Preparation of diphenhydramine hydrochloride sustained-release tablets
Objective:to prepare 24h extended-release diphenhydramine hydrochloride sustained-release tablets.Methods:diphenhydramine hydrochloride content determination method is established by ultraviolet spectrophotometry,the preparation process is determined by the forming of the tablets.To screen of the skeleton material of diphenhydramine hydrochloride sustained-release tablets to determine the prescription took by the degree of release.The diphenhydramine hydrochloride extended-release tablets is prepared according to a preferred prescribing process and its quality is examined.Results:in UV spectrophotometry:standard curves in purified water:y=0.0015x+0.015,r=0.9998,linear range:130.5-451.7 μg/mL;standard curves in simulated gastric juice:y=0.0016x―0.0074,r=0.9993,linear range:130.5-401.5 μg/mL;standard curve in simulated small intestinal fluid:y= 0.0016x-0.0041,r=0.0091,linear range:130.4-401.5 μg/mL;standard curve in simulated colonic fluid:y=0.0016x―0.0179,r=0.0091,linear range:150.5-401.5 μg/mL.Precision and recovery rates comply with regulations.The preferred prescription process is:diphenhydramine hydrochloride 75 mg,ethylcellulose 360 mg,talc 15 mg,powder direct tableting,pressure 70N.Diphenhydramine hydrochloride sustained-release tablets prepared by preferred prescription and preparation process,the tablet surface is smooth and tidy,the difference in tablet weight and the degree of release in the same release medium are more than 80%.Conclusion:the insoluble diphenhydramine hydrochloride skeleton tablets prepared with ethyl cellulose as the skeleton material can be slowly released for 24h,the preparation process is simple,and the cost is low.
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