Objective High performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC/MS) methods were developed for the determination of ganciclovir and its related substances. Methods A Hypersil ODS2 column (4.6mm×250mm, 5μm) was used with a mobile phase of 0.02M potassium 1.0mL/min, and UV detector set at 254nm was used for monitoring the eluents. Results The method was simple, rapid, selective and capable of separating all related substances at trace level with a detection limit of 0.04μg/mL. It has been validated with respect to accuracy, precision, linearity, and limits of detection and quantification. The linearity range was 10.2-153.0μg/mL with r=0.9998. The percentage recoveries ranged from 96.7% to 101.6%, and RSD was 1.24%-1.96% (n=5). Conclusion The method was found to be suitable not only for monitoring the reactions during the process development but also for quality control of ganciclovir. For identification of related substances, LC/MS was used. The mainly related substances of ganciclovir active pharmaceutical ingredients (API) were determined as guanine, (1, 3-dioxolan-4-yl) methyl acetate, and diacetyl guanine.

Objective To investigate the characteristic changes of the auditory brainstem response (ABR) of normal hearing newborn and infants .Methods One hundred and forty -five cases (290 ears) normal hearing new-born and infants were enrolled for ABR test .Before that they passed the distortion product otoacoustic emissions and acoustic immitance test previously .According to age ,13 (26 ears) of 145 were included in the 1~7 days age group ,17 (34 ears) was in the 30~59 days age group ,20 (40 ears) in the 2~4 months age group ,19 (38 ears) in the 5~7 months age group ,17 (34 ears) in the 8~10 months age group ,18 (36 ears) in the 11~13 months age group ,12 (24 ears) in the 14~16 months age group ,13 (26 ears) in the 17~19 months age group ,16 (32 ears) in the more than 20~24 months age group .The control group was 20 (40 ears) normal hearing young persons (18~25 years old) .The variation of the peak latency and interpeak latency of waves were observed ,and compared with the normal young people .Results In 70 dB nHL click sound stimulus ,the peak latency and interpeak latency ofⅠ ,Ⅲ ,Ⅴ waves of normal hearing neonates and infants progressively shortened as they grew older .As they ap-proach 18 months or more old age ,their peak latency and interpeak latency of Ⅰ ,Ⅲ ,Ⅴ waves may be same as nor-mal young people .Conclusion With the growth of the age ,the peak latency and interpeak latency of Ⅰ ,Ⅲ ,Ⅴwaves of normal hearing newborn and infants gradually shortened .The reason may be related to the maturity of the auditory system .

0.05), but there were significant differences after the operation (P

This article analyzed the types and causes of clinical research misconduct including the definition and background.We then set up the research management system to control and prevent such misconduct behavior.Our strategy includes using various technical tools to actively carry out clinical research integrity related education and training program,establishing integrated control model,and clinical research misconduct handling mechanism to jointly cope with the problems,to promote a good atmosphere for clinical research and to establish the integrity of the research.Our goal is to promote the medical technology development and to improve the patient care.

Objective:To study the clinical efficacy of acupuncture for ischemic stroke and its effect on ET-1 levels in IS cases.Method:The 63 cases were randomized into a treatment group (31 cases),receiving acupuncture and routine method,and control group (32 cases),receiving routine method alone.Seven days constitute a course of treatment,a 2-day interval between two courses.The clinical efficacy and ET-1 level in two groups were compared after four weeks.Result:The total effective rate in the treatment group and control group were 96.8% and 75% respectively,with a statistical significance (P＜0.05);the ET-1 level in blood plasma also with a statistical significance after the treatment (P＜0.05);the pre-treatment and post-treatment ET-1 level in the treatment group showed a statistical significance (P＜0.01),whereas the control group didn't.Conclusion:Acupuncture is effective for ischemic stroke and can lower the ET-1 level in ischemic stroke cases.

Objective To explore the value of contrast-enhanced ultrasound(CEUS)in the differential diagnosis of endometrial carcinoma and endometrial hyperplasia.Methods Forty-five patients with endometrial carcinoma and 21 patients with hyperplasia were studied by CEUS.Twenty-four normal women were enrolled as contrast group.Results In normal uterus, myometrium exhibited earlier enhancement later washout than the endometrium.Similar phenomenon was observed in patients with hyperplasia.In patients with endometrial carcinoma,the lesion showed wash-in and washout earlier, at least not later than the myometrium.Conclusions Endometrial carcinoma and hyperplasia showed different enhancement patterns,which may be helpful for the diagnosis of the two diseases.

Objective To investigate the contrast enhanced ultrasound(CEUS)features of ovarian tumor torsion(OTT).Methods Seventeen cases with OTT were evaluated using CEUS.CEUS was performed with low mechanical index and the contrast agent of Sono Vue.Results Thirteen cases with total torsion of ovarian tumor appeared as no enhancement.Four cases with partial torsion showecl hyperechoic enhancement in the early phase and hypoechogenicity in the late phase.Conclusions The enhancement of OTT has characteristic,which would be helpful for the diagnosis and differential diagnosis of OTT.

The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cronbach's alpha coefficient and structural equation modeling were adopted to empirically analyze the results. Six variables in the hypothetical model were included: compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality control of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality control of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical institution was only influenced by capability of government regulation.

This paper focuses on the quality risk control and management of Chinese medicine (CM) injections. The most important technological requirements are analyzed, and a strategy for integrated pharmacology to study CM mechanism is proposed. A key technology system for quality risk control and management was further constructed. The strategy and technology system was finally applied to Shengmai injection for quality risk control and management.
Drugs, Chinese Herbal ; pharmacology ; standards ; Humans ; Injections ; Medicine, Chinese Traditional ; Quality Control ; Risk ; Technology

Objective To observe the protective effect of silybin-phosphatidylcholine compound(SPC) on acute liver damage induced by alpha-naphthylisothiocyanate(ANIT) in mice.Methods Forty mice were randomly divided into 4 groups:normal group,model group,SPCⅠgroup,SPCⅡgroup.Intragastric administration of 0.5% carboxymethylcelluloes-Na(CMC-Na) suspension were given to the normal and model group,and 2 quantities of SPC suspension(150 and 300 mg/kg) were respectively given to SPCⅠ and SPC Ⅱ groups for 1 week.At 12 h after last administration of SPC,all of groups besides normal were given ANIT(dissolved in peanut oil,(60 mg/kg)) by lavage and the normal group just only were given peanute oil by the same volume and same way.After 16 h of ANIT administration,the levels of serum alanine transferase(ALT),aspartate aminotransferase(AST),serum total bilirubin(TB),malondialdehyde(MDA) and superoxide dismutase(SOD) were detected by biochemical method.Results Serum levels of ALT,AST,TB and MDA markedly increased after ANIT was administered via intragastric tube,and the level of serum SOD also decrease.SPC could obviously inhibit the alteration of the activities of serum ALT,AST,TB,MDA and SOD(P