CN108210755B - Traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension and preparation method thereof Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
- A61K36/8988—Gastrodia
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Abstract
The invention provides a traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension and a preparation method thereof, the traditional Chinese medicine preparation is prepared from the following effective components in proportion: 0-25.9 parts of total polysaccharide, 0-18 parts of total saponin and 0-14.5 parts of total polyphenol; meanwhile, the preparation method of the preparation is provided, on the premise of ensuring the full extraction of medicinal active ingredients, an efficient extraction and refining method suitable for large-scale production is established, the total polyphenol, total saponin and total polysaccharide components of the 6 traditional Chinese medicines of the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction are purified and refined, and the innovative traditional Chinese medicine with independent intellectual property, relatively clear medicinal effect substances and relatively clear action mechanism for treating the phlegm-dampness accumulation type hypertension is developed.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicine research and development, and particularly relates to a traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension and a preparation method thereof.
Background
Hypertension is a systemic disease characterized by an increase in systemic arterial blood pressure, which may be accompanied by functional or organic changes in a plurality of organs such as heart, blood vessels, brain or kidney, and is a disease caused by the interaction between polygenic genetic factors and environmental factors. According to the clinical research guidelines for treating hypertension by using new Chinese medicines (1993 version of Ministry of health), the differentiation and typing standards of hypertension are classified into 4 types of hypertension with hyperactivity of liver fire, hyperactivity of yin deficiency and yang, deficiency of both yin and yang and excessive phlegm-dampness, and the clinical research guidelines for new Chinese medicines (2002 version of State drug administration) also classify hypertension into 4 types of hyperactivity of liver fire, hyperactivity of yin deficiency and yang, deficiency of both yin and yang and excessive phlegm-dampness. Modern researches consider that dyslipidemia is closely related to 'phlegm-dampness' in traditional Chinese medicine, and the increase of TC, TG and LDL contents is an important biochemical index and material basis special for 'phlegm-dampness'. In modern society, hypertension with excessive phlegm-dampness becomes a common clinical disease due to aging population, fast pace of life, excessive nutrition, high mental stress and other factors, and is the largest in the proportion of the traditional Chinese medicine syndrome type composition of hypertension, thus seriously affecting people's daily life.
The concept of "the transmission of the traditional Chinese medicine is not to be measured" and "the secret of the transmission is to be measured" can be understood from 2 aspects. Firstly, the prescription of the traditional Chinese medicine formula forms the proportion of the dosage of the traditional Chinese medicine; secondly, the ingredients and the quantity ratio relationship of the components of the whole traditional Chinese medicine formula. The component traditional Chinese medicine is provided by Zhangli academy, and is an ideal mode for researching innovative traditional Chinese medicine by researching modern component traditional Chinese medicine in a component compatibility mode on the basis of traditional prescriptions and empirical formulas under the guidance of the traditional Chinese medicine pharmacodynamic component theory. The theory of component structure is the further development of the component Chinese medicine, which indicates that the material basis of the Chinese medicine is an ordered whole, the components are basic units forming the material basis, and the components have a quantitative relation, namely the so-called structure. The component structure traditional Chinese medicine is a novel traditional Chinese medicine composition which not only defines the quantity ratio relationship among the components but also clearly reveals the pharmacodynamic action mechanism of the traditional Chinese medicine on the basis of inheriting the integrity and systematicness of the traditional Chinese medicine and under the guidance of the theory of the component structure, is beneficial to clarifying the essence of the effective substance basis and the action of the traditional Chinese medicine, can embody the advantages of multiple components, multiple targets and integration action, improve the quality control level and the clinical curative effect of the preparation, and promote the traditional Chinese medicine to move to the domestic and foreign markets.
The BANXIA BAO ZHU HUANG TIAN TANG is derived from integrated medical book of Yongzheng decade (1732 years), and comprises rhizoma Pinelliae, rhizoma Gastrodiae, Poria, exocarpium Citri rubrum, Atractylodis rhizoma, and Glycyrrhrizae radix. Has effects of eliminating dampness and phlegm, calming liver and calming endogenous wind. The traditional Chinese medicine composition is mainly used for treating dizziness and headache, chest distress and nausea, white and greasy tongue fur, wiry and smooth pulse and other symptoms caused by wind-phlegm upward disturbance, is a representative prescription for clinically treating phlegm-dampness accumulation type hypertension in traditional Chinese medicine, and has definite curative effect. Although the related preparations prepared by gastrodia elata or gastrodin in clinic are used for treating hypertension at present. However, most of the preparations have the problems of unreasonable compatibility structure, backward preparation process, uncertain clinical curative effect, low use safety and the like, the existing varieties also can not meet the market requirements, and particularly, the market-selling preparation based on the classic formula of the pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup is not clinically applied.
