1.Preparation and in vitro Drug Release of Daptomycin Liposomes
China Pharmacist 2017;20(5):827-832
Objective: To prepare daptomycin liposomes and investigate the in vitro drug release.Methods: Daptomycin liposomes were prepared by an active loading method.The distribution of particle size and zeta potential of liposomes were determined by a laser particle size analyzer.The encapsulation efficiency and in vitro drug release were determined by HPLC.Results: The particle size of daptomycin liposomes was 109.5 nm, the heterogeneous dispersion coefficient was 0.042 and the zeta potential was-6.48 mV.The entrapment efficiency determined by gel column and centrifugation was 50.8% and 50.3%, respectively.The result of in vitro drug release showed that daptomycin liposomes had a good sustained-release effect when compared with daptomycin for injection.Conclusion: Daptomycin liposomes have uniform particle size, which can release drug slowly to reduce administration frequency.
2.Preparation and Determination of Encapsulation Efficiency and Content of Bererine Hydrochloride Lipo-somes
China Pharmacist 2014;(4):601-605
Objective:To prepare bererine hydrochloride ( BER) liposomes and establish an effective method for the determination of content and entrapment efficiency. Methods:BER liposomes were prepared by ammonium sulfate gradient method. The encapsula-tion efficiency of BER liposomes was respectively determined by supercentrifugation method, microcolumn gel method and ultrafiltration method, and the content of every component in BER liposomes was detected by HPLC-ELSD. Results:The results showed that super-centrifugation method could precisely separate the free drug from the liposomes. The optimum parameters of supercentrifugation method were the centrifugal speed of 60 000 r·min-1 , the centrifugal time of 1 h, the centrifugal temperature of 10℃ and the lipid concentra-tion of 6 mg·ml-1 . Conclusion:The method is simple and sensitive with good separation efficiency. HPLC-ELSD can be used to de-termine the content of every component in BER liposomes.
3.Preparation, Quality Control and Stability of Docetaxel Liposomes Mediated by Folic Acid Receptor
China Pharmacist 2016;19(2):282-286
Objective:To prepare docetaxel liposomes mediated by folic acid receptor using different preparation processes, estab-lish the quality control and determine the stability. Methods:HSPC, FA-PEG2000-DSPE and docetaxel were dissolved in the solvent with the ratio of 100︰5︰8. Docetaxel liposomes were prepared by three different methods. The mean diameter of liposomes was deter-mined by dynamic light scattering (DLS). Low-speed centrifugation was employed to determine the encapsulation efficiency (EE). The residual organic solvents were determined by gas chromatograph. Results:The mean diameter of docetaxel liposomes was (155 ± 10) nm with PdI below 0. 20. The EE was over 95. 0%. The inspection indices of docetaxel liposomes were not changed significantly after six-month storage under the temperature of (25 ± 2)℃. Conclusion:The third production process with high ratio of drug to lipid is feasible, controllable and stable in quality.
4.Quality Standard of Xiaofeng Granules
Fang QIAN ; Zhihui LIU ; Dengshan ZHANG
China Pharmacy 2005;0(15):-
OBJECTIVE:To establish the quality standard of Xiaofeng granules.METHODS:Rehmannia glutinosa,Schizonepetae tenuifolia,Radix et Rhizoma Glycyrrhizae,Rehmanniae glutinosa in the formulation were identified by TLC,and the content of decloxizine hydrochloride in Xiaofeng granules was determined by HPLC.RESULTS:The TLC characteristics were distinctive.At the corresponding position,the sample and its reference substance showed identical color of TLC spots,and there was no interference from negative control.The linear range of decloxizine hydrochloride was 2.45~78.4 ?g?mL-1(r=0.999 9)and its average recovery was 99.11%(RSD=1.30%,n=6).CONCLUSION:The established quality standard can be used for the quality control of Xiaofeng granules.
5.Correlation of contrast-enhanced ultrasonography with microvessel density and vascular endothelial growth factor expression of beast tumors
Yuan ZHANG ; Quan JIANG ; Jian CHEN ; Yunxiao ZHANG ; Dengshan WANG ; Xiaoming GU
Chinese Journal of Ultrasonography 2012;21(1):52-55
ObjectiveTo determine the correlation of real-time contrast-enhanced ultrasonography (CEUS) patterns and quantitative parameters with microvessel density (MVD) and vascular endothelial growth factor (VEGF) expression of breast tumors.Methods One hundred and five patients with 128 breast lesions(62 benign,66 malignant) underwent CEUS examination.CEUS patterns were analyzed and parameters were obtained by time-intensity curve analysis software.Immunohistochemical staining using anti-factor CD34 was performed to evaluated the MVD and VEGF expression was detected.Results All CEUS patternsweresignificantlyassociatedwithMVDandVEGFexpressionexceptboundary characteristics( P < 0.05).The enhancement parameters showed that the time to peak was significantly faster in malignant tumors than that in benign lesions,and the peak intensity and area under the curve were significantly higher in malignant tumors than those in benign lesions( P <0.05).The time to peak,the peak intensity,area under the time-intensity curve were statistically correlated with MVD (P <0.05),the highest correlation was between the area and MVD( r =0.81,P <0.001).Only the area under the timeintensity curve was significantly associated with VEGF expression (P < 0.05).Conclusions CEUS patterns and parameters of breast lesions are closely correlated with MVD,which can be used to evaluated the angiogenesis in breast tumors.
6.Thin layer chromatography quantitative analysis on gallic acid in Galla Chinensis based on image analysis technology
Hongliang ZHOU ; Yawei HUANG ; Mingxin TIAN ; Dengshan ZHANG ; Yue HAN
International Journal of Traditional Chinese Medicine 2024;46(3):363-368
Objectives:To discuss the feasibility of Image J in quantitative analysis on thin layer chromatography (TLC) using gallic acid in Galla Chinensis as research object.Methods:Silica gel GF 254 thin-layer plate was used with chloroform-ethyl formate-formic acid (5:5:1) as the developing solvent and the images were taken under ultraviolet light (254 nm). Polyamide film was used with 75% ethanol-glacial acetic acid (50:1) as the developing solvent and 1% ferric chloride ethanol solution as the chromogenic reagent, and the images were taken under sunlight. Images obtained from the above conditions were imported into Image J to analyze and calculate the content of gallic acid in Galla Chinensis by using external standard two-point method. High-performance liquid chromatography (HPLC) was used with a mobile phase of methanol-0.1% phosphoric acid solution (15:85) at a wavelength of 273 nm to determine the gallic acid content in Galla Chinensis. Results:The quantitation limit of gallic acid on silica gel GF 254 thin-layer plate was 0.401 6 μg, the linear range was 2.855 - 9.515 μg ( r2 = 0.996 0), and the average recovery was 105.12% ( RSD=3.48%); the quantitation limit of gallic acid on polyamide film was 0.363 4 μg, the linear range was 1.427 - 4.758 μg ( r2 = 0.991 5), and the average recovery was 103.75% ( RSD=4.60%). The HPLC method had a quantitative limit of 4.42 ng, a linear range of 0.122-0.977 μg ( r2 = 0.999 9), and a recovery rate of 98.30% ( RSD = 1.40%). The accuracy, repeatability and stability of RSD were all <5%. The gallic acid content measured using Image J showed a maximum relative error of 9.30% and a minimum of 1.62% compared to the HPLC results. Conclusions:Image J is feasible for quantitative analysis of TLC and can be used as a complementary method for quality control of Chinese materia medica.
