WO2008019588A1 - Préparation de médecine chinoise traitant la dépression et la neurasthénie; et son procédé d'élaboration - Google Patents

Préparation de médecine chinoise traitant la dépression et la neurasthénie; et son procédé d'élaboration Download PDF

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WO2008019588A1
WO2008019588A1 PCT/CN2007/002362 CN2007002362W WO2008019588A1 WO 2008019588 A1 WO2008019588 A1 WO 2008019588A1 CN 2007002362 W CN2007002362 W CN 2007002362W WO 2008019588 A1 WO2008019588 A1 WO 2008019588A1
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weight
parts
add
ethanol
water
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PCT/CN2007/002362
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English (en)
Chinese (zh)
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Bingqi Wang
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Xiamen Guilong Investment Management Co., Ltd
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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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/888—Araceae (Arum family), e.g. caladium, calla lily or skunk cabbage
    • A61K36/8888—Pinellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02—Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/618—Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • 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)
    • A61K36/48—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)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
    • 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
    • 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
    • A61K36/718—Coptis (goldthread)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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 relates to a traditional Chinese medicine composition, a preparation method thereof and a quality control method, in particular to a traditional Chinese medicine composition for treating insomnia, depression and neurasthenia, a preparation method thereof and a quality detecting method.
  • Insomnia, depression, and neurasthenia refer to excessive mental stress caused by certain long-standing mental factors, resulting in a decrease in mental activity. Its main clinical features are easy to get excited and easy to fatigue. Often accompanied by a variety of physical discomfort and sleep disorders, many patients have a certain predisposition or bad personality before the disease. Busy life, intense work, all kinds of unpleasant annoyances can cause people's brain function to be at high speed or super high speed, leading to neurological disorders, resulting in a series of clinical symptoms, such as insomnia, dizziness, dizziness, Forgetfulness, irritability, fatigue and other symptoms, long-term insomnia can lead to other serious diseases. Although there are dozens of treatments for insomnia in modern medicine, there are many dependences and addictions after taking them, and there are side effects after taking the medicine.
  • the object of the present invention is to provide a traditional Chinese medicine composition and a preparation method thereof. Another object of the present invention is to provide a method for quality detection of the preparation of the traditional Chinese medicine composition; and the object of the present invention is to provide the use of the traditional Chinese medicine composition.
  • composition of the drug substance of the traditional Chinese medicine composition of the present invention is as follows:
  • Method Pinellia 5-30 parts by weight bamboo radish 5-30 parts by weight Zhigancao 1-12 parts by weight Huanglian 0. 5-3 parts by weight ginger 2-20 parts by weight of cassia twig 2-20 parts by weight of chalk 2-20 parts by weight.
  • the preferred weight ratio of the above-mentioned ten-flavor drug substance of the present invention is as follows:
  • the preferred weight of the ten-flavor drug substance of the present invention is as follows:
  • Oyster 20 parts by weight keel 20 parts by weight Bupleurum 10 parts by weight Pinellia 15 parts by weight bamboo rugs 15 parts by weight Licorice 6 parts by weight Coptis 2 parts by weight Ginger 10 parts by weight Cinnamon 10 parts by weight Preferred in the present invention The weight is as follows:
  • the above-mentioned traditional Chinese medicine composition of the present invention may further comprise the following parts by weight of schisandra, salvia, fried jujube kernel, jujube, and fried rhubarb composed of fifteen flavor raw materials on the basis of the ten-flavor bulk medicine: schisandra 1-14 parts by weight of salvia miltiorrhiza 5-30 parts by weight of fried jujube kernels 2-20 parts by weight of jujube 1-12 parts by weight of fried rhubarb 1-10 parts by weight.
  • the ten- or fifteen-flavor drug substance of the traditional Chinese medicine composition is added into a conventional auxiliary preparation according to a conventional process, such as: a capsule, a pill, a tablet, a granule, an oral liquid preparation or an injection. .
