CAJ | 학술논문

目的：研究舒血宁注射液与环磷腺苷葡胺注射液的配伍稳定性。方法采用正交试验设计优选舒血宁注射液与环磷腺苷葡胺注射液的配伍方案，以舒血宁注射液中主要成分银杏总黄酮（以槲皮素、山奈素及异鼠李素为对照品）和银杏内酯（以银杏内酯A、B、C为对照品）的含量及环磷腺苷葡胺注射液中主成分环磷腺苷（以环磷腺苷为对照品）的含量为主要考察指标绘制标准曲线，选择温度（A）、光照（B）、放置时间（C）、溶媒种类（D）4个影响因素，同时考察配伍前后各溶液中不溶性微粒和pH值的变化情况。结果正交试验优选方案为A2 B1 C1 D1（25℃、避光、放置1 h、5％葡萄糖为溶媒），方差分析结果表明对于舒血宁注射液中的槲皮素、山奈素而言，温度（A）、光照（B）和放置时间（C）3个因素均对其含量有显著影响（P＜0.05），而溶媒（D）对它们的含量无显著性影响；温度（A）、光照（B）、放置时间（C）和溶媒（D）对配伍液中的其他5种成分均具有显著性影响（P＜0.05）。在0、1、4、6 h，配伍液（ A2 B1 C1 D1）的外观、pH值无明显变化，随着放置时间的延长，不溶性微粒数符合中国药典的相关规定。结论舒血宁注射液与环磷腺苷葡胺注射液在一定的条件下配伍稳定性较好，临床上可以配伍使用。
목적：연구서혈저주사액여배린선감포알주사액적배오은정성。방법채용정교시험설계우선서혈저주사액여배린선감포알주사액적배오방안，이서혈저주사액중주요성분은행총황동（이곡피소、산내소급이서리소위대조품）화은행내지（이은행내지A、B、C위대조품）적함량급배린선감포알주사액중주성분배린선감（이배린선감위대조품）적함량위주요고찰지표회제표준곡선，선택온도（A）、광조（B）、방치시간（C）、용매충류（D）4개영향인소，동시고찰배오전후각용액중불용성미립화pH치적변화정황。결과정교시험우선방안위A2 B1 C1 D1（25℃、피광、방치1 h、5％포도당위용매），방차분석결과표명대우서혈저주사액중적곡피소、산내소이언，온도（A）、광조（B）화방치시간（C）3개인소균대기함량유현저영향（P＜0.05），이용매（D）대타문적함량무현저성영향；온도（A）、광조（B）、방치시간（C）화용매（D）대배오액중적기타5충성분균구유현저성영향（P＜0.05）。재0、1、4、6 h，배오액（ A2 B1 C1 D1）적외관、pH치무명현변화，수착방치시간적연장，불용성미립수부합중국약전적상관규정。결론서혈저주사액여배린선감포알주사액재일정적조건하배오은정성교호，림상상가이배오사용。
Objective To study the compatibility stability of Shuxuening injection and meglumine adenosine cyclophosphate injection . Methods The compatibility program of Shuxuening injection and meglumine adenosine cyclophosphate injection was optimized by orthogonal experimental design, with the main components total flavone of Ginkgo biloba ( quercetin, kaempferide and isorhamnetin as control substance) and Ginkgo lactone ( ginkgolide A, B and C as control substance) of Shuxuening injection, the principal components adenosine cyclophosphate ( denosine cyclophosphate as control substance) of meglumine adenosine cyclophosphate injection as the main index to draw calibration curve, select temperature (A), illumination (B),storage time (C) and solvent (D) as factor, the change of insoluble particles and pH in solution was studied also.Results The optimal compatibility conditions of orthogonal experimental design was A2B1C1D1(25℃, lucifugal, storage time of 1 h,5% glucose solution), ANOVA results showed that temperature (A), illumination (B) and storage time (C) have significant effects on quercetin and kaempferide contents in Shuxuening injection (P<0.05), however, solvent (D) has no significant effect on them.The temperature (A), illumination (B),storage time (C) and solvent (D) have significant effects on the other five substances (P<0.05).At 0, 1, 4, 6 h, the appearance and pH value of compatible solution (A2B1C1D1) were not significantly changed and the number of insoluble particles in accordance with the relevant provisions of the Chinese Pharmacopoeia with storage time increasing.Conclusion The compatible stability of Shuxuening injection and meglumine adenosine cyclophosphate injection is good under certain conditions, and could use compatibility in clinical therapy.