Solid preparation of salvianolic acid A of red sage root and preparation process thereof

Abstract

The invention relates to a method for producing Danshen acid a solid agent, wherein it uses high-effect liquid spectrum to test, to obtain three share peaks; uses Danshen acid A as reference, while its held time is 1 and the held times of two foreign materials are 0.71 and 1. 36; using Danshen acid A as contrast, the foreign material with held time as 0.71 is 0.10-1. 96 content; the content of foreign material whose held time is 1. 36 is 0.11-5. 97%, as Danshen acid C; the whole content of foreign materials is not higher than 10%. The inventive agent comprises Danshen acid A and drug findings, without oxidization resistance; therefore, said agent is stable and safe.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a solid preparation of salvianolic acid A and a preparation method thereof. Background technique [0002] Salvia miltiorrhiza is the root of Salvia miltiorrhiza in the family Lamiaceae. Bitter in taste and slightly cold in nature, salvia miltiorrhiza is one of the most commonly used medicinal materials. It is used to treat cardiovascular and cerebrovascular diseases such as angina pectoris, hypertension, coronary heart disease and stroke. It is a commonly used medicinal flavor of traditional Chinese medicine for promoting blood circulation and removing blood stasis. Most of the existing Danshen preparations are crude extracts extracted from Danshen or directly used in Danshen decoction pieces, which are quickly absorbed and metabolized in the body, and it is difficult for the preparations to maintain the stability of blood drug concentration after o...

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Problems solved by technology

Chinese patents CN1397276A and CN1352985A disclose that salvianolic acid A is prepared into a solid preparation, but it only discloses a simple preparation method, without a reasonable and scientific quantitative analysis of the preparation; during the preparation process, antioxidant Antioxidant protection, but it is only a simple superposition of the basic properties of salvianolic acid A, and the added antioxidant is changed according to the total amount of the preparation, and its ratio cannot have a quantitative relationship during the preparation process, and the amount of The relationship is from 0.01% to 95%, with a difference of nearly 10,000 times. The selection range of excipients in the preparation process is too large, which will cause great difficulties in the preparation process, and the patent does not conduct in-depth research on the properties of the preparation. Especially in the preparation of solid preparations, the issue of whether antioxidants need to be added has not been studied in depth

[0006] In the prior art, the disintegration time limit method is used in the quality inspection of traditional Chinese medicine solid preparations, but it is obviously not perfect to rely on the disintegration time limit inspection as the evaluation standard for the absorption of all preparations in the body, because the particle size of the disintegration instrument sieve passes through the disintegration instrument after the drug is dissolved. It is usually between 1.6-2.0mm, and the drug needs to be in a solution state to be absorbed by the body. The particle size is calculated in A, so the disintegration is only the initial stage of drug dissolution, and the subsequent dispersion and dissolution process, disintegration The time limit inspection is uncontrollable, and the disintegration of the preparation is also affected by the prescription design, preparation preparation, storage process and many complex factors in the body, so the disintegration time limit inspection cannot objectively reflect the relationship and influence between the drug and the excipients , but the dissolution test includes the disintegration and dissolution process, so it is more important to study the dissolution rate of traditional Chinese medicine preparations

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