clearing the liver, promoting blood circulation, and collaterals, and treating liver and kidney yin deficiency and blood stasis type hyperlipidemia and blood disease.
  • the traditional Chinese medicine compound medicine preparation of the present invention consists of Cassia seed, Chinese wolfberry fruit, mulberry, hawthorn and safflower Five flavors of traditional Chinese medicine are made by extraction and processing.
  • Mulberry 1. "Compendium of Materia Medica” "to cure heat and thirst, to have a spirit”. 2. "Southern Yunnan Materia Medica”: “Yin kidney is dirty and solid, and Jiufu strikes an eye”. 3. "Materia Medica for Truth”: “Removing heat and nourishing yin”. 4. ⁇ Residential diet spectrum>: “Nourishing the liver and kidneys, filling blood, expelling rheumatism, walking well, restless wind, clear fire”.
  • Hawthorn 1. ⁇ Medicinal herbs for daily use>: "Remove food accumulation, nourish qi, broaden the stomach and relieve qi, and eliminate blood qi.” 2. “Shi Jian Materia Medica” “Reducing blood clots, air clots, and activating blood”. 3. “Compendium of Materia Medica”: To cure spleen deficiency, dampness and heat, digestion and abrasion, and facilitate bowel movements.
  • Safflower 1. "Ben Cao Yan Yi Bu Qi”: Breaking and retaining blood, nourishing blood. Use more to break blood, and use less to nourish blood. "2.” Compendium of Materia Medica “: Safflower, blood-splitting, running blood, and blood, blood regulating drugs are also evidence of qi and blood discord, non-safflower can not be adjusted. 3. ⁇ Pharmaceutical Chemicals>: Saffron Meridian Meridian.
  • the prescription of the present invention is based on the fact that hyperlipidemia is a microscopic examination index, although the motherland medicine does not have the name of hyperlipidemia. But there are related discussions. Such as “Lingshu. Wei Qi Disorders” Day: “Fat people, their serum, less air slippery.” This shows that phlegm is a disease, and because of its sticky and astringent characteristics, it can often cause choroidal stagnation. "Su Wen. General Commentary on the Theory of False Reality” Day: Fat and noble people, but also the disease of the Liangliang ";” Angel Tongtianlun Pian "pointed out the etiology, pathology and symptoms of hyperlipidemia. Black gas, unbalanced kidney. "There are many discussions on the mechanism and prevention of clinical symptoms of hyperlipidemia, and they are scattered in relevant works, such as:
  • liver and kidney yin deficiency and blood stasis are more common. Patients with inadequate body liver and kidney yin essence, or anger due to anxiety, dark consumption of yin and blood of the liver, and then damage the kidney essence, can cause liver and kidney deficiency. Both liver and kidney yin are deficient, yin does not control yang, and deficient heat is endogenous. Blood can be condensed as fat, and blood is consumed as stasis. The formation of pathological characteristics of liver and kidney deficiency and blood stasis.
  • liver and kidney yin Insufficient liver and kidney yin essence, empty marrow sea, deprivation of consciousness, so dizziness, tinnitus, and dazzle; waist is kidney, deficiency of kidney yin, kidney loss, but waist and knees are weak; yin does not control yang, liver yang is partial Hyperthyroidism, so head bloating, headache; Deficiency of heat and internal disturbance, so see the hands and feet heart heat, irritability; Yin deficiency is less, coupled with deficiency of heat consumption fluid loss, so dry mouth, dry stool; limb meridian loss, coupled with collateral vein stasis Obstruction, so see limb numbness; pulse stasis can also be seen in chest tightness, chest pain and other symptoms.
  • this card is based on liver-kidney yin deficiency, internal heat and hyperactivity as the standard, and changes in poor veins. Therefore, the treatment should be to nourish the liver and kidneys to clear the deficiency of heat, to develop the true yin to control the hyperyang, and to promote blood circulation to unblock ⁇ each.
  • cassia seed enters the liver, kidney, and large intestine meridian, is sweet and salty and bitter, has a mild coldness, and has the effects of nourishing kidney water, clearing liver heat, and purging turbidity. It is a medicine for nourishing yin and clearing liver, so it is Fang Zhongjun medicine. Lycium barbarum is sweet and flat. It enters the liver and kidney meridians, specializes in nourishing the liver and nourishing blood, nourishes the kidney and produces sperm, so that the yin and blood are sufficient, the water can contain the wood, and the deficiency heat disappears.
  • Mulberry "relieves heat by removing cold and blood, and replenishing blood for cooling blood” Yiyin's medicine, so this two medicine as a minister, to help cassia Zi Ziyin and liver cleansing, and Qingbu as long.
  • Liver and kidney yin deficiency is often accompanied by stagnation of veins and veins, so it is supplemented with safflower for promoting blood circulation and clearing blood stasis to clear the veins, so it is adjuvanted in the prescription;
