Shou Wu Fukang Capsule Technology And Quality Standards Study

Fukang Capsule of Radix Polygoni Multiflori is a compound preparation developed from clinic proved recipe with seven Chinese medical herbs, Radix Polygoni Multiflori , Glossy Privet Fruit, gentian and so on for nourishing liver and kidney, clearing heat, removing dampness, itching-alleviation and detoxication. It can be used for the cure of deficiency of liver and kidney, syndrome of dampness-heat flowing downward, blood-deficiency and wind-dryness, pudendum leukoplakia cream and vulvitis as well. For the development of this proved recipe into a new medicine to be registered in the Sixth Category of Drugs issued by State Food and Drug Administration, some pre-clinic researches on pharmacodynamices have been undertaken. With ointment-collecting rate and the portion of stilbene-glucoside as evaluation index, the water extract processing parameter has been optimized in orthogonal experiments; a single factor test has been done for the systematic study of macroporous resin purification technology, including the main factors influencing absorption or desorption, such as the type and dosage of resins, the temprature of upper sample medical solution, the dosage of washing liquid, the concentration and dosage of ethanol elution liquid, as well as the velocity of elution, then the optimized processing parameters have been screened out and then examined with spray drying. Quality standard have been established for this preparation; thin-layer chromatography identification of five medical herbs in this preparation has also been introduced along with the methods of measuring the content of stilbene-glucoside and gentianrin using HPLC. Pilot test has also been made for its stability. The research reveals that: the processing parameters screened out in a right way are reliable; the transfer rate of stilbene-glucoside is about 90%; D-101 macroporous resin can absorb the effective element of the compound preparation, reducing the ointment-collecting rate by 4% with stable processing; the quality standard can be fully carried out with good reproducibility; and the preparation remains stable. Conclusion: Fukang Capsule of Radix Polygoni Multiflori can be prepared with sound processing technology, meeting the quality standard with great stability.