Study On Preparation Process And Quality Control For Xingqilishui Mixture

Objective Xingqilishui mixture is a compound preparation for treatment of primary liver cancer withascites in clinic.The prescription which is established by BupleuriRadix,Scutellariae Radix,Poria,Prepared Rhizoma Pinelliae with juice of rhizima zingiberis rec-ens,Cinnamom Ramulus,Polyporus,Alismatis Rhizoma,CodonopsisRadix,Rhizoma Atractylodis Macrocephalae Stir-fried with Bran,Curcumae Hizoma,Lycopi Herba,Prepared Radix Glycyrrhizae,have a definite curative effect.This study is to explore the proper preparation process and quality control for Xingqilishui mixture and provide a reference for future large-scale production.Method The study refers to the Chinese Pharmacopoeia of 2015 edition.The experiment process using orthogonal test method for the extraction of Baicalin by three factors,volume of water,boiling time and boiling times,provides the preparation for the best solution extraction process.In the quality control,the study mainly inspected TLC through the literature review and related experiment,with prescription of Cinnamom Ramulus,Poria,Polyporus,Alismatis Rhizoma.A method for the determination of Baicalin was established.To establish and validate a method of microbial limit test for Xingqilishui mixture,and the preliminary stability has been done.Result The preparation processes of Xingqilishui mixture is adding 10 times of water,to extract the medicinal material.Combine the water extract and filter it when it is hot.After staying overnight,the supernatant is taken and the decoction is concentrated to 1000 ml.The preparation,adding preservative,is packed after mixing and filtering.Finally,the preparation needs to be sterilized.A TLC identification method of 4 crude drugs was established.Each kind of medicinal herbs have chosen two kinds of developing solvent to carry on the qualitative analysis.The two methods are feasible,the results are clear spots,the Rf value is moderate.The standard is tentatively prescribed that Baicalin shall be no less than 0.894mg/ml by HPLC,The linear range of Baicalin was 12.56~251.25?g/ml(r=0.9996);RSDs of precision,reproducibility and stability test were lower than 2%;recovery was 95.767%~101.587%(RSD=2.32%,n=6).Referring to the 2015 edition of Chinese Pharmacopoeia,the method of microbial limit test for Xingqilishui mixture was established,and the method suitability test was carried out.The total number of aerobic bacteria should not exceed 100 cfu/ml,and the total number of molds and yeasts should not exceed 10 cfu/ml,and Escherichia coli is not detected.In addition,quality control items such as character,relative density,pH value and loading quantity were established.The preliminary stability of the pilot samples of Xingqilishui mixture was studied.The results showed that the samples in the 1-3 months were in line with the quality requirements during the inspection period.Conclusion Thepreparation process is feasible.According to the quality requirements of the mixture,a quality control method has been established,including characters,identification,relative density,pH value,content uniformity,content determination,microbial limit,7 quality control items.It can provide some experimental theoretical basis for the quality standard of Xingqilishui mixture.The preliminary stability study showed that the gas water mixture was stable in 3 months.