Natural Remedies Research Center, BangaloreIndia.
Toxicol Mech Methods. 2005;15(3):193-204. doi: 10.1080/15376520590945612.
Abstract Each year more than 50 million Americans suffer from allergic rhinitis, which is a state of hypersensitivity or hyperimmunity. Basically, allergic rhinitis is symptomatically recognized as the inflammation and irritation of the nasal mucosal membranes; sneezing; stuffy/runny nose; nasal congestion; and itchy; watery, and swollen eyes; and defined as a state of hypersensitivity/ hyperimmunity caused by exposure to a particular allergen (antigen) that results in increased reactivity upon subsequent exposure. A novel polyherbal formulation (Aller-7/NR-A2) was developed for the treatment of allergic rhinitis using a unique combination of extracts from seven medicinal plants, including Phyllanthus emblica, Terminalia chebula, Terminalia bellerica, Albizia lebbeck, Piper nigrum, Zingiber officinale, and Piper longum. Earlier studies in our laboratories have demonstrated potent antihistaminic, anti-inflammatory, antispasmodic, antioxidant, and mast-cell stabilization activities of Aller-7 in addition to its efficacy in a clinical setting. A series of preliminary toxicological evaluations were also conducted in the past, which demonstrated its safety. In this study, we have conducted further safety studies on Aller-7, including acute oral, acute dermal, acute dermal irritation, eye irritation, and 90-day repeated dose toxicity studies. Acute oral toxicity of Aller-7 was found to be greater than 5,000 mg/kg body weight in both male and female rats and no mortality or toxicity was observed at this dose, while the acute dermal toxicity was found to be greater than 2,000 mg/kg body weight. In the acute dermal irritation study, the skin irritancy index was found to be 0.0, which classifies Aller-7 as a nonirritant to rabbit skin. In the acute eye irritation study, Aller-7 was found to have minimal irritancy to eyes of rabbits. In the repeated-dose 90-day oral toxicity study, Aller-7 was administered at dose levels of 100, 300, and 1,000 mg/kg rat body weight for 90 consecutive days by oral gavage. Aller-7 did not induce any significant change in the hematological parameters. No ocular abnormalities were observed. Some minor histopathological changes were observed, but did not reveal any significant treatment-related histopathological changes. The above findings revealed that the no observed adverse effect level (NOAEL) of Aller-7 is greater than 1,000 mg/kg body weight. Taken together, these studies demonstrate the broad spectrum safety of Aller-7.
每年有超过 5000 万美国人患有过敏性鼻炎，这是一种过敏或超敏状态。基本上，过敏性鼻炎被认为是鼻腔黏膜的炎症和刺激；打喷嚏；鼻塞/流鼻涕；鼻充血；眼睛发痒、水汪汪和肿胀；以及由于暴露于特定过敏原（抗原）而导致的超敏/高免疫状态，这种状态会导致随后暴露时反应性增加。一种新型草药配方（Aller-7/NR-A2）是为治疗过敏性鼻炎而开发的，它采用了七种药用植物提取物的独特组合，包括余甘子、诃子、使君子、阿勃勒、黑胡椒、生姜和长胡椒。我们实验室的早期研究表明，Aller-7 具有很强的抗组胺、抗炎、抗痉挛、抗氧化和肥大细胞稳定作用，此外还具有临床疗效。过去还进行了一系列初步的毒理学评估，证明了它的安全性。在这项研究中，我们对 Aller-7 进行了进一步的安全性研究，包括急性口服、急性皮肤、急性皮肤刺激、眼睛刺激和 90 天重复剂量毒性研究。发现雄性和雌性大鼠的急性口服毒性大于 5000mg/kg 体重，在此剂量下没有观察到死亡或毒性，而急性皮肤毒性大于 2000mg/kg 体重。在急性皮肤刺激研究中，皮肤刺激指数为 0.0，表明 Aller-7 对兔皮肤无刺激性。在急性眼睛刺激研究中，发现 Aller-7 对兔眼仅有轻微刺激。在重复剂量 90 天口服毒性研究中，Aller-7 以 100、300 和 1000mg/kg 大鼠体重的剂量水平通过口服灌胃给药 90 天。Aller-7 未引起血液学参数的任何显著变化。未观察到眼部异常。观察到一些轻微的组织病理学变化，但没有显示任何与治疗相关的组织病理学变化。上述发现表明，Aller-7 的无观察不良效应水平（NOAEL）大于 1000mg/kg 体重。综上所述，这些研究表明 Aller-7 的广谱安全性。
