[1]焦兴苹,范莹莹,才毛,等.藏药洁白丸（胶囊）质量标准提高研究[J].西部中医药,2020,33(07):69-73.[doi:10.12174/j.issn.1004-6852.2020.07.17]
　JIAO Xingping,FAN Yingying,CAI Mao,et al.Research on the Improvements of Quality Standard of Tibetan Medicine Jiebai Pills (Capsules)[J].Western Journal of Traditional Chinese Medicine,2020,33(07):69-73.[doi:10.12174/j.issn.1004-6852.2020.07.17]
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藏药洁白丸（胶囊）质量标准提高研究
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
33
期数:
2020年07期
页码:
69-73
栏目:
出版日期:
2020-07-15

文章信息/Info

Title:
Research on the Improvements of Quality Standard of Tibetan Medicine Jiebai Pills (Capsules)
文章编号:
1004-6852(2020)07-0069-05
作者:
焦兴苹，范莹莹，才毛，祁晓玲，杨凤梅
青海省药品检验检测院/青海省中藏药现代化研究重点实验室，青海 西宁 810003
Author(s):
JIAO Xingping, FAN Yingying, CAI Mao, QI Xiaoling, YANG Fengmei△
Qinghai Provincial Drug Inspection and Testing Institute/Qinghai Provincial Key Laboratory of Traditional Chinese and Tibetan Medicine Modernization Research, Xining 810003, China
关键词:
洁白丸（胶囊）; 显微鉴别; 薄层色谱鉴别; 气相色谱; 质量标准
Keywords:
Jiebai pills (capsules);  microscopic identification;  TLC;  gas chromatography;  quality standard
分类号:
R29
DOI:
10.12174/j.issn.1004-6852.2020.07.17
文献标志码:
A
摘要:
目的：提高藏药洁白丸（胶囊）质量标准。方法：采用显微鉴别、薄层色谱鉴别等方法对制剂所含药材特征成分进行定性鉴别，采用气相色谱法测定制剂中土木香内酯和异土木香内酯的总含量。色谱柱为Agilent DB-WAX(柱长30 m、内径0.25 mm)毛细管柱，检测器（FID）温度为280℃，分流比5∶1，程序升温，流量为1.5 mL/min，进样量为1 μL。结果：制剂中红花、翼首草、寒水石显微特征突出；诃子、丁香、沉香斑点清晰可靠，阴性对照无干扰；土木香内酯、异土木香内酯气相色谱检测质量浓度线性范围分别为0.0499～0.1997 mg/mL（r=0.999）、0.0417～0.1670 mg/mL（r=0.999）；精密度、稳定性、重复性实验的RSD＜2.0%；加样回收率为96.05%～97.72%（RSD=0.64%，n=6）。结论：该研究所建立的方法结果准确、重现性好，可有效提高洁白丸（胶囊）的质量标准。
Abstract:
Objective: To raise quality standard of Tibetan medicine Jiebai pills(capsules). Methods: Microscopic identification, TLC and others were used to qualitatively identify the characteristic ingredients of medicinal materials contained in the preparations, gas chromatography to detect total contents of tuffalolactone and isotuffalolactone in the preparations. Chromatographic column was Agilent DB-WAX(column length 30m, internal diameter 0.25 mm) capillary column, the temperature of the detector(FID) was 280℃, split ratio 5:1, temperature-programmed, the flow 1.5 mL/min, sample size was 1 μL. Results: Microscopic characterisitics of Honghua(Carthamus tinctorius L.), Yishoucao[Pterocephalus hookeri(Clarke) Hoeck] and Hanshuishi(Calcitum,Gypsum Rubrum) in the preparation were prominent; the spots of Hezi(Chebulae Fructus), Dingxiang (Caryophylli Flos) and Chenxiang [Aquilaria sinensis(Lour.) Spreng.] were clear and reliable, and there was no interference in the negative control; The linear ranges of the mass concentration of tuffalolactone and isotuffalolactone determined by gas chromatography were 0.0 499～0.1 997 mg/mL(r=0.999) and 0.0417～0.1670 mg/mL(r=0.999) respectively; RSD of precision, stability and repeatability test＜2.0%; the recovery rate was 96.05%～97.72%(RSD=0.64%,n=6). Conclusion: The method established in the study, which is accurate and reproducible, could effectively lift quality standard of Jiebai pills (capsules).

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备注/Memo

备注/Memo:
收稿日期：2019-02-20*基金项目：青海省科技计划项目(2017-ZJ-772，2017-ZJ-Y40)。作者简介：焦兴苹(1988—)，女，药师。研究方向：药品检验。△通讯作者：杨凤梅(1966—)，女，主任药师。研究方向：药品检验。
更新日期/Last Update: 2020-07-15