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OBJECTIVE To study the factors affecting the generation of the degradation impurity 2-[(4-acetylphenyl)methyl]cyclopentanone (loxoprofen sodium impurityⅠ) in loxoprofen sodium tablets thus to provide reference for the formulation, preparation process and packaging design of loxoprofen sodium tablets. METHODS Stress testing of loxoprofen sodium and loxoprofen sodium tablets were carried out in conditions of high temperature (60 ℃), high humidity (92.5% RH) and strong light irradiation (4 500 lx). The compatibility test of loxoprofen sodium with excipients, and the content of impurity Ⅰ in bare tablets and different packages of loxoprofen sodium tablets were investigated under accelerated test conditions (50 ℃ and 75% RH). The content of impurity Ⅰ was determined by HPLC. RESULTS Loxoprofen sodium impurity Ⅰ is sensitive to humidity. High water content, moisture attracting and hydrophilic excipients such as calcium hydrogen phosphate, silicon dioxide and sodium starch glycolate might cause a significant increase of impurity Ⅰ. Moreover, there was incompatibility between mannitol and loxoprofen sodium, and the sealing performance of the package of aluminum plastic plate plus aluminum foil bag was better than that of the aluminum plastic plate package alone. CONCLUSION In order to reduce the generation of potentially toxic impurity Ⅰ, the excipients of loxoprofen sodium tablets and the granulation after drying should be controlled for water content. The use of aluminum plastic plate plus aluminum foil bag with better sealing performance can effectively reduce the generation of impurity Ⅰ. In addition, mannitol and loxoprofen sodium have compatibility problems and should be avoided in the prescription.
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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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