Study On The Preparation And Quality Control Of Compound Radix Paeoniae Alba Granules

Compound Radix Paeoniae Alba Granules was formulated according to a clinicalprescription which had been widely used and has a good effect, it is composed ofPaeoniae lactiflora pall, Rhizoma Alismatis, glycyrrhiza uralensis and Semen Coixan.Years of clinical observation shows that it has the function of nourishing yin andinvigorating kidney, promoting blood circulation to remove blood stasis,dehumidification flooding turbidity. It was used clinically to cure the chronic nephritisand renal insufficiency. In clinical application, the traditional chinese medicinalmaterials were smashed into powder, and were taken with water, because of the dosageis too large and the poor compliance, This research developed the prescription intogranules to overcome those disadvantages. Compound Radix Paeoniae Alba Granuleswas prepared with modern extraction and pharmaceutical technologies. And a qualitycontrol method was developed, which lay a foundation for further development of thisprescription.Objective: To optimize the optimal preparation process of compound Radix PaeoniaeAlba Granules; To establish a method for quality control; Investigate the preliminarystability of preparation, to provide the experimental evidence for the new dug researchin the future.Methods:The crude materials were identified by TLC and HPLC according to Chinapharmacopeia(2010edition,I); Taking the yield of extractum and the extraction ratio ofpaeoniflorin as indexes to establish the optimal extraction process of compound RadixPaeoniae Alba Granules by using the orthogonal design; the extractum concentratingand drying process were investigated; with hygroscopicity, fluidity and forming rate asindex,kinds and rate of excipient and optimum granulating condition were screenedout;Meanwhile,middle test enlargement and quality standard of compound RadixPaeoniae Alba granules were performed; The qualitative identifications of Radix Paeoniae Alba and Rhizoma Alismatis in compound Radix Paeoniae Alba granuleswere carried out by TLC, and the content of paeoniflorin was determined by HPLC;Three batches of preparation for preliminary stability test were investigated bylong-term test and accelerated test.Results: The crude materials satisfied the demands of China pharmacopeia(2010edition,I);the best extraction technology was as follows: adding water equivalent to10times of volume of material medica, extracting for3times and extracting for1houreach time; the forming process: Take soluble starch and lactose as excipients,90%ethanol as wetting agent, wet granulation; the received products rate is above95%; Therelevant spots of Radix Paeoniae Alba and Rhizoma Alismatis on TLC plates were clearwithout the interference of the blank control. The content of paeoniflorin showed a goodlinearity in the rang of33.35μg/ml～333.5μg/ml, r=0.9991. The average recoverywas97.39%, and RSD was1.35%(n=6); Long-term test and accelerated test (3months)showed that the compound Radix Paeoniae Alba granules was stable.Conclusions: The optimum process is feasible, the quality control methods caneffectively control the quality of compound Radix Paeoniae Alba granules.