Studies On The Quality Control Standard Of Chaihuo Particles Preparations

Objective:Study the quality standard of Chaihuo preparations; establish quality standards and the draft; provide experimental support for effectively control of the preparations and the declaring of the hospital quality standard in preparations.Methods:(1) TLC identification method was used to identify the quality of the following6medicine in the preparations, Chaihuo particles, radix pogostemon patchouli, radix scutellariae, forsythia, the leaf; the chemical identification method was used to identify calcium salt and sulphate in gypsum. We only select the one which is easy for quality control and simple to test, and the one which has strong specificity and good repeatability to be involved in quality standard draft.(2) With reference to the Chinese pharmacopoeia2010edition I appendix C granules rule, we researched Chaihuo particles preparations.(3) Establish high-performance liquid chromatography (HPLC) method to identify the quantity of baicalin in Chaihuo particles preparations.The Diarnonsil C18(2) chromatographic column (250×4.6mm,5μm); Methanol-0.2%phosphoric acid (46:54) as mobile phase; Detected wavelength:280nm; Velocity:1mL/min; The column temperature:30℃.(4) Establish high-performance liquid chromatography (HPLC) method to identify the quantity of nucleoside forsythia bush in Chaihuo particles preparation. The Diamonsil C18(2) chromatographic column (250mm℃4.6mm,5μm); Acetonitrile and water (pour the6) as mobile phase;277nm wavelength detection; Velocity1mL/min; The column temperature:30℃.Results:(1) TLC identification qualitative research:in this study, the TLC map of3 kinds of drugs, pogostemon patchouli, radix scutellariae and forsythia bush was clear. Meanwhile the spots were well separated; the negative control was without interference and the method has a specificity. Therefor, it has already been involved as Chaihuo particles qualitative identification index into the preparation draft quality standard. Identification of radix existed negative interference. Indigo jade, which is the characteristic ingredient of radix in the leaf to identify its characteristic ingredients in indigo jade red spots of chromatography with lighter, identify the characteristic ingredients in conventional artesunate in the product in the chromatogram are not clear, it did not into the wood grain preparation of quantitative qualitative identification index.The chemical identification method of gypsum each other for calcium salt and sulphate rating, physical and chemical identification is due to traditional Chinese medicine preparation with reaction activecompositions or effective parts and its characteristic ingredients of the physical and chemical properties, to identify authenticity, existing, or purity. All have the same functional group composition, all may be positive reaction, in general physical and chemical reaction specificity is not strong, not as the final standard identification project, also did not include the draft quality standard.(2) As the China pharmacopoeia2010version of a I C granules of appendix general under grain size, moisture, dissolve sex, loaded quantity differences, microbial limits test check, the results are in line with granules requirements.(3) High performance liquid chromatographic method to determine the Chaihuo particles in preparations baicalin in content, baicalin in0.632～3.792u g (r=1, n=6) range of peak area into a good sample weight linear relationship, and the average recovery was101.46%(n=6), RSD=2.14%determined primarily, Chaihuo particles in preparations contain baicalin amount of not less than12mg/g.(4) High performance liquid chromatographic method to determine the Chaihuo particles in preparations in the content (forsythia, forsythia nucleoside at1.012～6.072u g (r=0.9998, n=6) range of peak area into a good sample weight linear relationship, and the average recovery was97.25%(n=6), RSD=2.21% determined primarily, Chaihuo particles in preparations contain glucoside forsythia bush the amount of not less than0.396mg/g.Conclusion:The establishment of the institute of pogostemon patchouli, radix scutellariae, thin layer of forsythia qualitative identification method and baicalin, content determination method of the nucleotides that forsythia, quality control, strong specificity, good repeatability, the method is simple, and can effectively control the quality of the preparation Chaihuo particles; The draft standards and worked the quality standard of quality of the draft to declare that the hospital preparations to provide the basis for approval.