Research Of Pharmaceutical And Main Pharmaco-dynamics On Xinfeng Capsule

Objective: The Subject would establish a method to research the preparation process, quality control and the main pharmacodynamics of Xinfeng capsule. The study can make the capsule standardization and mass production of standardized, also provide a basis for clinical application.Methods: 1. By orthogonal experimental design, taking Astragaloside Ⅳ, extract rate as index, to inspect ethanol concentration, the amount of ethanol, extraction times, reflux time, to preferably the best alcohol extraction process.2. After alcohol extraction, taking Astragaloside Ⅳ, extract rate as index, to inspect soaking time, add water, boiling time, to preferably the best water extraction process.3. Using the reference and reference drug as a reference, Astragali radix, Coicis semen,radix et Rhizoma Tripterygii,Scolopendra were identified by thin layer chromatography.4. We used UPLC to determine the content of Astragaloside Ⅳ, and we used HPLC to determine the content of Calycosin 7-O-β-D-Glucopyranoside and Formononetin.At the same time, we were carrying out the appropriate method validation.5.According to the part 1 of 2010 Chinese Pharmacopoeia,a series of quality studies about Xinfeng capsule were inspected, such as: Moisture load difference, disintegration, microbial limits, heavy metals, arsenic salt, and etc.6. To study the main pharmacodynamic of Xinfeng capsule, a model of adjuvant arthritis in rats was established. After the model and grouping, different doses of the drug were administrated. At last blood was taken and some relevant indicators were detected. At the same time, the secondary swelling of rats were counted. From the above experiment, the effect of Xinfeng capsule on AA rats was studied.Results:1.The best alcohol extraction technology was as follows:adding 65% concentration alcohol and 8 times volume,extracting 3 times per 1.5 hour.2.The optimal water extraction technology was as follows:soaking for 0.5h,adding 8 times volume of water, and boiling 2.0h.3. The methods of qualitative identification were established. Astragali radix, Coicis semen,radix et Rhizoma Tripterygii,Scolopendra of the capsule were identificated.The separation of the stains is apparent, and the negative contrast showed no disturbed. Identification method was highly selectivity.4. The assay methods of the content of Astragaloside Ⅳ,Calycosin 7-O-β-D-Glucopyranoside and Formononetinwere established. The methods were reproducible, sufficiently simple, sensitive and reproducible.5. Every preparing check was up to the General preparation of the capsules in Ch.P. 6. The experiment of the main pharmacodynamic show that Xinfeng capsule had a therapeutic effect on AA rats.Conclusion: The preparation of Xinfeng capsule was reasonable and feasible. The specificity and reproducibility of quality control methods were better. The research of the main pharmacodynamic showed that the capsule played a therapeutic role for RA.