  • the preparation method of the pharmaceutical composition of the present invention may be as follows: A. Take the drug substance, add water to cook 2-4 times, add 8-12 times the total weight of the drug substance for the first time, decoct for 1-3 hours, add 8-12 times the total weight of the drug substance for the second time. Water, decocted 0. 5-1. 5 hours, the third time plus 8-12 times the total weight of the drug substance, boiling 0.
  • the thick paste having a relative density of 1.30-1.35 is added to a conventional excipient, and is prepared into a capsule, a pill, a tablet, a granule, an oral liquid preparation or an injection according to a conventional method.
  • the preparation method of the pharmaceutical composition of the present invention is preferably as follows:
  • the alcohol content is 60%, stirred, and allowed to stand for 12 hours.
  • the supernatant is taken to recover ethanol and concentrated to 60 thick paste having a relative density of 1.30 ⁇ 1.35, added with conventional excipients, and prepared into a plasticizer according to a conventional method. , pills, tablets, granules, oral liquid preparations or injections.
  • the relationship between parts by weight and parts by volume of the present invention is: gram per liter.
  • the quality detecting method of the present invention includes the following identification method and/or content determination method.
  • the identification method includes one or more of the following identifications:
  • ⁇ take 1/3-1/2 of the daily dose of the pharmaceutical composition, equivalent to 21-42g of crude drug, finely ground, add 20ml of ethanol, immerse for 1 hour at room temperature, filter, the filtrate is evaporated to dryness, and the residue is added with methanol 1ml.
  • the method for determining the content in the quality control method includes the following:
  • the daily dose (daily dose or daily dose) of the different preparations of the pharmaceutical composition of the present invention varies depending on the preparation, but the daily dose of the different preparations contains the same amount of the raw medicine (the crude drug amount is 64 to 96 g).
  • the quality detecting method of the present invention uses a daily dosage as a unit of measurement.
  • the pharmaceutical composition of the invention has the functions of soothing liver and relieving stagnation, dissolving phlegm and dispersing phlegm, and calming the mind, and is suitable for upset depression caused by liver qi stagnation, chest fullness, insomnia anxiety, diet and tastelessness; Heart and kidney do not pay less than dreams, upsets, fatigue, body fatigue and other neurasthenia, clinical trials set up a total of 308 cases in the observation group, 112 cases in the control group. Clinical observations show that: the pharmaceutical composition of the invention has obvious curative effect on neurasthenia, and the total curative effect is superior to that of the nymidine granules ( ⁇ 0 ⁇ 01) compared with the control group of Ningning granules.
  • the pharmaceutical composition of the invention has high curative effect on turbidity and heart-dissipation type, heart-kidney non-crossing type and heart-spleen deficiency type, and the curative effect of turbidity and disturbing heart type is obviously superior to that of Ningning granules (P ⁇ 0.05). It is indicated that the pharmaceutical composition of the present invention and the Ningning Granule are satisfactory for both types of effects, but the pharmaceutical composition of the present invention is superior in terms of the percentage of efficiency, and the dosage is small and convenient to take.
  • the therapeutic effect of the pharmaceutical composition of the present invention on insomnia and dreams was significantly better than that of Ningning Granules (P ⁇ 0.01), and the improvement of irritability, dizziness, brain swelling and forgetfulness was better than night. Ning granules.
  • TCM classification was 70 cases of heart and spleen deficiency type, 108 cases of heart and kidney disharmony type, 13 cases of heart gallbladder qi deficiency type, and 117 cases of turbidity and disturbance type.
  • Control group 112 cases, including 51 males and 61 females, aged 29-65 years old, with an average age of 46.87 years old, ranging from 1 month to 26 years, with an average of 4.12 years, TCM classification is diphtheria There were 36 cases, 46 cases of heart and kidney disharmony, 4 cases of heart and qi deficiency, and 26 cases of turbidity and heart.
  • Case selection Sickness chooses neurasthenia with insomnia and dreams as the main syndrome, and excludes serious heart, liver, kidney, brain and other organic lesions.
