可吸收性明胶海绵的质量研究及控制

目的: 对可吸收性明胶海绵产品质量进行研究和控制。方法: 采用凯氏定氮法测定明胶海绵的蛋白含量、氯胺T法测定羟脯氨酸含量、变色酸钠法测定甲醛残留量，采用中国药典2010版方法测定干燥失重、硫酸盐灰分、重金属、铬含量等性能，同时还对产品的酸碱度、可消化性实验方法进行阐述。结果: 进口及国产共5批可吸收性明胶海绵样品中，1~4^＃样品明胶海绵中蛋白含量按干燥品计，均大于95%；羟脯氨酸含量按干燥品计均大于12%；2~5^＃样品单包装样品中甲醛残留量最高约为160 μg；1^＃、3^＃、4^＃样品干燥失重的测定结果约为15%；硫酸盐灰分不大于2.0%；重金属不大于30 mg·kg^-1；水浸提液的pH测定结果均在4.0~5.5之间；铬含量不大于2 mg·kg^-1；液体吸收量不少于自身重量的35倍；同一实验条件下1~4^＃样品可消化性实验表明，国产产品的消化时间明显高于进口产品，且均一性不如进口产品。结论: 本文所采用及建立的质量研究方法，可较全面地评价可吸收性明胶海绵的质量，从而对其质量进行有效控制。

Objective: To study and control the quality of absorbable gelatin sponge. Methods: The method of Kjeldahl determination was used to determine the protein content,the chloramine-T method to determine the hydroxyproline content,the sodium chromotropic method to determine formaldehyde residue,the test method of Chinese Pharmacopoeia 2010 to determine loss on drying,sulfate ash,heavy metal,and content of chromium,the test methods of pH value and digestibility were also demonstrated. Results: Among the 5 batches of samples including imported and domestic absorbable gelatin sponge,calculated on the anhydrous substance,the protein contents in samples 1-4^＃were more than 95%,the hydroxyproline contents were more than 12%.The maximum content of formaldehyde residue in single package of samples 2-5^＃ was 160 μg,loss on drying of samples 1^＃,3^＃,and 4^＃ was approximately 15%,the content of sulfate ash was not more than 2.0%,heavy metal was not more than 30 mg·kg^-1,pH valve of water extract was between 4.0-5.5,the content of chromium was not more than 2 mg·kg^-1,water absorption was not less than 35 times of the product's weight.Under the same experimental conditions of samples 1-4^＃,the digestion time of domestic products was significantly higher than that of imported products,and uniformity was worse than imported products.Conclusion: The established and adopted methods of quality study can comprehensively evaluate the quality of absorbable gelatin sponge,and can be used to control the quality effectively.

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