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硝西泮为抗焦虑、抗惊厥药,临床常用于失眠及癫痫等疾病。为加强对精神药品的管理,我们对此类药品进行了全面的质量考察。含量均匀度是反映片剂中每片主药含量的均匀程度。而硝西泮含量均匀度测定,中国药典1990年版及1995年版收载的方法均为直接振摇溶解法,但是,在实际操作中发现,直接振摇溶解法在药片连续振摇2小时后,在无水乙醇中无明显溶解,不能正确地反映药品的实际含量。本试验在对2个厂家4个批号药品的检验中,用研磨振摇溶解法代替直接振摇溶解法,增加了片剂中主药的溶解度,从而,较真实地反映出该药的实际含量。 1 仪器和试药:
Nitrazepam for the anti-anxiety, anticonvulsant drugs, clinically used in insomnia and epilepsy and other diseases. To strengthen the management of psychotropic substances, we conduct a comprehensive quality inspection of such drugs. The content uniformity reflects the uniformity of the content of each primary drug in the tablet. However, the content uniformity of nitrazepam, the Chinese Pharmacopoeia 1990 edition and the 1995 edition contained in the method are direct shaking dissolution method, however, in practice, found that the direct shaking dissolution method in the tablet continuously shaking 2 hours later, No obvious dissolution in anhydrous ethanol, can not correctly reflect the actual content of the drug. In this test, two batches of 4 batches of drugs in the test, the use of grinding vibration dissolving method instead of direct shaking dissolution method, increasing the solubility of the tablet in the main drug, which more accurately reflect the actual content of the drug . 1 instruments and reagents: