ABSTRACT
Objective::To establish the HPLC fingerprint of carbonized ginger and to determine the contents of zingerone, 6-gingerol, 6-shogaol, 10-gingerol, 8-shogaol and 10-shogaol with quantitative analysis of multi-components by single marker (QAMS). Method::The fingerprint of carbonized ginger was established by HPLC. All samples were analyzed by Waters SymmetryShield™ RP18 column (4.6 mm×250 mm, 5 μm) with gradient elution by acetonitrile(A)-water(B) (0-30 min, 25%-70%A; 30-50 min, 70%-90%A; 50-60 min, 90%A), the flow rate was 1.0 mL·min-1, the detection wavelength was set at 240 nm and the column temperature was 30 ℃. Zingerone, 6-gingerol, 8-gingerol, 6-shogaol, 10-gingerol, 8-shogaol and 10-shogaol was chosen as marker ingredients to establish HPLC fingerprint of carbonized ginger decoction pieces. Taking 6-gingerol as internal reference standard, the contents of zingerone, 6-shogaol, 10-gingerol, 8-shogaol and 10-shogaol were determined at the detection wavelength of 220 nm and 280 nm according to the relative correction factor. Result::The HPLC fingerprint of carbonized ginger was obtained and 10 common peaks were designated, and 7 of them were identified as zingerone, 6-gingerol, 8-gingerol, 6-shogaol, 10-gingerol, 8-shogaol and 10-shogaol, respectively. And there were no significant differences between the quantitative results of external standard method and QAMS. It is suggested that the content limits of carbonized ginger should be not less than 0.020%of zingerone (C11H14O3), 0.050%of 6-gingerol (C17H26O4), 0.120%of 6-shogaol (C17H24O3), 0.080%of 10-gingerol (C21H34O4), 0.030%of 8-shogaol (C19H28O3) and 0.050%of 10-shogaol (C21H32O3) calculated with reference to the dried products, respectively. Conclusion::The developed method is accurate and feasible, which can provide a simple and effective method for the quality control of carbonized ginger.
ABSTRACT
Xinshenghua Keli is known as the "preferred prescription of postpartum", with large demand in the field of gynecologic medicine. However, the quality of the preparation is uneven in the market, so its clinical efficacy cannot be guaranteed. In order to improve and establish its quality control standard, high performance liquid chromatography (HPLC) was used to establish the fingerprint of Xinshenghua Keli. The detection was performed on Agilent 5 HC-C₁₈ (2) column(4.6 mm×250 mm, 5 microns) with methanol-0.1% formic acid solution as mobile phase for gradient elution, at a flow rate of 1 mL·min⁻¹ with column temperature of 25 °C. The injection volume was 10 μL and detection wavelength was set at the maximum value between 210.0 nm and 400.0 nm by Photo-Diode Array (PDA) detector. The fingerprint of 12 batches of high-quality Xinshenghua Keli was established and 43 common peaks were identified. The similarities of crowned products, 10 batches of ordinary ones made by Jiangsu Rongyu Pharmaceutical and 10 batches produced by different manufacturers were evaluated. The composition identification and source analysis for the common peaks were performed by comparing the retention time of herbal medicines and ultraviolet absorption spectrum, along with high performance liquid chromatography-mass spectrometry (HPLC-MS) technology. The established fingerprint of Xinshenghua Keli, has proven to have good precision, stability and repeatability through the methodology validation, so it can be used to comprehensively evaluate the quality of Xinshenghua Keli.
ABSTRACT
The quality of traditional Chinese medicine affects the clinical efficacy and the market research at home or abroad, which is closely related to the standardization of production. At present, Chinese market still exist in drug quality and nonstandard production phenomenon. In addition to the existing GMP production standards, it is still necessary to ensure the authenticity and reliability of traditional Chinese medicine by means of retrospect. Based on the Xinshenghua granule, starting from the authenticity of the whole process of production, this study designs and constructs the traditional Chinese medicine traceability system which is equipped with the Internet platform by using two-dimensional code as a trace tool. By making authentic record of the production process and quality transfer, it is convenient for consumers to know the drug information. The production traceability system provides guarantee for the standardization of traditional Chinese medicine development, in order to obtain the production source，the testing quality, whereabouts and responsibility.
ABSTRACT
Xin-Sheng-Hua granule (XSHG) is a popular remedy commonly used in clinic for the treatment of lochiostasis after delivery. To comparatively investigate the roles of herb pairs containing Angelicae Sinensis Radix (Danggui) upon the formula by evaluating the blood coagulation and hemorheology function in acute blood stasis rats, acute blood stasis rat model was established by ice water bath and subcutaneous injection of adrenaline. And the blood stasis mice were administrated intragastrically with different samples of the formula minus herb pairs containing Danggui and the whole formula (XSHG, SHD, DY, DC, DT, DH, DJ and DZ). The whole blood viscosity (WBV), plasma viscosity (PV), erythrocyte sedimentation rate (ESR) and haematocrit (HCT) were applied to evaluate the effects of the formula minus herb pairs containing Danggui on hemorheology of blood stasis rats. The thrombin time (TT), activated partial thromboplastin time (APTT), prothrombin time (PT), and plasma fibrinogen (FIB) were used to observe the effects of the formula minus herb pairs containing Danggui on blood coagulation function of blood stasis rats. Additionally, the maximum aggregation induced by adenosine diphosphate (ADP) was tested to observe the effect of different samples on platelet aggregation index of blood stasis rats.Afterwards, multi-attribute comprehensive index methods and principal component analysis were both applied to comprehensively assess the total effects of the formula minus herb pairs containing Danggui on promoting blood circulation and dissipating blood stasis. Compared with normal group, the hemorheological parameters and coagulation indexes of model group had statistical differences (P<0.01). Compared with model group, different samples (XSHG, SHD, DY, DC, DT, DH, DJ and DZ) could improve the blood hemorheology indexes, coagulation parameters and platelet aggregation in acute blood stasis rats. According to multi-attribute comprehensive index methods and the principal component analysis, the effects of promoting blood circulation by removing blood stasis became poor when excluding herb pairs containing Danggui from the formula, the sample DY and DC had the weakest effect of activating blood circulation and dissipating blood stasis, and the effect of sample DY was slightly poorer than DC. The orders of contribution of herb pairs containing Danggui on the formula were Danggui-Yimucao>Danggui-Chuanxiong>Danggui-Honghua>Danggui-Zhigancao>Danggui-Taoren>Danggui-Jiangtan. In conclusion, various herb pairs containing Danggui played different roles on the effects of improving the abnormality of hemorheology and coagulation function. And the herb pairs Danggui-Yimucao were particularly important for the formula, which was consistent with the characteristics of XSHG and the traditional effect of Yimucao. Moreover, it could lay foundation to further reveal the compatibility mechanism of XSHG.