Disclosure of Invention
Aiming at the problems in the preparation, the invention provides a traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension and a preparation method thereof, the traditional Chinese medicine preparation is prepared by matching 6 effective components of pinellia ternate, rhizoma atractylodis macrocephalae and rhizoma gastrodiae decoction, namely total polyphenol, total saponin and 3 effective components of total polysaccharide of the traditional Chinese medicines, namely pinellia ternate, rhizoma atractylodis macrocephalae and rhizoma gastrodiae, and has a synergistic effect.
A traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction in parts by weight: 0-25.9 parts of total polysaccharide; 0-18 parts of total saponins; 0-14.5 parts of total polyphenol.
Preferably, the traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine effective components extracted from the decoction of pinellia ternate, bighead atractylodes rhizome and gastrodia elata in parts by weight: 12.95 parts of total polyphenols; 9 parts of total saponins; 14.5 parts of total polysaccharide.
A preparation method of a traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension comprises the following steps:
(1) extracting extractum from the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction: firstly, respectively crushing pinellia ternate, bighead atractylodes rhizome, gastrodia elata, poria cocos, exocarpium citri rubrum and liquorice in a prescription, weighing 10-20 meshes of coarse powder according to a proportion, respectively extracting for 3 times, adding water in an amount which is 10 times, 8 times and 8 times in sequence, extracting for 120min, 90min and 90min in sequence, roughly filtering the extracting solution in sequence, and 3500 r.min-1Centrifuging for 25 min, filtering, mixing, and concentrating to obtain extract;
(2) extracting total polysaccharide: adsorbing the extract obtained in the step (1) by polyamide with the ratio of the extract to the polyamide being 1: 3, adding the extract to the top of DM301 macroporous adsorption resin with the ratio of the extract to the resin being 1: 3, eluting by water with the elution amount being 10 times of the column volume and the elution volume flow being 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polysaccharide;
(3) extracting total saponins: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (2) with 50% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total saponin;
(4) extracting total polyphenol: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (3) with 80% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polyphenols;
(5) preparing the effective components extracted in the steps (2) to (4) into a preparation according to the specified parts.
The traditional Chinese medicine preparation for preventing and treating the phlegm-damp accumulation type hypertension is tablets, capsules, granules, oral liquid, syrup, dropping pills, sustained-release tablets or pellets.
Verification experiment
A4-factor 4-level orthogonal design method is adopted, and the optimal compatibility proportion of total polysaccharide, total saponin and total polyphenol is determined by comprehensively evaluating multiple drug effect indexes of a rat pharmacological model of excessive phlegm-dampness type hypertension, serum Total Cholesterol (TC), Triacylglycerol (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), blood sugar (Glu), fasting blood insulin (FINS), Nitric Oxide (NO), serum angiotensin II (ANG-II) and Endothelin (ET).
The experimental hypertension rat model with excessive phlegm-dampness accumulation is randomly divided into 8 groups (n = 8) for experiment, and the experimental groups are as follows: blank control group, pinellia tuber, white atractylodes rhizome and tall gastrodia tuber decoction high, medium and low dose groups (high dose group 8g kg)-1Middle dose group 4 g/kg-10.8 g/kg in the low dose group-1Corresponding treatment groups (optimal proportioning scheme, one of the effective components is removed in sequence) and component compound groups. Feeding 4W according to the above method. And (4) measuring TC, TG, HDL, LDL, Glu, FINS, NO, ANG-II and ET after the experiment is finished, and averaging the experiment results.
Table 1 ingredient compound verification experimental results (
，n=8）
Note that R =
The average values of CHO, TG, LDL, Glu, FINS, Ang II and ET of the rats in the blank group are average values of CHO, TG, HDL, LDL, Glu, FINS, NO, Ang II and ET of the rats in each group, the average values of HDL and NO of the rats in the blank group are average values of HDL and NO of the rats in each group, and the average values of HDL and NO of the rats in each group are average values of the rats in each group.
As can be seen from Table 1, the comprehensive effective rate (E) of the drug effect of the compound of the components with the optimal mixture ratio screened according to the orthogonal design is greater than that of each dose group of the decoction of the pinellia ternate, the bighead atractylodes rhizome and the gastrodia elata, and the dosage is obviously reduced, which indicates that the dosage can be greatly reduced when the compound of the components achieves the same drug effect. When one of 3 components is removed from the compound of the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction, the effective rate of the rat for resisting the phlegm-damp accumulation type hypertension is obviously weakened.
