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WO2006005219A1 - Composition pharmaceutique pour traiter la depression, et procede pour la preparer - Google Patents

Composition pharmaceutique pour traiter la depression, et procede pour la preparer Download PDF

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Publication number
WO2006005219A1
WO2006005219A1 PCT/CN2004/000551 CN2004000551W WO2006005219A1 WO 2006005219 A1 WO2006005219 A1 WO 2006005219A1 CN 2004000551 W CN2004000551 W CN 2004000551W WO 2006005219 A1 WO2006005219 A1 WO 2006005219A1
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WO
WIPO (PCT)
Prior art keywords
extract
drug
hypericum perforatum
pharmaceutical composition
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2004/000551
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English (en)
Chinese (zh)
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WO2006005219A8 (fr
Inventor
Lixin Guo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CHENGDU KANGHONG TECHNOLOGY ENTERPRISES (GROUP) Co Ltd
Original Assignee
CHENGDU KANGHONG TECHNOLOGY ENTERPRISES (GROUP) Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CHENGDU KANGHONG TECHNOLOGY ENTERPRISES (GROUP) Co Ltd filed Critical CHENGDU KANGHONG TECHNOLOGY ENTERPRISES (GROUP) Co Ltd
Priority to PCT/CN2004/000551 priority Critical patent/WO2006005219A1/fr
Publication of WO2006005219A1 publication Critical patent/WO2006005219A1/fr
Publication of WO2006005219A8 publication Critical patent/WO2006005219A8/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/254—Acanthopanax or Eleutherococcus
    • 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)
    • A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
    • A61K36/634—Forsythia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants

