Study On Quality Of The Compound Kendir Leaves Tablets Ⅰ

Objective: Drug quality control plays an important role in drug development and production.Due to the current standard quality control is very simple of the compound kendir leaves tablets Ⅰ,in this paper,a method for the determination of chemical constituents in compound kendir leaves tablets Ⅰ was established and the residual solvents were investigated to study on the quality of the compound preparation.In order to provide experimental basis for the quality study of compound kendir leaves tablets Ⅰ,the differences between the leaves of Apocynum from different habitats were studied.Methods: Determination the contents of six components in compound kendir leaves tablets Ⅰ by dual wavelengths of LC and the accuracy of the above method was further verified by UPLC.The dissolution experiment was carried out by paddle method,and the content of each dissolution component was determined by HPLC.Study on residual solvent of compound kendir leaves tablets Ⅰ by GC.The HPLC fingerprint of Apocynum leaves was established and the content of active components was determined.The difference of Apocynum leaves from different areas was further analyzed and compared by using the analysis software.Results: According to the regulation of quality control index in the current standard of compound kendir leaves tablets Ⅰ,12 batches of samples from four manufacturers are in accordance with the regulations.According to the composition of the prescription,it was found that the other five of the six chemical constituents were in accordance with the requirements except dihydrazidine sulfate.Determination of three organic solvents in compound kendir leaves tablets Ⅰ and its raw material hydrochlorothiazide by GC.The results showed that there were no methanol and ethyl acetate residues in the preparation and its raw materials,but some of the preparations contained ethanol.The results of HPLC fingerprint analysis showed that 10 batches of Apocynum leaves could be divided into two groups,Xinjiang and Hunan origin classified as a category,origin of Hebei and Hebei can be grouped into a category,and the content of active components varies greatly.Conclusions: In this paper,six chemical constituents of compound kendir leaves tablets Ⅰ and the leaves of Apocynum were analyzed and studied.Simultaneous determination of six chemical constituents in compound kendir leaves tablets Ⅰ by HPLC and UPLC,and study on dissolution and residual solvent to provides a data reference for the quality control of the compound preparation.The analysis of the fingerprint of the leaves of Apocynum and the comparison of the contents of the active components laid a foundation for the further control of the quality of the compound preparation.