WO2006097043A1 - Extrait de bacopa monnieri et son procede de preparation et d'utilisation - Google Patents

Extrait de bacopa monnieri et son procede de preparation et d'utilisation Download PDF

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Publication number
WO2006097043A1
WO2006097043A1 PCT/CN2006/000394 CN2006000394W WO2006097043A1 WO 2006097043 A1 WO2006097043 A1 WO 2006097043A1 CN 2006000394 W CN2006000394 W CN 2006000394W WO 2006097043 A1 WO2006097043 A1 WO 2006097043A1
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WO
WIPO (PCT)
Prior art keywords
extract
total
bacoside
oleracea
ethanol
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PCT/CN2006/000394
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English (en)
Chinese (zh)
Inventor
Mingfu Yang
Yunxiu Huang
Yuping Lei
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Chengdu Wagott Pharmaceutical Co., Ltd.
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Publication of WO2006097043A1 publication Critical patent/WO2006097043A1/fr

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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)
    • A61K36/80—Scrophulariaceae (Figwort family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • 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
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Definitions

  • the present invention relates to a shamrock extract, and more particularly to an extract of a natural medicinal material, Purslane, which comprises a preparation method and use of the extract, and belongs to the field of medicine.
  • the fake purslane is the whole grass of Bacopa monninera, a traditional Indian herb. It has the effects of clearing away heat and detoxifying, reducing inflammation and reducing swelling, treating red eyes and dysentery, redness and swelling of the eyes, redness and swelling of the skin, etc. It is a well-known antipsychotic and memory-enhancing drug in India.
  • Gingival sputum is an "adaptogen" with two-way regulation and anti-stress response, which can help regulate the body's ability to resist environmental stress and guide the return to normal health.
  • AS acute stimulation
  • CS chronic stimulation
  • oleracea extract will reduce the index of gastric ulcer and the activity of aspartate aminotransferase, and tend to 1 ⁇ . High dose will make the gastric ulcer index, adrenal gland The weight decreases, and the aspartate aminotransferase and creatine kinase activities decrease and tend to be normal. Therefore, the extract of the purslane has a soothing effect, is an environmental hormone, and adapts to the original.
  • Portulaca oleracea is a calcium blocker that has an antispasmodic effect on smooth muscle.
  • the existing literature is mainly on the identification of its chemical constituents, especially the triterpenoid saponin structure.
  • the extraction process of the saponin is as follows: The dried saponin is extracted with water or alcohol, separated by a solvent method or separated and purified by silica gel column chromatography.
  • WO2004060267-A2 The extraction and separation methods are as follows: water or organic solvent extraction, drying, removal of fatty substances in a non-polar solvent, extraction of residues with at least one organic solvent, extraction with water, drying of the organic layer under vacuum, separation by silica gel column chromatography, water or organic The solvent is eluted to obtain a product having a saponin A+B content of 80-100%, and A and hydrazine are separated by chromatography.
  • the second part is: WO2004054599-A1, extracting saponin A+B content of 20 ⁇ 30% extract.
  • n-hexane Decondensation of n-hexane, drying of filter residue, extraction of acetone (removal of non-BACOSIDE components and pigment substances), extraction of methanol residue, concentration of extract, addition of concentrate to acetone, filtration, filtration of water, filtration of n-butanol, concentration
  • a non-toxic stabilizer such as e-cyclodextrin
  • the technical solution of the present invention is to provide a extract of P. oleracea, and another technical solution of the present invention provides a preparation method and use of the extract.
  • the present invention provides a extract of P. oleracea, wherein the total percentage of total saponins of P. oleracea is from 10% to 80% by weight of Bacoside A.
  • BACODSIDE A consists of the following components:
  • Bacoside A 3 bacopaside II, bacopaside X, bacopasaponin C, the structure is as follows: bacoside A3: The aglycone is jujube saponin, the sugar chain is:
