Studies On The Precedure And Quality Standard Of Zhibaidihuang Pills

通过实验考察了稠膏的干燥温度,辅料的种类和用量以及酸碱的比例和用量对制剂质量的影响,确定了制剂的最佳制备工艺,即稠膏在70℃干燥,得到的干膏粉碎成细粉,加入二分之一量的乳糖和糊精(乳糖—糊精1:2)及丹皮酚的β-环糊精包合物,混匀,再加入四分之一量的柠檬酸和碳酸氢钠(柠檬酸—碳酸氢钠2:3),混匀,用适量的无水乙醇制粒,干燥,即制得知柏地黄泡腾颗粒。为控制药品的内在质量,确保临床用药的安全有效性,通过试验对知柏地黄泡腾颗粒进行了质量标准研究,采用薄层色谱法对制剂中的牡丹皮,山茱萸,黄柏进行定性鉴别,采用高效液相色谱法对山茱萸中主要有效成分马钱苷进行含量测定。定性鉴别和含量测定方法均进行了方法学验证,结果表明,薄层鉴别色谱法呈现斑点清晰,特异性强,可用于该制剂的定性鉴别;含量测定方法简便准确,重现性好,可用于定量控制。此外,在室温条件和加速条件下,对三批中试样品进行了为期6个月的初步稳定性考察和加速稳定性考察,结果显示室温留样放置及高温,高湿条件下放置的样品各项检测指标合格,样品稳定性较好。本研究对全粉末的知柏地黄丸处方中的8味药材全部进行了提取,精制成知柏地黄泡腾颗粒,是对大品种老药物进行的二次性开发研究,通过实验研究,确定了与以往全部药材粉碎入药的丸剂或仅部分药材提取的知柏地黄浓缩制剂有着本质区别的知柏地黄泡腾颗粒的制备方法和质量控制方法,丰富了知柏地黄丸处方的用药形式,增加患者用药的选择性和方便性,同时,有关研究填补了国内知柏地黄丸相关领域的空白,对今后类似药物的二次性开发也提供一定的借鉴意义和参考价值。 Zhibai Dihuang Pills, the classical famous drug, used for nourishing yin and purging fire, with the fountain-head of Golden Mirror of Medicine of Manchu Dynasty, were collected into the Chinese Pharmacopoeia (2005 Edition). In the prescription of Zhibai Dihuang Pills, there are eight kinds of ingredients, such as Rhizoma Anemarrhenae, Cortex Phellodendri Chinensis, Radix Rehmanniae Praeparata, Fructus Corni, Cortex Moutan, Rhizoma Dioscoreae, Poria and Rhizoma Alismatis. Zhibai Dihuang Pills, with the effect of nourishing yin and purging fire, can be used for the treatment of diabetes, Nephrosis syndrome, Uropoiesis infection, and so on. Zhibai Dihuang Pills have been widly used on the clinical treatment to cure yin deficient, and made into other dosage forms of preparations, such as tablets, capsules, granules. In recent years, along with the constant development of the clinical application, the application range of Zhibai Dihuang pills was extended correspondingly.Zhibai Dihuang honeyed Pills and water-honeyed pills, made with the powder of herbal ingredients without extraction, were collected into the Chinese Pharmacopoeia. The powder pills have the advantages of absorbing slowly, with affects lasting, but they also have the disadvantages of dissoluting too lowerly, absorbing poorly, and the granularity of powder might affect the effect of the pills.Effervescent preparation is a new dosage form progressed in recent years, with the advantages of quicklier collapsing, quicklier effection, and higher bioavailability, ect.In order to strengthen the effect of Zhibai Dihuang Pills, heighten their bioavailability and make them more convenient for patients, studies on the improvement of Zhibai Dihuang precedure and quality control methods were carried out, and a new patent drug--Zhibai Dihuang Effervescent Granules were developed. The herbal contents in the prescription was extracted. Orthogonal test experiment was used to choose the optimum extraction methods.In order to control its intrinsic quality to assure the clinical safety and effect, studies on the quality standard of Zhibai Dihuang Effervescent Granules were carried out. Thin layer chromatography ( TLC) and high performance liquid chromatography ( HPLC) were used. Cortex Moutan, Fructus Corni, and Cortex Phellodendri Chinensis were identifid by TLC, and the content of loganin in Zhibai Dihuang Effervescent Granules was determined by HPLC. The TLC identification methods were distinct and highly specific; the HPLC quantity determination method was simple, convenient, accurate and reproductable. The chosen analisys methods could be used for the quality control of Zhibai Dihuang Effervescent Granules.Initial stability test and acceleration stability test were car- ried for six monthes, and the results indicated that the samples had good stability.The studies on the Zhibai Dihuang Effervescent Granules will enrich Zhibai Dihuang preparations and application, strengthen their effect, enhance the bioavailability and increase selectivity and convenience for the patients.