Study On Manufacturing Technique And Quality Control Of Shuganhewei Granule

The recipe of Shuganhewei was based on the clinical application which had been used for many years.It could relieve stagnancy in liver,balance gastric acid and relieve stomachache.It majorly used in gastric abscess.This recipe was effectively applied in treatment by powder,the essential component of Shuganhewei recipe is Cyperi Rhizoma,Corydalis Rhizoma,Alpiniae officinarum Rhizoma,Sepiae endoconcha,Rhei radix et Rhizoma.Because of the bad taste,the recipe was restricted in clinic.We changed the recipe from powder to granule by improving the process.The type of granule had good taste,high stability,large drug loading capacity,convenient to use,onset quickly.In this thesis,we investigated the process techniques and quality control systematically of Shuganhewei granule,and the results showed that the manufacture process was simple;the requirement of equipment was low.It was fit for the general medical institution.If we manufactured on a large scale,it could have economical benefit.Research contents and main results:Firstly,By orthogonal test L9(34),the optimal process was determined according to the mixture of fluid extract and powder in different proportion.According to the amount of prescription,take 40% of Sepiae endoconcha,50% of Alpiniae officinarum Rhizoma,50% of Cyperi Rhizoma directly crushed into the thinest powder,60% of Sepiae endoconcha,,50% of Alpiniae officinarum Rhizoma,50% of Cyperi Rhizoma,100% of Rhei radix et Rhizoma and 100% of the thickest powder of Corydalis Rhizoma made into extract,then mixed them to the soft material.The ethanol extract was used as the evaluation index,the optimum extraction time was 120 minutes,14 times of water was added and 2 times were extracted;Took decompression concentrated(0.08MPa);Chose xanthan gum as suspending agent,the best dosage was 1.8%;Chose 95% ethanol as the best wetting agent;The drying process was determined to be 60 ℃ hot air circulation;Storage relative humidity should be less than 72%;Through the medium magnification test to determine the final industrial production process.The results showed that the process was mature,stable and reliable.Secondly,Cyperi Rhizoma,Corydalis Rhizoma and Rhei radix et Rhizoma were successfully identified by thin layer chromatography.It was confirmed that the samples contained α-adrenergone,tetrahydropalmatine and rhein,the experimental results showed that the characteristic spots are clear,the specificity is strong,the negative control had no interference,which can be used as their identification method.Thirdly,the content of galangin was assayed by high performance liquid chromatography accurately,which satisfactorily showed its application and repeatability,and could control the intrinsic quality,could be used for the quality control of the preparation.There was a good linearity in the range of the concentration of galangin in 4.05μg/mL ~81.00μg/mL,the regression equation was Y = 8.5 × 104 X-1.0 × 104,r = 0.9999(n = 6).Precision,stability,repeatability,recovery rate met the requirements.The minimum detection limit was 0.23 μg/mL;The minimum content was set at 0.17 mg / g.Fourly,the 6 months of accelerated stability test and 2 years of long-term stability test showed that it could coexist with the external package receptacle compatibly,the initial validity is confirmed as 18 months of the preparation.Selected multi-layer composite film as the packaging material(National Standard No.YBB20162012).Finally,the draft for quality standard was preliminarily laid by the study.In accordance with the relevant requirements of the State Food and Drug Administration,the proval of medical institution preparation was successfully ratified by Gansu Food and Drug Administration,the approval number: Z20140067.