1.Study on Preparation and Quality Standard of Flu Mixture
Yanfen CHEN ; Suihua RONG ; Zhaoguang GUO
China Pharmacy 2001;0(12):-
OBJECTIVE: To prepare Flu mixture and establish its quality standard. METHODS: The methods of decoction- boiling and distillation were adopted to prepare the flu mixture; TLC was used to identify Radix Et Rhizoma Rhei and Rhizoma Curcumae Longae, and HPLC was used to determine the content of Artemisinin. RESULTS: The spots characteristic of Radix Et Rhizoma Rhei and Rhizoma Curcumae Longae. were clearly identified with TCL. A good linearity was seen of Artemisinin in the range of 0. 42~ 2. 10? g( r=0. 999 3) . The recovery rate was 99. 84% ( RSD=2. 15% ) . CONCLUSIONS: The preparation is simple in preparation technique and good in stability. The TLC method is highly exclusive. The HPLC method is simple, accurate, and can be used for the quality control of flu mixture.
2.Prognostic value of preoperative aspartate aminotransferase to platelet ratio index for hepatocellular carci-noma after radical surgical resection
Zhaoguang CHEN ; Hui REN ; Jianbin ZHANG ; Zhijie LI ; Hongbo WANG
The Journal of Practical Medicine 2017;33(11):1814-1818
Objective To explore the prognostic value of blood aspartate aminotransferase to platelet ratio index(APRI)in patients with hepatocellular carcinoma(HCC)after radical surgical resection. Methods A retro-spective cohort study was conducted to analyze 228 patients with HCC who underwent radical surgical resection. Patients were divided into low APRI group(APRI<1.62)and high APRI group(APRI≥1.62). Patients′clinical and demographic data and overall survival(OS)were statistically analyzed and multivariate analysis was performed to identify prognostic factors. Results APRI was closely related to preoperative serum ALT level,PLT level,the positivity of HBsAg,liver cirrhosis and portal vein tumor thrombus. OS of patients in low APRI group was signifi-cantly better when compared to those with an elevated APRI(P<0.01). Multivariate analysis indicated that preop-erative APRI,maximum size of tumor,number of tumor nodules,portal vein tumor thrombus,TNM and differenti-ation of tumors were independent prognostic factors for HCC(P<0.05). Conclusions Preoperative APRI≥1.62 is an independent prognostic factor of OS for patients with HCC after radical surgical resection.
3.Phase I Clinical Study of Zhengbiguanjie Tablets:Human Tolerance Evaluation
Shuhua WANG ; Panhai LI ; Yan CUI ; Hengchang ZANG ; Zhaoguang CHEN ; Jie ZHUANG
China Pharmacist 2014;(9):1573-1575
Objective:To evaluate the tolerance and safety of Zhengbiguanjie tablets in healthy volunteers to provide the safe dose range for phase II clinical trial. Methods:Totally 36 healthy volunteers were randomly divided into five single dose groups at different doses ranging from 400 mg to 3200 mg per day and two multiple dose groups with 1600 mg and 2400 mg for continuous 7 days. The tol-erance and safety of the tablets were observed. Results: All vital signs were normal in all the volunteers in both single and multiple dose tests. Although some indicators turned into abnormal after the administration, it was not significant for clinical judgment. Neither drug combination nor serious adverse reactions were shown during the trial. However, two mild adverse events occurred and disap-peared later without any treatment. Conclusion:All the volunteers have good tolerance to Zhengbiguanjie tablets. The study proved the safety of Zhengbiguanjie tablets at single and multiple dose.
4.Randomized, Double-blind, Placebo Control and Multicenter Clinical Trials for Tiankui Antihypertension Tablets Combined with Chemical Drugs in the Treatment of Hypertension
Shuhua WANG ; Panhai LI ; Daqiang RAN ; Xiaofeng WANG ; Jie XUE ; Zhaoguang CHEN
China Pharmacist 2015;(6):964-966,967
Objective:To confirm the efficacy and safety of Tiankui antihypertension tablets combined with chemical drugs in the treatment of patients with hypertension whose blood pressure can 't reach the standard after the treatment only with chemical drugs. Methods:Randomized, double-blind, placebo control and multicenter clinical trials were performed on 240 subjects (160 in the ex-periment group and 80 in the control group) in 6 clinical trial centers. Tiankui antihypertension tablets and the placebo were respec-tively given with 4 tablets per time and 3 times a day. The efficacy and safety were observed. Results:For the blood pressure control, the significant efficiency of the experimental group was 63. 23%, while that of the control group was 31. 65%. The significant efficien-cy and effective rate of the traditional Chinese medicine (TCM) syndrome of the experimental group was 48. 39% and 20. 25%, re-spectively, while that of the control group was 20. 25% and 36. 71%, respectively. All of the studied clinical indicators showed signifi-cant differences between the two groups (P<0. 05). No severe adverse reaction was shown in the two groups. Conclusion:Tiankui an-tihypertension tablets combined with chemical drugs exhibits better curative effect and safety in the treatment of hypertension patients whose blood pressure can’ t reach the standard after the treatment only with chemical drugs.