Study On Quality Standard Of SheShang Capsule

SheShang Capsule is the ancestral preparation of the people’s Hospital of Fujian University of traditional Chinese Medicine. The whole prescription has 14 traditional Chinese medicine ingredients which consist of Cremastra appendiculata, Knoxia valerianoides, Rheum officinale, Rhizoma coptidis, Radix angelicae, etc. The prescription has the effect of clearing heat-fire and alleviating pain. It can be used effectively for the treatment of venomous snake bite, wasp sting and unknown swelling pain. Because the present quality standard of this preparation is simple, it is not enough to control the quality of it. Therefore, in order to ensure the clinical efficacy of the preparation, this study upgrades the original quality standards.Object:To establish reasonable qualitative and quantitative analysis methods for the hospital preparation of Sheshang Capsule and provide reference data for the establishment of new quality standards.Methods:Studies on the methods to identify the main ingredients of the Sheshang capsules by TLC, and determine the content of the indicators in the capsules by HPLC and GC. Moisture content, disintegration time limit, content uniformity and heavy metal content were examined on the basis above. Finally, try to establish the quality standard of the Sheshang capsules.Results:TLC methods for the identification of Knoxia valerianoides, Rheum officinale, Rhizoma coptidis, Radix angelicae, Radix Sophorae Subprostratae in the Sheshang capsules were established. In the identification, the color spots of test sample were displayed on the corresponding position of the positive control articles, and spots were vivid, well separated without interference of negative control articles.A HPLC method for determining the content of five kinds of components in the Sheshang capsules simultaneously was established. Aloe emodin, Rhubarb, Emodin, Rhubarb phenol and Emodin methyl ether had good linear relationship with the peak area integral value in the range of 4.04 x 10-2 μg～40.40 ×10-2μg,4.14 × 10-2 μg～41.40 × 10-2 μg、 4.16 × 10-2μg～41.60 × 10-2μg、4.10× 10-2μg～41.00× 10-2μg、2.16× 10-2μg～21.60 × 10-2μg. The linear regression equations were Y=653.26 X+0.1705 (r=0.9994), Y=710.46 X-0.0669 (r=0.9995), Y=752.48 X-0.1106 (r=0.9991), Y=977.13 X+0.2938 (r=0.9993), Y=633.88 X+0.0111 (r=0.9997) and the relative standard deviation of precision, repeatability and recovery were less than 5%.A GC method was established for the determination of Borneol in the Sheshang capsules. Borneol had good linear relationship with the peak area integral value in the range of 0.020～1.002 μg. The linear regression equation was Y=20.252 X+16.114 (r=0.9999) and the relative standard deviation of precision, repeatability and recovery were less than 5%.Moisture content, disintegration time limit,content uniformity and heavy metal test results are in line with the 2015 edition of Chinese Pharmacopoeia standards.The establishment of the draft of the quality standard of the Sheshang Capsule is practical and feasible.Conclusion:The thin layer identification methods have strong specificity and clear spots, and the GC, HPLC methods are simple, accurate, sensitive and fast. The method can be used as a method for quality control of the Sheshang capsule.