Jaisamut Patcharawalai, Tohlang Channong, Wanna Subhaphorn, Thanakun Acharaporn, Srisuwan Thawatchai, Limsuwan Surasak, Rattanachai Wissava, Suwannachot Jarinee, Chusri Sasitorn
Faculty of Traditional Thai Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.
Traditional Thai Medical Research and Innovation Center, Faculty of Traditional Thai Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand.
Evid Based Complement Alternat Med. 2022 Aug 3;2022:2530266. doi: 10.1155/2022/2530266. eCollection 2022.
In the traditional medical system in Thailand, medicinal plants and polyherbal medicines have been prescribed as lipid-lowering agents, including Nawametho decoction. This polyherbal formulation is described in the Worayokasan scripture. It consists of nine medicinal plants ( (L.), L., Linn., L., L., L., (Gaertn.) Roxb., Retz., and Roscoe). Apart from its utilization in Thai traditional medicine, there is a lack of evidence supporting its use. This research work thereby aims to formulate and evaluate the tablet containing Nawametho decoction. The feasibility of Nawametho decoction and NawaTab for patients with borderline hyperlipidemia was additionally examined using a prospective, open-label, randomized, parallel-group design. The dry granulation technique was employed to formulate the polyherbal tablets. The tablets were developed using the spray-dried Nawametho decoction as the active ingredient in addition to other excipients. The chosen formulation, the (NawaTab), consisted of 385 milligrams of the extract, 12% w/w of a diluent (lactose), 8% w/w of a lubricant (magnesium stearate), 5% w/w of a disintegrant (microcrystalline cellulose), and 5% w/w of an anti-adherent (talcum). Their hardness, friability, and disintegration time were 4.4 ± 0.32 kg, 0.05 ± 0.02%, and 4.60 ± 0.05 min, respectively. Accelerated stability study results revealed that NawaTab was stable for six months at 40°C/75% RH and 25°C/60% RH. Even though taking NawaTabs (500 mg twice daily) for eight consecutive weeks was unable to improve the lipid profile of the patients, the administration of Nawametho decoction (30 mL twice daily) was associated with a significant decrease in serum triglycerides of the patients. The results show that the dry granulation technique is suitable for the formulation of NawaTab based on the tablet evaluation. Furthermore, the triglyceride-lowering effect of Nawametho decoction was reported for the first time.
在泰国的传统医疗体系中，药用植物和多草药配方被用作降脂药物，包括纳瓦梅托煎剂。这种多草药配方在《沃拉约卡桑经》中有记载。它由九种药用植物组成（分别为[具体植物拉丁名1]、[具体植物拉丁名2]、[具体植物拉丁名3]、[具体植物拉丁名4]、[具体植物拉丁名5]、[具体植物拉丁名6]、[具体植物拉丁名7]、[具体植物拉丁名8]和[具体植物拉丁名9]）。除了在泰国传统医学中的应用外，缺乏支持其使用的证据。因此，本研究旨在制备并评价含有纳瓦梅托煎剂的片剂。此外，采用前瞻性、开放标签、随机、平行组设计，研究了纳瓦梅托煎剂和纳瓦片（NawaTab）对临界高脂血症患者的可行性。采用干法制粒技术制备多草药片剂。除其他辅料外，该片剂以喷雾干燥的纳瓦梅托煎剂作为活性成分制备而成。选定的配方纳瓦片（NawaTab）由385毫克提取物、12%（w/w）的稀释剂（乳糖）、8%（w/w）的润滑剂（硬脂酸镁）、5%（w/w）的崩解剂（微晶纤维素）和5%（w/w）的抗黏附剂（滑石粉）组成。其硬度、脆碎度和崩解时间分别为4.4±0.32千克、0.05±0.02%和4.60±0.05分钟。加速稳定性研究结果表明，纳瓦片在40°C/75%相对湿度和25°C/60%相对湿度下可稳定保存六个月。尽管连续八周每天两次服用纳瓦片（500毫克）未能改善患者的血脂状况，但服用纳瓦梅托煎剂（每天两次，每次30毫升）可使患者血清甘油三酯显著降低。结果表明，基于片剂评价，干法制粒技术适用于纳瓦片的制备。此外，首次报道了纳瓦梅托煎剂的降甘油三酯作用。
