| In recent years. cardiovascular and cerebrovascular disease showed a rising trend year by year, seriously affecting people's health and life. G-6607 is the clinical treatment of hypertension, coronary heart disease, myocardial infarction, cerebral infarction and other diseases of the commonly used drugs, their dosage forms listing mainly tablets, granules, powder for injection and injection.Preparation of a kind of bioavailability, rapid onset,ease of use of the G-6607 nasal spray, not only for the clinical appliction of a new dosage form, but it slso reduces injection pain caused by medication to patients.The main content of this article:screening at the prescription stage, the study cosolvent P can effectively improve the G-6607 solubility in aqueous solution; investigated at high temperature (60℃) and humidity (RH = 92.5%) drug delivery device under closed and continuous flow rates of accuracy:investigated at high temperature (100℃) G-6607 under the conditions of the stability of the solution and the B-CD and its derivatives on the main ingredients of the results showed thatβ-CD to a certain extent, the solution to improve the stability of G-6607; study preservative Methylparaben, propylparaben, triclosan tert-butyl alcohol and benzalkonium chloride at 100℃under the influence of drugs on the primary results showed that 0.01% benzalkonium chloride do not interfere with determination of the main drug, was chosen as the preservative benzalkonium chloride.B-CD in enhancing the stability of the solution also can be used as penetration enhancers investigate its cilia toxicity.For G-6607 nasal spray preparation of the establishment of G-6607 quality research methods, the characteristics of the three batches of nasal spray. pH. content, content and each jet to inspect the material. Determine the use of cosolvent P. with high water as solvent,β-CD increased the stability of its solution.0.01% benzalkonium chloride as preservative prescription and preparation process:establish a reliable, easy quality of research methods:The results show that the quality of three batches of samples is standard.Nasal spray on the G-6607 to accelerate preparations to stay on in 1,2,3,6 and 3,6,9,12,18 like to stay at room temperature on the stability of study samples.Stability of the preliminary test results show that the agent one month at 40℃accelerated stability test of good character of its appearance, pH, content, content of each spray, the material met the requirements. Through isolated toad palate cilia toxicity tests. the prescription of different concentrations of each component and the impact of prescription on the ciliary beat, and ciliary beat time with the saline group compared to calculate ciliary movement time. The results showed that phosphate buffer has a certain influence on the cilia, so select the high-water as solvent, absorption enhancers can reduce the cilia of benzalkonium chloride toxicity and the concentration with the absorption enhancers increased ciliary beat longer. Cilia toxicity test results combined with the final amount will be positioningβ-CD 1.5%. New Zealand white rabbits as the animal model used, with the eye irritation test method to evaluate G-6607 nasal spray mucosa irritation. A certain period of time by observing the eye of the tested drugs to stimulate the response rate by eye irritation, mild irritation of its irritating results.In this study,the G-6607 preparation of nasal spray formulation is reasonable, quality control, technology is feasible, good stability,cilia less toxic, less irritation of mucous, the basic design to achieve the purpose of the test. |
