藏药榜那质量标准研究

发布时间：2019-03-01 09:50

【摘要】：榜那为常用藏药,民间及临床的应用均取其消炎、镇痛及麻醉等功效,主要用于腰肌劳损,风湿关节痛等疾病的治疗。榜那药材为毛茛科乌头属植物,含有多种生物碱,其中双酯型生物碱是一类毒性较大的成分。由于榜那药材中所含生物碱既是活性成分又是其毒性成分,所以建立完善的榜那质量标准对保证其临床用药安全有效有重要意义。《中国药典》(2010年版一部)未收载榜那药材的质量标准,在《卫生部药品标准·藏药(第一册)》(1995年版)中也只有部分简单的规定,除有[性状]、[鉴别]、[性味]、[功能与主治]、[用法与用量]和[贮藏]等项外,缺乏作为现代药品质量标准标志的活性或毒性成分的[含量]及[检查]项等的规定,标准极不完善,为了有效的控制药物的安全性及有效性,需要建立一个完善的质量标准。本研究参照《中国药典》2010版一部,对其水分、灰分和浸出物进行了测定,并暂定其限度分别为12.5%、7%和15%；采用高效液相色谱法,建立了乌头碱的限量测定法,该方法专属性强,耐用性好,精密度高,平均回收率为99.15%,RSD=0.7%；采用紫外-可见分光光度法测定,建立了总生物碱的含量测定方法,本法测定的重复性良好,RSD=2.54%,平均加样回收率为95.41%,RSD=0.43%。另外,对榜那药材的薄层鉴别也进行了研究,但研究结果显示,所有药材找不到共有斑点,故无法建立薄层鉴别。
[Abstract]:Pangna is a commonly used Tibetan medicine, folk and clinical use of its anti-inflammatory, analgesic and anesthetic efficacy, mainly used in the treatment of lumbar muscle strain, rheumatic arthralgia and other diseases. Pongna is a kind of aconitum plant of Ranunculaceae, which contains many alkaloids, among which diester alkaloid is a kind of toxic component. Since the alkaloids contained in Pangna are both active and toxic, it is of great significance to establish a perfect quality standard for the safety and effectiveness of their clinical use. The Chinese Pharmacopoeia (2010 edition No. 1) does not contain the quality standard of that medicine. In the Drug Standard Tibetan Medicine of the Ministry of Health (Volume 1) (1995 edition), there are only some simple provisions, except for [characters], [identification]. With the exception of [sexual taste], [function and main treatment], [usage and dosage] and [storage], there is a lack of [content] and [examination] items, which are used as markers of quality standards for modern medicines, and so on, and the standards are extremely imperfect, In order to effectively control the safety and effectiveness of drugs, it is necessary to establish a perfect quality standard. According to the first part of the 2010 edition of Chinese Pharmacopoeia, the moisture, ash and extract were determined, and the tentative limits were 12.5%, 7% and 15%, respectively. The limit determination of aconitine was established by high performance liquid chromatography (HPLC). The method has high specificity, good durability and high precision. The average recovery is 99.15% and RSD is 0.7%. A method for the determination of total alkaloids by UV-vis spectrophotometry was established. The repeatability of the method was good. The average recovery of RSD=2.54%, and RSD were 95.41% and 0.43%, respectively. In addition, the TLC identification of Pangna was also studied, but the results showed that no common spots could be found in all medicinal materials, so the TLC identification could not be established.
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R29

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