Definitions

  • the present invention relates to a medicament for treating depression and a preparation method thereof.
  • the present invention provides an antidepressant medicine derived from a Chinese herbal medicine, having a low effective dose and a clear curative effect, and a preparation method of the medicament.
  • Depression is a brain disease, a common disease in modern society. It is an emotional psychosis. It is characterized by low mood, distressed sadness, loss of appetite, insomnia, and fatigue. WHO survey analyzes the depression of the world's population. The rate is about 3%. In modern society, the disease has seriously affected people's work and quality of life. As social competition intensifies, the number of such patients will increase year by year. Although the etiology and pathophysiology of depression are not well understood, it does not prevent modern medicine from effectively treating this condition.
  • the drugs for clinical treatment of depression at home and abroad are chemicals, such as selective serotonin (5-HT) reuptake inhibitors, tricyclic antidepressants, and tetracyclic antidepressants.
  • the antidepressant is represented by imipramine, which replaces the first antidepressant monoamine oxidase inhibitor that was introduced in the 1950s. It has become the drug of choice for depression. It has been monopolized for 30 years, but the side effects of the drug are obvious.
  • the invention provides a traditional Chinese medicine for treating depression, and a large number of experiments prove that the traditional Chinese medicine of the invention has the curative effect of treating depression, and has small toxic and side effects.
  • the object of the present invention is to provide a pharmaceutical composition which is composed of a traditional Chinese medicine raw material, Hypericum perforatum L. and Wujijia, which can be used for the treatment of depression.
  • Another object of the present invention is to provide a medicament for treating depression, the active ingredient of which is mainly derived from the extract of the above traditional Chinese medicine, and the experiment proves that the therapeutic effect is obvious and the side effects are small.
  • the present invention provides a pharmaceutical composition
  • a pharmaceutical composition comprising the following components by weight of a drug substance: Hypericum perforatum 51 - 65 %, thorn Wu Likou 35 - 49%; preferably: Hypericum perforatum 51-61%, Acanthopanax 39 - 49%.
  • the pharmaceutical composition can be processed into a pharmaceutical preparation of a suitable dosage form to obtain a natural medicine for treating depression.
  • the present invention also provides a medicament for treating depression, wherein the active ingredient in the medicine is an extract obtained by extracting the above-mentioned weight percentage of the raw material medicine, that is, the raw material medicine group used, including 51 - 65 %
  • the Hypericum perforatum and 35-49% of Acanthopanax senticosus and the active ingredient of the drug is mainly a mixture of the alcohol extract of the Hypericum perforatum raw material and the aqueous extract of the Acanthopanax raw material.
  • the present invention also provides a method for preparing the above medicament, which comprises:
  • the Hypericum perforatum L. is extracted with at least 70% ethanol reflux at least once, and the reflux extraction time is at least 1 hour to prepare an extract having a relative density of about 1.10;
  • Acne medicinal herbs are boiled at least once with water to prepare an extract having a relative density of about 1.18; the two extracts are dried and mixed separately.
  • the above-mentioned antidepressant medicine provided by the invention is composed of pure Chinese medicine extract, has exact curative effect, small toxic and side effect, and is simple and easy to prepare, and is convenient for industrial production operation.
  • An antidepressant according to the present invention wherein the alcohol extract of Hypericum perforatum can be The dried extract of Hypericum perforatum L. obtained by drying the ethanol extract of the raw material drug at a relative density of about 1.10; the water extract of the Acanthopanax senticosus can be dried when the aqueous extract of the raw material drug is at a relative density of about 1.18.
  • the pharmaceutical composition may further comprise a pharmaceutically acceptable adjuvant comprising at least one of pregelatinized starch, talc, magnesium stearate, and the like, or a mixture thereof.
  • the drug is preferably a solid dosage form, and the capsule is more preferably a capsule because the capsule can improve the stability of the medicine, the production process is simple, and it is easy to mechanize the production.
  • the composition of the drug substance is preferably 51-61% by weight of Hypericum perforatum, 39-49% by weight of Acanthopanax senticosus; most preferably 54.55 % by weight of Hypericum perforatum L., and 45.45 % by weight of Acanthopanax senticosus.
  • the preparation method of the antidepressant according to the present invention further comprises drying the extract obtained by extracting the above two raw materials into dry extracts, and then uniformly mixing them into a capsule to prepare a capsule; After the two extracts are respectively dried to form a dry extract powder, one or more of an appropriate amount of pregelatinized starch, talc powder or magnesium stearate is uniformly mixed and filled into a plastic capsule.
  • Other oral dosage forms such as tablets, granules and the like can also be prepared according to well-known pharmacy techniques.
  • the specific preparation method of the medicament of the present invention may be:
  • the extract of Hypericum perforatum L. and 70% ethanol is refluxed twice, the first time adding about 8-12 times the amount of ethanol, the second adding about 6-10 times the amount of ethanol, and extracting each time for 0.5 - 1.5 hours, combining the extracts, After filtration, the ethanol is recovered under reduced pressure, concentrated to an extract having a relative density of about 1.10, and spray-dried to obtain a dry extract powder; the acanthopanax medicinal material is pulverized into pieces, and about 6-10 times the amount of water is added, and decocted 3 times, each After 1.5-3 hours, the decoctions were combined, filtered, and the filtrate was concentrated to an extract having a relative density of about 1.18, and spray dried to obtain a dry extract powder.
  • pregelatinized starch talc, and magnesium stearate may be added and uniformly mixed, and the capsule may be added to form a capsule.
  • the invention has no special requirements for the raw material medicine used, but the Hypericum perforatum should comply with the relevant provisions of the current national drug standard under the Hypericum perforatum; Acanthopanax senticosus should comply with the current Chinese Pharmacopoeia under the acanthopanax senticosus Various regulations.
  • the components of the above formulations can be prepared into a variety of pharmaceutical dosage forms suitable for use in patients using conventional techniques in the pharmaceutical industry.
  • the clinically recommended dose of the drug of the present invention is 1.0 to 2 g/day, preferably 1.2 g/day, based on the active ingredient, and can be divided into two daily use.
  • the drug of the present invention has the following advantages compared with the anti-depressant of the same traditional Chinese medicine (for example, CN1381242A): a.
  • the effective dose is significantly reduced; b.
  • the dose-dependent effect is obvious, and the antidepressant effect is more accurate; c.
  • the number of daily meals can be reduced while improving the therapeutic effect, and only takes twice a day.
  • the medicament of the invention can be prepared into a capsule or other solid oral preparation, and is convenient to take. Specific implementation
  • test examples include pharmacodynamic comparison experiments of the drug obtained in Example 1 (hereinafter referred to as the drug of the present invention, the current trade name is Kai Yu Anzheng) and the CN1381242A drug (hereinafter referred to as A drug).
  • Rats were orally administered with a dose of 15.6 - 250 mg / kg of the present invention, administered twice at 24 hours before the test, compared with the solvent control group, 31.3 mg / kg, 62.5 mg / kg, 125 mg / kg group
  • Significantly reduced immobility time was dosewise and statistically significant (P ⁇ 0.001, P ⁇ 0.01 and P ⁇ 0.05), and the positive control imipramine showed the same effect (Table 1).
  • Table 1 Effect of oral administration of the drug of the present invention on the duration of forced swimming for 2 times/day
  • the drug of the present invention is orally administered twice a day, and the dose of compulsive swimming is significantly reduced at a dose of 31.3 mg/kg, and the drug A is orally administered three times a day, and can be significantly reduced at a dose of 62.5 mg/kg.
  • the forced swimming in rats does not move for a long time, so the effective dose of the drug of the present invention is obviously lower than that of the A drug, and the number of sputum service is also less than that of the A drug;
  • the drug of the present invention was orally administered twice a day, and the effects at doses of 31.3 mg/kg, 62.5 mg/kg, and 125 mg/leg were dose-dependent; while the effect of drug A at 62.5 mg/kg was better than that of A drug at 62.5 mg/kg. 125mg/kg, which is ineffective at doses of 250 mg/kg and 500 mg/kg, so The curative effect of the medicament of the invention for treating depression is more precise.
  • mice were orally administered with the drug of the invention at a dose of 31.3-250 mg/kg, once a day, 5 times in a row, 62.5 mg/kg, 125 mg/kg, 250 mg/kg.
  • the time was significantly decreased in a dose-dependent manner, with statistical significance (P ⁇ 0.01 and P ⁇ 0.05) (see Table 3), and the positive control imipramine group also showed the same effect.
  • the drug of the present invention is orally administered once a day for 5 times, and the time of 62.5 mg/kg is significantly reduced, and the A drug needs to be taken orally twice a day for 7 times.
  • the effective dose of the drug of the invention is obviously lower than that of the drug A.
  • the number of daily clothes is also less than that of the A drug.
  • the drug of the present invention is administered once a day for 5 times.
  • the effect at 62.5 mg/kg, 125 mg/kg, 250 mg/kg is dose-dependent; while drug A is only 125 mg / kg. It has an effect at the dose and is ineffective at the dose of 250 mg/kg and 500 mg/kg, so the curative effect of the medicament of the present invention for treating depression is more precise.
  • the drug group of the present invention 62.5 X 5 10 5 * * * * The drug group of the present invention 125 x 5 10 ⁇ * * * * The drug group of the present invention 250x 5 10 7 * * Note: Each administration group is compared with the depression model group: * *P ⁇ 0.01; * * * P ⁇ 0.001
  • Table 5 shows that 62.5 mg/kg, 125 mg/kg, 250 mg/kg of the drug of the present invention was taken once a day, and after 5 consecutive administrations, reserpine caused a significant antagonistic effect on the drooping of the eyelids in mice, and in three The dose was dose-dependent, demonstrating that the drug of the invention has an antidepressant effect.
  • test drug is the drug of the present invention obtained by the method of Example 1, and its trade name is Kaiyu Anjing, which is equivalent to the original drug l lg per gram.
  • the 30% thick liquid of Kaiyu Anshen Ginger Powder was given to the mice twice a day for 6 hours, 0.4ml/10g body weight. The mice were observed to have no death on the 7th day, and the maximum tolerance of the mice to the drug was known. It is 24g/kg - d.
  • Kaiyu Anshen capsules powder 3.3, 1.9, 0.95g / kg (equivalent to 164, 95, 47 times the clinical dose, respectively), continuous intragastric rats for 90 days, animal behavior, appearance signs, feed consumption and There was no significant effect on weight gain and peripheral blood levels. There were no significant differences in blood biochemical tests between the 10 indicators and the control group (P>0.05). There were no visible lesions in all major organs. The main organ coefficients were not significantly different from those in the control group (P > 0.05). Histopathological examination showed no abnormalities in the main organs of each animal.
  • API St. Hypericum 1800g Acanthopanax 1500g
  • the above capsule contains 0.36 g/grain of the above-mentioned Hypericum perforatum and Acanthopanax senticosus extract, and is recommended to be taken twice a day, 2 capsules each time.
  • the preparation method was the same as in Example 1 to prepare a capsule.
  • the preparation method was the same as in Example 1.
  • API Hypericum perforatum 65 % Acanthopanax 35 %
  • the preparation method was the same as in Example 1 to prepare a capsule.
  • the preparation method was the same as in Example 1 to prepare a capsule.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition pharmaceutique pour traiter la dépression, qui est préparée à partir du fruit du forsythia et de l'écorce d'acanthopanax. L'invention a également pour objet un procédé pour préparer cette composition, comprenant principalement les étapes suivantes : extraction du fruit de forsythia avec de l'alcool et extraction de l'écorce d'acanthopanax avec de l'eau ; et production des extraits dans des capsules ou autre forme de dosage solide.
PCT/CN2004/000551 2004-05-27 2004-05-27 Composition pharmaceutique pour traiter la depression, et procede pour la preparer Ceased WO2006005219A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2004/000551 WO2006005219A1 (fr) 2004-05-27 2004-05-27 Composition pharmaceutique pour traiter la depression, et procede pour la preparer