  • Bacopaside II The aglycon is: pseudojujube saponin, the sugar chain is:
  • Bacopaside X aglycon is: jujube saponin, the sugar chain is: 3-0- a-L-furan arabinosyl-(1 _ ⁇ 2) - [ ⁇ -D-glucopyranosyl-(1 ⁇ 3) - ] - ⁇ - L-pyranose
  • the aglycon is: pseudojujube saponin
  • the sugar chain is: 3- O- ⁇ -D-glucopyranosyl-(1 -[ aL-furan arabinyl-(1- 2) ] - a- L pyran Arabinosyl
  • the total percentage of total saponins of P. oleracea is in the range of Bacoside A, which accounts for 10% to 40% of the extract.
  • the total percentage of total saponins of P. oleracea is from 10% to 30% by weight of Bacoside A.
  • the total percentage of total saponins of P. oleracea is in the range of Bacoside A, which is 20% ⁇ 0.04 of the extract.
  • the total percentage of total saponins of P. oleracea is in the range of Bacoside A, which accounts for 40% to 70% of the extract. 01 ⁇ The total weight of the total saponin of the saponin is determined by Bacoside A, accounting for 50% ⁇ 0.1 of the extract.
  • the false purslane is derived from the whole grass of the scrophulariaceae plant Bacopa monnieri L.
  • the extract of the scutellaria chinensis is extracted by the following method: taking the whole grass of the dried scorpionfish Bacopa monnieri L., extracting 40% ⁇ 80% ethanol, and extracting the extract directly and drying to obtain the extract of the scutellaria Or after concentrating the extract, the macroporous adsorption resin is adsorbed, and then eluted with 10% to 95% ethanol, and the eluate is collected and dried to obtain.
  • the invention also provides a method for preparing the extract of the purslane, which comprises the following steps: a, weighing the whole grass of Bacopa monnieri L., adding 40% ⁇ 80% ethanol extraction, and extracting the extract, Concentrated liquid;
  • the concentrated extract is purified and purified by a macroporous adsorption resin method, and 10-95% ethanol is used as an eluent, and the eluate is collected and dried to obtain.
  • the ethanol elution described in step b is: eluted with 60-95% ethanol. Further, the ethanol elution described in step b is: first eluted with 10% to 60% ethanol, and then with 60% to 9% ethanol.
  • elution can be carried out in the following two ways: (1) directly eluted with 60 to 95% ethanol. (2) First elute with 10% ⁇ 60% ethanol, and then elute with 60% ⁇ 95% ethanol when the color of the eluent is obviously lighter.
  • the present invention also provides the use of the extract of Pseudomonas sinensis in the preparation of an antidepressant and puzzled drug.
  • the present invention also provides a pharmaceutical composition which is prepared by adding an effective amount of a extract of P. oleracea as a raw material, and adding a pharmaceutically acceptable excipient or an excipient.
  • the preparation is an oral preparation or an injection.
  • the invention also provides the use of the pharmaceutical composition for the preparation of a medicament for antidepressant.
  • the weight percentage of the total saponins of Pseudomonas sinensis in the drug containing Baccoon A is 10% to 80% of the extract.
  • the pseudo-dentate width extract of the medicament contains the total content of the total saponins of the purslane in a Bacoside A ratio of 10 to 40%.
  • the drug has a weight percentage of the total saponin of the purslane, which is 20% ⁇ 0.04 in terms of Bacoside A.
  • the invention also provides the use of the pharmaceutical composition for the preparation of a puzzle drug.
  • the weight percentage of the total saponins of Pseudomonas sinensis in the drug is Bacoside A, which accounts for 10% to 80% of the extract.
  • the drug contains 0.1% by weight of the total saponins of P. oleracea extract in terms of Bacoside A, and is 40-70% by weight.
  • the drug has a weight percentage of the total saponin of the scutellaria sinensis in the medicinal saponin of the scutellaria saponin, which is 50% ⁇ 0.1 in terms of Bacoside A.
  • the preparation is an oral preparation or an injection.
  • a medically acceptable variety of preparations consisting of extracts of P. oleracea or extract of P. oleracea and pharmaceutical excipients. Such as tablets, capsules, soft capsules, granules, injections, and the like.
  • the auxiliary materials used in the present invention are excipients commonly used in pharmaceutical engineering such as solid preparations: dextrin, starch, starch derivatives, carboxymethyl cellulose, sucrose, calcium sulfate, magnesium stearate, lactose, micro-fine cellulose , glucose, sorbitol, mannitol, etc.
  • Excipients used in liquid preparations such as: water, ethanol, glycerin, propylene glycol, polyethylene glycol, and the like.
