Study On The Prescription Process Of Cefalexin Tablets

There are several types of cefalexin dosage forms on the market,with the sugar coated tablets taking a great proportion.However,the sugar coated tablets have lots of problems,such as long production cycle in the process of production and storage,too weight,easily to be polluted by dust,discoloured or spotted,and meanwhile,cane sugar is often used in these tablets,which is not applicable to diabetic patients.With the aim to overcome the existing problems,the paper replaces the sugar coated cafalexin with film-coating.This paper researches on the technique and formula of preparation,preparation procedure,quality standard and quality stability of cefalexin film-coated tablets.Conduct optimized screening on the technique and formula of preparation of chip core preparation prescription and film-coating materials through single factor test and orthogonal test;the optimized technique and formula of preparation is:in each 1000 tablets,cefalexin 250g,carboxymethyl starch sodium 15g,magnesium stearate 1.5g,10%starch slurry 39g.the optimal technique and formula of preparation of film-coating is:HPMC15g?PEG-40015 g,polysorbate-8015g,propylene glycol 15g,talcum powder 10g,itanium dioxide 10g,tartrazine 0.5g,85%ethanol solution 1000ml.By orthogonal test to launch optimized screening on the process parameters of film-coating,the final optimal coating parameters are:the jet velocity of coating fluid is 10g/min,temperature when in tube is 85?,coating pan rotating with 8r/min,and airbrush pressure is 0.4Mpa,which can produce products of high quality.Doing researches on the quality standard of cefalexin sugar coated tablets to confirm whether the quality standard of sugar coated tablets is applicable to that of film-coated tablets.Through tests,it confirms that the standard is still effective.To verify the quality of film-coated tablets produced with the aforementioned technique and formula of preparation and preparation method,the paper increases the prescription dosage to conduct pilot testing.It produces 3 bulks of chip cores based on the above core preparation method,and divides them into two equal parts,respectively conducting sugar-coating and film-coating.Then,the paper makes detailed comparison on their quality.The paper conducts a six-month accelerated stability test and long term test on film-coating,and then carries on the quality detection according to the quality standard to further test the quality of film-coated tablets.Through comparing the quality of film-coated tablets and sugar-coated tablets of the same core,it turns out that the film-coated tablets are superior to the sugar coated ones in terms of production cycle,tablet weight and relevant substances.After the six-month accelerated stability test and long term test,it concludes that the film-coated tablets are of stable quality,which accords with the stipulations of Chinese Pharmacopoeia.This test improves the traditional coating technique of cefalexin,which is workable and reliable.In the meantime,it overcomes the above-mentioned problems of sugar coated tablets in the process of production and storage,greatly enhances the product quality and is applicable to more people.The test provides theoretical foundation and test data for industrial production and establishment of drug validity of cefalexin film-coated tablets.