Technology and Qulity Standard Study on Hawthorn Leaves Flavonoids Dispersible Tablets
|Keywords||Hawthorn leaves flavonoids dispersible tablets Process Quality standards Stability|
Objective: hawthorn leaves flavonoids dispersible tablets of hawthorn leaves flavonoids as a model drug made dispersible tablets. Hawthorn leaves flavonoids widely exact treatment of cardiovascular and cerebrovascular diseases. Reducing myocardial oxygen consumption, increase coronary blood flow, lower blood viscosity, increased myocardial nutritional blood supply, of myocardial hypoxic ischemic heart disease have a significant effect. Long-term use of hawthorn leaves flavonoids can produce positive prevention and treatment of coronary heart disease, angina, arrhythmia, cerebral arteriosclerosis, cerebral insufficiency, cerebral thrombosis, Alzheimer's disease and a variety of brain injury sequelae. Dispersible tablets in addition to ordinary tablet stability, portable, easy to take advantage of the rapid disintegration and drug dissolution, bioavailability advantages can be swallowed, Juefu or dispersed into the water taking, particularly suitable for patients with swallowing difficulties, and good taste, and improved patient compliance. Therefore increasing attentions. Methods: A single factor variable method combined with the orthogonal experimental design research methods, in-depth research dispersible tablets prescription design rules, optimize prescription; investigate the of key excipients composition of formulation performance impact, choose the the efficient disintegration and dosage, Add Method The appropriate choice of fillers, binders and other necessary accessories; research method to control the quality of products, the establishment of the UV spectrophotometric determination of hawthorn leaves flavonoids dispersible tablets and dissolution, and method for linearity, precision , stability and recovery methodology test. Results: According to the prescription process research results to develop hawthorn leaves flavonoids dispersible tablets prescription, 1000 the amount of the small test preparation tablets each check items and friability, dispersed evenly and content to meet the requirements of quality standards. Determined in accordance with the prescription in GMP workshop consecutive three batches in scale-test, each batch of 10,000 prepared, results the continuous zoom prepared finished yield greater than 98%; tests and analysis of three batches of samples were prepared, tablets agent the inspection and friability, evenly dispersed and content to meet the requirements under the hawthorn leaves flavonoids dispersible tablets of Chinese Pharmacopoeia. Three batches of the continuous zoom prepared test results show that the prescription of the product and the process is reasonable and feasible. Reference to Chinese Pharmacopoeia 2005 edition two hawthorn leaves flavonoids piece under the relevant provisions of the relevant provisions and dispersible tablets, developed for the quality standards, and determination of dissolution methodology. By UV spectrophotometry assay. The methodological study results show that: rutin within in 8.128ug/ml-48.768ug/ml range, the absorption and concentration showed a good linear relationship. The linear correlation coefficient of 0.9996; reproducible sample results show that the average 28.36mg / RSD 1.77% (n = 5), indicates that the method shows good reproducibility. The precision experiments RSD 1.08% (n = 6), to meet the precision requirements. The stability test results showed that with time, the absorbance of the sample is decreased, and thus the sample should be measured immediately after 15 minutes. The average recovery was 98.21%, RSD as 1.70% (n = 5), tablet excipient content determination. Based on the assay results to determine the hawthorn leaves flavonoids tablets each containing flavonoids anhydrous rutin (C27H30O16), shall not be less than 25.0 mg, accounting for about 80% of the total flavonoids. Hyperin content was determined by HPLC. The methodological study results show that: hyperin the 0.0408ug/ml-0.3246ug/ml within the peak area and concentration showed a good linear relationship. The linear correlation coefficient of 0.9998; reproducible results show that the sample average of 0.183mg / RSD 1.61% (n = 6), show that the method shows good reproducibility. The precision experiments RSD 1.53% (n = 5), to meet the precision requirements. Stability test results show that the basic stability of the sample solution within 8 hours. The average recovery was 99.29%, RSD as 1.06% (n = 6), tablet excipient content determination. The methodology of this Law, provided a sufficient basis. Based on the assay results to determine the hawthorn leaves flavonoids tablets each containing hyperin shall not be less than 0.13 mg. Using ultraviolet spectrophotometry dissolution of the drug, the methodology, results showed that: 4.05ug/ml-32.4ug/ml concentration range, the measured absorbance value and concentration showed a good linear linear correlation coefficient is 0.9999. Precision experimental results show that the RSD was 0.73%, in line with the precision requirements. The stability test results showed that with time, the value of absorbance of the sample is decreased, so the sample should be measured immediately after 15 minutes. The average recovery was 100.50%, RSD as 1.67% (n = 6), tablet accessories Dissolution. Dissolution test method was used on three batches of samples were prepared, of 10min total flavonoids dissolution were at more than 98%, in line with the requirements of more than 70%. Plastic blister packaging, the product at 40 ° C ± 2 ° C, relative humidity 75% ± 5% under the conditions of long-term retention samples investigated six months after accelerated testing under 6 months, and 25 ° C conditions, no obvious indicators change, the product quality is stable in the selection of packaging. Conclusion: hawthorn leaf flavonoids as a model drug, according to the relevant provisions of the Chinese Pharmacopoeia 2005 edition of dispersible tablet formulations, the prescription process, the completion of the preparation and evaluation of hawthorn leaves flavonoids dispersible tablets; hawthorn leaves flavonoids dispersible tablets quality control methods, and methodological studies and stability studies. The targets are met the requirements of the Chinese Pharmacopoeia 2005 edition of dispersible tablet formulation. Hawthorn leaves flavonoids dispersible tablets successfully developed, will provide a fast-acting drug for clinical treatment, and prevention of diseases such as coronary heart disease, angina.