Effect Of Different Materials On Hygroscopicity Of Compound Lu Hui Granules

Most of traditional Chinese medicine solid preparations have different degrees of hygroscopicity, mainly show soft, lump or mildew. Hygroscopicity is one of the most difficult issues of the solid preparation of Chinese medicine. From the perspective of hygroscopicity, the reports of solid preparation of traditional Chinese medicine are few. The methods of preventing hygroscopicity of Chinese medicine solid preparations mainly are improving granulation process and using coating process. Lu Hui granules compound is commercial traditional Chinese medicine preparation to treating constipation, it formed by the romaine, meddler, bupleurum, Chinese angelica, aloe powder and pearl powder. The productions of original preparation are water extraction after mixing the medicinal material, then drying and concentration, finally granules is made. After making the granules into capsules the aluminum granules packed. Granules in the capsule shell have strong hygroscopy,seriously affect the stability and clinical application of this product. Therefore, grain moisture during storage of the goods is an urgent problem needed to solve now. The writer choose different coating materials and coating methods to study effect of different materials on hygroscopicity of compound Lu Hui granules, in order to reduce the hygroscopicity of compound Lu Hui granules, and improve the stability of compound Lu Hui capsule. The main contents are summarized below:(1) study on preparation of compound Lu Hui granulesObjective:Study the preparation of compound Lu Hui granules to reducing compound aloe extract (dry extract) hygroscopicity. Method:As an indicator of total flavonoids use the method of orthogonal to select the best conditions of water extraction and ethanol and based on the water extraction technology, water extraction are treated with alcohol precipitation., then partly detect dry extract moisture of water extraction, ethanol and water extraction and alcohol precipitation. Result:Use water as solvent,the optimum is 6 times the amount of water each time boiling 2times 2h each decoction,hygroscopicity rate was 34.06% after concentration,drying, etc.use alcohol as solvent,the optimum is plus 8 times each 80% ethanol, extracted three times, each time 3 hours.Moisture absorption rate was 30.01% after concentration,drying,etc.based on the water extraction technology, hygroscopicity rate was 28.02% after concentration,drying, etc. Conclusion:Compared with the water extraction,water extraction and alcohol sedimentation technique can reduce the hygroscopicity of Lu Hui granules.But not significant,so it need to study the coating process of Lu Hui granules to further reduce the hygroscopicity of Lu Hui granules. (2) Study on best coating materials and coating processObjective:To study effect of different coating materials (hydroxy- propyl methylcellulose, ethylcellulose, polyacrylic resin) on hygroscopicity of granules of traditional Chinese medicine. Method:The methods coated with the single coating material, the complex membrane (coating with two or three kinds of coating materials in turn), the mixed membrane (coating with two or three kinds of coating materials mixed) and the combination of mixed membrane with complex membrane were used respectively. Taking lowering percentage of moisture absorption of coated granules as index, the optimum condition of coating technology (the optimum coating method, coating material and its dosage) was optimized by orthogonal test. Result:The damp-proof effect of coating with the combination of mixed membrane with complex membrane (lowering percentage of moisture absorption of coated granules:35.39%) was better than that of coating with the single coating material (lowering percentage of moisture absorption≤21.82%), the complex membrane (lowering percentage of moisture absorption: 30.28%), or the mixed membrane (lowering percentage of moisture absorption: 31.37%) (P<0.05). Conclusion:The method coated with the combination of mixed membrane (mixed coating materials composed of ethylcellulose and polyacrylic resin) with complex membrane (coating material composed of HPMC; The granules were coated first with the mixed coating materials, followed by HPMC), obviously reduced the hygroscopicity of compound Lu Hui granules, and raised stability of compound Lu Hui capsules. It is advantageous to the preparation production, storage and application.