| Objective:According to the preparation method of Yixinshu capsule,which is stipulated in the Chinese Pharmacopoeia,this study explored the crushing method of ginseng,the improvement of the extraction process parameters and the moisture-proof measures of Yixingshu capsule,in order to reach the unified preparation method of Yixingshu capsule,enhance the purpose of capsule moisture.Methods:This project was included the study on crushing panax ginseng,the consummate of extraction process parameters,and the determination of moisture absorption of Yixinshu capsule powder,and the study on the moisture resistance of Yixinshu capsule.The study on the moisture resistance of Yixinshu capsule was consisted of the hygroscopicity of powder,the screening of excipients and the different specific gravity coating and packaging materials.Based on the panax ginseng powder under sieve mesh 80 by Chinese herbal medicine grinder,this article was prepared vibrating powder and grinding powder 1,2,2.5,4,10 by micronizing pharmaceutical vibrating mill and SPEX SamplePrep Freezeer Mill.To choose the best crushing method,this study was detected-the size,shape,angle of repose,bulk density and the total of ginsenoside Rgl and Re of all kinds of panax ginseng powder.To study the influence on salvianolic acid B,Tanshinone IIA and the extract yield by the soaking period,medicine form of Salvia miltiorrhiza,amount of solvent,Methods Orthogonal experiment was used.The same method was detected to study the influence on Astragaloside and the extract yield by the soaking period and water amount.In moisture resistance studies,moisture absorption and critical relative humidity are the main evaluation indexes.First,this study was detected the moisture absorption and critical relative humidity of Yixinshu Capsule Powder and the mixture of powder and excipients with the proportion of 1:1.Then,compared with drug production qual-ity management documents provided by Guizhou Xinbang Pharmaceutical Co.,Ltd.and the actual production situation,the proportion of excipients-powder was ensured and its hygroscopicity was detected.Third,Simplex Lattice was used to study the hygroscopicity of the lonely excipient or the mixture of excipients with different pro-portion.The film coating material named Yishili was chose in this study.Coating is carr-ied out using a bottom jet fluidized bed,and the specific gravity coating were 0%,2.5%,5%,8%,10%.To select a different specific gravity coating,this study was detected the moisture absorption,critical relative humidity and Angle of repose of all kinds of goated granules.Based on Aluminum foil material,the article chose double,three,four aluminum foil composite membrane materials.Choosing the better packaging materials,the study was detected the Tensile Strength,tearing performance and the barrier properties.Results:Of the normal panax ginseng powder made by pharmaceutical factory and the laboratory,grinding powder 1,2,2.5,4,10 and vibrating powder 1,2,2.5,4,10,the size were 123.153,169.288,118.692,79.580,68.181,60.747,49.948,127.926,104.097,94.298,81.313,53.564 ?m respectively,the angle of repose were 44.02°,46.57°,46.96°,52.85°,51.08°,53.81°,42.66°,44.02°,46.20°,48.13°,48.87° respectively,the total of ginsenoside Rgl and Re were 0.467%,0.471%,0.530%,0.379%,0.440%,0.357%,0.429%,0.607%,0.416%,0.385%,0.305%,0.361%respectively.At the alcohol extraction fraction of salvia miltiorrhiza,the effect of salvia miltiorrhiza on the form of salvianolic acid B and the rate of paste yield was the most significant,and there was significant difference.At the water decoction part of radix astragali,radix ophiopogonis,rhizome chuanxiong,hawthorn,the soaking time and the amount of solvent had no influence on the amount of astragaloside and the the rate of paste yield.Of the powder,the initial velocity of moisture absorption was 0.562%h-1,the absorbance acceleration was-0.006 08%*h-2,the time required to reach the balance was 92.4 h,the balance moisture absorption rate was 26.86%,the critical relative humidity was 66.7%.Of the powder of excipients mixted with powder at the proportion of 1:1,the ba-lance moisture absorption rate in a asending order in a asending order were lactose<mannitol<calcium hydrogen phosphate<micro crystalline cellulose<ethyl cellulose<soluble starch<dextrin<hydroxypropyl methyl cellulose<corn starch<Low-sub-stituted hydroxypropylcellulose,the time required to reach the balance in a asending order were ethyl cellulose<corn starch<lactose<Low-substituted hydroxypropylc-ellulose<dextrin<calcium hydrogen phosphate<mannitol<hydroxypropyl methyl cellulose<soluble starch<micro crystalline cellulose,the initial velocity of moisture absorption in a asending order were soluble starch<micro crystalline cellulose<hyd-roxypropyl methyl cellulose<calcium hydrogen