Kaggwa Bruhan, Kyeyune Henry, Munanura Edson Ireeta, Anywar Godwin, Lutoti Stephen, Aber Jacqueline, Bagoloire Lynn K, Weisheit Anke, Tolo Casim Umba, Kamba Pakoyo Fadhiru, Ogwang Patrick Engeu
Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda.
Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda.
Evid Based Complement Alternat Med. 2022 Apr 13;2022:1304839. doi: 10.1155/2022/1304839. eCollection 2022.
The Uganda National Drug Authority requires phytochemical screening, freedom from microbial contamination, and evidence of safety and efficacy of the constituent plants to register herbal products. Since Uganda has no pharmacopeia, safety, efficacy, and plant processing information are not readily available. We documented the plant materials used to manufacture products in Uganda and established evidence of their safety and efficacy and availability of monographs.
The NDA register of herbal products was reviewed, and a product list was extracted. The herbal products were purchased from local pharmacies, and their labels were studied to identify plant ingredients and drug use. Literature was reviewed to document evidence of the safety and efficacy of the plant materials concerning manufacturer's claims. Also, the WHO and available African Pharmacopeia were searched to establish the availability of the plant monographs.
Of the 84 NDA-registered local products, only 18 were obtained from the market; 82% were indicated for respiratory tract disorders. Thirty-three plant materials were listed with Labill, being the commonest. Several and studies demonstrate efficacy, thus supporting the use of the selected plant species for empirical treatment as stated on the product label. While most plants were safe, some species such as Oliv. had dose-dependent toxicities that cannot be predicted in combinations. The WHO, African Pharmacopoeia, and West African Herbal Pharmacopoeia had only 16 plant monographs of the 33 plants of interest. Nevertheless, (L.) Burm.f., A.Juss., Roscoe, and L. monographs were published by all three pharmacopoeias.
Preclinical evidence of safety and efficacy exists in the literature for most of the plants used to manufacture registered herbal products in Uganda. More specific bioassays and clinical trials are required for the products to provide conclusive evidence of safety and toxicity. Monographs are urgently needed for the Ugandan plants.
乌干达国家药品管理局要求对草药产品进行植物化学筛选、无微生物污染，并提供所含植物的安全性和有效性证据，以便对其进行注册。由于乌干达没有药典，安全性、有效性和植物加工信息难以获取。我们记录了乌干达用于生产产品的植物材料，并确定了其安全性、有效性证据以及专著的可用性。
查阅了乌干达国家药品管理局的草药产品注册记录，并提取了产品清单。从当地药店购买了这些草药产品，并研究其标签以确定植物成分和药物用途。查阅文献以记录植物材料安全性和有效性的证据，以验证制造商的声明。此外，检索了世界卫生组织和现有的非洲药典，以确定植物专著的可用性。
在乌干达国家药品管理局注册的84种本地产品中，仅从市场上获得了18种；82%的产品用于治疗呼吸道疾病。列出了33种植物材料，其中拉比勒氏植物最为常见。多项研究证明了其有效性，从而支持了产品标签上所述的将所选植物物种用于经验性治疗的做法。虽然大多数植物是安全的，但有些物种，如奥利弗氏植物，具有剂量依赖性毒性，在组合使用时无法预测。世界卫生组织、非洲药典和西非草药药典中，在所关注的33种植物中仅有16种植物的专著。然而，三种药典都出版了短叶龙血树、美丽马兜铃、刺果苏木和光果甘草的专著。
文献中存在乌干达用于生产注册草药产品的大多数植物的安全性和有效性的临床前证据。需要更具体的生物测定和临床试验，以便为产品提供安全性和毒性的确凿证据。乌干达植物迫切需要专著。
