The Pharmaceutical Study Of Sarcandra Glabra Sanqing Granule

According to the technical requirements of the "Guidelines for the Research of Traditional Chinese Medicine and Natural Medicine Technology",we developed some pharmaceutical research on Sarcandra Glabra Sanqing Granule,mainly including:production process research,quality standard research and stability test,which provided theoretical guidance and basis for the development of a stable,safe and effective compound preparations of traditional Chinese herbal medicines.Methods:(1)Production process research:According to the boiling time,the number of boiling times and the amount of water as the main investigate factors and the content of isofraxidine and extraction extract as the index of evalution,we choose the water extraction method and used orthogonal table L9(34)to optimize extraction process.For the forming process,Comprehensive evaluation the particle moisture absorption rate,melting rate and yield rate,screening the best compatibility of excipients in prescriptions,and determining the molding process of granules were carried out.Under the premise of having determined the prescription and process conditions,we carried out the pilot production research of three batches of samples(particles),which the rate of finished products and effective component transfer rate as the main indicators.Based on the above research,the feasibility of scale up can be verified.(2)Quality Standard Research;Thin layer chromatography(TLC)were to establish the identification methods of Sarcandra Glabra,Shoot dry and Licorice in Sarcandra Glabra Sanqing Granule,separately.And similarly,High performance liquid chromatography(HPLC)was used to establish the method for determination of the main active constituents of the genus Isoazine and rosmarinic acid in granular preparations,on the basis of which,formulate the quality standard of Sarcandra Glabra sanqing granule.(3)Stability study:According to the provisions of the Ministry of Agriculture "Guidelines for the Technical Testing of Veterinary Chinese Medicines and Natural Medicines",three batches of Sarcandra Glabra Sanqing Granule were subjected to light acceleration test,constant temperature and humidity accelerated test and long-term stability test.Results:(1)The best process for extracting the extraction of Sarcandra Glabra Sanqing extract was water volume of 10 times,extraction time of 3 times,extraction time of 1 hour.And the best forming prescription is as follows:the rate of extract,sucrose and dextrin is 1:3.6:2.4;The finished product rate of three batches of Sarcandra Glabra Sanqing granule were 93.6%-94.6%,the transfer rate of Isoazine and rosmarinic acid in granular preparations were 57.04%-60.36%,43.36%-48.30%,respectively,this results showed the rate of finished product and the content of target ingredient of Sarcandra Glabra Sanqing granule were well controlled.(2)Quality standard of the Sarcandra Glabra Sanqing Granule extract was formulated.Through the research of the quality of the preparation,a TLC identification method was established for the main components of Sarcandra Glabra,Shoot dry and Licorice,etc.And the high-efficiency liquid of the main active components of the Sarcandra Glabra,Isoprozil and rosmarinic acid was established.The above results provided a foundation for determination of the quality standard of d etermining the content of phase chromatography and the quality standard of Sarcandra Glabra Sanqing Granule.(3)The light acceleration test of the three batches of Sarcandra Glabra Sanqing Granule showed that the light had a slight influence on the active ingredients in the preparation,however,it was still within the limits of the quality standards.The constant temperature and humidity accelerated test showed that the high temperature and high humidity have a slight effect on the particle size,moisture and content of Sarcandra Glabra Sanqing granule,but the quality indicators of the test samples within six months are within the limits specified by the quality standards.With the long-term stability test,it is finally determined that the Sarcandra Glabra Sanqing Granule should be preserved in the sealed and cool conditions,and the validity period is tentatively set at 2 years.Conclusion:The production process of Sarcandra Glabra Sanqing Granule is scientific and reasonable,the quality standards are simple and easy to operate,and the stability is good.All of them can achieve the expected research goals,and further provide scientific basis for clinical trials and industrial production.