Has the advantages that:
1. the extraction, enrichment and purification process of the effective components comprises the following steps:
on the premise of ensuring the full extraction of medicinal active ingredients, an efficient extraction and refining method suitable for large-scale production is established, and the total polyphenol, total saponin and total polysaccharide components of the 6 traditional Chinese medicines of the whole formula of the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction are purified and refined. In the formula, the gastrodia elata, the poria cocos, the exocarpium citri rubrum and the liquorice contain a large number of chemical components of polyphenols (including phenolic acid and flavone) which are main drug effect substances, particularly gastrodine which is a main chemical component in the gastrodia elata serving as a monarch drug, and the research on the blood pressure reduction drug effect is relatively thorough, so that the preparation process of the effective components takes the polyphenols chemical components in the enriched and purified formula as the primary purpose, then the saponins chemical components and the polysaccharides and other macromolecular chemical components. The adopted polyamide can form hydrogen bonds with compounds rich in phenolic hydroxyl groups for adsorption, and is an excellent resin material rich in polyphenols. However, polyamides have a "double chromatography" effect in addition to "hydrogen bonding, and when polar solvents (such as aqueous solvents) are used as mobile phases, alkyl groups in polyamides are used as non-polar stationary phases, and the chromatographic behavior is similar to reversed phase partition chromatography, so that the phenolic glycoside is eluted earlier than aglycone; the DM301 macroporous absorption resin is styrene type medium-polarity copolymer, is suitable for separating and purifying organic compounds with weak polarity and polarity, and can better enrich and purify polyphenol chemical components in a purifying method by combining the two.
2. The compatibility of effective components is optimized:
in order to comprehensively reflect the multi-component and multi-effect action characteristics of the pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup, a plurality of efficacy evaluation indexes such as serum Total Cholesterol (TC), Triacylglycerol (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), blood sugar (Glu), fasting blood insulin (FINS), Nitric Oxide (NO), serum angiotensin II (ANG-II), Endothelin (ET) and the like are used, weight coefficients are given according to the importance of different efficacies, and the comprehensive effective rate is calculated to comprehensively balance the efficacy of the compound components; the orthogonal design is the design method mainly adopted by the new drug research and development process screening. Compared with a mathematical model in which the mathematical structure expressions of a plurality of factor levels, complex relationships and internal relationships are simplified into a grey box, the method can embody the relationship principle of the system theory, namely the multi-body non-additive compatibility relationship of synergy, attenuation and the like, not only saves manpower, material resources and test time, but also can analyze effective components, functional components, useless components and the interaction (synergy or antagonism) among the components and the optimal compatibility dosage of the component compound.
3. The preparation process comprises the following steps:
according to the compatibility theory of traditional Chinese medicines, the component structure theory and the modern pharmacodynamics screening, the combination effect relationship, the component compatibility, the optimization design and the modern preparation process technology are applied, each link is studied in detail, compared with the prior art, the method has the characteristics of solid basic research work, clear effective component pharmacodynamic substance basis, mature extraction and separation technology, high application degree of new technology and the like, develops the innovative traditional Chinese medicine for treating the phlegm-dampness accumulation type hypertension with independent intellectual property rights, relatively clear pharmacodynamic substances and action mechanisms, fills the blank of the market, and has great practical significance and application value.
Detailed Description
The present invention further describes the preparation method of the effective component compatible traditional Chinese medicine and the preparation thereof by the following examples, but the present invention is not limited to the contents contained in the following examples.
Example 1
A traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup in parts by weight: 18 parts of total saponins; 14.5 parts of total polyphenol.
A preparation method of a traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension comprises the following steps:
(1) extracting extractum from the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction: respectively pulverizing rhizoma Pinelliae, Atractylodis rhizoma, rhizoma Gastrodiae, Poria, exocarpium Citri rubrum, and Glycyrrhrizae radix, weighing coarse powder of 10-20 meshes at a certain proportion, extracting for 3 times, adding water 10 times, 8 times, and 8 times, extracting for 120min, 90min, and 90min, coarse filtering the extractive solution, and centrifuging (3500 r.min)-125 min), filtering, mixing, and concentrating to obtain extract;
(2) extracting total polysaccharide: adsorbing the extract obtained in the step (1) by polyamide with the ratio of the extract to the polyamide being 1: 3, adding the extract to the top of DM301 macroporous adsorption resin with the ratio of the extract to the resin being 1: 3, eluting by water with the elution amount being 10 times of the column volume and the elution volume flow being 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polysaccharide;
(3) extracting total saponins: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (2) with 50% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total saponin;
(4) extracting total polyphenol: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (3) with 80% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polyphenols;
(5) preparing the effective components extracted in the steps (2) to (4) into a preparation according to the specified parts.
