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Composition of oral medicine preparation and its preparing method

A technology of oral preparations and compositions, which is applied in the field of traditional Chinese medicine and pharmaceuticals, and can solve the problems of no practical significance and instability in the combination of active ingredients

Inactive Publication Date: 2007-07-18
PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many medical workers hope to develop salvianolic acid A and salvianolic acid B into new traditional Chinese medicines, especially the combination of salvianolic acid A and salvianolic acid B, but there are great doubts: (1) salvianolic acid A and salvianolic acid B are compounds with strong antioxidant activity in nature. They are easy to be oxidized, unstable in aqueous solution, and easier to degrade during high temperature sterilization. Therefore, their stability has become a technical barrier that is difficult to overcome. Whether the combination can avoid degradation and oxidation and make the two more stable; (2) Salvianolic acid A and salvianolic acid B belong to the active ingredients of the same traditional Chinese medicine, and their pharmacological activity and other properties are similar. Is there a certain internal relationship between the two combinations? , whether the combination can play a greater role through a certain combination, rather than a simple combination of 1+1=2; (3) Salvianolic acid A and salvianolic acid B enter the body through a certain combination, and their absorption and distribution Whether there are new changes in , metabolism, etc.; and many other problems have plagued medical researchers, and the combination of the two cannot be developed into a clinically safe and effective pharmaceutical preparation
[0004] Chinese patent "A method for extracting phenolic acid components from the traditional Chinese medicine Salvia miltiorrhiza and its freeze-dried powder injection" (application number 03132382.0) discloses the preparation of freeze-dried powder injection by combining salvianolic acid A and salvianolic acid B, but its main It is to study how to extract salvianolic acid A and salvianolic acid B from Salvia miltiorrhiza, and the combination of salvianolic acid A and salvianolic acid B has only been studied briefly through pharmacological experiments: the more the amount of salvianolic acid B in the combination, the better the pharmacological effect; The research is just a simple superposition of the active ingredients of Danshen, and the in-depth study of the combination of active ingredients has no practical significance

Method used

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  • Composition of oral medicine preparation and its preparing method

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Effect test

Embodiment 1

[0144] Preparation method of salvianolic acid A:

[0145] Extract the salvia miltiorrhiza with water to obtain the water extract, adjust the pH value to 7.5, and heat at 30°C for 1 hour; the solution is filtered, and the filtrate is separated by HPD-100 macroporous resin column chromatography, and firstly eluted with water and 10% dilute ethanol to remove Impurities, then elute with 30% ethanol, collect the eluent, and recycle the ethanol to the utmost; the concentrated solution is separated by Sephadex LH-20 chromatography column, first eluted with water and 20% ethanol solution, discarded Remove the eluent, then elute with 50% ethanol solution, collect the eluent, and recover the ethanol from the eluent to the utmost; adjust the pH value of the concentrated solution to 2, extract through organic solvent ethyl acetate, and separate the organic solvent phase to obtain medicinal solution, concentrated, dried or freeze-dried to obtain salvianolic acid A;

[0146] Salvianolic ac...

Embodiment 2

[0161] Preparation method of salvianolic acid A:

[0162] Salvia miltiorrhiza was extracted with 50% ethanol solution to obtain an alcohol extract, the alcohol extract was concentrated with ethanol until it was exhausted, the pH value was adjusted to 9.0, the temperature was 80°C, and the temperature was heated for 6 hours; the solution was filtered, and the filtrate was separated by HPD-300 macroporous resin column chromatography , first eluted with water and 30% dilute ethanol to remove impurities, then eluted with 70% ethanol, collected the eluate, and recovered the ethanol to the utmost; Solution elution, discard the eluent, and then elute with 95% ethanol solution, ethanol is recovered from the eluent to the utmost; the concentrated solution is adjusted to pH 5, extracted with organic solvent butyl acetate, and the organic solvent phase is separated to obtain medicinal solution, concentrated, dried or freeze-dried to obtain salvianolic acid A;

[0163] Salvianolic acid B...

Embodiment 3

[0178] Preparation method of salvianolic acid A:

[0179] Salvia miltiorrhiza was extracted with water to obtain the water extract, adjust the pH value to 8.0, and heat at 55°C for 4 hours; the solution was filtered, and the filtrate was separated by HPD-400A macroporous resin column chromatography, first eluted with water and 20% dilute ethanol, and removed Impurities, then elute with 50% ethanol, collect the eluent, and recover the ethanol to the utmost; the concentrated solution is separated with Sephadex LH-20, first eluted with water and 35% ethanol solution, and discard the eluent , and then eluted with 70% ethanol solution, and the eluent recovered ethanol to the utmost; the concentrated solution was adjusted to a pH value of 4.0, extracted with an organic solvent n-butanol, and the organic solvent phase was separated to obtain a drug-containing solution, concentrated, dried or freeze-dried , to get salvianolic acid A;

[0180] Salvianolic acid B preparation method:

...

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PUM

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Abstract

A medicinal composition for the orally taken medicines in the form of tablet, capsule, particle, micropill, dripping pill, etc contains danshinolic acid A and dashinolic acid B. Its preparing process and quality control method are also disclosed.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a pharmaceutical composition containing salvianolic acid A and salvianolic acid B as effective components of traditional Chinese medicines and a preparation method for oral preparation thereof. Background technique [0002] The active ingredients of traditional Chinese medicine are monomeric compounds extracted from traditional Chinese medicine. On the basis of retaining the functions of traditional Chinese medicine, they have the characteristics of high content, strong activity, and clear targets. Under the guidance of TCM theory, the development of active ingredients into clinically safe and effective TCM preparations is of great significance in the modernization of TCM. [0003] The chemical components of Danshen can be mainly divided into water-soluble components and fat-soluble components. As we all know, the traditional application method of Da...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/216A61K31/343A61P9/00A61P1/16A61P35/00
Inventor 顾群李志刚金志刚渠守峰栗艳彬鄯慧珍
Owner PHARMA RES INST OF BENCAO TIANYUAN OF BEIJING
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