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| The preparation and quality control of Leukoplakia Cream (Ι) |
| LI Yan, WANG Bin, ZHANG Jinjie, HE Jing, WANG Zhenzhen |
| Department of Pharmacy,Binzhou Medical University Hospital, Binzhou 256603, P.R.China |
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Abstract Objective To Prepare Leukoplakia Cream (Ι) and to establish its quality control method.Methods Emulsion process was used to compound Leukoplakia Cream (Ι). HPLC method was developed to determine the compounds of Leukoplakia Cream (Ι).Results The quality of cream was eligible in appearance properties,microbial limit,and stability.As for Dyclonine hydrochloride,baicalin, diethylstilbestrol,vitamin E,their concentration and peak area displayed good linear relationship. The average recovery rates:dyclonine hydrochloride was 100.42%,RSD was 0.77%;baicalin was 100.49%,RSD was 0.68%;diethylstilbestrol was 100.06%,RSD was 0.82%,vitamin E was 100.46%,and RSD was 0.85%.Conclusion The preparation process is simple.The quality of the preparation is controllable,and the property is stable.The method of content determination is also simple, rapid and accurate.
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Received: 25 April 2018
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