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对《中国药典》2005年版蒲黄薄层鉴别、检查项修订的研究

Improvement on Identification and Impurity Test Methods for Pollen Typhae in ChP 2005
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摘要 目的:对《中国药典》2005年版一部中蒲黄薄层鉴别和检查项进行修订。方法:以香蒲新苷和异鼠李素-3-O-新橙皮苷作对照,采用聚酰胺薄膜,以丙酮-水(1∶2)为展开剂进行鉴别;杂质检查时将筛分法与显微镜检相结合;采用2005年版药典附录ⅨK方法,测定了总灰分与酸不溶性灰分。结果:采用改进后的薄层鉴别方法对蒲黄中的香蒲新苷和异鼠李素-3-O-新橙皮苷进行鉴别,灵敏度高,斑点清晰,分离度好。采用筛分法进行杂质检查时,用7号药筛,称样量为10.0g,筛分时间为2min;增订的总灰分限度为10.0%,酸不溶性灰分的限度为4.0%。结论:改进后的薄层鉴别方法简便,快速,灵敏;修订后的检查项较为合理,更有利于蒲黄的质量控制。 Objective: To improve the TLC identification and impurity test methods for Pollen Typhae in ChP 2005. Methods : Polyamide film was chosen to be as coating substance, and acetone-water (1:2) was chosen to be as mobile phase to identify typhaeneoside and isorhamnetin-3-O-neohesperidoside. Sieving method combined with microscopy were used in impurity limit test. Total ash and acid insoluble ash were determined according to the method of Appendix IX K in Ch. P 2005. Results: Using the improved method, typhaeneoside and isorhamnetin- 3-O- neohesperidoside had more clear spots, higher sensitivity and better resolution. In impurity limit test, about 10. 0 g of the power was passed through No. 7 sieve for 2 rain to inspect foreign matter. The limits of total ash and insoluble ash were defined 10. 0% and 4. 0% , respectively. Conclusions : The improved TLC identification method is simple, rapid, sensitive. The revised examination items are more reasonable. They are more useful for quality control of Pollen Typhae.
出处 《中国药品标准》 CAS 2010年第2期145-147,共3页 Drug Standards of China
基金 <中国药典>2010版一部标准研究课题(YD-106) 辽宁省高等学校科研项目(2008718)
关键词 蒲黄 鉴别 总灰分 酸不溶性灰分 Pollen Typhae identification impurity total ash insoluble ash
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