Study On The Preparation And Control Of Diltiazem Hydrochloride SR Capsule

On the basis of studying Diltiazemi Hydrochloridum tablets, the Diltiazemi Hydrochloridum sustained-release capsules were made by modern dosage forming technique,combining to establish the related quality control standards.Diltiazemi Hydrochloridum sustained-release beads were finished by centrifugal coating technique. Using orthogonal design analysis, four main factors to the influence of the finished products'quality including coating liquid density; spraying quantity; dry air temperature and drying temperature drying time were researched. The content of Diltiazemi Hydrochloridum was determined by HPLC, combining to establish the related quality control standards. Results as followed: The sustained-release coating was made on the conditions that coating liquid density is 20%; spraying quantity is 140~150g/min;dry air temperature is between 60℃and 70℃; drying temperature is 40℃; drying time is 18hours. These sustained-release beads'dissolution was the range of 51~55%. This result of experiment was satisfied. The quick-release coating was made on the conditions that coating liquid density is 4%; spraying quantity is 130~140g/min; dry air temperature is between 60℃and 70℃; drying temperature is 40℃; drying time is 18hours. The semi-processed beads'dissolution was satisfied.On the basis of making hydrochloride diltiazem sustained-release beads, hydrochloride diltiazem sustained-release capsules are made. After mixing hydrochloride diltiazem sustained-release beads and stearate magnesium,uniform mixture are made. In the mixture, the range of stearate magnesium content is between 1.0% and 1.2%. After packing the mixture into #3-capsules, the hydrochloride diltiazem sustained-release capsules are finished.HPLC analysis was carried out with SYMMETRY C18 column (150mm*4.6mm,5μm) and Sodium acetate-d-sulfonic camphor(4:1) as the mobile phase(adjust PH6.6 with acetonitrile and methanol). the detection wavelength was set at 240nm.The results of content determination showed that there was a good linear relationship between the concentration and the areas of Diltiazemi Hydrochloridum in the range of 120μg/ml to 210μg/ml (r=0.9999), and the method of content determination was sensitive,accurate and reproducible.In a word, the processes of Diltiazemi Hydrochloridum sustained-release capsules were stable; The quality control standard is dependable; The results of experiment provided the guarantee for the industrialization of Diltiazemi Hydrochloridum sustained-release capsules.