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用于海绵体内注射的盐酸罂粟碱-甲磺酸酚妥拉明混合物的物理化学稳定性:初步评估

Physicochemical stability of papaverine hydrochloride-phentolamine mesylate mixtures used for intracavernous injection: a preliminary evaluation.

作者信息

Hadzija B W, Mattocks A M, Stahl G M

机构信息

School of Pharmacy, University of North Carolina, Chapel Hill.

出版信息

J Urol. 1988 Jul;140(1):64-5. doi: 10.1016/s0022-5347(17)41487-x.

Abstract

Physicochemical stability of intracavernous injections of 30 mg. per ml. papaverine hydrochloride with 0.5 or 1.0 mg. per ml. phentolamine mesylate used to induce erection in patients with impotence was examined. The samples were stored at room temperature, in the refrigerator at 4C and in the freezer at -20C for 6 months. The examination consisted of visual observation for change in color or evidence of precipitation, measurement of pH and thin layer chromatography at different intervals. During the 6 months of storage no change had occurred in pH, color development, precipitation or formation of new moieties. Therefore, the aforementioned injection solutions of papaverine hydrochloride with phentolamine mesylate can be dispensed safely with instruction to patients for adequate storage and manipulation.

摘要

对用于治疗阳痿患者勃起功能的每毫升含30毫克盐酸罂粟碱与每毫升含0.5或1.0毫克甲磺酸酚妥拉明的海绵体内注射剂的理化稳定性进行了研究。将样品分别在室温、4℃冰箱和-20℃冰柜中储存6个月。检查内容包括观察颜色变化或沉淀迹象、测量pH值以及在不同时间间隔进行薄层色谱分析。在6个月的储存期内,pH值、显色、沉淀或新成分的形成均未发生变化。因此,上述含盐酸罂粟碱和甲磺酸酚妥拉明的注射溶液可以安全配药,并告知患者妥善储存和使用。

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