| Compound Paracetamol and Vitamin C Yinqiao tablets are compound preparations of Chinese-western medicine. It is indexed in 《State Food and Drug Administration (SFDA) local standard update to nation standard Vol.14》. It is the most common Over-the-Counter (OTC) drug in China’s market for the treatment of a cold. The medicine has an effect on dispelling wind diaphoresis, clearing heat and detoxification. It is used for treating influenza caused by exogenous wind-heat; the common symptoms include fever, headache, cough, dry mouth, and sore throat. Its prescription contains the chemical composition, Chinese traditional medicine extract, and it also contains volatile oil components.The current drug quality standards of Compound Paracetamol and Vitamin C Yinqiao tablets are not completely enough; it only examined five indicators by using chemical reaction to identify the flavonoids, saponin-like substances and volatile oil in the prescription, by using thin-layer chromatography (TLC) to identify the existance of Acetaminophen and Maleate Chlorpheniramine, and to check the disintegration time. However, the current standards have the following vulnerabilities:1. The identification is not comprehensive enough, and the methods of using chemical reaction has low specific attributes. It can not effectively identify prescription Yinqiao extract and other chemical constituents. This can lead to improper identification of the drug’s authenticity.2. In investigated attributes, only the disintegration time is inspected, it can not distinguish the pros and cons in the production process of the preparation.3. It does not contain the amount of the active ingredient, which can lead to improper dosage problems when using it.In recent years, the reports of toxic effects caused by Acetaminophen, Maleate Chlorpheniramine and Vitamin C is common, most of them were caused by abuse or excessive use. This implies that the current quality standards of Compound Paracetamol and Vitamin C Yinqiao tablets should be improved. The new quality standards should be more comprehensive, reasonable and workable. The work to improve the quality standards is imperative. Based on the above described, this study focuses on simplifications and vulnerabilities of the current quality standards of Compound Paracetamol and Vitamin C Yinqiao tablet. It contains enhancements and amendments to the current standards. Through the experiment the following were completed:1. Established a method to identify the presence of Phillyrin in prescription by TLC. Using silica gel G as an absorbent, chloroform-methanol (5:1) as an expansion agent,10%sulfuric acid in ethanol solution (v/v) as a chromogenic reagent, and heated to105℃to view color.2. Established a method to identify the Vitamin C in prescription by TLC. Using Silica gel GF254as an absorbent, ethyl acetate-ethanol-water (50:40:15) as an expansion agent, and viewed the spot under the254nm fluorescence.3. Established a method to determine the contents of the active ingredients acetaminophen, maleate chlorpheniramine, and Yinqiao extract by high-performance liquid chromatography (HPLC). By using C18column (250mm×4.6mm) at35℃,0.05mol·L-1potassium dihydrogen phosphate (containing0.5%of tetrabutylammonium bromide, adjusted with triethylamine to pH3.0) and acetonitrile (85:15) were mixed to create the mobile phase, isocratic elution, with a flow rate of1.0mL·min-1. This was injected by10μL samples into HPLC and detected the component under235nm. Acetaminophen has a good linear range at1.0～50.0μg·mL-1, the regression equation Y=24550x+51708, R2=0.9996; Maleate Chlorpheniramine has a good linear range at10.0～50.0μg-mL-1, the regression equation Y=12724x-9356.3, R2=0.9990. Chlorogenic Acid has a good linear range at5.0～100.0μg·mL-1, the regression equation Y=12880x-12073R2=0.9993.4. Established the Todometric determination, to test the content of Vitamin C in prescriptions. Using iodine titration solution (0.05mol·L-1), as a starch indicator solution to indicates the end of the test. Vitamin C has a good linear range was50.0～150.0μg, the regression equation Y=0.113x-0.004, R2=1.0.5. Investigated the effects of different dissolution media, dissolution phenomenon of different methods under different speed conditions, established the dissolution curve and eventually established Acetaminophen’s dissolution condition using the basket method with water as the solvent at150RPM.Furthermore, on the basis of the above tests, the original standard was revised to more reasonable. This is completed by increasing the test to view the content as well as the range of the active compounds. By viewing the proper range of content, the development of a new compound paracetamol and Vitamin C Yinqiao tablets drug quality standards are improved. Through the new quality standards, it can better ensure the quality of medicines from the source of raw materials to the full range of control of the production process, greatly improving the safety of the drug usage. |
PDF Full Text Request