phosphate<mannitol<lactose<de-xtrin<Low-substituted hydroxypropylcellulose<corn starch<ethyl cellulose,the a-bsorbance acceleration in a asending order were soluble starch<micro crystalline cel-lulose<hydroxypropyl methyl cellulose<calcium hydrogen phosphate<mannitol<lactose<dextrin<Low-substituted hydroxypropylcellulose<corn starch<ethyl cellulose,the critical relative humidity in a asending order were hydroxypropyl meth-yl cellulose<dextrin<calcium hydrogen phosphate<Low-substituted hydroxyprop-ylcellulose<corn starch= soluble starch= ethyl cellulose= lactose<micro crystalline cellulose<mannitol.Of the powder of lactose,mannitol,micro crystalline cellulose mixted with cap-sule powder at the proportion of 0.1:1,0.05:1 and 0.007:1 respectively,the balance moisture absorption rate in a asending order were 0.007:1<0.05:1<0.1:1,the critical relative humidity of the lactose-capsule powder in a asending order were 0.007:1<0.05:1<0.1:1,the critical relative humidity of the micro crystalline cellulose-capsule powder and mannitol-capsule powder in a asending order were 0.05:1<0.007:1<0.1:1.The regression equation equation for the moisture absorption of mixed materials was that the moisture absorption= 16.56 A+14.08 B+18.10 C+0.97 AB+4.67 AC+4.10 BC,R-Squared=0.8447,Adj R-Square=0.7476,Pred R-Square=0.5945,Adeq Precision=8.556.Of the 0%,2.5%,5%,8%,10%coated particles,the angle of repose were 42.25°,39.360,38.470,36.00°,35.22°,the bulk densitywere 0.566,0.573,0.612,0.607,0.622 g mL-1,the water content were 4.60%,4.88%,4.92%,4.93%,4.91%,the solemn difference were below 10%,the disintegration time limit were below 30min,the balance moisture absorption rate in a asending order were 10%<8%<5%<2.5%<0%,the critical relative humidity in a asending order were 8%=5%<2.5%<10%=0%.Of the packaging materials,the tear strength in a asending order were PET/AL/NY/PE<PET/AL/PE<PVC/AL,the tensile strength in a asending order were PET/AL/PE<PVC/AL<PET/AL/NY/PE,the elongation at break in a asending order were PVC/AL<PET/AL/PE<PET/AL/NY/PE,the water vapor permeation were 0.0000 g/(mzˇ24h),the oxygen permeation a asending order were PET/AL/NY/PE<PET/AL/PE<PVC/AL.Conclusions:Based on the particle size,morphology and fluidity of each panax ginseng powder,combined with the total amount of ginsenoside Rgl and Re,the vibrating powder 1 was chosen in the study.At the alcohol extraction fraction of salvia miltiorrhiza,the best process parameters were that no soaking time,that salvia miltiorrhiza on the form was the middle powder,that the amount of 85%ethanol is 4 times the amount of pieces at the first and 3 times second.At the water decoction part of radix astragali,radix ophiopogonis,rhizome chuanxiong,hawthorn,there is no change.As the main assessment indicators,the balance moisture absorption and critical relative humidity were detected.After all kinds of excipients mixed with the powder at the proportion of 1:1,the resistance to moisture of microcrystalline cellulose,lacto-se,mannitol,is best.Mixing microcrystalline cellulose lactose,mannitol with the po-wder at the proportion of 0.1:1,0.05:1 and 0.007:1 respectively,the resistance to mois-ture of 0.1:1 is best and of 0.05:1 is better.At the same proportion,the resistance to moisture of microcrystalline cellulose is best.And there is significant difference.In the Design Expert software,the Simplex Lattice method ran in 14 recipes.The moist-ure resistance of lactose,mannitol,microcrystalline cellulose does not exist the syner-gistic effect in two components.In summary,the preferred moisture-proof material is microcrystalline cellulose,the best auxiliary ratio of 0.1:1.Then,0.1:1 the microcry-stalline cellulose-powder granules were coated at the proportion of 0%,2.5%,5%,8%,10%.With the increase in the proportion,hygroscopicity decreased,and there was si-gnificant difference.So it is preferable that 10%of the coated particles was used as t-he capsule contents.Tear resistance is an important indicator of whether the packaging is easy to open,and the size of the tear determines its of the consumer to open the packaging.Ex-perimental data did show that PET/AL/NY/PE was easier to tear than PVC/AL and PET/AL/PE.The tensile resistance test can effectively solve the problem of packaging rupture due to insufficient tensile strength of the selected packaging material.The experimental results did show that PET/AL/NY/PE has the highest tensile strength and maximum elongation at break,indicating that PET/AL/NY/PE has the strongest tensile strength and strong toughness.In the study of barrier properties,the water vapor permeabilities of the three materials were 0.0000 g/m2ˇ24h,and the oxygen permeation rate decreased with the increase of the number of layers.Therefore,this experiment was used PET/AL/NY/PE as the packaging of Yixin Shu capsule. |
PDF Full Text Request