Study On The Preparative Technology And Quality Control Of Spatholobi Caulis Total Flavonoids Dropping Pills

Objective: Throughout history, the caulis millettiae always occupy a seat in all drugs which are used for invigorating blood circulation and eliminating stasis. The main composition for it is flavonoids compound. It contains a largest amount of total flavonoids, which is the efficacious content of the caulis millettiae for invigorating blood circulation and eliminating stasis. It can do well in the treatment of hematopoietic system diseases. The caulis millettiae has a very good market development prospects, we can develop new prepareations. In this thesis, we approach partly pharmacal research about the caulis millettiae total flavonoids dripping pills, include its fabrication and standard evaluation.Methods:According the pharmacal peculiarity of drugs in the anagraph and the function of this anagraph, we used orthogonal design to optimize the best moulding techniques of the caulis millettiae total flavonoids dripping pills. And we used orthogonal design to investigate several indexes such as difference of appearance characteristics of dropping pills, dissolution time and weight variation of pills. Then we scored by weighted score synthesis method to investigate several indexes such as proportion of mixed substrate, proportion of drug and substrate, diameter of drop head, length of dropper, velocity of droplet and temperature of condensing agent.We used following methods to investigate several indexes, such as:According to the Chinese Pharmacopoeia(2015), we investigated three indexes: moisture, ignited residue and content of the caulis millettiae total flavonoids.we investigated the dissolution and weight variation of the caulis millettiae total flavonoids dripping pills.On these bases, we did an accelerated six-month-long stability investigation on the samples.Results:(1)The conditions for better moulding technique of the caulis millettiae total flavonoids dripping pills are: use PEG4000:PED6000 1:7 as the mixed substrate, the proportion(weight) of drug and substrate is 1:3, the inner diameter of drop head is 4.5mm, the length of dropper is 10 cm, velocity of droplet is 30 d/min and temperature of condensing agent is 8 ?. The technique which comply with the conditions which are mentioned above is the best technique.(2)The tests of moisture, ignited residue and content of the caulis millettiae total flavonoids are all in line with the Pharmacopoeia standards. The weight variation of it is within ±12%. The standard curve for its dissolution is Y=0.0605X+0.0059(R2=0.9993), and the RSD(%) of precision is 0.76, the RSD(%) of stability is 0.89. The recovery rate(%) is between 99.88-100.42, and its RSD(%) is 3.80. The sampling time of dissolution testing is 40 min. The testing of disintegrating time is in line with the Pharmacopoeia standards.(3)Compared with zero-month, the result of accelerated six-month-long stability investigation of the caulis millettiae total flavonoids dripping pills shows that: there are no marked changes in character, dissolution and microorganism. All the indexes are in line with the requirements of drug quality standards.Conclusion:The quality criteria which is built by this thesis for the caulis millettiae total flavonoids dripping pills has strong controllability. Thus it can provide a reference for fabrication and quality standard research of the caulis millettiae total flavonoids dripping pills. This quality criteria lays the foundation for quality standardization of the caulis millettiae total flavonoids, and makes contribution to Chinese Traditional Medicine modernization.