中国临床药学杂志

目的 考察氢溴酸山莨菪碱注射液与复方电解质醋酸钠葡萄糖注射液的配伍稳定性。方法 取氢溴酸山莨菪碱注射液1.5 mL，用复方电解质醋酸钠葡萄糖注射液或0.9%氯化钠注射液定容至100 mL，混匀后得配伍溶液Ⅰ和配伍溶液Ⅱ(对照)。考察2种配伍溶液在室温下放置0、1、2、4、8 h后的外观性状、pH值、电导率、不溶性微粒数量及氢溴酸山莨菪碱含量。结果 2种配伍溶液在室温下放置8 h内，配伍溶液始终澄清透明，未见变色、产生气泡、形成沉淀或出现浑浊等异常现象。配伍溶液Ⅰ和配伍溶液Ⅱ的pH值分别为4.60～4.73和5.23～5.43，电导率分别为3.86～4.19 mS·cm^-1和13.09～14.11 mS·cm^-1，不溶性微粒数量均符合《中国药典》规定限度，氢溴酸山莨菪碱含量在0～8 h内的RSD分别为0.36%和0.59%。结论 在室温、避光条件下，氢溴酸山莨菪碱注射液与复方电解质醋酸钠葡萄糖注射液配伍后8 h内稳定性良好。

AIM To investigate the compatibility stability of anisodamine hydrobromide injection combined with compound electrolyte sodium acetate glucose injection after storage for different durations. METHODS After 1.5 mL of anisodamine hydrobromide injection was made up to 100 mL with compound electrolyte sodium acetate glucose injection or 0.9% sodium chloride injection, the mixture was mixed thoroughly to obtain compatibility solution Ⅰ and compatibility solution Ⅱ(control). The appearance, pH value, conductivity, number of insoluble particles, and content of anisodamine hydrobromide in the mixture were determined at 0, 1, 2, 4, and 8 h, respectively. RESULTS Within 8 h after compatibility, the solution remained clear and transparent throughout the period, with no abnormal phenomena such as discoloration, bubbling, precipitation, or turbidity observed. The pH values of compatibility solution Ⅰ and compatibility solution Ⅱ were 4.60-4.73 and 5.23-5.43, respectively; the conductivities were 3.86-4.19 mS·cm^-1 and 13.09-14.11 mS·cm^-1, respectively; the number of insoluble particles all met the limits specified in the Chinese Pharmacopoeia; and the RSDs of anisodamine hydrobromide content over 0-8 h were 0.36% and 0.59%, respectively. CONCLUSION Anisodamine hydrobromide injection shows good stability within 8 h after being mixed with compound electrolyte sodium acetate glucose injection at room temperature and protected from light.