Study On Preparation Technology And Quality Control Of Salvia Miltiorrhiza Granules

Objective:According to the traditional Chinese medicine formula particles quality control standards and technical requirements: "the traditional Chinese medicine formula particles need to establish a standard mainly include as starting materials for the standard of Chinese medicinal materials,used as extracting the slices of standard,used as a preparation of intermediates and end products as a finished product standards".This paper mainly established the standards of salvia miltiorrhiza,salvia decoction and salvia decoction,completed the optimization of technical parameters of salvia miltiorrhiza formula granules and the establishment of standards,and preliminarily explored the preparation process of salvia miltiorrhiza formula granules,and established the quality standards of salvia miltiorrhiza formula granules.Methods:1.Study on the quality of salvia miltiorrhiza: 15 batches of salvia miltiorrhiza(3 batches of salvia miltiorrhiza for each producing area)from 5 main salvia miltiorrhiza producing areas were collected,and the quality of salvia miltiorrhiza was investigated according to the provisions of the first salvia miltiorrhiza in the Chinese pharmacopoeia of 2015.2.Study on the quality of salvia miltiorrhiza decoction pieces: 15 batches of salvia miltiorrhiza medicine were processed into salvia miltiorrhiza decoction pieces according to law,and salvia miltiorrhiza decoction pieces were studied from the aspects of character,identification,examination,extract determination and content determination to establish the fingerprint of salvia miltiorrhiza decoction pieces.3.Research on the quality of standard decoction: 15 batches of salvia miltiorrhiza standard decoction were prepared by extracting the prepared slices according to the technology.The quality standard of standard decoction was established by determining the paste rate and transfer rate and determining the characteristic map of standard decoction.4.Study on the quality of formula particles: to determine the preparation process of salvia miltiorrhiza formula particles and prepare 15 batches of salvia miltiorrhiza formula particles.The character,identification,inspection,extract,content determination,characteristic map and initial stability of formula granules were studied systematically,and the quality standard of formula granules was established.Results:1.Study on the quality of salvia miltiorrhiza: the characters,identification,examination,extract and content determination of 15 batches of salvia miltiorrhiza all met the requirements of pharmacopoeia.There were some differences in the characteristics of salviae miltiorrhiza samples from different regions,and the characteristics of salviae miltiorrhiza samples from sichuan and shandong provinces were significantly different from those from other regions.The taproot was stout and less fibrous,with a length of 13-27 cm,a diameter of 0.5-1cm,and a diameter of 0.1-0.4cm.In other areas,the identification of crude drug samples is low,with few obvious differences.TLC identification of 15 batches of salvia miltiorrhiza showed the same color spots or fluorescence spots in the corresponding positions of the chromatogram of the samples compared with that of the control drugs and the control drugs.The results of water content,ash content,sulfur dioxide residue and heavy metal harmful elements in 15 batches of crude drug samples were all within the limits prescribed by pharmacopoeia.The content of water-soluble extract in 15 batches of salviae miltiorrhiza samples ranged from 40.31% to 58.58%,and that of alcohol-soluble extract ranged from 19.39 to 27.89%.The content of tanshinone,tanshinone IIA and salvianolic acid B was 0.365% ~ 0.832%,0.173% ~ 0.382% and 4.14% ~ 8.24% respectively.Tanshinone(tanshinone IIA)was found to have higher content of salvia miltiorrhiza from sichuan and shandong,while salvianolic acid B was found to have better quality of salvia miltiorrhiza from fangcheng of henan province and zhongjiang of sichuan province.2.Study on the quality of decoction pieces: all inspection indexes of 15 batches of salvia miltiorrhiza decoction pieces met the pharmacopoeia standards,established the fingerprint of salvia miltiorrhiza decoction pieces,determined 12 common peaks,and identified 7 characteristic peaks.The quality standard of salvia miltiorrhiza was established.3.Study on the quality of standard decoction: according to the test,the paste output rate of 15 batches of standard decoction is between 26.7% and 31.9%;Tanshinone IIA transfer rate was 3.7% ~ 4.4%,tanshinone transfer rate was 4.2% ~ 4.8%,salvianolic acid B transfer rate was 56.2% ~ 63.5%.A standard decoction fingerprint was established,with salvianolic acid peak B as the S peak,and the relative retention time and peak area of the fingerprint were compared.4.Study on the quality of formula particles: the appearance,identification,particle size and water content of 15 batches of salvia miltiorrhiza formula particles all met the relevant requirements in the 2015 edition of Chinese pharmacopoeia,and the specifications of formula particles were defined.The fingerprints were consistent with those of standard decoction,and the quality standards of salvia miltiorrhiza formula particles were established.Conclusion: This subject initially established the quality inspection system of salvia miltiorrhiza crude drugs,salvia miltiorrhiza decoction slices,standard decoction and formula granules,and preliminarily determined the preparation process of salvia miltiorrhiza formula granules and the range of related quality evaluation parameters,providing reference for the production and quality control of formula granules.