| 1. ObjectiveRheum is a common disease caused by external factors,such an wind evil, whosesymptom are snuffle, sneezing, headache, fever, unwell at every pore. It is apopular epidemic which usually aroses serious syndrome and does great harm topeople's heathy. Although most of the medicines against rheum are taken orally atpresent, nonnasality spraying medicament is used with this prescription. Asindicated in recent researches, it is effective to avoid first-pass metabolism,enhance bioavailability and treat patients from head to foot when medicine isabsorbed through mucous membrane. At the same time, the method is simple andconvenient and easy for sufferers to accept. The medications against cold aremainly to cure cold,hot and wind rheum in the market while Binghua sprayingmedicament studied in this paper is able to prevent and treat hot and wet rheum.Here we focus on its process technology, quality specification, priliminarystability and forecast for period of validity.2. Methods(1) Study on process technology: Optimum extraction factors for choosing FlosLonicerae, Mosla Chinensis, Pogostemon cablin and Folium Perilla weredetermined by crossing designs and comparative experiments. In order to cover upthe odor of the volatile oil from Mosla Chinensis and Pogostemon cablin, it wasprepared into a HP-β-CD inclusion compound by means of CD inclusiontechnology. The pH value of the spray was studied, in order to establish thepreparation technology of the Binghua spray, so were the categories and dosagesof solubilization. (2) Study on quality specification:HPLC method was used forquantitative analysis on chlorogenic acid, Baicalin. GC method was used forquantitative analysis on (-)-Bornol. And TLC method was used for qualitativeanalysis on each other chinses medicinal materials. (3) Study on preliminarystability:The preliminary stability of the finished product of Binghua spray wasstudied through kept samples. (4) Forecast for the expiry date: The stability of thespray was analysised separately through temperature coefficient method andclassical isothermal method. The effect of antioxidant such as NaHSO3 or VitaminC was also studied separately through temperature coefficient method.3. Results(1) Through procedure selection, the optimum extraction conditions of FlosLonicerae were extracted 3 times by 80% ethanol reflux. The first time is: 10 foldof 80% ethanol, refluxing 1.5h; The second time is: 8 fold of 80% ethanol,refluxing 1h; The three time is: 6 fold of 80% ethanol, refluxing 0.5h. AndOptimum extraction factors for Mosla Chinensis were extracted by water-vapordistillating method: dip in 2h, 8 fold of water, so was Pogostemon cablin. Theoptimum extraction factors for Folium Perilla were extracted by water-vapordistillating method: no dip in, 10 fold of water. The HP-β-CD inclusion compoundcoverd up the bad breath of the volatile oil effectively. Tween-80 was selected asthe solubilization of the spray, dosage was 5% of the spray.It was 6.6-7.1 that thepH value of the spray. (2) The quality specification of Binghua spray showed thatthese methods had great veracity and were sensitive, exclusive and reiterative. Thequantity of the indexes was accord with the standard. (3) The preliminary stabilityinvestigation showed that the medicament was stable in quality. (4) The resultsshowed that the expiry date got through the two methods were almost same as 8months. The results also showed that there were not significant improvements forthe stability when the antioxidants were appended.4. ConclusionAccording to the research of pharmacy, it was proved to be steady and feasible tothe preparation technology of Binghua spray. And it was proved to be steady andcontrollable to the quality specification of Binghua spray. |
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