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目的:改进、提高《中国药典》标准,提高地高辛使用的安全性和有效性。方法:对中、英、美、日药典收载的地高辛有关物质检查方法和限度进行比较。结果:四国药典的检查方法、对照品、限量都不相同,英、美、日药典都使用了吉妥辛时照品,《英国药典》最为严谨,《中国药典》仅对洋地黄毒苷做了限度规定。结论:有待努力改进生产、提高标准,与国际接轨。
Objective: To improve and enhance the standard of “Chinese Pharmacopoeia” to improve the safety and effectiveness of digoxin use. Methods: The methods and limits of digoxin-related substances in Chinese, English, American and Japanese pharmacopoeia were compared. Results: The inspection methods, reference substance and limited quantity of the four states pharmacopoeia are all different, and the use of ghuxin in Britain, the United States and Japan is the most rigorous. The “British Pharmacopoeia” is the most rigorous. The “Chinese Pharmacopoeia” only makes use of digoxigenin The limit requirements. Conclusion: We must make efforts to improve production, raise standards and keep pace with international standards.