  • Dialectical of TCM belongs to (1) turbidity and disturbing heart type: Insomnia and more dreams, and the head is heavy, chest tightness, dizziness, pale tongue, greasy fur, slippery pulse.
  • heart and kidney non-crossing type upset, dreaming, dizziness, tinnitus, palpitations, forgetfulness, dry mouth Shaojin, backache or mouth sores, tongue red, pulse breakdown.
  • Heart qi deficiency type Insomnia and heart ⁇ ⁇ ⁇ , shortness of breath, sputum, pale tongue, pulse breakdown.
  • Heart and spleen deficiency type Insomnia and dreams and heart and mind are divided into forgetfulness, head-spotted, distressed, pale-skinned, thin white fur, weak pulse.
  • Example 1 The granules prepared in Example 1 were taken one to two bags (6 g) each time, 2 to 3 times a day.
  • Control group Ningning granules, 20 grams each time, 2 times a day, 1 time in the morning and evening.
  • Treatment and precautions Both groups of patients took a 7-day course of treatment. Each case required to take a course of treatment before counting the statistics, and taking the drug to prevent sleeping pills, so as not to affect the observation. The accuracy of the fruit.
  • Observation indicators All cases were based on insomnia and dreams, combined with tongue image and pulse image as observation indicators, and graded observation. Other symptoms of neurasthenia are sub-acceptors. Such as dizziness, bloating, irritability, forgetfulness, distress, and so on, the changes to the sub-test are expressed as (a) ( + ) ( ++ ). (-) is normal, (+) is normal, and (++) is severe.
  • Insomnia Grading (1) Level 0: Asymptomatic. (2) Level I: It is difficult to fall asleep, it takes about half an hour to fall asleep, or sleep time is short. After waking up, I feel that my body is more relaxed, or I don’t know how to squat, when I wake up, I wake up and wake up easily. (3) ⁇ grade: It is difficult to fall asleep, tossing and turning, it takes half an hour to sleep above, wake up early, feel sleepy after waking up, fatigue or weakness, sleep when awake, wake up is more difficult to fall asleep. (4) m level: sleepless nights or sleep more dreams, sleep or not sleep 3 to 4 hours, although there is sleep but fatigue, dizziness and brain swelling and other symptoms did not improve significantly.
  • Dream rating (1) Level 0: No dreams or less dreams. (2) Level I: More dreams. (3) ⁇ Level: Dreaming more, still sleep after waking up. (4) m level: Dreams are different, wake up and wake up.
  • Control group 112 2 ( 1. 79 ) 22 (19. 64) 58 (51. 79) 30 (26. 78)
  • Example 1 The results showed that the efficacy of the observation group was significantly different from that of the control group.
  • the granules prepared in Example 1 were significantly better than the control yin granules.
  • the results showed that the granules prepared in the observation group, ie, the granules prepared in Example 1 were effective for various types of neurasthenia, such as turbidity, heart and kidney, heart and spleen deficiency, heart and spleen qi deficiency type, and the curative effect was significantly better than night. Ning granules.
  • the present invention is a granule (that is, the granule prepared in Example 7), formulated into a suspension of 8% and 4% with water, and administered to Kunming mice by intragastric administration; , Lot number 9908056, produced by Sino-American Shike Pharmaceutical Co., Ltd.
  • mice male and female, were divided into groups and administered once daily for 20 days.
  • the mice were placed in an open glass jar (high 19 cm, diameter 12 cm, water depth 8 cm, water temperature 22-23) 1 hour after the second administration, and the time was recorded from the time when the mice entered the water for 6 minutes, and accumulated within 4 minutes after the recording. Do not move time.
  • Table 4 Each of the administration groups significantly shortened the time during which the mice were forced to swim.
  • Control group 10 151.0 ⁇ 48.6
  • Granules of the invention lg"0 10 103.2 ⁇ 39.5*
  • Granules of the invention 2gx 20 10 96.1 ⁇ 36.2*
  • mice 178 ⁇ 6 g male rats were selected, grouped and administered once daily according to the dose of Table 5, for 20 consecutive days.