  • the extract of the purslane of the present invention may be a low content of 10 to 30%, or a high content of 60 to 80%, and different specifications of the extract of the purslane have different effects.
  • the resin is used for adsorption and impurity removal, the processing amount in the production process is large, and it can be reused through activation, which saves cost, and the organic solvent involved only ethanol, reducing organic solvent Damage to operators and production pipelines.
  • the extract of the purslane extract of the present invention has low cost, remarkable drug effect, strong controllability and stable quality.
  • Figure 1 Mouse platform test - Mean latency map of each group of mice (24-hour memory retention) (S)
  • Figure 2 Mouse platform test ⁇ Mean mouse latent period (long-term memory retention) mean point map S)
  • Figure 3 Antidepressant Screening - Forced Mouse swimming Test (Day 9)
  • Mouse Immobility Time Mean (S)
  • Figure 4 Antidepressant Screening - Forced Mouse swimming Test (Day 15)
  • HP 1100 quaternary pump HP 1100 column incubator; HP 1100 detector; reference purity ⁇ 97%; instrument water for re-distilled water; experimental water for heavy distilled water; acetonitrile for chromatographic purity; other reagents are of analytical grade.
  • bacopaside II The reference substance of Bacoside A 3 , bacopaside II, bacopaside X, bacopasaponin C dried to a constant weight by phosphorus pentoxide was accurately weighed, and methanol was added to make a mixed solution containing 0.15 mg per 1 ml, which was used as a reference solution.
  • test solution Weigh accurately two samples of 100mg in two 50ml volumetric flasks, add about 40ml of analytical methanol, sonicate in ultrasonic, let cool to room temperature, dilute to volume, shake well and use 0.45um microporous membrane Filter, that is.
  • test sample was injected into the liquid chromatograph, and the peak area was recorded and calculated according to the external standard method.
  • the content of bacoside A in this product is based on the total amount of Bacoside A 3 , bacopaside II, bacopaside X, and bacopasaponin C.
  • the extract of Pseudomonas cuspidatum of the present invention prepared in Example 1 was 60%, and 20% of fine cellulose, stevioside 5°/. , starch 10%, magnesium stearate 0.8%, hydroxypropyl cellulose 4.2%, fully mixed and granulated, packaged in the required dosage to obtain granules.
  • the granules obtained according to the examples were dispensed into the empty plastic shell at the required dosage to obtain a capsule.
  • the granules obtained according to the examples were directly tableted and film-coated to obtain tablets.
  • the above extract 30 g with water for injection, was completely dissolved under aseptic conditions, respectively, and passed through a glass filter G3, G6, potted in an ampoule, and sterilized at 100 ° C for 30 min to obtain 1000 pieces.
  • the pharmaceutically acceptable preparations of different specifications can be prepared by using the extracts of different specifications as described.
  • Test sample - The extract of P. oleracea prepared according to the method described in Examples 1-8, calculated as Bacoside A:
  • test sample is prepared according to the method of the embodiment: corresponding samples are respectively examples 2, 5, 7)
  • Promipramine Hydrochloride Lot Number: 050401, Specification: 25mg/tablet, produced by Shanghai Pharmaceutical Group Co., Ltd. According to the human clinical dose, it is converted into a dose of mouse H according to the body surface area, and is prepared by using pure water to prepare 0.75 mg/inl.
  • Naofukang piracetam
  • batch number 040302
  • specification: 0.4g/tablet produced by Guangdong Kangbotong Pharmaceutical Industry Co., Ltd.
  • the daily dose of the mouse is converted according to the body surface area, and 50 mg/ral is prepared by using pure water at the time of use.
  • the above positive control materials are all sealed and stored at room temperature.
  • Test Example 1 Screening test of the puzzle effect of the present invention - a mouse platform test
  • mice After the mouse plague was qualified, the computer (PEMS2.1 software) completely divided the mice into 12 groups, which were blank control group (saline group), positive (brain rehabilitation) control group, model control group and this group.
