Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.
China ; Clinical Trials as Topic ; standards ; Drug Evaluation ; Drug Therapy ; standards ; trends ; Drugs, Chinese Herbal ; standards ; therapeutic use ; Humans ; Quality Control ; Research

China ; Humans ; Pulmonary Medicine

Objective:To prepare compound mupirocin film forming gel and establish the quality control methods. Methods:The compound film forming gel was prepared using tannic acid and salicylic acid as the esterifying agents interacting with hydroxypropyl cel-lulose followed by cross-linking with tartaric acid and sorbitol to form a new film forming material, and then antimicrobial mupirocin and anesthetic dyclonine were added to prepare compound mupirocin film forming gel. The contents of mupirocin and dyclonine were deter-mined by HPLC. The column was Hypersil ODS2 (250 mm × 4. 6 mm, 5 μm) and the mobile phase consisted of methanol-ammonium acetate buffer (1. 15 g ammonium acetate, 300 ml water, 1 ml glacial acetic acid) (75 :25). The flow rate was 1. 0 ml·min-1 and the detection wavelength was 230 nm. The column temperature was 30℃ and the injection volume was 20μl. Results:The film form-ing gel was yellow, brown and gelatinous at the normal temperature, and formed transparent film after coating on the skin. The linear range of mupirocin and dyclonine was 20-400μg﹒ml-1(r=0. 9999) and 10-200μg﹒ml-1(r=0. 9996), respectively. The aver-age recovery was 99.9%(RSD=0.54%, n=9) and 99.6%(RSD =1.45%, n =9), respectively. Conclusion: The preparation process is reasonable, simple and controllable in the preparation of ideal film forming gel.

Objective Using Ginaton to treat old patients of vascular hyperkinesia after spontaneous subarachnoid hem- orrhage.Methods 34 patients of spontaneous subarachnoid hemorrhage were treated by Ginaton.Test the plasma en- dothelin(ET),thromboxanes(TXB2),(PGF)before and after the treatment.Results The patients using Ginaton got significantly lower ET and TXB2 after the treatment ET(52.52?18 048 )ng/L; TXB2(62.95?22.94)ng/L and higher PGF(75.98?20.78)ng/L.Conclusion Using Ginaton is a good way to treat vascular hyperkinesia after spontaneous subarachnoid hemorrhage.

Objective: To observe the rheological properties of octoxynol-9 vaginal thermosensitive in situ gel [(O-9)-VTG] for predicting the gelation behavior in vivo, and evaluate the retention ability in vagina.Methods: The rheological parameters of (O-9)-VTG and (O-9)-VTG diluted by stimulant vaginal fluid (SVF) were measured by a Haake Rheomix to characterize the rheological properties.The vaginal samples after the administration of self-made (O-9)-VTG and O-9 gel were withdrawn, and then the concentration of octoxynol-9 in the samples was determined to evaluate the retention ability.Results: (O-9)-VTG was Newtonian fluid with low viscoelasticity under room temperature and converted to gel at 32.6℃.The formula could still transform into gel at body temperature after diluted by SVF, and resided in the vagina of mice above 8 h.Conclusion: (O-9)-VTG has suitable gelation temperature and rheological properties.Compared with the self-made octoxynol-9 gel, (O-9)-VTG has satisfactory retention in vagina, which meets the requirements for vaginal topical use.

OBJECTIVETo confirm the inhibitory effect of Chinese herbs of acid taste on melanin synthesis.

METHODSActive ingredients of 22 kinds Chinese herbs of acid tastes were extracted by alkali extraction and acid precipitation, alcohol extraction, and water extraction, respectively, which was then dispensed into 25.00, 12.50, and 6.25 g/L suspension. Their effects on activities of tyrosinase were detected using mushroom-tyrosinase-DOPA speed oxidation. Their inhibition rates on activities of tyrosinase were respectively compared with inhibition rates of 1.0, 0.5, and 0.1 mmol/L arbutin.

