中国药师
中國藥師
중국약사
CHINA PHARMACIST
2014年
2期
207-209
,共3页
吴樱%殷钰婷%钱亿柔%朱正林
吳櫻%慇鈺婷%錢億柔%硃正林
오앵%은옥정%전억유%주정림
温灸凝胶膏剂%稳定性%细胞毒性试验%致敏试验%刺激试验
溫灸凝膠膏劑%穩定性%細胞毒性試驗%緻敏試驗%刺激試驗
온구응효고제%은정성%세포독성시험%치민시험%자격시험
Warming moxibustion gel-unguentums%Stability%Cell toxicity test%Sensitization test%Irritation test
目的：：对温灸凝胶膏剂进行稳定性、生物安全性研究。方法：模拟市售包装,置温度(40±2)℃,相对湿度(75±5)%条件下放置6个月,考察稳定性；通过细胞毒性试验、豚鼠皮肤致敏以及家兔皮肤刺激试验考察安全性。结果：稳定性测试样品性状、含膏量、黏附性、赋形性、重量差异、TLC鉴别各项检查指标与0月结果比较均无明显变化；细胞毒性试验显示：具有轻微细胞毒性。豚鼠皮肤致敏反应试验显示：皮肤反应等级为0。对家兔皮肤刺激试验显示：皮肤组织的原发性刺激指数为0。结论：温灸凝胶膏剂质量稳定,经皮肤给药安全。
目的：：對溫灸凝膠膏劑進行穩定性、生物安全性研究。方法：模擬市售包裝,置溫度(40±2)℃,相對濕度(75±5)%條件下放置6箇月,攷察穩定性；通過細胞毒性試驗、豚鼠皮膚緻敏以及傢兔皮膚刺激試驗攷察安全性。結果：穩定性測試樣品性狀、含膏量、黏附性、賦形性、重量差異、TLC鑒彆各項檢查指標與0月結果比較均無明顯變化；細胞毒性試驗顯示：具有輕微細胞毒性。豚鼠皮膚緻敏反應試驗顯示：皮膚反應等級為0。對傢兔皮膚刺激試驗顯示：皮膚組織的原髮性刺激指數為0。結論：溫灸凝膠膏劑質量穩定,經皮膚給藥安全。
목적：：대온구응효고제진행은정성、생물안전성연구。방법：모의시수포장,치온도(40±2)℃,상대습도(75±5)%조건하방치6개월,고찰은정성；통과세포독성시험、돈서피부치민이급가토피부자격시험고찰안전성。결과：은정성측시양품성상、함고량、점부성、부형성、중량차이、TLC감별각항검사지표여0월결과비교균무명현변화；세포독성시험현시：구유경미세포독성。돈서피부치민반응시험현시：피부반응등급위0。대가토피부자격시험현시：피부조직적원발성자격지수위0。결론：온구응효고제질량은정,경피부급약안전。
Objective:To evaluate the stability and bio-safety of warming moxibustion gel-unguentums( WMG) . Methods: With the commercially available package and at 40℃ ± 2℃, RH (75% ± 5%) for six months,the stability of WMG was inspected. Guinea pig skin sensitization test, rabbit skin irritation test and cell toxicity test were used to investigate the safety. Results:Compared to the results of 0 month, there was no difference in the sample character, containing paste percentage, adhesion, shape, weight difference and all theindices in TLC identification. Cell toxicity test showed that WMG had slight cytotoxicity. Guinea pig skin sensitization test and rabbit skin irritation test indicated that the grade of skin reaction was zero and the primary stimulus index of skin tissues was also zero. Conclusion:The quality of WMG is stable and the production preparation technology is feasible. Moreover, it is safe in transder-mal administration.