  • the rats were individually placed in an open glass jar (40 cm high, 80 cm in diameter, 15 cm in water depth, 24 to 26 ° C), and the rats were exposed to water for 15 minutes. Take out, dry at 32*C; 1 hour after the administration on the 20th day, measure the cumulative immobility time in the rats for 5 minutes. The results are shown in Table 5.
  • Each of the administration groups significantly shortened the time of forced swimming in rats.
  • Granules of the invention 0.8gx 20 10 146.9 ⁇ 29.2*
  • the granules of the present invention can significantly shorten the time of forced swimming, increase the mood of animals and enhance the behavior of animals.
  • These experimental results show that the granules of the present invention can be used for the treatment of depression with symptoms of anxiety, insomnia, restlessness, and fatigue, and have a good antidepressant effect.
  • the raw material is mixed, pulverized into 15 mesh coarse particles, added with water 6 liters, and extracted by microwave extraction method for 60 times or less, and the extract is centrifuged, and the immersion liquid is concentrated to a relative density of 1.30 ⁇ 1. 35 , adding conventional excipients, and making pills according to conventional methods.
  • the raw material is mixed, pulverized into a 17-mesh coarse particle, and 7 liters of water is added, and the mixture is extracted by a microwave extraction method for 60 times or less, and the extract is centrifuged, and the immersion liquid is concentrated to a relative density of 1.30 ⁇ 1. 35 5 ⁇
  • the relative density is 1. 30 ⁇ 1.
  • the organic material is mixed and pulverized into 20 mesh coarse particles, and added with water, 7 liters, and extracted by microwave extraction method for 60 times or less, and the extract is centrifuged, and the immersion liquid is concentrated to a relative density of 1. 30 ⁇ 1. 35, adding conventional excipients, making oral liquid preparations according to conventional methods, single The formulation is 10 liters per bottle.
  • Example 1 Take 6 g of the pharmaceutical composition granules of Example 1, which is equivalent to a crude drug amount of 32 g, and add 30 ml of ethanol, immersed for 1 hour at room temperature, shaken occasionally, filtered, and the filtrate is evaporated to dryness. The residue is added with water 20 ml to dissolve, and saturated with water. The n-butanol was shaken and extracted three times, 20 ml each time, and the n-butanol extract was combined, washed once with water saturated with n-butanol, and the aqueous layer was discarded. The n-butanol solution was evaporated to dryness in a water bath, and the residue was added with ethanol.
  • Lml is dissolved, added with alumina 0.6 g, stirred on a water bath, dried, and charged into a pre-packed neutral alumina adsorption column with a particle size of 200-300 mesh, a weight of lg, and an inner diameter of 10-15 mm.
  • the neutral alumina adsorption column was eluted with 60 ml of ethanol, and the eluate was collected, evaporated to dryness, and the residue was added with 1 ml of ethanol to dissolve, and used as a test solution; another reference substance of paeoniflorin was added, and ethanol was added to prepare a solution containing 1 mg per ml.
  • Example 1 Take 6 g of the pharmaceutical composition granules of Example 1, which is equivalent to a crude drug amount of 32 g, and add 30 ml of ethanol, reflux under heating for 30 minutes, let cool, filter, take 10 ml, evaporate to dryness, and add 10 ml of water to dissolve the residue.
  • Example 9 Method for determining content in quality testing
  • Example 1 6g taking the pharmaceutical composition granules of Example 1 6g, corresponding to the crude drug amount 32g plus ethanol 30ml, immersed for 1 hour at room temperature, shaking at any time, filtered, the filtrate is evaporated to dryness, the residue is added with water 20ml to dissolve, water is saturated with n-butyl The alcohol was shaken and extracted three times, 20 ml each time, and the n-butanol extract was combined, washed once with water saturated with n-butanol, and the aqueous layer was discarded. The n-butanol solution was evaporated to dryness in a water bath, and the residue was dissolved in ethanol to dissolve 1 ml. Add 0.