  • Cassia, wolfberry, and mulberry are cold and cold, and the taste is rich and noisy.
  • hawthorn to strengthen the spleen and stomach, digestion and stagnation, so as to eliminate the stagnation and obstruction of the stomach, and not to cause sputum turbidity
  • the hawthorn has the function of promoting blood circulation and removing blood stasis, which can help safflowers to clear the veins, Therefore, the same adjuvant medicine. All the medicines work together to play the effects of nourishing yin and clearing the liver and promoting blood circulation and collaterals. Nourishing yin and clearing the liver, promoting blood circulation, removing blood stasis, and lowering fat and clearing collaterals can effectively prevent cardiovascular and cerebrovascular diseases in middle-aged and elderly people.
  • the prescription of the present invention is experimentally confirmed, and has the functions of nourishing yin, clearing liver, promoting blood circulation, and clearing collaterals, and treats liver and kidney yin deficiency and stasis type hyperlipidemia.
  • the Chinese medicinal preparation of the present invention has the following prescription composition and formulation of each component:
  • the weight is calculated based on the crude drug. If the unit is gram, the composition can be made into 1000 doses of pharmaceutical preparations.
  • the 1,000 doses refer to finished pharmaceutical preparations, such as 1000 capsules made of capsules. 1000 tablets, 1000 bags of granules, 1000 ampoules of oral solution, etc.
  • As granules can also be made into large packages, such as 100-500 bags, specifically 100 bags, 125 bags, 200 bags, 250 bags, 500 bags Etc. Each bag can be taken as a single dose.
  • the above composition In terms of grams, can be made of 50-1000 times dosage formulations, such as tablets, made from 1000, each dosage can be 1 - 3 0, taking a total of 50-1000 times . Such as granules, made of 125 bags, taking 1-2 bags each time, a total of 62. 5-125 times can be taken.
  • the above composition is proportioned by weight. It can be increased or decreased according to the corresponding proportion during production. For example, large-scale production can be in kilograms or tons, and small-scale production can also be in milligrams. Weight It can be increased or decreased, but the proportion of the weight ratio of the raw medicinal materials between the components is unchanged.
  • the above weight ratio is obtained through scientific screening. For special patients, the composition ratio can be adjusted accordingly, and the increase or decrease should not exceed 100%.
  • the single-traditional Chinese medicine in the above composition can also be replaced by appropriate Chinese medicine with the same medicinal properties, and the medicine effect of the replaced traditional Chinese medicine preparation remains unchanged.
  • a pharmaceutically acceptable carrier may be added.
  • the pharmaceutically acceptable carrier may be: starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and its derivatives, Alginate, gelatin, polyvinylpyrrolidone, glycerin, earth temperature 80, agar, hook carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, ⁇ -cyclodextrin, phospholipids, kaolin, Talcum powder, stearic acid, magnesium stearate, etc.
  • the traditional Chinese medicine preparation of the present invention may be any pharmaceutically acceptable dosage form.
  • These dosage forms include: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard gel tinctures, soft gel tinctures, Oral liquid, buccal solution, granules, granules, granules, pills, powders, pastes, elixir, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, patches Agent.
  • the preparation of the present invention is preferably an oral dosage form, such as a capsule, a tablet, an oral solution, a granule, a pill, a powder, an elixir, a plaster, etc., and preferably a granule.
  • the dosage of the preparation of the present invention is determined according to the condition of the patient during use, and can be taken three times a day, 1-20 doses each time, such as: 1-20 bags or tablets or tablets.
  • the formulation of the invention can be prepared by the following methods:
  • the extract is based on The active ingredient of the invention traditional Chinese medicine preparation.
  • This active ingredient can be made into a variety of edible Chinese medicinal types through common formulation processing techniques.
  • auxiliary materials such as: lactose, sucrose, etc.
  • auxiliary materials such as: lactose, sucrose, etc.
  • the concentrate stir to dissolve, and then spray dry to obtain a dry extract powder.
  • the dry paste powder Take the dry paste powder and use a dry granulation mechanism to obtain dry particles. Packed in aluminum-plastic composite film bag.
  • the above granules can be packed into a gelatin tincture.
