Red sage root salvianolic acid A tablet for treating cardiovascular disease and preparation process thereof

Abstract

The invention relates to a method for producing Danshen acid a tablet for treating cardiovascular disease, 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 8%. The inventive tablet comprises Danshen acid A, stuff, slaking agent, lubricant, wetting alcohol, whose dissolubility is higher than 80% in 45min. 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 salvianolic acid A tablet for treating cardiovascular diseases 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 dru...

AI Technical Summary

Problems solved by technology

Chinese patents CN1397276A and CN1352985A disclose that salvianolic acid A is prepared into tablets, 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. In particular, the issue of whether antioxidants need to be added to the preparation of tablets has not been thoroughly studied

[0006] In the prior art, the method of disintegration time limit is used in the quality inspection of traditional Chinese medicine tablets, but it is obviously not perfect to rely on the disintegration time limit inspection as the evaluation standard for the absorption of all tablets in the body, because after the drug is dissolved, it passes through the sieve of the disintegration instrument. The diameter is usually between 1.6-2.0mm, and the drug needs to be in a solution state to be absorbed by the body. The disintegration time limit inspection is uncontrollable, and the disintegration of the tablet 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 between the drug and the excipients and impact, but the dissolution test includes the disintegration and dissolution process, so it is more important to study the dissolution of traditional Chinese medicine tablets

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