Sultacillin granule preparation and preparation method thereof
A technology of cilin granules and sutacillin, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of reduced drug efficacy, drug resistance, poor stability, etc. To achieve the effect of improving use safety, good use safety and improving stability
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[0039] see figure 1 , the preparation method of the sultacillin granule preparation of one embodiment is a kind of preparation method of the sultacillin granule preparation of the above-mentioned embodiment, comprises the steps:
[0040] Step S110: Weigh the following raw materials by mass percentage: 5%-8% of sultacillin, 80%-90% of sweetener, 1.0%-2.5% of ion regulator and 0.5%-13.0% of essence.
[0041] Wherein, the mass percentage of sultacillin can be 5%, 5.5%, 6%, 6.58%, 7%, 7.5% or 8%. In one of the embodiments, the mass percentage of sultacillin is 6.58%.
[0042] The sweetener is at least one selected from sucrose, sucralose, xylitol, stevioside, aspartame, sorbitol and mannitol. Further preferably, the sweetener is at least one selected from sucralose and xylitol. In the sultacillin granule preparation, the mass percent of the sweetener can be 80%, 82%, 82.28%, 84%, 84.56%, 85%, 86%, 86.72%, 86.99%, 87%, 87.2%, 87.6% , 87.8%, 88%, or 90%. In one of the embodimen...
Embodiment 1
[0063] The components and proportioning ratio of the sultacillin granule preparation of the present embodiment are shown in Table 1 below:
[0064] Table 1
[0065]
[0066] The preparation process of the sultacillin granule preparation of the present embodiment is specifically as follows:
[0067] (1) Separately pulverize the sultacillin, sweetener, ion regulator and powder essence, and pass through a 60-mesh sieve.
[0068] (2) According to the ratio in Table 1, weigh 330.5g of sucralose, 1.45g of sodium dihydrogen phosphate and 6.65g of disodium hydrogen phosphate, put them into a wet granulator, and pre-mix for 6 minutes. Use a peristaltic pump to add 20 g of wetting agent isopropanol at a constant speed, and then granulate for 5 minutes.
[0069] (3) Transfer the wet granules obtained in step (2) to an oven, dry at 60° C., control the residual solvent of isopropanol to 0.23%, and pass through a 60-mesh sieve to obtain a dry material.
[0070] (4) Add the dry materia...
Embodiment 2
[0074] The components and proportioning ratio of the sultacillin granule preparation of the present embodiment are shown in Table 2 below:
[0075] Table 2
[0076]
[0077] The preparation process of the sultacillin granule preparation of the present embodiment is similar to the preparation process of the sultacillin granule preparation of embodiment 1, the difference is: in step (2), 15g of water is used as a wetting agent; in step (3), Moisture control after drying is 0.36%.
[0078] The sultacillin granule preparation prepared in this example has uniform granules, strawberry flavor, sweet taste, content of 99.78%, extremely low related substances, and excellent stability.
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