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目的:考察丹参粉针在不同pH下7h内的稳定性。方法:在20℃下,配制不同pH的0.9%氯化钠溶液,模拟临床用药方法,将丹参粉针与不同pH的0.9%氯化钠溶液配伍,测定配伍后7h内配伍液的UV吸收值,根据UV吸收值计算200～400nm范围内绝对和相对紫外光谱相似度及每一点的紫外光谱相似度,并绘制7h内的每一点的紫外光谱相似度变化图谱。结果:除pH9.97的配伍液外,丹参粉针与其余5种同pH溶液配伍,7h内配伍液的外观、紫外吸收图几乎没有变化,波峰与波谷均没有明显偏移,pH基本保持不变,不溶性微粒数量均有不同程度增多。紫外光谱相似度大小依次为pH为7.0,8.08,4.55,3.03,2.04,9.97的配伍液。pH8.08以下时,丹参粉针中“非有效成分”较“有效成分”更易受到pH的影响。在弱酸性环境中,电解质对丹参粉针成分的影响可能更大。结论:丹参粉针最适宜的pH7.0,pH2.02以下或9.97以上均不宜配伍。以传统方法考察中药注射剂配伍稳定性存在一定缺陷,而结合紫外光谱相似度方法可弥补该方法的不足。
Objective: To investigate the stability of Danshen powder injection at different pH within 7h. Methods: 0.9% sodium chloride solution with different pH was prepared at 20°C. The simulated clinical method was used. The Salvia miltiorrhiza powder was combined with 0.9% sodium chloride solution of different pH, and the UV absorption value of the compatibility solution within 7 hours after compatibility was determined. Calculate the similarity of the absolute and relative ultraviolet spectra in the range of 200 to 400 nm and the similarity of the ultraviolet spectrum at each point according to the UV absorption value, and plot the similarity change spectrum of the ultraviolet spectrum at each point within 7 hours. Results: In addition to the compatibility solution of pH 9.97, Salvia miltiorrhiza powder was compatible with the other 5 solutions in the same pH solution. There was no change in the appearance and UV absorption pattern of the compatibility solution within 7 hours. There was no significant shift in peaks and troughs, and the pH remained basically unchanged. Change, the number of insoluble particles have increased in varying degrees. The similarity of UV spectrum was pH of 7.0, 8.08, 4.55, 3.03, 2.04, and 9.97 respectively. Below pH 8.08, the “non-active ingredients” in the powder of Salvia miltiorrhiza are more susceptible to pH than the “active ingredients.” In weakly acidic environments, electrolytes may have a greater effect on the composition of Danshen powder. Conclusion: The most suitable pH value of the salvia miltiorrhiza powder is less than pH2.02 or more than 9.97. There are some defects in the compatibility of traditional Chinese medicine injections with traditional methods. The combination of ultraviolet spectrum similarity method can make up for the deficiency of the method.