Development of the hottest chenxianglu Bailu film

2022-08-26
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Preparation of Chen Xianglu Bailu film coated tablets

Abstract: Objective: to prepare Chen Xianglu Bailu film coated tablets and improve the stability of drugs. Methods: different adhesives were used to prepare tablet cores, and then different coating materials were used for coating. The stability of Chen Xianglu Bailu film coated tablets and sugar coated tablets were compared. Results: using 10% polyvinylpyrrolidone ethanol solution as the adhesive to prepare the core, using the isolation material corn Ruan to protect the core, and using the yellow or reddish brown stomach soluble coating powder of Shanghai kalekang company to prepare chenxianglu Bailu film coating tablets, the appearance quality is superior to the finished products prepared by other materials, especially in terms of anti-seepage oil and moisture resistance; The stability of film coated tablets is better than that of sugar coated tablets. Conclusion: the quality of chenxianglu Bailu film coated tablets is stable and the preparation process is simple

key words: Chenxiang Bailu; Film coated tablets; preparation; Stability

Chen Xianglu Bailu tablet is a traditional Chinese medicine raw material tablet, which has rough surface, poor hardness and poor wear resistance. The calibration mode of 152 frequently used infrared thermometers produced by 49 different manufacturers is easy to absorb moisture. At the same time, because it contains volatile oil, it is also prone to oil seepage, flower spots and migration, heat sensitivity, mildew and other problems. In order to improve the stability of Chen Xianglu Bailu tablets, the author developed Chen Xianglu Bailu film coated tablets

1 reagent and instrument

Chen Xianglu Bailu tablet mixed raw powder (provided by Sichuan Institute of traditional Chinese medicine, batch number: 020924); Crosslinked polyvinylpyrrolidone K-30 (pvpk-30, Shanghai Yuanyue Chemical Co., Ltd.); Acrylic acid IV resin (Jiangsu Lianyungang iodine plant); Yellow and reddish brown stomach soluble coating powder (Shanghai kalekang company); Hydroxypropyl methyl cellulose (HPMC, Fuzhou No.2 Chemical Reagent Factory); Ethyl cellulose (EC), polyethylene glycol 6000 (PEG6000) (Shanghai Pharmaceutical Company); Corn Ruan (Chongqing No.5 pharmaceutical factory, batch No.: 020214); Lemon yellow (Shanghai dye factory); Diethyl phthalate (Chongqing Changjiang chemical plant, batch No.: 030421); Red and yellow aluminum lake (Shanghai kalekang company)

by-1000 sugar coating machine (Shaanxi Baoji pharmaceutical machine factory); 78x-2 tablet four purpose tester (Shanghai Huanghai drug testing instrument Co., Ltd.)

2 methods and results

2.1 preparation of Chen Xianglu Bailu tablet core

2.1.1 prescription: Chen Xianglu Bailu tablet mixed with 300g raw powder, peg600015g, 250g sucrose, 10g magnesium stearate, pvpk-303g

2.1.2 preparation of tablet core: mix the excipients with chenxianglu Bailu tablets, mix the raw powder and the adhesive to be selected, and press the tablets. Each tablet contains 0.3g of the main drug. Select different adhesives, fix the concentration and dosage, and fix other conditions to make 9nm shallow punching chip core. The effects of various adhesives on the hardness, disintegration, fragility and appearance of the chip core were investigated. The fragility was measured by the fragility tester: take 10 pieces, weigh them accurately, take them out after 10min, and then weigh them accurately. The percentage of powder loss was calculated by the difference of two weighing. The results are shown in Table 1

it can be seen from table 1 that the chenxianglu Bailu tablet core prepared with 10% pvpk-30 ethanol solution as the adhesive has a hardness of 8.5Kg, the powder loss rate measured by brittleness is only 24, the maximum stroke is 800mm (excluding the gripper) 0%, the appearance is smooth, bright, and free of oil spots, and the result is ideal

