Application of Dry Granulation in Preparation of Qiangxin Capsule
ã€Abstract】 Objective To prepare granules of Qiangxin Capsule by dry granulation process, and to solve the problem of production difficulties caused by collapsed pot in boiling granulation of Qiangxin Capsule. Methods According to the particle size of the particles, the orthogonal experimental method was used to optimize the process conditions of Qiangxin capsule dry granulation. Results The process conditions of Qiangxin capsule dry granulation zui were A2B1C1D2, namely: liquid roller pressure 9500 kPa, rolling speed 12 r/min, pressed cake thickness 0.8 mm, and spray powder 20%. Conclusion Dry granulation shortens the process route, saves costs, meets the requirements of GMP, and is suitable for large-scale production.
ã€Key words】 dry granulation; capsule; orthogonal test
Qiangxin Capsule is a traditional Chinese medicine preparation for treating mild to moderate acute heart failure caused by coronary heart disease and hypertension. Due to the complex composition of the drug, the sugar-containing components and the spray powder are very viscous. In the boiling granulation process, the spray temperature is not easy to control, the pan is easy to collapse, the moisture is not easy to control, and the moisture is easily absorbed, and the production is laborious and labor-intensive. Difficulties, it is difficult to guarantee quality during the life of the finished product. Dry granulation is a granulation method developed after the second generation granulation method "boiling granulation". The advantage is that the environmental granulation process requires no wetting agent and no pollution. We optimized the dry granulation process conditions of the cultivar by orthogonal test method, and determined the particle size of the granules as the investigation index, and determined the good process conditions of the dry granulation of the strong heart capsule, and solved the collapse in boiling granulation. The production difficulties caused by the pot shorten the process route and save costs.
1 Equipment and materials
GLZ-70 intelligent dry granulator rolling type equipment ( manufactured by Suzhou Jituo Machinery Co., Ltd. ), JA2003X type electronic analytical balance (accuracy: 0.001, Shanghai Precision Scientific Instrument Co., Ltd.), standard sieve ( Suzhou Jituo Machinery) Co., Ltd. ), spray powder (homemade).
2 Qiangxin capsule dry granulation process and condition optimization
2.1 Preparation of spray powder and factors affecting dry granulation: The liquid medicines of various components are treated and mixed, concentrated to a thick paste with a relative density of 1.15 to 1.20, and sprayed into a spray powder for use.
Combined with material properties and equipment performance and reference literature, the liquid roll pressure is small, the particles are loose, the pressure is too large, the material stability is poor, and the bonding is easy; the rolling speed is too slow. The dry granulation particles are too hard and the particle size is large; That is, the choice of the pressure wheel gap, the thickness of the large particle size can not be controlled, the thickness of the small particles is high hardness; the proportion of the spray powder is too high, the viscosity of the particles is too large, the dry granulation is not possible, the proportion is small, and the content of the active ingredients in the particles is not up to standard. Now combined with the actual production, after pre-test, it is found that the liquid roller pressure (kPa) A, the rolling speed (r/min) B, the thickness of the pressed cake (mm) C, the proportion of the spray powder to the total powder (%) D is the influence of dry The main factor of the particle size of the process. The four factors were set according to the L9 (34) orthogonal table, and the mass ratio of the 16 to 60 mesh particles in the granules was taken as an index. The granulation process conditions were screened, and the factors and levels are shown in Table 1. 
The method for determining the particle size is the sieving method: take 30g of granules, accurately weigh the quality, set the specified 16 mesh and 60 mesh medicinal sieves, keep the horizontal state sifted, turn left and right, sift and sway for 3 min, and weigh the mass. Calculate the percentage of particles between 16 mesh and 60 mesh (N=5, repeated 5 times). Percentage of particles (%) = mass of 16-60 mesh particles / total mass of particles × 100%. This data is good at 55% to 70%.
2.2 Experimental results and analysis of variance: According to the orthogonal design experimental scheme (Table 2), 9 samples were prepared respectively, that is, 3.0 kg of spray powder was taken for each sample. The L9 (34) orthogonal test was carried out by using the particle size of dry granulation as an index. The experimental data are shown in Table 2. 
It can be seen from Table 3 that the RA value is large, A is an important factor affecting the particle size preparation of Qiangxin Capsule, D is secondary, and C and B are more important factors. According to the K value of each factor, the process condition is A2B1C1D2, that is, the liquid roller pressure is 9500 kPa, the rolling speed is 12 r/min, the pressed cake thickness is 0.8 mm, and the spray powder accounts for 20%.
3 verification
Take 15kg of spray powder separately, according to the Zuijia process conditions, namely, the liquid roller pressure of 9500kPa, the rolling speed of 12r/min, the thickness of the pressed cake of 0.8mm, and the spray powder accounted for 20% of the amplification experiment, and the particle size of the particles of 16-60 mesh was determined. Calculate the proportion of the particles, and do 3 particle size inspections. Verify the experimental results, see Table 4. 
According to the verification results, the reproducibility of the experiment is good, so it is determined that the Zuijia production process is the GLZ-70 intelligent dry granulator for the strong-heart capsule spray powder at the liquid roller pressure of 9500 kPa, the rolling speed of 12 r/min, and the pressure. Dry granulation was carried out at a ratio of a cake thickness of 0.8 mm and a spray powder of 20%. The particles have a large particle size and good fluidity, and are suitable for production after being granulated. Moisture is also well controlled and solves the problem of fast moisture absorption.
4 Discussion
In the preparation process of capsules, the preparation of particles is a key step. The particle size and the control of moisture directly affect the quality of the filling and the effective period of the finished product. The pressure of the liquid roller in this experiment is an important factor affecting Zui. When the pressure of the liquid roller is 9500 kPa, the particle size of the particles is good. After the whole grain, it is suitable for capsule filling. Table 5 shows the comparison of the loading difference Z, the particle moisture S, and the shelf life Q (accelerated experimental results) of the Qiangxin capsule by the dry granulation process and the boiling granulation process. 
Dry granulation shortens the process route and saves production cost; solves the collapse phenomenon in boiling granulation and meets GMP requirements. There are large differences in the properties (adhesiveness, adhesion, etc.) of the spray powder between different varieties. In the dry granulation, different process conditions are needed, and the orthogonal experiment is used to screen the process. It is possible to determine the optimum technological conditions of each variety and obtain the Chinese granules with better properties.
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