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Hydrochloride diltiazem tablets based on modern preparation techniques , preparation of sustained-release diltiazem hydrochloride capsules , and the establishment of a quality control standard . Drug-containing pellets prepared by the centrifugal coating granulation technology equipment , focus on this basis , the orthogonal design experiments investigated the concentration of the coating liquid in the centrifugal coating granulation process , the spray amount of the coating liquid , the coating air temperature , semi-finished drying temperature of four factors that affect the quality of the final product ; established by high performance liquid chromatography method for the determination of the hydrochloride diltiazem , and the establishment of quality standards . The results show that : the concentration in the coating liquid is 20% , the amount of coating solution was sprayed to 140 ~ 150g/min , the the coated air temperature is 60 to 70 ° C , the semi - finished drying temperature time of 40 ° C , 18h under the process conditions , the prepared the controlled release particles of dissolution between 51 % to 55% , in line with the conditions of dissolution ; concentration of 4% in the coating liquid , the amount of coating solution was sprayed to 130 ~ 140g/min, coated air temperature is 60 to 70 ° C , the semi-finished drying temperature to 40 ° C , 18h process conditions , the release of the immediate-release granules prepared in accordance with the design criteria . Was prepared on the basis of the release granules prepared capsules. Hydrochloride diltiazem release granules of magnesium stearate , the amount of control in the 1.0 % to 1.2% , after mixing, to obtain uniform particles . No. 3 capsule filling this particle to become hydrochloride diltiazem sustained-release capsules . In the chromatographic conditions (SYMMETRY C-185μm4.6 × 150mm column; sodium acetate - d camphorsulfonic acid (4:1), with acetonitrile and methanol, the pH was adjusted to 6.6 as the mobile phase ; detection wavelength was 240nm ) , high performance liquid phase chromatography determination of the results showed that : diltiazem hydrochloride Zhuo release capsules in 120 ~ 210μg/ml the concentration range of concentration and peak area between the linear relationship between good ( r = 0.9999 ) , established hydrochloric ground Seoul sulfur Zhuo 's content determination method is sensitive , accurate and re- good reproducibility . Comprehensive study results show that : excellence established diltiazem hydrochloride sustained-release capsules preparation process is stable , reliable and quality standards , and provided a guarantee for the industrial production of our preparations .
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