2.2 coating process

2.2.1 preparation of coating solution: take 25g of corn Ruan and peg600010g, add 800ml of 60% ethanol for slight heat dissolution, add 5g of diethyl phthalate, stir and dissolve, put it in a colloidal mill for circulation for 10min, add 60% ethanol to 1000ml, and mix well. Take 50g of yellow stomach soluble coating powder, add 75% ethanol to 1000ml, and mix well. The reddish brown stomach soluble coating slurry is prepared by the same method

2.2.2 package of isolation layer: take 5kg of chenxianglu Bailu tablet core, put it into a nylon sieve, lay a thin layer, and slowly blow with an air compressor to remove the fine powder. Gently put it into the pot, start the sugar coating machine at the speed of 2 ~ 3r/min, preheat with hot air at 60 ℃, spray the isolating layer slurry after the temperature of the tablet bed rises to about 45 ℃ and the speed is adjusted to 8 ~ 10R/min. Dry for 30min after spraying

2.2.3 film coating: take the chenxianglu Bailu film core wrapped with the isolation layer, put it in the pot, control the temperature at about 50 ℃, rotate at 8 ~ 10r/min, and the elevation of the pot is about 50 degrees, and prepare the film coating. Dry for 30min after coating. Five coating materials, including acrylic resin IV, yellow and reddish brown stomach soluble coating powder, HPMC and EC5, were selected respectively, and their coating effects were compared for screening. The results are shown in Table 2

it can be seen from table 2 that chenxianglu Bailu film coated tablets prepared with two coating powders of Shanghai kalekang company are superior to the other three coating materials in appearance quality, and have obvious advantages in anti-seepage oil and moisture resistance

2.3 stability test of film coated tablets and sugar coated tablets

2.3.1 stability acceleration test of film coated tablets [1]: take three batches of Chen Xianglu Bailu film coated tablets samples, put them into commercial packages respectively, and inspect them for 6Mo under the conditions of temperature (40 ± 2) ℃ and relative humidity (75 ± 5)%. See Table 3 for the results

2.3.2 accelerated stability test of sugar coated tablets [1]: take the tablet core prepared under "2.1.2", add 65% syrup, prepare sugar coated tablets in the sugar coating machine, and operate according to the method under "2.3.1". See Table 4 for the results

comparing Table 3 and table 4, it can be seen that Chen Xianglu Bailu film coated tablets are more stable to heat and humidity than sugar coated tablets, no moisture absorption and cracking are found during the test period, and the disintegration time is shorter than sugar coated tablets

3 discussion

traditional Chinese medicine extract tablets have moisture absorption, so it is necessary to wrap 3-5 layers of isolation layer before coating. Chenxianglu Bailu raw material tablets are easy to absorb moisture. The author selects a commonly used coating material - corn Ruan alcohol solution [2] as the coating layer. The results show that the film coated tablets prepared by using corn Ruan to protect the core first, and then using yellow or reddish brown stomach soluble coating powder produced by Shanghai kalekang company have good moisture resistance and oil permeability. The coating powder produced by Shanghai kalekang company is a relatively advanced film coating material at present, and its moisture-proof effect is ideal after coating traditional Chinese medicine preparations, which is consistent with the results reported in the literature [3, 4]

the fineness of the coating slurry has a great impact on the quality of the tablets. It is better to apply it on the hands without roughness, and use a microscope with a ruler to check the fineness. The international market is warming up, and its fineness is required to reach 10 μ Below M. Therefore, when preparing coating slurry, it is usually circulated in the colloidal mill for more than 10min, and can completely pass the 200 mesh sieve

peg6000 as coating material has the advantages of not affecting the disintegration and dissolution of coated tablets [2]. In the experiment, the author found that the dosage of PEG6000 had nothing to do with the disintegration and dissolution rate of chenxianglu Bailu coated tablets in a certain range, but the moisture-proof effect was poor when used alone, and it could adjust the disintegration and dissolution rate when combined with isolation material corn Ruan

the film coating should have a certain tensile strength during and after molding, otherwise it is easy to produce wrinkles and orange peel in case of high temperature changes. Therefore, the author selects diethyl phthalate as plasticizer, and its dosage is 0.5%

Li Anrong 1 *, Xu qunfen 2

1. The First Affiliated Hospital of Chongqing Medical University 2. The second West China Hospital of Sichuan University

source: China Pharmacy

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