  • Reference solution according to the thin layer chromatography test, take 10 ⁇ l of each of the above two solutions, respectively, on the same silica gel G thin-layer plate, to 40: 5: 10: 0.2 chloroform-ethyl acetate-sterol a citric acid as a developing agent, expand , take out, dry, spray with 5% vanillin sulfuric acid solution, heat to the spots to develop color clear; for the test sample, in the position corresponding to the reference color, the same color spots;
  • Example 6 taking the pharmaceutical composition granules of Example 1 6g, corresponding to the amount of 32g of crude drug, 20ml of ethanol, immersed for 1 hour at room temperature, filtered, the filtrate was evaporated to dryness
  • Another 50mg of berberine reference medicine add 10ml of methanol, heated on a water bath for 10 minutes, filtered, the filtrate was evaporated to dryness, the residue was added with methanol 1ml to dissolve, as a reference drug solution; then take berberine hydrochloride reference substance, add methanol Prepare a solution containing 0.5 ⁇ g per lml as a reference solution; according to the thin layer chromatography test, take 2 ⁇ ⁇ of each of the above three solutions, respectively, on the same silica gel G thin layer plate, to 7: 1: 2 n-butanol monohydrate acetic acid-water
  • the developing agent unfold, take out, dry, and set it under the 365nm ultraviolet light; in the chromatogram of the test sample
  • Example 1 Take 6 g of the pharmaceutical composition granules of Example 1, which is equivalent to a crude drug amount of 32 g, and add 30 ml of ethanol, reflux under heating for 30 minutes, let cool, filter, take 10 ml, evaporate to dryness, and add 10 ml of water to dissolve the residue.
  • Example 11 Quality Inspection Method A. Take 4 g of the pharmaceutical composition capsule of Example 3, which is equivalent to 32 g of crude drug and 30 ml of ethanol, immersed for 1 hour at room temperature, shaken occasionally, filtered, and the filtrate is evaporated to dryness. The residue is added with water 20 ml to dissolve, and the water is saturated. The butanol was shaken and extracted three times, 20 ml each time, and the n-butanol extract was combined, washed once with water saturated with n-butanol, and the aqueous layer was discarded. The n-butanol solution was evaporated to dryness on a water bath, and the residue was added with 1 ml of ethanol. Dissolve, add 0.
  • Example 3 4g taking the pharmaceutical composition capsule of Example 3 4g, corresponding to the amount of 32g of crude drug, adding 30ml of ethanol, heating and refluxing for 30 minutes, allowing to cool, filtering, taking 10ml, evaporated to dryness, adding 10ml of water to dissolve the residue, Add 1 ml of hydrochloric acid, heat on a water bath for 30 minutes, immediately cool, extract twice with diethyl ether, 10 ml each time, combine the ether extract, remove the ether, and add 1 ml of ethyl acetate to dissolve the solution.
  • the reference drug solution was prepared in the same manner as the test solution; the chrysophanol and the emodin reference substance were added, and methanol was added to make a mixed solution containing 0.5 mg each of 1 ml, as a reference solution;
  • 5 ⁇ l of each of the above solutions was taken up on the same silica gel crucible plate with sodium carboxymethylcellulose as a binder, and 15:5:1 of 30-60* petroleum ether monoethyl ester
  • the upper layer of monoformic acid is used as a developing solvent, unrolled, taken out, dried, and placed under a 365 nm ultraviolet light.
  • the same five orange-yellow fluorescent spots are displayed at the position corresponding to the chromatogram of the reference drug.
  • the same orange-yellow fluorescent spot is displayed; smoked in ammonia gas, examined in daylight, and spotted in red; determined by high performance liquid chromatography; chromatographic conditions and system suitability test; Using octadecylsilane bonded silica as a filler; 14: 86 acetonitrile - 0.
