Experimental Study On Forming Process Improvement And Quality Standard Improvement Of Mingmu Zishen Tablets

Objective:Mingmu Zishen Tablets has beneficial effects such as nourishing liver and kidney,and improving eyesight.Its function on poor vision,giddy tinnitus,soreness and weakness of waist and knees caused by liver and kidney yin-deficiency is accurate,with little side effect.Not only its actual production process was prone to the phenomenon such as tablets loose and split,but also the current quality standard for this product has lower controllability.In view of the above-mention facts,the project aimed to improve Mingmu Zishen Tablets fonning process and its quality standard,in order to provide reliable preparation process and internal-control standards for the enterprise,complete promulgated national drug request.That is to investigate chrysophanol content-determination of the original standard,lay down a more reasonable content-limit,and establish rehmannia,glossy privet fruit,achyranthes and other crude medicines content-determination method by further research.Expect that providing the market with safe,effective,stable and reliable quality Mingmu Zishen Tablets products.Methods:1 Molding process inspection:The single factor experiment method was adopted.According to the actual situation,firstly,investigated sucrose powder filler,and made sure of adding sugar powder for forming process with adding sodium carboxymethylcellulose.Secondly,studid on the granulation mesh number and lubricant,optimized the best molding process.Finally,compared the tablet of after optimization performance forming process with the original forming process one.2 Improvement of Quality Standard(1)Studied on rehmannia,glossy privet fruit,semen cassiae,chrysanthemum,barbary wolfberry fruit and achyranthes in Mingmu Zishen Tablets by TLC method,retained the semen cassiae,glossy privet fruit and barbary wolfberry fruit thin layer identification method and added the thin layer identification method of chrysanthemum.(2)Improved original chrysophanol content determination standard,and added the content determination method of specnuezhenide andβ-Ecdysone.3 Study on preliminary stabilityTook three batches of test samples and run a test in samples room under the condition of simulated market packaging,according to "Chinese pharmacopoeia" 2010 edition VolumeⅡ(appendixⅪⅩC)drug stability test guidelines for pharmaceutical preparations long-term experiment method.Results:1 The results of studies on forming processAdded the sugar powder for molding while adding the 0.6%sodium carboxymethylcellulose.After granule dried,used 14 mesh whole granule.Used 0.7%magnesium stearate as a lubricant.Took the troche of optimal forming process and the troche of original forming process to performance comparison,to determine the optimal forming process that can solve the original quality problem such as tablets loose and split.2 The results of studies on quality standard improvementInvestigated and retained the semen cassiae,glossy privet fruit and barbary wolfberry fruit thin layer identification method.Added the thin layer identification method of chrysanthemum.The methodology experiment showed that the all four drug testing methods had specificity and good reproducibility.Raised original chrysophanol content-limit standard.Added specnuezhenide and(3-Ecdysone component determinations,and determined the content-determination method for them respectively.Lay down the reasonable finished product content-limit to strengthen the control of production process to guaranteed the quality of the finished product.3 The preliminary stability study resultsConduct a six-months accelerated and long-term stability test on the three batches of Mingmu Zishen.The results showed that each indicator met the provisions and the tablets quality was stable during the investigation period.Conclusion(s):1 The best preparation process of Mingmu Zishen Tablets was determined by the test,which was stable and practical.2 Investigated and retained the original semen cassiae,glossy privet fruit and barbary wolfberry fruit thin layer identification method.The method of Adding the thin layer identification method of chrysanthemum which could get some clear spots was specific.The method which added specnuezhenide and(3-Ecdysone content determination was specific,high accuracy,good reproduce and effective control over the quality of preparation.3 The accelerated stability and long-term stability test of three batches of Mingmu Zishen Tablets for 6 months.The results showed that each indicator met the quality provisions during the investigation period.It’s proven that the optimum forming process and quality standards were feasible.