WO2019072051A1 - 一种具有抗抑郁功效的中药提取物及其制备方法和应用 - Google Patents

一种具有抗抑郁功效的中药提取物及其制备方法和应用 Download PDF

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Publication number
WO2019072051A1
WO2019072051A1 PCT/CN2018/103870 CN2018103870W WO2019072051A1 WO 2019072051 A1 WO2019072051 A1 WO 2019072051A1 CN 2018103870 W CN2018103870 W CN 2018103870W WO 2019072051 A1 WO2019072051 A1 WO 2019072051A1
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Prior art keywords
chinese medicine
paste
traditional chinese
water
extract
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PCT/CN2018/103870
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English (en)
French (fr)
Chinese (zh)
Inventor
秦雪梅
赵玉娇
田俊生
张潇
杜冠华
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山西大学
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Priority to JP2019559814A priority Critical patent/JP6880236B2/ja
Publication of WO2019072051A1 publication Critical patent/WO2019072051A1/zh

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    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/232—Angelica
    • 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)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233—Bupleurum
    • 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
    • A61K36/284—Atractylodes
    • 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
    • A61K36/484—Glycyrrhiza (licorice)
    • 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
    • A61K36/534—Mentha (mint)
    • 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)
    • A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
    • 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)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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 invention belongs to the field of Chinese medicine extraction, and particularly relates to a traditional Chinese medicine extract with antidepressant effect, a preparation method and application thereof.
  • Xiaoyao San is a classic Chinese medicine prescription for soothing the liver and relieving depression.
  • the two authorized patents of this research group (201010110283.7 and 201110084715.6) extracted with ethyl acetate and petroleum ether, indicating that Xiaoyao San has a clear anti-depression effect, but on the one hand, industrial production has many safety hazards, and the process controllability is poor; Xiaoyao Sanyuan prescription has more medicinal materials, and the dosage is relatively large, and the quality is not easy to control. Therefore, based on the research on Xiaoyao San, the present invention prepares a traditional Chinese medicine extract by using the alcoholic water extraction method which is simpler in composition and more suitable for the pilot production, and studies the antidepressant effect characteristics.
  • the object of the present invention is to provide a traditional Chinese medicine extract with simple composition, scientific and reasonable technology, and a plurality of medicinal properties with significant improvement in depression, and a preparation process and application thereof.
  • the invention provides a traditional Chinese medicine extract with antidepressant effect, which is characterized by a distribution ratio and a preparation method of the traditional Chinese medicine group:
  • the traditional Chinese medicine component is in terms of mass parts: Bupleurum 20-60, Angelica 20-60, bran-frying atractylodes 20-60, white peony 20-60, mint 8-20, licorice licorice 8-20;
  • the preparation method comprises the following steps: 1) adding 6-10 times weight of 60-90% ethanol to the component medicine, extracting twice, each time 1-3 h, filtering, combining the filtrate, and concentrating to obtain alcohol extract 2)
  • the dregs are added with 6-10 times the weight of water for 2 times, each time 1-3h, filtered, the filtrate is combined, concentrated to obtain a water extracting paste, and ethanol is added to the water extracting paste to make the alcohol content Up to 60-80%, let stand for 24h, take the supernatant, concentrate to clear the paste; 3) combine the clear paste with the alcohol extract paste, mix and concentrate to thick paste, dry under microwave pressure, smash through 80 mesh sieve , that is, the Chinese medicine extract.
  • the components are preferably: Bupleurum 30, Angelica 30, Brassica chinensis 30, Angelica 30, Peppermint 10, and Zhigancao 15 in parts by mass.
  • the weight of the ethanol added in the step 1) is 8 times the weight of the medicinal material, the ethanol concentration is 75%, and the extraction time is 2 hours.
  • the weight of the added water in the step 2) is 8 times the weight of the medicinal material, and the extraction time is 2 hours.
  • Step 3 The water content of the water extracting paste after adding ethanol is 70%.
  • the density of the above alcohol extracting paste, water extracting paste and clearing paste is controlled to be 1.08 to 1.10, and the density of the thick paste is controlled to be 1.24 to 1.26.
  • the invention provides a traditional Chinese medicine granule comprising the traditional Chinese medicine extract and the auxiliary material and the like as described above.
  • the invention provides that the prescription is simpler, the dosage is less, the quality is more controllable, the pharmacological activity reaches or exceeds the listed antidepressant western medicine venlafaxine, the antidepressant traditional Chinese medicine Shugan Jieyu and Xiaoyao San.
  • the antidepressant effect is equivalent, and: 1 no venlafaxine-induced constipation, decreased gastrointestinal motility and decreased sexual desire; 2 improved CUMS-depressed rats Learning memory decline and anxiety.
  • Figure 1 is a flow chart of the preparation process of the traditional Chinese medicine extract of the present invention
  • Venlafaxine hydrochloride Choengdu Kanghong Pharmaceutical Group Co., Ltd., specification: 25mg/granule, batch number: national medicine standard word H20070269
  • Stimuli include fasting, water ban, 4°C ice water swimming, 50°C thermal stimulation, tail trapping, intermittent foot shock, restraint, ultrasound stimulation, and day and night reversal.
  • One stimulus was randomly given daily, and each stimulus was used 2-3 times cumulatively. Except for the blank control group, the other groups were housed in a single cage and the modeling procedure was carried out. The modeling time was 28 days.
  • the drug was administered by intragastric administration. The drug group was given the corresponding concentration of the drug solution, and the model group and the blank control group were given an equal volume of distilled water.
  • Body weight Rat body weight was weighed on the 0th, 7th, 14th, 21st, and 28th day of the experiment.
  • Rats were placed in the open field box for 5 min, and the number of penetrating and erecting times of the rats within 4 min after recording were recorded.
  • Chinese herbal extracts can improve the growth of rat body weight caused by CUMS modeling stress.
  • the decrease of activity and the preference for sucrose sweetness indicate that the extract of Chinese medicine has a good antidepressant effect, and its pharmacological activity meets or exceeds the listed antidepressant western medicine venlafaxine and antidepressant Chinese medicine Shugan solution. Yu.
  • Gastric residual rate (stomach weight - stomach net weight) / homemade semi-solid nutrient paste weight ⁇ 100%
  • Small intestine propulsion rate length of small intestine / distance of self-made semi-solid paste propulsion ⁇ 100%
  • Table 4 shows that CUMS stress increases the number of bowel movements in rats and decreases the water content of feces. Compared with venlafaxine, this phenomenon can not be improved and negative regulation is observed.
  • Tables 5 and 6 show that modeling stress slows the intestinal peristalsis and gastric emptying function in rats, and venlafaxine has a decreasing trend in the small intestine propulsion rate and intragastric meal rate compared with the model group, suggesting that venlafaxine It may have the effect of reducing gastrointestinal function.
  • Chinese herbal extracts can improve gastrointestinal function in rats while treating depression.
  • mice 48 h before the experiment, female mice were injected subcutaneously with estradiol 10 ⁇ g (dissolved in 0.1 ml safflower oil); 2 h before the experiment, 10 ⁇ g of progesterone was injected subcutaneously.
  • estradiol 10 ⁇ g dissolved in 0.1 ml safflower oil
  • progesterone 10 ⁇ g was injected subcutaneously.
  • the CUMS male and the estrus female were caged, and at 7-9 pm, the males' sexual behavior was observed within 30 minutes, and the crawling latency and the number of crawling backs were recorded.
  • the crawling behavior of male rats in mating experiments can reflect the size of their sexual desire to a certain extent.
  • Table 7 shows that CUMS stress prolongs the crawler latency of the rats and reduces the number of crawling backs. To some extent, the arousal of rat sexual desire is affected by the modeling stress. Compared with venlafaxine, this indicator is negatively regulated. After administration of traditional Chinese medicine extract, the abnormality of the above indicators can be improved, indicating that the Chinese herbal extract improves the depression-like symptoms of CUMS rats without causing side effects of libido reduction.
  • the Morris water maze and the elevated cross maze experiment were carried out.
  • the spatial navigation latency and the number of crossing platforms in the water maze were selected as the investigation of the cognitive function of CUMS rats.
  • the number of open arms in the elevated cross maze was selected. Proportion and ratio of time to open arm were used as an examination of anxiety in CUMS rats.
  • Table 8 shows that CUMS-depressed rats have a reduced number of crossing platforms and target quadrants during the spatial exploration period, suggesting that CUMS-depressed rats are associated with cognitive impairment. Compared with venlafaxine, this phenomenon can be adjusted, and the Chinese herbal extract can improve this symptom after administration.
  • the traditional Chinese medicine extract powder and the pregelatinized starch are mixed in a ratio of 5:2, and are granulated by dry granulation to prepare granules.
  • the parameters of the dry granulator are adjusted to: extrusion speed 6.0 rpm; feed speed 7.0 rpm; The pellet speed was 10.0 rpm; the side seal pressure was 13 MPa; the extrusion pressure was 27 MPa.
  • the mesh used in the granulation was 10 mesh, and the whole sieve was 40 mesh.
  • the granules are granulated and packaged by the composite film to obtain the finished product.
  • Chinese herbal extract powder is mixed with sucrose and dextrin in a ratio of 2:0.5:0.5, using 75% ethanol as a wetting agent, swaying granulator, passing through 10 mesh stainless steel mesh, granulating, drying, passing 40 mesh sieve The net is granulated and packaged in a composite film.

