Study on Quality Standard for Kazakhstan Medicine Peganum harmala
- VernacularTitle:哈萨克药骆驼蓬草的质量标准研究
- Author:
Huan XU
1
,
2
;
Asen JANGAGUL
3
;
Jing WANG
1
,
2
;
Xiaojing LI
1
,
2
;
Bin CHEN
1
,
2
;
Kizaibek MURAT
3
;
Yiping HUANG
1
Author Information
1. School of Third Clinical Medicine，Nanjing University of TCM，Nanjing 210046，China
2. Jiangs u Province Academy of TCM & Key Laboratory for TCM Drug Release System under State Administration of Traditional Chinese Medicine，Nanjing 210028，China
3. TCM Hospital of Ili Kazakh Autonomous Prefecture & Kazakhstan Medicine Institute of Ili Kazakh Autonomous Prefecture，Xinjiang Yining 835000，China
- Publication Type:Journal Article
- Keywords:
Peganum harmala;
Quality standard;
Examina- tion;
Identification;
Harmaline;
Harmine;
Content determina- tion;
TLC;
HPLC
- From:
China Pharmacy
2019;30(20):2818-2823
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To establish the quality standard for Kazakhstan medicine Peganum harmala. METHODS： Ten batches of P. harmala collected in Xinjiang Kazakh region were selected as research objects to investigate their characteristics. Qualitative identification of harmaline and harmine was conducted by TLC. The contents of water， total ash， acid-insoluble ash and ethanol extract were tested according to Chinese Pharmacopoeia（2015 edition）. The contents of harmaline and harmine were determined by HPLC. The determination was performed on X-bridge C18 column（250 mm×4.6 mm，5 μm） with mobile phase consisted of acetonitrile-ammonium acetate buffer （adjusted to 6 with glacial acetic acid， gradient elution） at the flow rate of 1 mL/min. The detection wavelength was set at 267 nm， and column temperature was 25 ℃. The sample size was 5 μL. RESULTS： TLC identification results showed that 10 batches of medicinal material showed clear spots at the same position as harmaline and harmine reference substances. Water， total ash， acid-insoluble ash should not be more than 12％，22％，2％， respectively； ethanol extract must not be less than 16％. HPLC results showed that the linear ranges of harmaline and harmine were 15.22-301.40，15.09-301.80 μg/mL； RSDs of precision， reproducibility and stability tests were all lower than 4％； average recoveries were 100.22％ and 100.94％（all RSD＜2％）. The determination results showed that the content of total alkaloids （harmaline and harmine） should not be less than 6.5 mg/g. CONCLUSIONS： Based on the original standard， test items are added in this study. TLC method is established to identify harmaline and harmine. HPLC method is established to determine their contents. Established quality standard can be used for comprehensive quality control of P. harmala from Xinjiang Kazakh region.
