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Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems.Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010),and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results.Results All 42 batches of samples were qualified.The production process of each enterprise was steady.Conclusion At present the quality of recombinant human interferon αlb injection is generally good.The current standards are feasible,but the specified standard of osmolality needs to be improved.
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OBJECTIVE:To provide reference for improving the homogeneity and stability of domestic cefetamet pivoxil hydro-chloride oral solid preparation and its control standrads. METHODS:105 batches of cefetamet pivoxil hydrochloride preparations (tablets,granules,dry suspensions and dispersible tablets)were tested by statutory inspection test in respects of property,identifi-cation,weight difference or load difference,moisture,microbiological limits,related substances,dissolution degree and content, etc.,and results were analyzed. Exploratory research was conducted for its impurity sources,dissolution consistency evaluation, the correlation between the remaining validity period with relative substance and content,etc. RESULTS:Statutory tests showed, 103 batches were qualified in the 105 batches of samples(98.1%). The unqualified items were property and related substances,the other items met relevant regulations. Besides,the determination method for related substances in dispersed tablets was quite differ-ent with other preparations. Results of exploratory research showed the related substances in preparations originated from raw materi-als,degradation reaction in manufacturing or storage. Compared with domestic reference tablets and granules,f2 of dissolution of other products were mostly less than 50;there was no correlation in related substances,content with the remaining validity period. CONCLUSIONS:The 105 batches of domestic oral solid preparation of cefetamet pivoxil hydrochloride are basically qualified;cur-rent standard is basically feasible for tablets,granules and dry suspensions,while the standard for dispersible tablets needed to be improved immediately.
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OBJECTIVE: To understand the quality status and problems of domestic heparin products and evaluate the suitability of statutory standard and test methods. METHODS: The statutory methods were adopted to test the samples. Many testing methods were established or improved on the basis of domestic and international standards and literature review and field research, including ion chromatography, capillary electrophoresis, mutiangle laser light scatter (MALLS), reverse phase chromatography, size exclusion chromatography, micro-chromogenic substrate methods, etc. RESULTS: The national evaluation test in two consecutive years of 2009 and 2010 showed that the majority of the samples complied with the 2005 edition of Chinese Pharmacopoeia. But this standard lacked control of impurities, and the limits of some items were not suitable. A few samples contained heparin-like impurities; phenol was added as preservatives arbitrarily. The assay method of anti-factor X a and anti-factor II a activity had high specificity, which was better to control the potency of heparin. Ethanol residues in the raw material of some samples exceeded the standard limit. The control of nucleic acid and protein was good. The determination of polarimetry and osmolality reflected some problems. Through this study, the quality specification of heparin in the 2010 edition of Ch. P had been improved a lot. CONCLUSION: Domestic heparin products have better quality at present. The quality specification of the raw material and injection of heparin in the 2010 edition of Chinese Pharmacopoeia is relatively perfect and close to European Pharmacopoeia and the United States Pharmacopoeia. Our capability of quality test of heparin has been substantially improved. Consequently, we have taken part in several international collaborative studies and won international voice in the quality control of heparin products.