| Objective:Common cold with cough, chronic bronchitis and bronchial asthma are common and frequent diseases. Particles for relieving cough and expectorant are Chinese patent medicine used for the cure of these diseases and have reliable efficacyand Safety.It is not convenient to take and not suitable for diabetic patients because of the large dosage and the content of sucrose. So it's necessary to improve the dosage form. Mistura has large dispersion degree, don't need disintegration and dissolution, have a rapid effect, convenient taking and can be made without sucrose. So it is necessary to change the form of particles to mistura, furthermore, the preparation process and quality standards of expectorant cough mistura were also studied in order to ensure the medicines which produced under these standards are the qualified product can be controlled in quality.Method:The extraction process and the preparation process of expectorant cough mistura were optimized. Extracting time, quantity of volume and concentration of ethanol with orthogonal test of lticriteria was studied using multi-factor orthogonal design experiment. And then, the extraction process was optimized using single factor and orthogonal experimental design with total saponin content as the indexes. The mixture preparation process was identified by choosing corrigent and studying methods of sterilization, pH and the relative density, other parameters. The feasibility of preparation process was verified through the replicate test. Result:The best procedure conditions for Zhike Qutan Mistura was: extracted twice with 8 times water,3hours every time,65%concentration of ethanol; concentrated to Relative density:1.25～1.30(tested in 85℃; adjusting pH to 4.0-5.5 with epHedrine hydrochloride, citrate acid and sweet chrysanthemum sugar.In the Qualitative Identification, the balloonflower root, Stemona japonica, Bitter Apricot Seed, EpHedrine Hydrochloride in the recipe was distinguished by TLC, established the measurable method of HPLC on the containment of EpHedrine Hydrochloride and made the research of linearity period,accuracy, stability, repeatability, recovery ratio on measure metheod. The standards in Qualitative Identification have good Selectivity and repeatability.Conclusion:The experiment shows the extraction procedure and preparation procedure for Zhike Qutan Mistura are reliable and practical and the determined quality standards can take the drug quality under control. |
