The Study Of Quality Standard,Compatibility,Preparation And Stability Of Aspirin Compound Double Layer Tablets

The clinical common symptoms of muscle spasmodic pain included neck-shoulder pain,low back pain,back pain and so on.Muscle spastic pain exerted a severe influence on the patient’s rehabilitation and daily activity.Clinically,the compounding of non-steroidal anti-inflammatory drugs and muscle relaxants could effectively treat muscle spasms pain.Nevertheless,there were few relevant drugs listed in China.No the combination drug of aspirin and robaxin which was commonly used in foreign.The study selected foreign listed drugs as reference to carrying out imitation research and development.And it was to fulfill the domestic blank.The main results are as follows:1.Quality research: To develop a controllable quality standard,this paper established the methodologies of the relevant substances,dissolution and content determination.The results showed that the garment accessories in tablets did not affect the determination of the related substances and contents.For the HPLC analysis,the calibration graph for the measurement of active pharmaceutical ingredient A and B was in the range of 2.0-800 μg/mL and 2.0-500 μg/mL,respectively.The limit of quantitation of impurity A and B was 0.2 and 0.1 μg/m L,respectively,which indicated that the method had good stability and sensitivity.2.Compatibility study: By studying the compatibility of active pharmaceutical ingredients and excipients to provide reference for the prescription.The content of active pharmaceutical ingredients and related substances during the experiment were taken as the subject.The result showed that the excipients had good compatibility with the two drugs,and could be used for the screening of the prescription.3.Formulation Research: The study selected vitro dissolution as the main index,from various aspects of formulation and technological variables to reflect the dissolution behavior.According to the results,the optimal prescription and technology were developed.In the end,the best prescription was screened out by dissolution,in which disintegrating agent consisted of sodium carboxymethy starch and triple corn starch.The tablets were pressed by a rotary tablet press,the core of which weighed 986 mg,and the coated weight was 1000 mg.The results showed that the compound aspirin bilayer tablets could dissolve in the prescribed time and meet the requirement.4.Stability study: To assess the influence of temperature,humidity and illumination on the quality of of homemade compound bilayer tablets,the stability test and influence factor experiment was carried out.After the test of influencing factors(10 days),accelerated test(6 months)and long-term test(18 months)showed that the products had good stability,validity period of the product was tentatively scheduled for 2 years.This paper established a method of HPLC to determine the relevant substances,content and dissolution rate of tablets.The quality standard was established on the basis of original tablets.Method validation revealed that this method was precise,simple and rapid,could be used for the quality control of compound aspirin tablets.A series of experiments showed that the homemade bilayer tablets meeting the quality standards and were similar to those of the original products.