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OBJECTIVE To investigate and analyze the quality status of lysozyme oral preparations, and study the key quality control technologies for common problems in current standards, so as to provide technical support for drug supervision. METHODS The 28 batches of lysozyme lozenges and 47 batches of lysozyme enteric-coated tablets obtained by medicine post market quality surveillance were tested according to the current legal standards, and several analytical methods were established for exploratory research. RESULTS According to the legal standard test, although the qualified rate of 75 batches of lysozyme oral preparations was 100%, it was still found that there were problems in the legal standard such as the potency determination has significant errors and lacks key quality control items such as dissolution and content uniformity. The results of exploratory study on potency differed greatly from those of statutory test, the results of dissolution study showed that some enteric-coated tablets were not easy to dissolve, and the results of content uniformity study showed that some large size enteric-coated tablets did not meet the requirements. CONCLUSION As a traditional biological extraction type of biochemical drugs, lysozyme oral preparations are marketed early, so some quality standards can no longer reflect the current situation of the products. The enterprises should optimize the production processes and improve current standards.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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