【作者】 段志红；

【导师】 元英进；

【作者基本信息】 天津大学 ， 制药工程， 2004， 硕士

【摘要】 本文针对熊胆丸制剂缺乏安全、有效、可控、稳定的质量标准体系的问题，结合中药品种的产业化、现代化和国际化进程的要求，运用正交试验方法、显微鉴别方法、TLC、HPLC 色谱分析技术，对熊胆丸现行的质量标准进行研究，并建立其指纹图谱。从提取、浓缩和制剂等方面，优化了熊胆丸的工艺，建立了熊胆丸的显微鉴别特征、主要成分龙胆的 HPLC 鉴别方法及黄连、大黄、决明子、黄芩、栀子、冰片的 TLC 鉴别方法，确立了黄连的 HPLC、大黄的 TLC 扫描含量测定方法，所建立的质量标准重现性好、专属性强，确保了产品质量。通过与功能主治有关的部分药效学量效关系试验，证实熊胆丸具有抗炎、镇痛、抑菌、利胆和解痉胆囊平滑肌的作用，为增加治疗急性咽炎、牙周病和胆囊炎适应症提供依据，为实现中药制剂的二次开发积累经验。通过对色谱条件的研究，建立了熊胆丸的 HPLC 指纹图谱。在 254 nm 检测波长下，确定了 26 个共有峰作为熊胆丸质量体系的指纹特征。并通过共有峰与药材关系的研究，进一步确定了龙胆、黄连、大黄、栀子和黄芩的专属吸收峰。经方法学考察，证明该 HPLC 指纹图谱精密度高、重现性强、稳定性好，符合中药指纹图谱的建立原则，完全可用于控制熊胆丸的成品质量，为该品种实现制剂的中药现代化，逐步成长为“大品种”奠定了基础。更多还原

【Abstract】 In this context, aimed at resolving the lack of quality standard system onsafety, efficacy, controllability and stability of Bear Gall Pill, and to meet therequirements of industrialization, modernization and internationization forTraditional Chinese Medicine (TCM), quality standards of Bear Gall Pill werestudied, and its fingerprint was established by using microscope, orthogonal test,thin layer chromatography (TLC) and high performance chromatography (HPLC). Extract, condensation and preparation for Bear Gall Pill were studied, andmanufacturing process was optimized. Characters of Bear Gall Pill undermicroscope were founded, TLC methods for differentiation of rhizoma coptidis,rhizoma rhei ,semen cassiae, radix scutellariae , fructus gardeniae and borneolumsyntheticum, and HPLC method for differentiation of radix gentianae were buildup. Scanning measurements of HPLC for the content of rhizoma coptidis, and ofTLC for the content of rhizoma rhei were determined. Quality standardsestablished herein possess repeatability and specificity, guaranteeing the products. According to the test of partial pharmaceutical dose-effect relationship to thefunction and indications, Bear Gall Pill serves for anti-inflammation, easing pains,bacteriostatics, benefiting gallbladder, and relieving the spasm of cystic smoothmuscle. This offers evidence for curing indications of acute pharyngitis,periodontal disease, and cholecystitis. And it also accumulates experiences forsecondary development of the product. Chromatographic parameters including temperature, rate and mobile phasewere studied, and HPLC fingerprint map of Bear Gall Pill was achieved. At 254nm, total of shared 26 peaks were determined as characters of the map. Therelationship of the shared peaks between Bear Gall Pill and medicinal herbsconfirmed the absorptive peaks specific for radix gentianae、rhizoma coptidis,rhizoma rhei, fructus gardeniae and radix scutellariae. The results of themethodological studies indicated that this HPLC fingerprint is of high precision,strong repeatability and good stability, conforming to the establishment principleof TCM fingerprint. The established standards have been validated through testingof three batch samples taken from pilot production and verified. The fingerprintcan fully be used for controlling the final quality of Bear Gall Pill and has laid afoundation for the modernization of the product and for its growth into a “leadingproduct”.更多还原