  • the above granules can be obtained by adding the lubricant to a tablet and compressing the tablets.
  • the traditional Chinese medicine preparation of the invention has the effects of nourishing yin and clearing the liver, promoting blood circulation and clearing collaterals. Indication of liver and kidney yin deficiency and blood stasis of hyperlipidemia. Symptoms include dizziness or swelling or pain, tinnitus, soft waists and knees, hot or irritable hands and feet, numbness or chest pain, dry mouth, dry stools, dark red tongue, or spots with paralysis spots on the side, less moss, fine Or count.
  • Treatment group Zhikang granule group (This group uses the drug granules prepared by the method of Example 1, named here as Zhikang granules, 1 packet each time, 2 times a day)
  • Control group Feno Bate group (Fenofibrate is a lipid-lowering western medicine, 2 tablets each time, 3 times a day)
  • Table 6 shows the changes and comparison of symptom scores between the two groups before and after treatment.
  • Zhikang granules have significantly improved the symptoms of liver-kidney yin deficiency and blood stasis syndromes.
  • the efficacy of the syndromes and the main symptoms of dizziness, waist and knee weakness, and limb numbness are significantly better than those of the control group.
  • Zhikang granules have certain blood pressure lowering and weight loss effects, and are particularly suitable for patients with abnormal blood lipids accompanied by stage I hypertensive blood pressure and mild obesity with liver and kidney yin deficiency and blood stasis.
  • Zhikang granules are safe to use and have no toxic reactions in clinical observation. It is a safe and effective new lipid-lowering drug.
  • Preparation method 5 herbs in Zifang Fang, soak for 12 hours with 12 times the amount of water, boil for 1.5 hours, and filter; add 10 times the amount of water, boil for 1 hour, and filter; combine 2 extractions , Concentrated to a relative density of 1. 05-1.
  • lactose was added to the concentrated solution, stirred to dissolve, and then spray-dried to obtain a dry extract powder (the yield of dry extract powder after deducting the added lactose) 25%), take dry paste powder, use dry granulation mechanism to granulate, then sieve coarse powder through 8-10 mesh sieve, remove fine powder through 60-65 mesh sieve, get about 1 GOOg dry granule, Dry granules are packed into 1000 capsules of hard gelatin capsule No. 1, each capsule containing lg drug.
  • sucrose take 5 herbs in the recipe, soak for 12 hours with 12 times the amount of water, boil for 1.5 hours, and filter; add 10 times the amount of water, boil for 1 hour, and filter; combine the 2 extraction solutions, add Sucrose, stir to dissolve, add water to 10000ml, mix, filter, and fill into 1000 bottles of 10ml ampoule.
  • Control group 61 27 27 7 0 44.26 88.52 Note: Comparison between groups ⁇ P> 0.05 Table 2 Comparison of the efficacy of various indicators for the treatment of dyslipidemia in the two groups. The number of cases in the blood lipid project group was markedly effective, ineffective, worsened, and markedly effective (%). Recovery rate (%). Total effective rate (%). P Treatment group 69 30 31 7 1 40.48 39.13 88.40
  • the treatment group has the same effect in reducing TG LDL-C and increasing HDL-C as the control group, but the effect of reducing IC AI is better than the control group .
  • Control group 35 7.21 ⁇ 0.974 6.01 ⁇ 0.673 ** -1.20 ⁇ 0.613
  • Treatment group 94 2.35 ⁇ 1.362 1.25 ⁇ 0.723 *** -1.10 ⁇ 1.217
  • Control group 57 2.32 ⁇ 0.923 1.11 ⁇ 0.627 *** -1.21 ⁇ 0.705
  • Treatment group 56 1.01 ⁇ 0.374 1.71 ⁇ 0.417 *** 0.70 ⁇ 0.397
  • Control group 38 1.09 ⁇ 0.416 1.74 ⁇ 0.431 ** 0.65 ⁇ 0.379
  • Treatment group 102 6.36 ⁇ 0.713 4.47 ⁇ 0.415 *** -1.89 ⁇ 0.475
  • Control group 61 6.31 ⁇ 0.695 4.67 ⁇ 0.529 *** -1.04 ⁇ 0.546
  • Control group 61 6. 21 ⁇ 1.415 5.17 ⁇ 0.717 ** -0.74db0.517 Note: Compared with before treatment: * P> 0.05, ** P ⁇ 0.05 *** P ⁇ 0.01 Comparison between groups: AP> 0.05
  • Table 4 The curative effect and comparison between the treatment group and the control group in the treatment of liver-kidney yin deficiency and blood stasis syndrome group number of cases clinical control markedly effective effective ineffective markedly effective% of total effective rate 102 28 42 28 4 68.62 96.08
  • Treatment group 101 2.15 ⁇ 0.941 0.43 ⁇ 1.353 * ** 1.72 ⁇ 0.713 Dizziness ⁇ Control group 59 2.23 ⁇ 0.317 2.07 ⁇ 0.278 * 0.16 ⁇ 0.217
  • Treatment group 91 2.17 ⁇ 0.861 0.59 ⁇ 0.473 *** 1.58 ⁇ 0.713 Head swell ⁇ Control group 49 2.21 ⁇ 0.792 1.19 ⁇ 0.517 ** 1.02 ⁇ 0.471
  • Treatment group 96 2.31 ⁇ 0.631 0.49 ⁇ 0.417 *** 1.82 ⁇ 0.379 Headache ⁇ Control group 51 2.29 ⁇ 0.693 1.67 ⁇ 0.617 ** 0.62 ⁇ 0.417
  • Treatment group 78 2.03 ⁇ 0.734 0.59 ⁇ 0.273 *** 1.44 ⁇ 0.374 Waist and knee Tart ⁇ control group 42 2.13 ⁇ 0.617 2.01 ⁇ 0.537 * 0.12 ⁇ 0.431 treatment group 75 2.75 ⁇ 0.713 0.47 ⁇ 0.617

