Study On Pharmaceutical Research Of A New Freeze-dried Puerarin Injectable Powder

Based on the disadvantages of puerarin injection samples sold in market, this study was aimed at reducing adverse drug reaction and preparing a new kind of freeze-dried puerarin injectable powder with puerarin-HBD inclusion compound. In this paper, the preparation technology, the quality standards, and the stability studies with freeze-dried puerarin injectable powder were studied, which lay the foundation of for further study of the new freeze-dried puerarin injectable powder.In the study of preparation technology of puerarin from Puerariae Lobatae Radix slices, firstly,Puerariae Lobatae Radix slices was broken down by enzyme M to improve the extraction ratio of puerarin; secondly, with the extraction and content of puerarin as indexes, the optimum extraction process for the volume, concentration, extracting time and extracting times were selected by orthogonal design; thirdly, with the content of puerarin as index, concentration of extracted solution and parameters of extracting process and crystallizing process were investigated; finally, after recrystallizing and discolouring, the puerarin product of high purity and high yield was prepared.In the study of preparation technology of freeze-dried puerarin injectable powder, firstly, with the inclusion rate as index, the inclusion process parameters was selected by orthogonal design; secondly, the pre-freeze drying and freeze drying process of freeze-dried puerarin injectable powder were investigated, and verification test was carried out and pilot scale production was finished. The quality of three batch samples was not bad than that of samples sold in market besides the total area of impurities in the chromatogram obatained with three batch samples was less than that of impurities in the chromatogram obatained with sold samples.In the study of the quality standards of freeze-dried puerarin injectable powder, firstly, the characters, identifications and tests of this product were investigated. Secondly, the quality standards draft of the new injectable powder was established. Then according to the tests and assay of puerarin (C21H20O9) in freeze-dried puerarin injectable powder was required to be93.0per cent-107.0per cent; the area of each impurity was required to be not more than that of the principal peak in the chromatogram obatained with reference solution(0.5per cent), and the total area of impurities was required to be not more than1.5times the area of the principal peak in the chromatogram obatained with reference solution(3.0per cent).The quality standards of freeze-dried puerarin injectable powder was basically complete, and the quality of the research samples was stable and controllable.In addition, the accelerated stablity and long-term stableity were tested with the characters, identifications, tests and assay of freeze-dried puerarin injectable powder. The results showed that nature of this product was stable.The results showed that the prescription and the preparation technology of the new freeze-dried puerarin injectable powder was reasonable and practicable; the quality standards were basically complete; the quality of the new injectable powder was not worse than that of samples sold in market; and especially in terms of some indexes such as impurities the quality was better than that of samples sold in market.