Method for monitoring quality of salvia milliorrhiza tablets in whole process

Abstract

The invention relates to a method for monitoring the quality of salvia milliorrhiza tablets in a whole process. The method comprises the following steps: step 1, establishing fingerprints of salvia milliorrhiza medicinal materials, intermediate extract and salvia milliorrhiza finished products; step 2, determining the fingerprints of salvia milliorrhiza medicinal materials, the intermediate extract and the salvia milliorrhiza finished products; and step 3, comparing the fingerprints of salvia milliorrhiza medicinal materials, the intermediate extract and the salvia milliorrhiza finished products with a standard fingerprint; taking the salvia milliorrhiza medicinal materials with the whole similarity meeting the requirements as raw materials to produce; enabling the intermediate extract with the whole similarity of the fingerprint and the standard fingerprint thereof meeting the requirement to enter the next path of the procedure; taking the salvia milliorrhiza finished products with the whole similarity of the fingerprint and the standard fingerprint thereof meeting the requirement as qualified products to be delivered. According to the method provided by the invention, the quality monitoring of the whole process of obtaining the medicinal materials, obtaining the intermediate extract and obtaining the finished products can be realized so that a production process is easy to control; the adjustment is scientific and reasonable and the quality of the finished products is stable and consistent.

Description

technical field [0001] The invention relates to a quality monitoring method of traditional Chinese medicine tablets, in particular to a method for monitoring the quality of Danshen tablets in the whole process. Background technique [0002] Danshen tablets are national standard medicines, basic medicines in Henan Province, made from Danshen, which are extracted, concentrated, refined, and added with auxiliary materials. The key part of quality control in the current standard of this drug is the qualitative thin-layer identification of Danshen medicinal materials, which has poor specificity, and there are control indicators for the uniformity of each batch of finished products. The evaluation of drug quality is one-sided, and it is difficult to guarantee the quality between different batches. Whether it is stable, or whether it is consistent with similar drugs from other pharmaceutical companies. [0003] According to the general requirements of production management, it is ...

AI Technical Summary

Problems solved by technology

The key part of the current national standard quality control of Danshen medicinal materials is the qualitative, quantitative detection and content determination of salvia saponins a and b, which are one-sided for evaluating the quality of medicinal materials, and it is difficult to ensure stable and consistent quality of medicinal materials

In addition, there is no national standard for the intermediate extract produced during the production process, which makes it impossible to monitor the quality during the production process