  • the preparation of the drug composition capsules of Example 3 is obtained by the method of accurately weighing the paeoniflorin reference substance, adding 50% ethanol to make a solution containing 0. lmg per lml; , equivalent to the amount of raw drug 10. 7g finely ground, mixed, accurately weighed, placed in a triangular bottle, precision added 50ml ethanol 50ml, weighed, sonicated for 30 minutes, let cool, then weighed, 50% The weight of the lost weight of ethanol is adjusted, shaken, filtered, and the filtrate is taken and filtered through a 0.
  • the determination method precision extraction of the reference solution and the test solution respectively. ⁇ , injected into the liquid chromatograph, measured, that is;; containing paeoniflorin C 23 H 28 0 administrat not less than 24. Omg / daily dose.
  • Example 5 Take 8 g of the pharmaceutical composition tablet of Example 5, which is equivalent to 32 g of crude drug and 30 ml of ethanol, immersed for 1 hour at room temperature, shaken occasionally, filtered, and the filtrate is evaporated to dryness. The residue is added with water 20 ml to dissolve, and the mixture is saturated with water. The alcohol was shaken and extracted three times, 20 ml each time, and the n-butanol extract was combined, washed once with water saturated with n-butanol, and the aqueous layer was discarded. The n-butanol solution was evaporated to dryness in a water bath, and the residue was dissolved in ethanol to dissolve 1 ml. Add 0.
  • Another 50mg of berberine reference medicine add 10ml of methanol, heated on a water bath for 10 minutes, filtered, the filtrate was evaporated to dryness, the residue was added with 1ml of sterol to dissolve, as a reference drug solution; then take berberine hydrochloride reference substance, add Methanol is made into a solution containing 0.5 mg per 1 ml, as a reference solution; according to the thin layer chromatography test, 2 ⁇ ⁇ of each of the above three solutions is taken up, respectively, on the same silica gel G thin layer plate, 7: 1: 2 n-butanol monohydrate acetic acid-water as a developing agent, unfold, take out, dry, and set under 365nm ultraviolet light; in the chromatogram of the test sample, the fluorescence of the same color is displayed at the position corresponding to the color of the reference drug Spot; the same yellow fluorescent spot at the position corresponding to the chromatogram of the control;

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Abstract

L'invention porte: sur une préparation de médecine chinoise traitant la dépression, l'insomnie et la neurasthénie; sur son procédé d'élaboration, sur sa méthode de détection de qualité et sur ses utilisations. Ladite préparation comporte les ingrédients suivants: rhizoma zingiberis recens, caulis bambusae in taenia, rhizoma pinelliae preparata, rhizoma coptidis, radix paeoniae alba, ramulus cinnamomi, radix glycyrrhizae preparata, radix bupleuri, concha ostreae, et os draconis.
PCT/CN2007/002362 2006-08-09 2007-08-07 Préparation de médecine chinoise traitant la dépression et la neurasthénie; et son procédé d'élaboration WO2008019588A1 (fr)

