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《中华人民共和国药典》是我国国家药品质量标准,是控制药品质量的法定性文件之一,是药品质量监督的重要依据。 建国以来我国共颁布实施了五版药典(1953年版、1963年版、1977年版、1985年版和1990年版),不久还将颁布1995年版,每版药典的编纂都在上一版的基础上有所改进和提高(表1),特别是1985年版和1990年版都较上一版有较大改进和提高,除增加药品品种数量、专项检查和剂型等方面外,在检测方法上采用了高效液相色谱、气相色谱、紫外光谱、红外光谱等仪器和薄层色谱分析方法的药品品种有较大幅度增加。
The Pharmacopoeia of the People’s Republic of China is a national drug quality standard in our country and one of the legal documents that control the quality of medicines. It is also an important basis for drug quality supervision. Since the founding of our country, a total of five Pharmacopoeia (1953, 1963, 1977, 1985 and 1990) have been promulgated and promulgated. In 1995, the edition of the Pharmacopoeia will be promulgated on the basis of the previous edition (Table 1). In particular, the 1985 edition and the 1990 edition have been greatly improved and improved over the previous edition. In addition to increasing the number of varieties of medicines, special examinations and dosage forms, etc., the detection methods used were high performance liquid chromatography , Gas chromatography, UV spectroscopy, infrared spectroscopy and other thin-layer chromatography and analytical instruments of drugs have a more substantial increase.