The Research And Development Of Blumea Riparia (BL.) DC Dropping Pills

Objective:To change the formulation of Fuxuekang granules into Blumea riparia(Bl.)DC dropping pills based on the prescription and production process of Fuxuekang granules.The study focused on the quality control of the intermediate product of Blumea riparia(Bl.)DC dropping pills Blumea riparia(Bl.)DC extractum,the preparation technology,quality control,stability and the efficacy of ovulation induction of Blumea riparia(Bl.)DC dropping pills,and established the quality standard draft to provide technical support for follow-up study and development of Blumea riparia(Bl.)DC dropping pills.Methods:?The content of protocatechuic acid in the Blumea riparia(Bl.)DC extractum was determined by HPLC.?The preparation technology was optimized by single factor experiment.The factors to consider included variation coefficient,time of dissolution,appearance quality,types of matrix,the proportion of drug and matrix,dropping temperature,dropping speed,dropping distance,cooLing temperature and types of condensation.The orthogonal experiment was studied after identified factors.?Description of Blumea riparia(Bl.)DC dropping pills were observed.TCL was used to identify Blumea riparia(Bl.)DC dropping pills.The products were inspected with the indexes of solution time,weight variation and content uniformity.The content of Protocatechuic acid in the products was determined by HPLC.?Accelerating test and long-term test was studied by using TLC,determination,in combined with dissolution time,the weight variation and content uniformity three inspections.? Positive expression of VEGF in ovarian microenvironment follicle development regulator was observed,then researched the drug efficacy of ovulation induction of Blumea riparia(Bl.)DC dropping pills preliminarily.Results:?Determined the content of Protocatechuic acid in this extractum by HPLC.The methodological evaluations showed that the precision,repeatability,stability and accuracy met all the requirements.The methods were simple,accurate and reliable.A draft quality control standard of this extractum was established.?Optimized preparation technology was determined by single factor and orthogonal experiments:matrix was PEG4000 and PEG6000(1:1),ratio of drug and matrix was 1:2,temperature of dropping was 80?,dropping speed was 22?25 drop/min,dropping distance was 10 cm,condensate temperature was 10?15 ? and the condensation was dimethicone.?Description of Blumea riparia(Bl.)DC dropping pills were good.Blumea riparia(Bl.)DC dropping pills displayed the same spots in the TLC graphs as Protocatechuic acid reference substance and the Blumea riparia(Bl.)DC control herbs in the same position.All of the basic performance conformed to the requirements of Chinese pharmacopoeia.Determined the content of Protocatechuic acid in the products by HPLC.The methodological evaluation showed that the precision,repeatability,stability and accuracy met all the requirements.The methods were simple,accurate and reliable.A draft quality control standard of the products was established.?Accelerated stability test and long-term stability test results showed that the appearance,content of the product and other related material did not change during the tests,besides time of dissolution and content uniformity met the requirements of Chinese pharmacopoeia,which indicated that the product had good stability.?Research on efficacy of ovulation induction of the product,The vascular endothelial growth factor(VEGF)of Blumea riparia(Bl.)DC dropping pills group was obviously higher than that of model group on the masccline area,the rate of masccline area,photodensity value and average optical of follicular development stage and preovulatory phase.The effect of high dosage group was obviously higher than that of low dosage and middle dosage group.The above indexes of follicular development stage were obviously higher than that of preovulatory phase in rats of every group.Conclusion:The study established the preparation technology of Blumea riparia(Bl.)DC dropping pills,and it is suitable for great production because of good repeatability.Quality control tests were studied,and established a draft quality control standard of the products based on the experiments available for Blumea riparia(Bl.)DC dropping pills quality control.The stability test of the products showed that they were stabile in 12 months.The efficacy of ovulation induction of the product was researched,which confirmed the product has the role of promoting the follicular development and ovulation.The results of all experiment could provide a reliable basis for follow-up study and development.