Application Research Of boiling Drying Granulation Technology In Solid Preparation Drying

Objective: Through the comparison of the drying efficiency, quality and energy consumption of solid preparations between the boiling drying granulator and the hot air circulation oven, to explore the feasibility of using the boiling drying granulator for solid preparation drying.

Method: The moisture content and disintegration time of solid preparations were used as the investigation indexes, and the t-test was carried out on the results. Results: When drying solid preparations, there was a significant difference between boiling drying method and traditional drying method (p<0.01).

Conclusion: The drying efficiency of boiling drying granulator is better than that of traditional drying method, and it is worth popularizing.

Drying is a key link in the preparation of solid preparations and plays an important role in controlling the quality of solid preparations. Hot air circulation oven (oven) drying is a traditional drying method, which has the advantages of low cost and large drying capacity, but because the solid preparation is in a static state during drying, it has poor drying uniformity, high hardness, and poor disintegration. problem, and the drying time is long (2-3 days). Boiling drying technology is a new technology introduced in my country in the 1990s. The material is dynamic during drying and can maintain a gradient temperature. Therefore, it has high thermal efficiency and fast drying speed. It has become a common technology for traditional Chinese medicine granulation. The author’s application of this technology to the drying of water pills is a technological innovation. Starting from the actual production conditions, the three types of solid preparations, water pills, small honey pills and concentrated pills, are used as research objects, and the drying time, moisture content, disintegration time limit, Energy consumption is studied and compared in order to improve the quality of solid preparations and obtain the best drying method.

1 Instruments And Reagents

1.1 Instruments:

① BY-1000fg sugar coating machine;

② FL-60 boiling drying granulator;

③ CT-CI type hot air circulation oven;

④ GZX-9070MBE digital display electric blast drying oven;

⑤ AEL-200 electronic balance;

⑥ ZB-1 automatic disintegration time limit tester.

1.2 Test Drug:

Select the type of pills according to the principle of commonly used clinically and representative components of decoction pieces. They are:

① Contains a lot of mucus and polysaccharides: Bushen Zhuyun Pills;

② Contains animal medicine: Ruangan Pills;

③ poor adhesion: turmeric pills;

④ Xiaomi Wan: Cong Er Xi Ming Wan;

⑤ Concentrated pills: Tongqi Conger Pills.

2 Experimental Methods And Results

2.1 Sample Preparation

Preparation of water pills: Make the Chinese herbal pieces of the above five types of prescriptions into fine powders, mix them evenly according to the respective prescription amounts and proportions, use millet in the coating pan to mold, and use water as a binder to make water pills of uniform size , each prescription 30kg, that is, samples. Three batches were prepared in parallel for each prescription. The numbers of Bushen Zhuyun Pills were 090217, 090610, and 090912; the numbers of Ruangan Pills were 090204, 090701, and 091027;

Preparation of small honey pills: take the prescribed traditional Chinese medicine pieces, mix and pulverize, sieve, mix evenly, add appropriate amount of refined honey, combine medicines, make pills, and dry to obtain. Three batches were prepared in parallel for each prescription, which were 090117, 090531, and 091009 in sequence.

Preparation of concentrated pills: Take Tongcao and loofah in the prescription and add 10 times the amount of water to decoct twice, each time for 1 hour, combine the decoction, filter, and concentrate the filtrate to a thick paste for later use; powder, pass through a 100-mesh sieve, and mix well. Add refined honey and the above-mentioned thick ointment, stir, make pills, and you get it. Three batches were prepared in parallel for each prescription, which were 080709, 080924, and 090428 in sequence.

2.2 Drying Of Samples

Divide each sample of each prescription prepared into three parts, each 10kg. Set the drying time according to actual experience (see Table 1). Sample 1 was placed in the fluidized bed of a fluidized drying granulation dryer, set the air supply temperature to 70°C, fan frequency to 40 Hz, and drying time to 1.5 h; Set the drying temperature to 70°C and the drying time to 1.5 hours; Sample 3 was spread evenly in the hollow drying tray and dried in an oven. The drying temperature was set to 70°C and the drying time was 18 hours. Record the readings of electric meters and gas meters, and calculate energy consumption.

2.3 Evaluation Of Experimental Results

According to Chinese Pharmacopoeia 2005 edition one water pills, small honey pills, concentrated pills inspection.

2.4 Determination Results Of Moisture Content

2.4.1 Determination results of water content in water pills. After drying, take a sample and seal it quickly. After cooling, measure the moisture content and observe its appearance quality.

2.4.2 Determination results of the water content of the small honey pills. After drying, take a sample and seal it quickly. After cooling, measure the moisture content and observe its appearance quality.

2.4.3 Determination results of moisture content of concentrated pellets. After the drying is completed, take a sample and seal it quickly. After cooling, check and measure the moisture content according to the regulations under the Chinese Pharmacopoeia 2005 edition, a water pill, and observe its appearance quality.

2.5 Determination Results Of Dissolution Time Limit

2.5.1 Determination results of the dissolution time limit of water pills. After drying, samples were taken and quickly sealed, and after cooling, the dissolution time limit was determined.

2.5.2 Determination results of the dissolution time limit of the small honey pills. After drying, samples were taken and quickly sealed, and after cooling, the dissolution time limit was measured.

2.5.3 Determination of the dissolution time limit of the concentrated pellets. After the drying is completed, take a sample and seal it quickly, and measure the dissolution time limit after cooling.

2.6 Evaluation Of Experimental Results

Taking the moisture content as the investigation index, the boiling drying granulator is lower than the oven in the same period of time, and the moisture content meets the requirements of the Pharmacopoeia; after 18 hours of drying in the oven, its drying effect is equivalent to that of the boiling drying granulator, and there is a significant statistical difference between the two (t<0.01). The water pellets obtained by oven drying have more burrs and fine powder, and the drying time is long, which is very unfavorable for some heat-sensitive ingredients, and the loss is also large, which affects the product quality.

From the perspective of dissolution time, when the moisture content obtained by the two drying methods is equivalent, the disintegration time of boiling-dried water pills and small honey pills is shorter than that of oven-dried disintegration time, and there is a significant statistical difference (t<0 .01).

3 Discussion And Conclusion

The drying process of the boiling drying granulator is a dynamic process of decompression and drying. The material is suspended in the hot air, and the humidity gradient between the material and the hot air can be continuously maintained to achieve a continuous and efficient drying effect. It can effectively reduce the loss of heat-sensitive components; while the traditional hot air circulation oven drying method is a static process, and the material is in a passive drying process. The drying environment of the two is fundamentally different, so the boiling drying granulator is used to dry water pellets, small The honey pill can be completed in a short time at a lower temperature and can meet the requirements of the Pharmacopoeia. Therefore, the boiling drying granulation technology can be popularized and applied to other water pill drying production processes, and the process parameters can be designed according to the material characteristics of each prescription water pill and small honey pill to form a complete production process for practical use. Production.

It can be seen that the water pellets and small honey pellets obtained by the boiling drying granulation method not only meet the requirements, but also can save energy and reduce energy consumption. It is a good drying method.