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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)
PCT/CN2018/103870 2017-10-12 2018-09-04 一种具有抗抑郁功效的中药提取物及其制备方法和应用 WO2019072051A1 (zh)

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JP2019559814A JP6880236B2 (ja) 2017-10-12 2018-09-04 うつ病に効果がある漢方薬エキス及びその調製方法と使用

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CN201710947004.4 2017-10-12
CN201710947004.4A CN107625813A (zh) 2017-10-12 2017-10-12 一种具有抗抑郁功效的中药提取物及其制备方法和应用
CN201810724541.7A CN108653405A (zh) 2017-10-12 2018-07-04 一种具有抗抑郁功效的中药提取物及其制备方法和应用
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Publication number Priority date Publication date Assignee Title
CN111665107A (zh) * 2020-06-16 2020-09-15 湖南一方天江药业有限公司 一种便于定量提取的中药实验检验用提取装置

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CN114053337B (zh) * 2020-07-30 2023-12-26 天士力医药集团股份有限公司 一种具有缓解精神及抗抑郁功效的中药组合物及其制备方法
CN111973692B (zh) * 2020-08-24 2022-01-21 江西普正制药股份有限公司 一种红花逍遥制剂及其制备方法、抗抑郁中的应用
CN114191426B (zh) * 2021-11-12 2023-11-10 成都中医药大学 一种柴胡当归薄荷复方提取物及其制备方法和用途

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CN101732427A (zh) * 2008-11-24 2010-06-16 广州白云山和记黄埔中药有限公司 预防和/或治疗抑郁症和更年期综合症的药物组合物

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN111665107A (zh) * 2020-06-16 2020-09-15 湖南一方天江药业有限公司 一种便于定量提取的中药实验检验用提取装置

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