Pharmaceutical Research On Fufangqima Capsule

Objective:To develop a TCM compound preparation for prevention and treatment of qi deficiency and phlegm syndrome of hypertension. According to the relevant provisions of "The Guidelines of Research Technology of Chinese Medicine and Natural Medicine", from the preparation process, quality standard and stability and pharmacodynamics launch the research on Fufangqima capsule, and lay the foundation for the declaration of six type of new traditional Chinese medicine and further clinical research.Methods:(1) Study on preparationWith the lowering effect of systolic and diastolic blood pressure in the ratsreceiving renal artery ligation as index, combined with the results of the literature study, to compare the pros and cons of different preparation, studiedand determined the preparation of Fufangqima capsule.With the content of astragaloside and calycosin-7-glucoside and total solid contentas the indexes, the single factor experiment and orthogonal design was used to optimize factors of amount of water, extraction hours and extraction times which effect extraction.With the retention rate ofastragaloside and calycosin-7-glucoside as index, to concentrate on a comparative study of atmospheric concentration and vacuum concentration, spray drying and vacuum drying.With the yield of gastrodia elata powder as index, to study the feasibility of crushing process of Gastrodia elata.Under the premise of the extract physical properties investigated, with the moisture absorption weight percentage and disintegration time as indexes, to screen of the filler type.With the bulk density and tap density ofthe particle as indicators for screenning of the dry granulation process.With the moisture absorption weight percentage of preparation as indexes, toscreen of the packing materials.Using three batches spilot scale test of Fufangqima capsule, to verify the feasibility of preparation.(2) Study on quality standard and stabilityThe medicinal related Fufangqima capsule was analyzed by thin layer chromatography; the content of astragaloside and calycosin-7-glucoside and methodological study was deteminated by HPLC; using room temperature and accelerated stability method, to study preliminary stability investigation of three batches finished product with listing package conditions.(3) Study on pharmacodynamicWith the blood pressure, aortic complianceand hemodynamicsas observation indexes, using SHR rats as model group, to investigate the effect of different dosage of Fufangqima capsule on spontaneous hypertensive rats. Results:(1)Study on preparationThe preparation technology identified as:gastrodia elata grinded, the rest of herbal with water as solvent, made of extract by extraction, concentration, drying, molding, made into capsules; optimization of the water extraction prcess conditions identified as:the rest of herbal except gastrodia elataadded 12 times the amount of water, extracted 3 times, each time 1.5 hour, the extraction rate of astragaloside and calycosin-7-glucoside under this condition respectively were 64.02% and 51.97%; optimized concentrated way was vacuum concentration, the retention rate of astragaloside and calycosin-7-glucoside were 92.03% and 93.56%; optimized drying method was spray drying process, when relative density of concentrated soluid was 1.05～1.10(60℃), the content of index components in dried product were higher than the dried product by vacuum drying; by using conventional crushing method to grind gastrodia elata is feasible, the yield of fine powder was 92.07%; molding process identified as:medicinal starch as filler, adopted dry granulating method with 14 mesh sieve for granulating effect was best;finished product moisture to choose the medicinal composite membrane of PET/AL/PE structure for packaging; verified by three batch of pilot test show that the preparation technologywas reasonable and feasible, the transfer rate of astragaloside was 44.87%-47.88%.(2) Study on quality standard and stabilityEstablish the quality standard of Fufangqima capsule, included TLC method for the identification of astragalus, gastrodia elata, chrysoidine, rhizoma ligusticum chuanxiong, method for the content determination of astragaloside and gastrodin in finished product, and the provision of the minimum limit of its content. Accorded to the requirements of under appendix IL capsulein "Chinese pharmacopoeia" 2010 version, and specified the properties, moisture, load difference, disintegration time limit, hygiene inspection method and limitof the final products. The accelerated stability test and room temperature stability test results of listed packaging products showed good stability of the product formulation.(3) Study on pharmacodynamicsFufangqima capsule prepared for this preocessused in spontaneously hypertensive rats can obviously reduce the systolic pressure and diastolic pressure, improve the aortic compliance, regulate the cardiac hemodynamics, prevent the aortic arch wall thickening and lesions. Conclusion:The preparation technology of Fufangqima capsuleis reasonable and feasible, and stable, effective and quality control, to achieve the desire research purposes. For the next step, the study to carry out the industrial production and provide the experimental basis for clinical research.