Technology And Quality Standard Of Compound Notoginseng Dropping Pills

Objective:By studying the molding process, the quality control standards, the vitro dissolution and the pharmacokinetics of Compound Notoginseng Dropping Pills, these work aimed to establish the best molding process conditions and quality control standards, provided experimental basis for the pills that it has hypolipidemic action and prevention of atherosclerosis formation.Methods:1.Molding process:On the basis of the single factor test, taking the dropping speed, distance and temperature as independent variables, dissolution time, weight difference and appearance as dependent variable, the Box-Behnken central composite design was used to select the best molding process of the pills.2. Quality control standards:The contents of lovastatin.α-methyl linolenic and notoginseng total saponin were selected as indicators, set up differentiation method and determine the contents by using high performance liquid chromatography and thin layer chromatography.3. Dissolution in vitro:The paddle method was used to study the drug release properties by measuring the dissolution rate of effective constituents.4. Pharmaceutical research:Feeding the rat with high-fat diet to get hyperlipidemia model, studying if the preparation could prevent and cure the disease.Result:1.The best molding process was:use the PEG4000:PEG6000=1:3as substrate, then mix with the drug according to the proportion of1:4, drop it in paraffin, the temperature of cooling liquid was80degree, speed was30～40drops per minute, the distance from liquid level to outlet was4centimeter.2. The qualitative identification and content determination methods which were established could control the quality of the pills.4. Comparing with model group, the preparation(middle, high) reduced rats’weight obviously; medium and high dose group (0.06,0.12,0.24g/kg) had the same action with lovastatin group but reduced the TC and TG differently (P<0.05);0.24g/kg dose group had lower LDL and elevated APOA1(P<0.05); the low, medium and high dose group (0.06,0.12,0.24g/kg) of the pills have different degrees of reduction of APOB effect (P<0.01)Conclusion:The molding process was simple and stable; the qualitative identification and content determination method were stable and repeatable, it could be used as the preparation’s quality control standards; the dissolution quantity of preparation has a fast speed and could arrive at99.0%; the preparation could regulate hyperlipidemia, in addition, it could prevent atherosclerosis.3.the T0.5of Pills was7.25min, Td was11.32min, Dissolution rate was99.0%。...