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OBJECTIVE:To provide ideas for revise and improve the standard and related method of the quality control of ben-zalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS:The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia(2015 edition,Ⅱ),British Pharmacopoeia(2013 edition),European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS:Com-pared with Chinese Pharmacopoeia(2015 edition,Ⅱ),the standards abroad provided the component and the ratio of the benzalko-nium chloride substituted homolog,the method for ammonia compound test had higher sensibility,it also added the test for benzyl alcohol,benzaldehyde and benzyl chloride impurity,as well as the component ratio test and average relative molecular mass calcu-lation. CONCLUSIONS:The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoe-ia(2015 edition,Ⅱ)still need to be further improved.
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OBJECTIVE:To establish a method for the determination of related substances in bifonazole raw material. METH-ODS:HPLC method was performed on the column of Kromasil C18 with mobile phase of methanol-0.02 mol/L phosphoric acid(ad-justed pH to 7.5 with triethylamine)(70:30,V/V)at a flow rate of 1.0 ml/min,detection wavelength was 258 nm,volume injection was 20 μl,and the column temperature was 40 ℃. RESULTS:The linear range was 0.05-0.25 μg/ml for bifonazole(r=0.9996), 0.05-0.25 μg/ml for impurity A(bifonol)(r=0.9997)and 0.05-0.25 μg/ml for impurity B(4-C isomer)(r=0.9995);the detec-tion limits were 8.2 ng/ml,7.5 ng/ml and 8.4 ng/ml,and the quantification limits were 27.1 ng/ml,24.7 ng/ml and 27.8 ng/ml,re-spectively;RSDs of precision and reproducibility tests were lower than 1%;recovery of impurity B was 95.13%-101.29%(RSD=1.89%,n=9);both impurity A and impurity B were were detected in the 3 batches of samples. CONCLUSIONS:The method is accurate,sensitive and reproducible,and can be used for the determination of the related substances in bifonazole raw material.
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Objective:To evaluate the quality status of lithium carbonate tablets and lithium carbonate sustained-release tablets. Methods:The samples were examined in accordance with the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results:In accordance with the statutory standard,among 120 batches of samples, only one was unqualified in dissolution,and the others were qualified. The qualified rate was 99. 2% . Conclusion:The quality of the most products meets the current standard and the quality evaluation standard needs to be improved.
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Objective To optimize the extraction procedures of compound Three-Flower-Tea (CTFT) by orthogonal design. Methods After having established the methods of quantifying the chlorogenic acid by TLC-UV, the orthogonal design was used to select the best extraction procedures, using chlorogenic acid content and extract yield as the measuring index, through controlling four different factors, naming extraction temperature (A), extraction time (B), watervolume added (C) and extraction number of times (D), and three levels at each factor. Result The effective factors which influenced the extraction procedures were A, C and D. Conclusion The optimum extraction procedures for CTFT should be 15-fold water volume, three-time decocting with 20 minutes per time at temperature of 100 ℃.