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Application Number Priority Date Filing Date Title
PCT/CN2004/000551 WO2006005219A1 (fr) 2004-05-27 2004-05-27 Composition pharmaceutique pour traiter la depression, et procede pour la preparer

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WO2006005219A1 true WO2006005219A1 (fr) 2006-01-19
WO2006005219A8 WO2006005219A8 (fr) 2006-04-20

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112494520A (zh) * 2021-01-07 2021-03-16 广西壮族自治区中医药研究院 蛤蚧或其提取物在制备抗抑郁症药物中的应用
CN112641100A (zh) * 2020-11-24 2021-04-13 北京斯利安药业有限公司 一种含叶酸的抗抑郁冲剂

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1381242A (zh) * 2001-04-16 2002-11-27 成都康弘制药有限公司 一种治疗抑郁症的胶囊

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1381242A (zh) * 2001-04-16 2002-11-27 成都康弘制药有限公司 一种治疗抑郁症的胶囊

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
MINGSHENG L. ET AL: "Collection of Pharmaceutical Vehicle", 1993, SHANGHAI SCIENCE AND TECHNOLOGY PRESS, pages: 627 AND - 716 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112641100A (zh) * 2020-11-24 2021-04-13 北京斯利安药业有限公司 一种含叶酸的抗抑郁冲剂
CN112494520A (zh) * 2021-01-07 2021-03-16 广西壮族自治区中医药研究院 蛤蚧或其提取物在制备抗抑郁症药物中的应用

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Publication number Publication date
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