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WO2011139118A2 (fr) * 2010-05-06 2011-11-10 Cj Cheiljedang Corporation Composition pharmaceutique et composition d'aliment naturel fonctionnel pour la prévention, le traitement ou l'amélioration de maladies de type dyskinésie gastro-intestinale
CN108273021A (zh) * 2018-03-14 2018-07-13 周振海 一种可双向调节治疗疾病的中药制剂
CN108445139A (zh) * 2018-03-26 2018-08-24 河南省洛正药业有限责任公司 一种治疗滑膜炎的中药制剂的鉴别方法
CN111595986A (zh) * 2019-02-20 2020-08-28 山西华康药业股份有限公司 一种益心复脉颗粒质量控制方法
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CN116870121A (zh) * 2023-08-18 2023-10-13 北京中医药大学东方医院 一种治疗双心病的中药组合物及其制备方法和应用
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CN104623599A (zh) * 2015-01-27 2015-05-20 刘卓韬 一种治疗神经衰弱的中药组合物及穴位组合针灸应用
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CN106110280A (zh) * 2016-08-28 2016-11-16 福州海王金象中药制药有限公司 桂龙咳喘宁片制备工艺
CN106267104A (zh) * 2016-09-24 2017-01-04 四川金堂海纳生物医药技术研究所 一种治疗抑郁、失眠及神经衰弱症的汤剂药物及制备方法
CN107397790A (zh) * 2017-08-11 2017-11-28 福州薛沐华生物科技有限公司 一种安神助眠的洗浴中草药组合物及其制备方法

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WO2011139118A3 (fr) * 2010-05-06 2012-04-19 Cj Cheiljedang Corporation Composition pharmaceutique et composition d'aliment naturel fonctionnel pour la prévention, le traitement ou l'amélioration de maladies de type dyskinésie gastro-intestinale
WO2011139118A2 (fr) * 2010-05-06 2011-11-10 Cj Cheiljedang Corporation Composition pharmaceutique et composition d'aliment naturel fonctionnel pour la prévention, le traitement ou l'amélioration de maladies de type dyskinésie gastro-intestinale
CN108273021A (zh) * 2018-03-14 2018-07-13 周振海 一种可双向调节治疗疾病的中药制剂
CN108445139B (zh) * 2018-03-26 2022-10-21 河南省洛正药业有限责任公司 一种治疗滑膜炎的中药制剂的鉴别方法
CN108445139A (zh) * 2018-03-26 2018-08-24 河南省洛正药业有限责任公司 一种治疗滑膜炎的中药制剂的鉴别方法
CN111595986A (zh) * 2019-02-20 2020-08-28 山西华康药业股份有限公司 一种益心复脉颗粒质量控制方法
CN114869959B (zh) * 2020-08-24 2023-04-28 河北平安健康集团股份有限公司 中药组合物在制备用于治疗抑郁的药物中的应用
CN114869959A (zh) * 2020-08-24 2022-08-09 河北平安健康集团股份有限公司 中药组合物在制备用于治疗抑郁的药物中的应用
CN114689783B (zh) * 2020-12-31 2023-09-12 四川新绿色药业科技发展有限公司 一种苓桂术甘汤冻干粉快速薄层鉴别方法
CN114689783A (zh) * 2020-12-31 2022-07-01 四川新绿色药业科技发展有限公司 一种苓桂术甘汤冻干粉快速薄层鉴别方法
CN113341007A (zh) * 2021-05-24 2021-09-03 北京大学 一种基于hplc特征图谱的枣仁安神胶囊全药味多成分含量测定方法
CN113341007B (zh) * 2021-05-24 2023-10-10 北京大学 一种基于hplc特征图谱的枣仁安神胶囊全药味多成分含量测定方法
CN114324725A (zh) * 2021-12-24 2022-04-12 承德燕峰药业有限责任公司 一种照山白浸膏片的梯度全信息薄层鉴别方法
CN114324725B (zh) * 2021-12-24 2023-12-22 承德燕峰药业有限责任公司 一种照山白浸膏片的梯度全信息薄层鉴别方法
CN114740136A (zh) * 2022-04-28 2022-07-12 广西壮族自治区食品药品检验所 水田七药材的质量检测方法
CN114740136B (zh) * 2022-04-28 2024-03-19 广西壮族自治区食品药品检验所 水田七药材的质量检测方法
CN116870121A (zh) * 2023-08-18 2023-10-13 北京中医药大学东方医院 一种治疗双心病的中药组合物及其制备方法和应用
CN116870121B (zh) * 2023-08-18 2024-04-02 北京中医药大学东方医院 一种治疗双心病的中药组合物及其制备方法和应用
CN117159658A (zh) * 2023-11-02 2023-12-05 中国人民解放军总医院第六医学中心 一种预防、减缓或治疗顽固性失眠的中药组合物及制作工艺
CN117159658B (zh) * 2023-11-02 2024-02-13 中国人民解放军总医院第六医学中心 一种预防、减缓或治疗顽固性失眠的中药组合物及制作工艺

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