共查询到18条相似文献,搜索用时 218 毫秒
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目的:为民族药对照药材研制工作的顺利开展提供可行策略。方法:分析民族药对照药材研制工作中的难点问题,主要包括原料收集难度大、鉴定困难、标准不完善以及研究基础薄弱等方面。结果:在符合国家药品标准物质研制要求的前提下,提出民族药对照药材切实可行的研制方案,包括原料收集与遴选方法、生药学鉴定、理化标定、均匀性考察和稳定性考察方法。结论:民族药对照药材的研制工作起步晚、基础弱、困难多,但对民族药质量评价与监管具有极其重要的意义,也可为民族药科研工作的顺利开展奠定基础。 相似文献
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Monira Alwhaibi Wesam M. Asser Noha A. Al Aloola Nouf Alsalem Aliyah Almomen Tariq M. Alhawassi 《Saudi Pharmaceutical Journal》2021,29(2):166-172
ObjectivesPurchasing medicinal products from the internet has become more popular in the last three decades. Understanding consumers’ use and perception of the safety of medicinal products obtained online is essential. Therefore, this study aims to evaluate the extent of medicines purchased from the internet in Saudi Arabia, types of products, sources of information, the satisfaction, the motivational factors, and estimate consumers’ vigilance and tendency to report ADRs if occurred.DesignA prospective cross-sectional study using a custom-designed questionnaire was conducted among community adults in Saudi Arabia, age ≥ 18.SettingEvaluation of community subjects' perception towards buying medicinal products was done through the internet in Saudi Arabia from 1st July 2020 until the end of August 2020.Main outcome measure(s)The main outcome of the study was purchasing medicinal products from the internet (Yes, No).ResultsOverall, 36% of the study participants (n = 643) have ever bought medicinal products from the internet (Table 2). Of those, the most obtained was herbal medicine, supplements, or cosmetics (61.3%). Motivational factors towards purchasing medicinal products from the internet were mostly positive, with the most commonly reported agreed motivational factors were lower cost (55.7%), easy online access (54.1%), a wide variety of products (52.6%), and more privacy (43.6%). Around 60.4% of participants believed that buying medicinal products from the internet can be safe. The most perceived risk was the difficulty of distinguishing between registered online pharmacies and other unlicensed commercial websites, with only 32.7% of the participants distinguishing between registered and unlicensed commercial websites.ConclusionsThis study sheds light on the consumers’ use and perception of the safety and risks of medicinal products purchased from the internet. The study findings noticeably describe the great need to increase safety awareness about obtaining medicinal products from the internet among the Saudi community. 相似文献
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目的:为规范临用现配制剂和多剂量包装制剂在使用过程中的期限管理提供参考。方法:对我院2017年在用药品说明书进行整理,对其中临用现配制剂和多剂量包装制剂说明书中使用期限的标注情况进行调查和分析。结果:我院2017年在用药品共1047种。其中,临用现配制剂357种,多剂量包装制剂194种。在357种临用现配制剂说明书中,标注使用期限的109份,占30.53%;在194种多剂量包装制剂说明书中,标注使用期限的共26份,占13.40%。结论:尽管我国在《化学药物(原料药和制剂)稳定性研究技术指导原则》中要求临用现配制剂和多剂量包装制剂应根据其具体的临床使用情况进行稳定性试验,但目前在说明书中标注使用期限相关信息的药品比例仍较低。建议药品监督管理部门以及药品生产企业积极加强对《化学药物(原料药和制剂)稳定性研究技术指导原则》中有关要求的落实,逐步完善临用现配制剂和多剂量包装制剂说明书中使用期限的相关信息。 相似文献
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Abstract The therapeutic community (TC) views cultural diversity as an essential ingredient in its treatment approach. However, based on clinical observation and some research, questions persist concerning the relevance of TC programing for numerical race/ethnic minorities. This article briefly reviews pertinent research and presents findings from recent studies on race/ethnic differences in readine ss and suitability for, and retention in, TC treatment. A framework is outlined for the empirical study of cultural relevance issues in TCs. 相似文献
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目的:通过开展通草的国家药品评价性抽验,掌握全国范围的通草质量问题及对策,为该药材的监管提供技术支持,保障公众用药安全。方法:按照《中国药典》2015年版一部进行法定检验,针对存在的问题,进行探索性研究。结果:共抽验118批通草药材及饮片,按现行质量标准检验,合格86批,不合格32批,不合格项目为性状和总灰分;市场调研显示通草药材品种混乱,与抽样结果相符;针对通草非法增重问题,建立了补充检验方法。结论:超过四分之一的通草饮片质量存在问题,主要为品种混乱及非法增重。 相似文献
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目的:通过分析PIC/S GMP附录《无菌药品的生产》,为我国无菌药品检查与国际化接轨提供借鉴。方法:通过对PIC/S GMP无菌药品附录的主要内容以及与我国现行版GMP无菌药品附录进行对比分析,结合我国无菌药品生产检查中的常见问题,为完善我国无菌药品GMP检查提供建议。结果与结论: 修订后的PIC/S GMP无菌药品附录对比我国现有的GMP无菌药品附录从概念和内容都有了相当大的更新,体现了药品监管的与时俱进,提示我们在规范检查、提升检查水平的同时,应引导企业主动了解国际先进的质量管理理念,向国际水平和国际标准靠拢,提升我国无菌药品生产行业的整体水平。 相似文献
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《Clinical Research and Regulatory Affairs》2013,30(3):265-284
AbstractPreparation claiming certain indications are regarded as medicinal products in Germany. The German Medicines Law applies uniformly to all medicinal products, including herbal medicinal products. A pre-marketing approval is required including proof of quality, safety, and efficacy. The quality documentation comprises the raw material and its purity, the manufacturing process, the control of the final product and its stability. Pharmacological and toxicological examinations are requested in principle, and efficacy has to be proven by clinical studies. However, for substances with a “well-established medicinal use”, data from published literature may be used to substantiate safety and efficacy. As a national approach to review medicinal products, a system of monographs was established. For herbal medicinal products, Commission E was responsible for the evaluation of more than 300 medicinal plants. Recent European developments, particularly in the field of “well-established medicinal use” and “traditional use”, include harmonized assessment criteria for herbal medicinal products. 相似文献
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Simone van Binnendijk Marieke B. Snijder Aart H. Schene Eske M. Derks Wim van den Brink 《Journal of dual diagnosis》2020,16(3):271-284
AbstractObjective: Ethnic minorities report different levels of drinking and smoking and higher rates of depression compared to native populations. In this study we aimed to investigate in six ethnic groups whether tobacco and alcohol use were associated with depressive symptoms, which are more prevalent in ethnic minorities.Methods: Cross-sectional data from the multi-ethnic Healthy Life in an Urban Setting (HELIUS) study sample (N?=?22,471) was used, comprising 4,580 native Dutch participants which were compared with participants from five ethnic minority groups (3,259 South Asian Surinamese, 4,292 African Surinamese, 2,262 Ghanaian, 3,891 Turkish, and 4,187 Moroccan).Results: Alcohol misuse was positively associated with depressed mood in all ethnic groups except for the Dutch and the Ghanaians. Nicotine dependence was positively associated with depressed mood in all ethnic groups except for the Ghanaian group.Conclusions: Alcohol misuse and nicotine dependence were significantly associated with depressed mood in most but not all ethnic groups and especially in men. However, across all groups the contribution of alcohol misuse and nicotine dependence to depressed mood was small. Prospective multi-ethnic studies should confirm whether the relations are causal and elucidate their direction. 相似文献