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Objective: To evaluate the quality status of piroxicam tablets. Methods: The samples were examined by the statutory standard,and the exploratory studies were carried out. The results were statistically analyzed. Results: Totally 138 batches were exam-ined according to the statutory standard, and among them, 135 batches were qualified with the qualified rate of 97. 8% . The unquali-fied item of 3 unqualified batches was dissolution. The exploratory studies showed that there were two crystal forms of piroxicam used in the tablets, and the dissolution of the two crystal forms was different with form 1 less than form 2. An inspection method for the relative substance was established. Totally 14 impurities were detected out and the structures of 8 impurities were identified. The impurities were mainly derived from the raw materials, and many batches of samples were with single largest impurity content exceeding 0. 5% , and the total of impurity content above 1. 0% . A class I solvent 1,2-dichloroethane was detected out in 13 batches of tablets by GC and confirmed by GC-MS. Through the dissolution consistency test, it was found that there was a great difference in the dissolution behavior among the products from different manufacturers. Conclusion: The overall quality of piroxicam tablets is not ideal, and the production process of some manufacturers needs to be improved.
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Objective: To determine the content of crystal type α in glycine by X-ray power diffraction technique to provide evi-dence for the polymorphic research. Methods: A calibration curve was established by using the characteristic peak ratio of glycine form α at 2θ=19. 1° to form γ at 2θ=25. 4° as the quantitative parameter to determine the content of crystal type α. Results: The charac-terization figures of form α and form γ were obtained. The linear range of form α was 1%-99% (r=0. 996 7), and the average recov-ery was 102. 8% with the RSD of 4. 0% (n=9). Conclusion: X-ray powder diffraction method is a feasible analytical method for the quantitative determination of form α and form γ of glycine with simple,sensitive and accurate properties.
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OBJECTIVE:To analyze the results of national evaluation inspection for 83 batches of Compound jiegeng mahuangjian syrup(Ⅱ)from 4 manufacturers,and to evaluate their quality. METHODS:Legal inspection method and exploratory research were adopted to test,analyze and evaluate sample statistically. The contents of exploratory research included HPLC method was used to determine the contents of preservative benzoic acid and ephedrine hydrochloride;antibacterial efficacy examination of formulation was studied;pH value of solution was determined;the content of sucrose was determined by polarimetry photometry;the relationship of the content of ammonium chloride with microbial contamination was studied;headspace GC method was used to determine the contents of menthol and ethanol;Platycodon grandiflorum extractum was identified and studied by TLC. RESULTS:Results of legal inspection showed that among 83 batches of sample,80 batches were qualified and 3 batches were unqualified,with qualified rate of 96.4%. Unqualified items were loading capacity,microbial limit and content ofammonium chloride,content of ammonium chloride. The results of legal test combined with exploratory research showed thatantibacterial efficacy of formulation of one manufacturer was not in accordance with the regulations;Some raw materials were notfed according to formulation, and the quality of products was not even. It is recommended to revise the quality standard:identificatied the Campanulaceae by TLC; determination the pH, preservative content, menthol content; revision ephedrinehydrochloride assay method to HPLC. CONCLUSIONS:The overall quality of Compound jiegeng mahuangjian syrup(Ⅱ)is notsatisfactory;there is a big flaw in the production process and quality control of some manufacturers;quality standards needed to beimproved.
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AIM: To establish a new quality standard for Kangbindu Oral Solution (Radix Isatidis, Gypsum Fibrosum, Rhizoma Phragmitis, Radix Rehmannia, etc.). METHODS: Rhizoma Acori Tatarinowii and Fructus Forsythiae were identified by TLC. The forsythin content was determined by HPLC on Inertsil ODS column (4.6mm?250mm,5?m). The mobile phase was acetomitrile water(25∶75). The detection wavelength was set at 277nm. RESULTS: The linear range of forsythin was in the range of 4.24～21.2?g. The average recovery was 99.09%, and RSD was 0.4%( n =6). CONCLUSION: The method is simple and accurate, and can be used for the quality control of Kangbindu Oral Solution.