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Abstract

L'invention concerne un médicament convenant pour le traitement de l'hyperlipémie, en particulier une préparation de médecine chinoise traditionnelle, qui, en nourissant le principe Yin, apaise le foie, active la circulation du sang et stimule le flux menstruel, et en particulier permet de traiter l'hyperlipémie due à une déficience du principe Yin au niveau du foie, des reins et de la circulation sanguine. La préparation de l'invention s'obtient en mélangeant et en extrayant cinq plantes médicinales qui sont la graine de séné (Semant Cassie), le fruit de la symphorine chinoise (Frustes Hoveniae), la mûre blanche (Fructus Mori), le fruit de l'aubépine (Fructus Cartaegi) et le carthame (Flos Carthami).
PCT/CN2003/000128 2002-11-27 2003-02-09 Medicament traditionnel chinois agissant efficacement contre l'hyperlipemie WO2004052382A1 (fr)

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Application Number Priority Date Filing Date Title
AU2003221274A AU2003221274A1 (en) 2002-11-27 2003-02-09 A kind of chinese traditional medicine having efficacy of reducing blood-fat

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CN02153307.5 2002-11-27
CNB021533075A CN1211111C (zh) 2002-11-27 2002-11-27 一种降血脂中药

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Publication number Priority date Publication date Assignee Title
CN100339099C (zh) * 2005-09-26 2007-09-26 杨淑华 具有减肥美容功能的保健品及其制法
CN101732491B (zh) * 2010-02-26 2011-06-22 王忠民 一种治疗高血压、高血脂、高血粘度与抗衰老的药物
CN103961428B (zh) * 2013-01-30 2016-08-03 紫光古汉集团股份有限公司 一种具有行气活血作用的中药组合物制剂的检测方法
CN103961429B (zh) * 2013-01-30 2017-01-25 紫光古汉集团股份有限公司 一种具有行气活血作用的中药组合物及其制备方法
CN105661542A (zh) * 2016-01-19 2016-06-15 吉林金恒制药股份有限公司 一种降脂保健油

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CN1298938A (zh) * 2000-12-15 2001-06-13 姚力克 一种保健葡萄酒

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Publication number Priority date Publication date Assignee Title
CN1298938A (zh) * 2000-12-15 2001-06-13 姚力克 一种保健葡萄酒

Non-Patent Citations (2)

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Title
TAN YUANSHENG ET AL: "Clinical Research of ZHIKANG GRANULES in Treatment of Hyperlipoidemia due to Yin-Deficiency of Liver and Kidney and Blood Stasis", SCIENCE AND TECHNOLOGY OF CHINA CHINESE TRADITIONAL MEDICINE, vol. 6, no. 4, 1999, pages 213 - 214 *
ZHU DONGYOU ET AL: "Clinical Observation of JIANGZHI liquid in Treatment of Hyperlipoidemia", CHINESE TRADITIONAL MEDICINE, vol. 14, no. 1, 1994, pages 28 *

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AU2003221274A1 (en) 2004-06-30
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