Preparation Process And Quality Standard Research Of Shen Xi Oral Liquid

Shen Xi Oral Liquid is composed of ginseng,Cyathulae radix,Astragalus membranaceus,Lycium barbarum,Ziziphus jujuba.It has the functions of strengthen the vitality,strengthen the capital,strengthen the body,etc.Specially used to treat people with physical weakness and lack of Weiyang.Based on the theory of TCM health care and long-term practical experience,based on the advantages of drug use,absorption effect,and portability,made into an oral liquid,using pharmaceutical technology to study on the preparation process,the quality standard to ensure that the conditions were reliable,reasonable and scientific,product stability,controlled,safely and effectively.First,Single factor test combined with Uniform design analyse alcohol precipitation and determination of total polysaccharide,the alcohol content was 80%,placed for 24 hours,and added with 8 mL of 0.2%anthrone-sulfuric acid test solution,and heated in a boiling water bath（100℃）for 20 min.A quality assessment method（QAMS）for ginseng was proposed to provide a useful reference for the follow-up ginseng and ginseng-containing prescriptions.Combined with process research,according to the physicochemical properties of drugs,Using water as the extraction solvent,the content of cyasterone,ginsenosides Rb₁,Rb₂,Rc,Rd,Re,Rg₁,ratio of dry extraction and total polysaccharides as comprehensive evaluation indexes,Based on the Analytic Hierarchy Process（AHP）combined with the Criteria Importance Through Intercriteria Correlation（CRITIC）mixed weighting method,subjectively and objectively assigning weight coefficients to each indicator.Optimization of extraction technique by Box-Behnken response surface methodology,the optimal process parameters:Soak for 2 h,make up 0.98 times of water absorption,10 times water,heat the reflux extraction 3 times,each time 80min.Verification testing results proved reasonable,stable and reproducible.To avoid loss of components in high temperature,concentration method set as decompression.By comparing the four purification methods of the raw liquid,filter cloth filtration,centrifugation,activated carbon adsorption and chitosan precipitation,finally,using high-speed centrifugation,based on uniform design to select the centrifugal parameters:liquid（1:4）,revolutions:5000 r/min,and 50 minutes,concentration to the relative density of1.20-1.25（60℃）,The effect of pH on the solubility and stability of liquid formulations is very important,comprehensive analysis,the pH stability range is set at 5.0-6.0,the solution is stable and relatively clear.For sample dosing,inspection,filling,sterilization,packaging,that is.Established the study on quality standard of Shen Xi Oral Liquid,products were inspected,all in keeping with the regulation of Pharmacopoeia.Established the TLC chromatographic identification standard of ginseng,astragalus membranaceus,lycium barbarum and cyathulae radix in this product,establish an HPLC method for determining the content of ginsenosides Rg₁,Re and Rb_1,considering the actual production conditions and the composition loss,make a limited stipulation.A preliminary study of the fingerprint of the entire production chain.as a result,most of the substances exist and are continuously transferred,and the whole link is relatively stable.