| Procaterol hydrochloride, chemically5-(1-hydroxy-2--isopropyl-amino-butyl)-8-hydroxy-quinolone hydrochloride hemihydrate is a high selective β2receptor agonists. It has strong effect of bronchial spasm. Microdosage of Procaterol hydrochloride can produce significant Bronchiectasis effect, and last a long time. It can be maintained for10-12hours after dosing. Side effects of cardiovascular system are very silight. In addition, Procaterol hydrochloride has strong anti-allergic effects, and can stabilize mast cell membranes, inhibit the release of histamine and other allergic substances. It can also cure the allergen-induced bronchial asthma. Tolerance have not obvious. Mainly it can be used to cure bronchial asthma, asthmatic bronchitis, bronchial reactivity associated with increased acute bronchitis, chronic obstructive pulmonary disease.There are various formulations of Procaterol hydrochlorideavailabel. Tablets, capsules, buccal tablet, granules, syrup, aerosol have come into the market. Procaterol hydrochloride tablets have been received in the Chinese Pharmacopoeia2005. However, oral preparation produce effect slowly, and suppository is inconvenient to use which people is not easy to accept, whereas aerosol is expensive. Hence, a rapid and easy preparation was needed for asthma attacking fastly and chronic disease. The sublingual pills is just an ideal choice.In the study,we firstly established a high performance liquid chromatography method of procaterol hydrochloride. And method specificity, linear range, detection limits, precision and recovery rate were investigated. The results show that the method is sensitive, accurate and feasible.Secondly, the prescription technology of procaterol hydrochloride sublingual pills were optimized through orthogonal test, and the prepared sublingual pills were quality controlled and stable.Finally, the stability tests of procaterol hydrochloride sublingual pills were inspected.The results show that its character, content, related substances, dissolution time and other indexes were no significant changes,which indicated the preparation was stable. |