Study Of The Shengmai Preparation Quality Control Methods

Shengmai pharmaceuticals are commonly used in the diseases of cardiovascular system.The qudlity standards of several common pharmaceutical preparations are not perfect well.The dissertation explored the method to control the quality of Sheng Mai pharmaceuticals(Shengmai Troche,Shengmai Capsule,Shengmai Syrup).To improve the quality standard system of Shengmai pharmaceuticals.To enlarge the social and economic benefits of Shengmai pharmaceuticals.When researching the TLC of Shengmai Troche,fried many extract methods and different mobile phases for the TLC of Radix Ophiopogonis, the negative sample always offer nonnegative response.Finally using cyclohexane-acetone(20:0.5) as developing agent,the problem was solved.Established the new developing agent of Radix Ophiopogonis.To add the microscopic inspection for sclereid of Radix Codonopsis,and revise the sampling weight from 5g to 5 pills.To establish HPLC assay for schisandrin,and examined the preparation method of testing sample,chromatographic system,the parameters analytical method to be validated.Through three batches of samples,to stipulate that schisandrin(C₂₄H₃₂O₇)'content should not less than 0.035mg each pill.Researching the TLC of Shengmai Capsule,emended TLC of Panax as to inspect ginsenoside Rg1,Re,Rb1.Using cyclohexane-acetone (20:0.5) as developing agent again to solve the problem that the negative sample always offer nonnegative response.Adding TLC of Fructus Schisandrae Sphenantherae and Radix Ophiopogonis.To establish HPLC assay for inspecting ginsenoside Rg1,Re at the one time, and examined the preparation method of testing sample,chromatographic system,the parameters analytical method to be validated.Through three batches of samples,to stipulate that ginsenoside Rg1(C₄₂H₇₂O₁₄)and ginsenoside Re(C₄₈H₈₂O₁₈)'content should not less than 1.5mg each granule.Researching the quality control of Shengmai Syrup,adding TLC of Radix Codonopsis and Radix Ophiopogonis,To establish HPLC assay for inspecting schisandrin(C₂₄H₃₂O₇),and examined the preparation method of testing sample,chromatographic system,the parameters analytical method to be validated.Through three batches of sample, to stipulate that schisandrin(C₂₄H₃₂O₇)'content should not less than 0.050mg each milliliter.As detector a spectrophotomefer set at 250 nm,taking schisandrin,schisa(?)therin,deoxyschizandrin,r-schisandrin as CRS,using HPLC to distinguish Fructus Schisandrae Chinensis and Fructus Schisandrae Sphenantherae and validate the rationality of HPLC assaying method with schisandrin CRS.By research the quality standards of Shengmai Troche,Shengmai Capsule and Shengmai Syrup,the new quality standards can control the quality of each prescription.To improve and administer the quality standards is propitious to the improvement of drugs' quality and curative effect.It is of very important practical value.