| Cangyi Bioadhesive Nasal Gel, prepared form the drugs of Fructus Xanthii and Radix Angelicae Dahuricae, etc. possesses the functions of freeing nasal passage and scattering evil wind, and is indicated for the treatment of rhinorrhea with turbid discharge, nasal obstruction and nose running. Under the guidance of Traditional Chinese Medicine theories, and with the help of the modern pharmaceutical technology, Cangyi bioadhesive nasal gel was studied on pre-clinical pharmaceutical reasearch.On the basis of demands of clinic as well as the administration route, the dosage form was changed from nasal oil to gel. Based on the functions and indications and the characteristics of the ingredients in the herbs, the extract conditions about alchohol -extract were selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. The optimum extract conditions were determined as follows: cracked Fructus Xanthii and Radix Angelicae Dahuricae slices were extracted with 80% ethanol under reflux twice, using 8 volumes of ethanol for 1 hours each time, then filtered with filter cloth. The ethanol-extract filtrates were recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.02～1.05(60～70℃). Borneol was comminuted and mixed with peppermint oil and extracted oil from biond magnolia flower. And the mixed oil was included by HP-β-CD, then dissolved with quantity sufficient water and added into the clear extract above-mentioned. The forming technology was taking 6g of Carbopol 971PNF and making it swell in quantity sufficient water, then add 6g of natrium benzoicum and the mixed clear extract above-mentioned into it, with certain input of water to reach the total volume of 1200mL and pH adjusted to 5.86.2 by 1mol·L-1 natrium hydroxydatum solution, then the mixture was stirred even, subpackaged and sterilized, then made the gel.In the reseach of quality standard, every ingredient was studied respectively. Borneol was identified by physical chemistry character. The identification effect of Fructus Xanthii, Radix Angelicae Dahuricae and extracted oil from biond magnolia flower by TLC were good. The quantitative determination of peulustrin in Radix Angelicae Dahuricae by HPLC and the total phenolic acid in Fructus Xanthii by UV was applied as the quality-controlling index, with the systematic methodology accomplished.Preliminary stability research had kept on 3 months, the further research is in progress. The results indicated that Cangyi bioadhesive nasal gel was stable.In the reseach of toxicity of the gel nasal administration, the method of rat nasal cilium toxicity evaluation is chosen, and no apparent nasal mucosa and cilium toxicity was manifested in the test.The experimental results suggest that the preparation process of our product is reasonable and practical, the standard is controllable, the quality of the sample is steady on the whole as well and there shows no overt toxicity under nasal administration. |