7.Yisui Shengxue Pills (益髓生血丸) as Adjuvant Treatment for Myelosuppression after Chemotherapy for 40 Patients of Malignant Tumours with Qi and Yin Deficiency Syndrome:A Randomised Controlled Trial
Ning JIAO ; Dengshan ZHANG ; Lina SHI ; Mao MAO ; Guochang TAN
Journal of Traditional Chinese Medicine 2024;65(19):2018-2024
ObjectivesTo observe the clinical effectiveness, safety, and potential mechanism of Yisui Shengxue Pills (益髓生血丸) as adjuvant treatment for myelosuppression after chemotherapy for malignant tumours with qi and yin deficiency syndrome. MethodsEighty patients of myelosuppression after chemotherapy for malignant tumours with qi and yin deficiency syndrome were randomly divided into trial group and control group, with 40 cases in each group. Both groups received conventional western medicine treatment, while the control group added placebo taken orally, and the trial group received Yisui Shengxue Pills orally, and both groups were treated for 21 consecutive days. Granulocyte colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), soluble intercellular cell adhesion molecule-1 (sICAM-1), Jagged 1 (Jagl), Notch homolog 2 (Notch2), cell fate determinant membrane associated protein 1 (Numb1), neutrophils, platelet count, white blood cell count, hemoglobin, cluster of differentiation 4+ (CD4+), and cluster of differentiation 8+ (CD8+) were detected before and after treatment; myelosuppression grade and TCM syndrome scores of the two groups were evaluated before and after treatment, and clinical effectiveness and adverse events of the two groups were compared. ResultsThe difference in myelosuppression grading between the two groups after treatment was statistically significant (P<0.05). Compared with this group before treatment, plasma G-CSF, GM-CSF, sICAM-1, Numb1 expression, platelet count, neutrophil count, leukocyte count, haemoglobin, CD4+ level decreased, Jagl, Notch2 expression and CD8+ level increased, and fatigue, spontaneous sweating, palpitation, night sweating, insomnia, scanty complexion, mouth erosion, vexing heat in chest, palms and soles scores all reduced (P<0.05). Compared with the control group after treatment, plasma G-CSF, GM-CSF, sICAM-1, Numb1 expression, platelet count, neutrophil count, leukocyte count, haemoglobin, CD4+ levels increased, Jagl, Notch2 expression and CD8+ levels decreased, and fatigue, spontaneous sweating, palpitations, night sweating, insomnia, pale face, mouth erosion, and vexing heat in chest, palms and soles scores decreased in trial group (P<0.05). The total effective rate of the trial group was 95.00%, which was significantly higher than that of the control group, which was 80.00% (P<0.05). Comparison of the incidence of liver function damage and renal function damage between the two groups showed no statistically significant difference (P>0.05), and the incidence of gastrointestinal damage in the trial group was lower than that in the control group (P = 0.02). ConclusionYisui Shengxue Pills as adjuvant treatment for myelosuppression after chemotherapy for malignant tumours with qi and yin deficiency syndrome can improve the myelosuppression and clinical symptoms, improve the clinical effectiveness, and has a good synergistic and toxicity-reducing effect, and its mechanism of action may be related to the regulation of the Notch signalling pathway and the reduction of immune function impairment.
8.Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis
Jian LIU ; Hongchun ZHANG ; Chengxiang WANG ; Hongsheng CUI ; Xia CUI ; Shunan ZHANG ; Daowen YANG ; Cuiling FENG ; Yubo GUO ; Zengtao SUN ; Huiyong ZHANG ; Guangxi LI ; Qing MIAO ; Sumei WANG ; Liqing SHI ; Hongjun YANG ; Ting LIU ; Fangbo ZHANG ; Sheng CHEN ; Wei CHEN ; Hai WANG ; Lin LIN ; Nini QU ; Lei WU ; Dengshan WU ; Yafeng LIU ; Wenyan ZHANG ; Yueying ZHANG ; Yongfen FAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(4):182-188
The Expert Consensus on Clinical Application of Qinbaohong Zhike Oral Liquid in Treatment of Acute Bronchitis and Acute Attack of Chronic Bronchitis (GS/CACM 337-2023) was released by the China Association of Chinese Medicine on December 13th, 2023. This expert consensus was developed by experts in methodology, pharmacy, and Chinese medicine in strict accordance with the development requirements of the China Association of Chinese Medicine (CACM) and based on the latest medical evidence and the clinical medication experience of well-known experts in the fields of respiratory medicine (pulmonary diseases) and pediatrics. This expert consensus defines the application of Qinbaohong Zhike oral liquid in the treatment of cough and excessive sputum caused by phlegm-heat obstructing lung, acute bronchitis, and acute attack of chronic bronchitis from the aspects of applicable populations, efficacy evaluation, usage, dosage, drug combination, and safety. It is expected to guide the rational drug use in medical and health institutions, give full play to the unique value of Qinbaohong Zhike oral liquid, and vigorously promote the inheritance and innovation of Chinese patent medicines.