  • Invention drug three The high, medium and low dose groups of the test articles, 12 mice in each group, were divided into conventional words. The drug was administered to the corresponding group (dosing volume of 0.2 ml/10 g) once a day. After 7 days, the platform training was carried out. 45 min before the training, each group of mice was intragastrically administered once, 30 min before the training, except for the blank control group, the other groups of mice ip scopolamine 2. 5 mg / kg, blank control group ip the same volume of normal saline .
  • test animals were placed in the reaction chamber for 3 minutes, and then immediately passed the 36V alternating current, training 5 ⁇ , and the number of times the animals were subjected to electric shock was recorded as the academic achievement. Animals were routinely taken after removal. After 24 hours, the test was repeated (24-hour memory retention test), the number of animals that were shocked, the latency of the first jump off the platform and the total number of errors within 3rain. The above test (long-term memory retention test) was repeated 6 days later, data was recorded and statistical analysis was performed.
  • Model control group saline 12 1. 33 ⁇ 0. 65 1. 42 ⁇ 0. 79 47. 5 ⁇ 61. 0 positive (brain rehabilitation) control group 50 11 0. 64 ⁇ 1. 29* 1. 45 ⁇ 1 81 147. 8 soil 61. 3*
  • the drug A-low dose group of the invention 30 10 0. 50 ⁇ 0. 97** 0. 8 ⁇ 0. 79 128. 8 ⁇ 82. 5
  • Drug A-high dose group 120 12 0. 75 ⁇ 0. 97 1. 50 ⁇ 1. 51 101. 9 ⁇ 84. 1
  • the incubation period is the main indicator, which can objectively and accurately judge the memory ability of mice.
  • the other two are secondary indicators. The judgment is relatively subjective and the evaluation efficiency is low, so it is used as a secondary indicator.
  • the experimental results showed that: in the 24-hour memory retention test results of the mouse platform test, SPSS1. 0 One-way ANOVA-LSD-TUKEY was used for data analysis, and the blank control group compared with the model control group, the number of mouse errors, the number of electric shocks and There were significant differences in the indexes of the platform latency (P ⁇ 0.01). At the same time, there were significant differences between the positive (brain rehabilitation) control group and the model control group in terms of the number of mouse errors and the platform latency ( ⁇ 0. 05), indicating that the experimental model is established and the experimental evaluation system is reliable (see Table 2). Among the three tested samples of the present invention, 50.37% of the low dose (30 mg/kg) group was significantly different from the model control group (p ⁇ 0.05); 50.
  • mice have a memory retention effect in the short- and medium-term of the mice, which is more effective than the other samples.
  • Test Example 2 Antidepressant Screening Test of the Drug of the Invention - Forced Mouse swimming Test (Acquired Despair Model) After the mouse was quarantined, the computer (PEMS 2.1 software) completely randomized the mice into 12 groups, respectively Control group (saline group), positive (brain rehabilitation) control group, model control group and high, medium and low dose groups of three test articles of the present invention, 12 mice in each group, caged conventional words .
  • the corresponding group of drugs (administered volume 0.2ral/10g) was administered once a day.
  • Two days before the test the model mice were given lOmin swimming training once a day. The mice were fasted for 16 h before the test.
  • mice After 30 minutes of re-administration for the first 30 minutes of the evaluation, a single mouse was placed in the swimming pool water for 6 minutes, and the cumulative time of the mice within 4 minutes after the recording was recorded (test on the 9th day). (Do not move means that the mouse stops struggling in the water, or the animal is floating, only the small limbs move to keep the head floating on the water surface), and the above test is repeated once every 7 days (the 15th day test). Data was recorded and statistically analyzed.
  • each group of data is removed from the highest and lowest values and statistically processed. Therefore, the number of samples in each group is reduced by two compared with the actual sample. Analysis was performed using SPSS 11.0 One-way ANOVA-LSD.
  • the three samples of the present invention have certain functions to promote the mental and anti-depressive functions of the model mice, but the efficacy is not the same.
  • the range should be 80% - 120% of the test concentration; the uniformity of the preparation content, the scope should be the test concentration 70%-130%.
  • the optimal range of pharmacodynamic effects of the puzzle in this experiment is: 50% ⁇ 0.1, the best anti-depression sample range: 20% ⁇ 0.04.

