中成药欧盟注册分析

自2004年起，欧盟和美国分别发布了《传统植物药注册程序指令》和《植物药产品指南》，掀起了中药的新篇章，西方发达国家第一次在法律层面上认可中药作为药品的地位，现通过对欧盟植物药注册法规法律的探讨以及注册成功案例的分析，为我国中成药国际化注册提供一定参考。     

Opioidergic mechanisms underlying the actions of Vitex agnus-castus L.

Vitex agnus-castus (VAC) has been used since ancient Greek times and has been shown clinically to be effective for the treatment of pre-menstrual syndrome. However, its mechanism of action has only been partially determined. Compounds, fractions, and extracts isolated from VAC were used in this study to thoroughly investigate possible opioidergic activity. First, an extract of VAC was found to bind and activate μ- and δ-, but not κ-opioid receptor subtypes (MOR, DOR, and KOR respectively). The extract was then resuspended in 10% methanol and partitioned sequentially with petroleum ether, CHCl₃, and EtOAc to form four fractions including a water fraction. The highest affinity for MOR was concentrated in the CHCl₃ fraction, whereas the highest affinity for DOR was found in the CHCl₃ and EtOAc fractions. The petroleum ether fraction had the highest agonist activity at MOR and DOR. Several flavonoids from VAC were found to bind to both MOR and DOR in a dose-dependent manner; however only casticin, a marker compound for genus Vitex, was found to have agonist activity selective for DOR at high concentrations. These results suggest VAC may exert its therapeutic effects through the activation of MOR, DOR, but not KOR.     

Inhibition of the growth and development of mosquito larvae of Culex quinquefasciatus(Diptera:Culicidae) treated with extract from leaves of Pseudocalymma alliaceum(Bignonaceae)

Objective:To determine larvicidal activity of the essential oil,hydrolat and botanical extracts derived from leaves ol Pseudocalymma alliaceum an mosquito larvae of Culex quinquefasciatus.Methods:Groups of twenty lanae were used in the larvicidal assays.The mortality,relative growth rate,the larval and pupal duration and viability was estimated.The essential oil was analyzed by solid phase microextraction using gas chromatography coupled to mass spectrometry.Results:Essential oil at 800 ppm showed larvicidal activity at 24 h with lethal values of LC_(50) and LC_(90) of 267.33 and 493.63 ppm.The hvdrolat at 20% and 10% on 2nd stage larvae showed 100%effectiveness after 24 h.The aqueous extract at 10% had a relative growth index of 0.58.while the ethanolic and methanolic extract obtained values of 0.76 and 0.70 and control reached 0.99.Larvae treated with 10% of methanol,ethanol and aqueous extract showed a reduction in larval duration of 5.00,2.20 and 4.35 days;ethanol extract at 1% provoke decrease of 2.40 days in the development and exhibited an increment of 3.30 days when treated with 0.01%.Aqueous,ethanol and methanol extracts at 10%reduced in 6.15,3.42 and 5.57 days pupal development.The main compounds were diallyl disulfide(50.05%),diallyl sulfide(11.77%) and disulfide di-2-propenyl(10.37%).Conclusions:The study demonstrated for the first time,the larvicidal activity of the essential oil and hydrolat of Pseudocalymma alliaceum:aqueous,ethanol and methanol extracts inhibited the normal growth and development of mosquito larvae,prolonging and delaying larval and pupal duration.     

《浙江省中药炮制规范》2015年版收载品种的变化情况

目的 介绍《浙江省中药炮制规范》2015年版收载品种的变化情况。方法 分为地方习用品种和独特炮制方法、新增品种和新炮制工艺品种进行介绍。结果 《浙江省中药炮制规范》2015年版共收载632个品种,数量较2005年版大幅减少,结论 《浙江省中药炮制规范》2015年版接轨中国药典大幅提高质量标准,并扩大了先进检测技术的应用。     

环境友好型卫生杀虫剂的研究进展

随着社会进步和经济发展,人们的健康意识及环保意识逐渐增强,对卫生杀虫剂的要求越来越高。与此同时,化学合成农药的缺点日益突出,植物源、微生物源和昆虫调节剂渐为今后卫生用药的发展趋势和迫切需要。根据国内外这3类杀虫剂在主要媒介昆虫防治研究中所取得的成果,系统介绍了它们的活性成分、靶标害虫、作用方式及在我国病媒生物防制中已登记用药等方面的研究进展,提出我国卫生杀虫剂的发展方向。     

Multi-laboratory validation of very high sun protection factor values

Background: High sun protection factor (SPF) sunscreens have multiple benefits but there has not been validation of the test method for determining SPF values higher than 50. This study addresses specifically the accuracy and reproducibility of the high SPF test. Methods: Two high SPF formulations with a standard reference (SPF 15) were tested at four independent test facilities according to the 2007 FDA proposed amendments to the sunscreen monograph. Statistical analysis was performed to compare the SPF results within each lab as well as the SPF results between different labs. Results: The test formulations have overall mean values of 90.5 and 70.7. There was no statistically significant difference between the labs for either formulation and all four labs were able to statistically differentiate these two levels of SPF values. The coefficients of variance (CV) for the high SPF formulations were comparable to those of the corresponding SPF 15 reference within each lab. Conclusions: The data show that SPF values above 50 and up to at least 90 can be measured by multiple laboratories with accuracy and reproducibility.     

A prospective, controlled study of the botanical compound mixture LCS101 for chemotherapy-induced hematological complications in breast cancer

Background.

This prospective, controlled study evaluated the safety, tolerability, and efficacy of the mixture of botanical compounds known as LCS101 in preventing chemotherapy-induced hematological toxicity in breast cancer patients.

Methods.

Female patients diagnosed with localized breast cancer were randomly allocated to receive treatment with either LCS101 or placebo capsules, in addition to conventional chemotherapy. The study intervention was initiated 2 weeks prior to the initiation of chemotherapy and continued until chemotherapy was completed, with participants receiving 2 g of LCS101 capsules thrice daily. Subjects were assessed for the development of hematological and nonhematological toxicities, as well as the tolerability and safety of the study intervention.

Results.

Sixty-five breast cancer patients were recruited, with 34 allocated to LCS101 and 31 allocated to placebo treatment. Patients in the treatment group developed significantly less severe (grades 2–4) anemia (p < .01) and leukopenia (p < .03) when comparing grades 0–1 with grades 2–4, with significantly less neutropenia (p < .04) when comparing grades 0–2 with grades 3–4. This effect was more significant among patients undergoing a dose-dense regimen. No statistically significant effect was found with respect to nonhematological toxicities, and side effect rates were not significantly different between the groups, with no severe or life-threatening events observed in either group.

Conclusion.

The addition of LCS101 to anthracycline- and taxane-based chemotherapy is safe and well tolerated, and may significantly prevent some chemotherapy-induced hematological toxicities in early breast cancer patients. These results should encourage further larger and more extensive clinical trials.     

我国非处方药遴选与研制的思路

我国OTC市场蕴藏巨大的潜力，到2000年销售额将逾越10亿美元。这一机遇无疑为国内、外制药企业提供了良好的发展契机，树立前瞻的开发意识和拓宽研制的思路已是迫在眉睫的课题。