RESULTSThe 22 kinds Chinese herbs of acid taste included Cornus Officinalis, Crataegus pinnatifida, dark plum fruit, Schisandra Chinensis, Chaenomeles sinensis Koehne, Reynoutria japonica Houtt, Achyranthes Bidentata, Sanguisorba officinalis L., Semen Ziziphi Spinosae, Herba Ecliptae, blueberry, immature bitter orange, submature bitter orange, Prunus mume Var, Hovenia acerba Lindl., Fructus Mori, Pomegranate Rind, white paeony root, Rosa laevigata Michx., Portulaca oleracea L, Terminalia chebula Retz, Rhus chinensis Mill. Their alkaline extractions showed inhibition to activities of tyrosinase to different degrees except Herba Ecliptae. Of them, the highest inhibition rate (88.49% ± 9.98%) was got by dark plum fruit at 25 g/L, while the lowest inhibition rate (11.22% ± 3.36%) was got by immature bitter orange at 6.25 g/L. Their alcohol extractions showed inhibition to activities of tyrosinase to different degrees except Herba Ecliptae. Of them, the highest inhibition rate (75.92% ± 5.57%) was got by Hovenia acerba Lindl. at 25 g/L, while the lowest inhibition rate (9.60% ± 1.15%) was got by submature bitter orange at 6.25 g/L. Their water extractions all had inhibition on activities of tyrosinase. Of them, the highest inhibition rate (54.23% ± 3.56%) was got by Fructus Mori at 25 g/L, while the lowest inhibition rate (10.25% ± 1.83%) was got by Semen Ziziphi Spinosae at 6.25 g/L. Compared with 1 mmol/L arbutin water solution, alkaline extractions of dark plum fruit, Schisandra Chinensis, Rhus chinensis Mill., Rosa laevigata Michx., blueberry, Chaenomeles sinensis Koehne, Portulaca oleracea L, Fructus Mori, Achyranthes Bidentata, Pomegranate Rind; alcohol extractions of dark plum fruit, Rhus chinensis Mill., Pomegranate Rind, Hovenia acerba Lindl., Crataegus pinnatifida, Achyranthes Bidentata; water extractions of Chaenomeles sinensis Koehne, blueberry, and Fructus Mori at 25 g/L got obviously higher inhibition rates (P < 0.05, P < 0.01). Compared with 0.5 mmol/L arbutin water solution, alcohol extraction of Chaenomeles sinensis Koehne and alcohol extraction of dark plum fruit at 12.5 g/L got obviously higher inhibition rates (P < 0.05, P < 0.01).

CONCLUSIONChinese herbs of acid taste could inhibit melanin synthesis, and its mechanism was related to inhibiting activities of tyrosinase.

Drugs, Chinese Herbal ; pharmacology ; Humans ; Melanins ; metabolism ; Monophenol Monooxygenase ; metabolism ; Oxidation-Reduction ; Schisandra ; Taste

Staphylococcus aureus,an important foodborne pathogen,can contaminate foods through variety of ways and produce enterotoxin that may cause Staphylococcal food poisoning.In addition to food safety problems,Staphylococcus aureus could also cause clinical infection.The study of its pathogenicity is not only beneficial to prevent and control foodborne diseases,but also provide a new point for clinical treatment.This paper analyzes the types and characteristics of common strains of Staphylococcus aureus in food,and summaries the effect of food processing on pathogenicity and the methods for pathogenicity research in order to provide reference for the related study on pathogenicity of Staphylococcus aureus.

Objective To study the frequency of the derivative chromosome 9 [der(9)] deletion among patients with chronic myeloid leukemia (CML), and explore the application value of local-specific inspector (LSI) 9q34 probe in detect the der (9) deletion. Methods Cytogenetic analysis was performed by 24 h unstimulated culture, GTG banding and karyotype. Dual colour/dual fusion or extra signal(ES) DNA probe was used to perform interphase-FISH for the detection of bcr-abl fusion gene in 52 patients with CML. LSI 9q34 DNA probe was used to detect der(9) deletion. Results FISH results showed bcr-abl fusion gene existed in all 52 patients with CML. der(9) deletion was detected in 12 patients with ES/DCDF probe, but only in 11 patients with LSI 9q34 probe. Conclusion It's more efficient in detection of der(9) deletion with LSI 9q34 probe. Deletion of der(9) might be a poor prognostic factor for CML patients, and LSI 9q34 probe should be used in all the CML patients with positive bcr-abl fusion gene.

Objective To investigate the effects of interferon-α (IFN-α) and gefitinib on the proliferation and apoptosis of human colon cancer cell line HCT116. Methods Colon cancer cell line HCT116 was selected as research objective. The biological effects of IFN-α and gefitinib alone or combined on the cells were observed at different time point (after worked for 24, 48 and 72 hours). The proliferation inhibition of the medicine on the HCT116 cells was measured by methyl thiazolyl tetrazolium (MTT) assay. Morphologic changes were observed under optical microscope. Apoptosis was measured by flow cytometry (FCM). The results were analyzed with SPSS 13.0 software, two groups compare was tested by t test, and single factor variance analysis was for multiple group data compare. Results IFN-α and gefitinib alone or combined could significantly inhibit the proliferation of HCT116 cells (P<0.05), and there was a time and dose-dependent manner between the degree of inhibition and the working time and concentration of the medicine. With the work of the medicine, apoptosis morphologic changes were observed in the cells. And FCM result indicated that the apoptosis rate significantly increased. After treated with IFN-α and gefitinib alone or combined for 72h, the cell apoptosis rate were 15.6%±0.6%, 13.6%±0.4% and 31.2%±0.3% respectively, which was obviously higher than control group (6.8%±0.3%, P<0.05). Conclusion Both IFN-α and gefitinib were able to inhibit the proliferation and induce apoptosis of HCT116 cells moreover, and a synergistic effect was observed while combine used there two medicines.

Anemia, Dyserythropoietic, Congenital ; pathology ; Child ; Humans ; Male ; Siblings