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Abstract

L'invention concerne un extrait de Bacopa monnieri, dont la saponine totale est comprise entre 10 et 80 % en poids, en termes de bacoside A. L'invention concerne également des compositions pharmaceutiques contenant un extrait de Bacopa monnieri et leur procédé de préparation et d'utilisation. L'extrait de Bacopa monnieri de l'invention ayant différents quantités de bacoside A est utilisé à plusieurs égards, dans le secteur clinique notamment, en raison de son coût réduit, de sa contrôlabilité améliorée et de la stabilité de sa qualité.
PCT/CN2006/000394 2005-03-15 2006-03-14 Extrait de bacopa monnieri et son procede de preparation et d'utilisation WO2006097043A1 (fr)

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CN200510020517.8 2005-03-15
CN2005100205178A CN1833692B (zh) 2005-03-15 2005-03-15 一种假马齿苋提取物及其制备方法和用途

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016109856A1 (fr) 2015-01-02 2016-07-07 Melaleuca, Inc. Compositions multi-compléments
US10137164B2 (en) 2015-01-02 2018-11-27 Melaleuca, Inc. Dietary supplement compositions
US10576112B2 (en) 2015-01-02 2020-03-03 Melaleuca, Inc. Bacterial compositions

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CN107796882A (zh) * 2016-08-24 2018-03-13 山东颐正达医药科技有限公司 假马齿苋总皂苷提取物有效成分含量的测定方法
CN107789429A (zh) * 2016-08-24 2018-03-13 山东颐正达医药科技有限公司 假马齿苋总皂苷提取物的分离纯化方法及其在制备神经系统药物中的应用
CN106550950A (zh) * 2016-11-06 2017-04-05 徐州得铸生物科技有限公司 一种含假马齿苋皂苷ii的杀虫剂组合物
CN106831932A (zh) * 2016-12-29 2017-06-13 陕西嘉禾生物科技股份有限公司 一种从假马齿苋中提取分离假马齿苋皂甙的方法
IT201900013707A1 (it) * 2019-08-01 2021-02-01 Cristalfarma S R L Integratore alimentare, per uso come coadiuvante, per la prevenzione della demenza vascolare
CN114287626A (zh) * 2022-01-12 2022-04-08 唯思敦食品(上海)有限公司 一种健脑组合物及其制备方法

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WO2004054599A1 (fr) * 2002-12-18 2004-07-01 Council Of Scientific And Industrial Research Procede permettant la preparation d'une fraction stable enrichie en bacosides sous une forme non hygroscopique
WO2004060267A2 (fr) * 2003-01-03 2004-07-22 Ganga Raju Gokaraju Procede de production de fractions enrichies contenant jusqu'a 100 % de bacoside a et de bacoside b a partir de substances vegetales de l'espece bacopa
US6833143B1 (en) * 2003-03-26 2004-12-21 Council Of Scientific And Industrial Research Process for the preparation of a extract rich in bacosides from the herb Bacopa monniera
CN1651455A (zh) * 2004-12-09 2005-08-10 中国人民解放军第二军医大学 假马齿苋皂苷化合物、总皂苷及其在医药中的应用

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CN1277555A (zh) * 1998-09-07 2000-12-20 马哈拉伊·克里森·潘迪塔 用于改善哺乳动物智力机能的组合物
WO2004054599A1 (fr) * 2002-12-18 2004-07-01 Council Of Scientific And Industrial Research Procede permettant la preparation d'une fraction stable enrichie en bacosides sous une forme non hygroscopique
WO2004060267A2 (fr) * 2003-01-03 2004-07-22 Ganga Raju Gokaraju Procede de production de fractions enrichies contenant jusqu'a 100 % de bacoside a et de bacoside b a partir de substances vegetales de l'espece bacopa
US6833143B1 (en) * 2003-03-26 2004-12-21 Council Of Scientific And Industrial Research Process for the preparation of a extract rich in bacosides from the herb Bacopa monniera
CN1651455A (zh) * 2004-12-09 2005-08-10 中国人民解放军第二军医大学 假马齿苋皂苷化合物、总皂苷及其在医药中的应用

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016109856A1 (fr) 2015-01-02 2016-07-07 Melaleuca, Inc. Compositions multi-compléments
US10137164B2 (en) 2015-01-02 2018-11-27 Melaleuca, Inc. Dietary supplement compositions
US10576112B2 (en) 2015-01-02 2020-03-03 Melaleuca, Inc. Bacterial compositions
US11207388B2 (en) 2015-01-02 2021-12-28 Melaleuca, Inc. Multi-supplement compositions
US11273195B2 (en) 2015-01-02 2022-03-15 Melaleuca, Inc. Dietary supplement compositions
EP3973972A1 (fr) 2015-01-02 2022-03-30 Melaleuca, Inc. Compositions multi-compléments
US11433107B2 (en) 2015-01-02 2022-09-06 Melaleuca, Inc. Bacterial compositions

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