Example 2
A traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup in parts by weight: 25.9 parts of total polysaccharide; 14.5 parts of total polyphenol.
The preparation method of the Chinese medicinal preparation is the same as that of example 1.
Example 3
A traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup in parts by weight: 25.9 parts of total polysaccharide; and 18 parts of total saponins.
The preparation method of the Chinese medicinal preparation is the same as that of example 1.
Example 4
A traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction in parts by weight: 12.95 parts of total polyphenols; 9 parts of total saponins; 14.5 parts of total polysaccharide.
A preparation method of a traditional Chinese medicine preparation for preventing and treating phlegm-dampness accumulation type hypertension comprises the following steps:
(1) extracting extractum from the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction: respectively pulverizing rhizoma Pinelliae, Atractylodis rhizoma, rhizoma Gastrodiae, Poria, exocarpium Citri rubrum, and Glycyrrhrizae radix, weighing coarse powder of 10-20 meshes at a certain proportion, extracting for 3 times, adding water 10 times, 8 times, and 8 times, extracting for 120min, 90min, and 90min, coarse filtering the extractive solution, and centrifuging (3500 r.min)-125 min), filtering, mixing, and concentrating to obtain extract;
(2) extracting total polysaccharide: adsorbing the extract obtained in the step (1) by polyamide with the ratio of the extract to the polyamide being 1: 3, adding the extract to the top of DM301 macroporous adsorption resin with the ratio of the extract to the resin being 1: 3, eluting by water with the elution amount being 10 times of the column volume and the elution volume flow being 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polysaccharide;
(3) extracting total saponins: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (2) with 50% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total saponin;
(4) extracting total polyphenol: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (3) with 80% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polyphenols;
(5) preparing capsules: taking 242g of total polysaccharide, 180g of total saponin and 161.9g of total polyphenol, crushing, adding a proper amount of starch, uniformly mixing, and encapsulating to prepare 1000 granules.
Preparing syrup: dissolving 242g of total polysaccharide, 180g of total saponin and 161.9g of total polyphenol in a proper amount of water, stirring, standing, filtering, adding 200g of sucrose and 3g of sodium benzoate, adding 1000ml of water, stirring uniformly, filling and sterilizing to obtain the traditional Chinese medicine.
The content (calculated by glucose) of the total polysaccharide of the effective components in the step (2) reaches 80 percent; the content of the total saponins (calculated by the glycyrrhizin) of the effective component in the step (3) reaches 68 percent; the content (calculated by gastrodin) of the total polyphenol of the effective components in the step (4) reaches 89 percent.
Claims (2)
1. The traditional Chinese medicine preparation for preventing and treating phlegm-damp accumulation type hypertension is characterized by being prepared from the following traditional Chinese medicine effective components extracted from pinellia ternate, bighead atractylodes rhizome and gastrodia elata soup in parts by weight: 12.95 parts of total polyphenols; 9 parts of total saponins; 14.5 parts of total polysaccharides;
the preparation method of the traditional Chinese medicine preparation comprises the following steps:
(1) extracting extractum from the pinellia ternate, bighead atractylodes rhizome and gastrodia elata decoction: firstly, respectively crushing pinellia ternate, bighead atractylodes rhizome, gastrodia elata, poria cocos, exocarpium citri rubrum and liquorice in a prescription, weighing 10-20 meshes of coarse powder according to a proportion, respectively extracting for 3 times, adding water in an amount which is 10 times, 8 times and 8 times in sequence, extracting for 120min, 90min and 90min in sequence, roughly filtering the extracting solution in sequence, and 3500 r.min-1Centrifuging for 25 min, filtering, mixing, and concentrating to obtain extract;
(2) extracting total polysaccharide: adsorbing the extract obtained in the step (1) by polyamide with the ratio of the extract to the polyamide being 1: 3, adding the extract to the top of DM301 macroporous adsorption resin with the ratio of the extract to the resin being 1: 3, eluting by water with the elution amount being 10 times of the column volume and the elution volume flow being 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polysaccharide;
(3) extracting total saponins: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (2) with 50% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total saponin;
(4) extracting total polyphenol: eluting the 'polyamide + DM301 type macroporous adsorbent resin' column in the step (3) with 80% ethanol, wherein the elution amount is 10 times of the column volume, and the elution volume flow is controlled to be 0.5 mL/min-1Collecting eluate, concentrating under reduced pressure, and drying to obtain total polyphenols;
(5) preparing the effective components extracted in the steps (2) to (4) into a preparation according to the specified parts.
2. The Chinese medicinal preparation of claim 1, wherein the preparation is in the form of tablets, capsules, granules, oral liquid, dripping pills or pellets.
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