Studies On E’zao Nasal Drop

Objective: To prepare E’zao nasal drop using Centipeda minima and sodium alginate as main raw material and investigated its quality, stability, function and security to provide new drug experimental study of the development of E’zao nasal drop.Method:(1) UV spectrophotometry was adopted to establish the content determination method of total flavonoids in Centipeda minima;(2) Single factor tests are employed.The factor such as ethanol concentration, dosage liquor ratio, extraction time and number of times was used to carry out L9(34) orthogonal test. Total flavonoids extraction rate and purification extraction diversion rate were employed to inspect and optimize the best technical parameter of Centipeda minima’s extraction technology and purification technology;(3) To optimize the formulation of E’zao nasal drop with Centipeda minima extract, sodium alginate, wetting agent, stabilizing agent and preservative;(4) By characters, identification, inspection, the content determination method of total flavonoids and stability tests to estimate the quality of the product;(5) By the test of xylene induced swelling of ear in mouse, antibacterial test and moisture retention test to estimate the function of the product;(6) By eye stimulating test in rabbits and toadish palate mucosa cilia toxicity test to estimate the security of the product.Results:(1) Established the content determination method of total flavonoids in Centipeda minima by UV spectrophotometry;(2) The optimal extraction technology was as follows:35% ethanol as 14 times of drugs was used to extract total flavonoids for 3times and every time for 1.5 h, and the extraction rate was 75.93%. The extracted concentrated solution(concentrated solution:drug =1:1) was precipitated respectively by70% and 80% ethanol, and the total flavonoids diversion rate was 63.07% and 51.50%respectively;(3) The product consisted of water, Centipeda minima, sodium alginate,sodium hexametaphosphate, D-panthenol, sodium hydrogen phosphate, sodium chloride and ethylparaben. The formulation is operability;(4) Established the content determination method of total flavonoids and thin layer identification method of Centipeda minima of nasal drop; The results of stability tests showed that the quality of product was stable, avoiding direct sunlight and store under the condition of room temperature, the product was valid for two years;(5) The test of xylene induced swelling of ear in mouse showed that the welling inhibition ratio was 53.31% in group E’zao nasal drop, the swelling of E’zao nasal drop group and blank control group were(0.60±0.30)mg and(1.29±0.83) mg respectively, and there were distinct differences between them(P<0.05), the product had anti-inflammatory effects; The antibacterial test showed that the minimal inhibitory concentrations of proteus, escherichia coli and staphylococcus aureus were 0.115 g/m L(2 drug/m L) and product was no inhibitory to candida albicans,the product had inhibitory effects; The moisture retention test showed that the moisture retention rate in saturated sodium carbonate and in silica desiccators of E’zao nasal drop were 89.57% and 77.58% respectively, the moisture retention ability of the product is better than 15% glycerinum’s;(6) The eye stimulating test in rabbits showed that the product was with no irritation; The toadish palate mucosa cilia toxicity test showed that the lasting time of ciliary movement of E’zao nasal drop group and blank control group were(282±11) min and(318±46)min respectively, and there were no distinct differences between them(P﹥0.05), the relatively percentage of lasting time of ciliary movement in E’zao nasal drop group was 88.42%, which was significantly higher than the positive drug control group(27.92%), the product was no obvious side effects on toadish palate mucosa cilia.Conclusion: The content determination method of total flavonoids in Centipeda minima by UV spectrophotometry is highly sensitivity, accurate and easy to operate; This maneuverability of extraction and purification technology is feasible, and extraction efficiency is superior; The formulation of E’zao nasal drop was reasonable and the quality of product was stable; The product has preferable moisture retention, anti-inflammatory and inhibitory effects, and the product is safe and with no irritation. These can provide new drug experimental study of the development of E’zao nasal drop.