CN-121987576-A - Furosemide tablet and preparation method thereof

Abstract

The invention relates to a furosemide tablet and a preparation method thereof, wherein the furosemide tablet comprises 25.00% of furosemide, 40% -45% of filler, 27% -33% of adhesive, 0.5% -1.5% of lubricant, 1.0% -2.0% of anti-adhesion agent and 0.5% -1.5% of glidant, the furosemide tablet is prepared by directly adding purified water without preparing the adhesive, the process of preparing the adhesive by starch is reduced, scalding is avoided, the wet granulation process is adopted, the controllability of technological parameters in the production process is high, the artificial influence of operation of a plurality of technological steps is reduced, the quality stability of the medicine is effectively improved, the medicine is equivalent to that of a reference preparation, a plurality of dissolution curves are similar to that of the reference preparation, the in-vitro dissolution behavior similar to that of the reference preparation is shown, the in-vitro dissolution behavior is stable, and the dissolution behavior between batches is consistent.

Inventors

• Lin chuangsheng
• YANG JIAQI
• Lai Lijie
• ZHANG ZHIGANG
• Liang Kangmei
• Liao Jieyu
• YIN MENGDI
• XIE BIN
• LAN LIUQIN

Assignees

• 珠海润都制药股份有限公司

Dates

Publication Date

20260508

Application Date

20241104

Claims (5)

1. 1. The furosemide tablet is characterized by comprising furosemide, a filler, a binder, a lubricant, an anti-adhesion agent and a glidant, wherein the filler is selected from any one or more of lactose and sucrose, the binder is pregelatinized starch, the lubricant is selected from any one or more of magnesium stearate, stearic acid and calcium stearate, the anti-adhesion agent is selected from talcum powder, and the glidant is selected from any one or more of colloidal silicon dioxide and silicon dioxide.
2. 2. The furosemide tablet according to claim 1, wherein the weight ratio of the components is 25.00% of furosemide, 40% -45% of filler, 27% -33% of adhesive, 0.5% -1.5% of lubricant, 1.0% -2.0% of anti-adhesion agent and 0.5% -1.5% of glidant.
3. 3. The furosemide tablet according to claim 2, wherein the particle size D90 of the bulk drug of furosemide is controlled to be 20-80 μm.
4. 4. A process for preparing the furosemide tablet according to any one of claims 1 to 3, characterized in that it comprises the following steps: (1) Firstly, putting furosemide, an adhesive and a filler into a wet mixing granulator to mix for 3-10 min, and then adding purified water to granulate; (2) After granulating, carrying out fluidization drying until the moisture is lower than 3.0%; (3) After the drying is finished, adding a glidant and a lubricant to carry out total mixing after finishing the drying, wherein the total mixing time is 5-15 min; (4) Tabletting, wherein the tablet weight is controlled to be 100% +/-5%, and the hardness is 20-80N.
5. 5. The method of claim 4, wherein the purified water is added in step (1) in an amount of 25-28% of the granulation recipe.

Description

Furosemide tablet and preparation method thereof Technical Field The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a furosemide tablet and a preparation method thereof. Background Furosemide (Furosemide), also called as fast urine, is an anthranilic acid derivative, belongs to a loop diuretic furosemide, achieves a diuretic effect by inhibiting Na-K-2Cl pump of a thick branch ascending section of a tubular loop, has strong diuretic effect by inhibiting absorption of ions, is one of commonly used diuretics in clinic, is a first-marketed loop diuretic in China, is widely used for hypertension, heart failure, various edema diseases and the like, and is safe and effective. According to the information of the reference preparation on the market of US orange books, the prescription contains furosemide, the inactive ingredients are lactose monohydrate, magnesium stearate, starch, talcum powder and colloidal silicon dioxide, the starch needs to be prepared into starch slurry to be used as an adhesive, the process of preparing the adhesive by the starch slurry is complex, and two preparation methods, namely a slurry flushing method and a slurry boiling method exist at present. The starch is suspended in a small amount of water, then a certain amount of boiling water is added according to the concentration requirement, stirring and gelatinization are carried out continuously, the safety risk of scalding exists in the preparation process, the starch is suspended in the whole amount of water, heating and stirring are carried out continuously (direct fire heating is not needed to avoid coking) in a sandwich container, until gelatinization is carried out, the time for preparing the starch is long, the defect of long cooling time is overcome, and the commercial mass production is not facilitated. The preparation formula in the prior art contains starch, the fluidity of the starch is poor, the starch and magnesium stearate are mixed and then tabletted, the tablet has softening effect, and the preparation process of the starch preparation adhesive is complex compared with the preparation method of directly adding purified water into materials, the scald is caused, the isolation pump cannot work normally due to the too high concentration, and a part of adhesive residual quantity can be left. Disclosure of Invention In order to solve the problems in the prior art, the invention provides a furosemide tablet and a preparation method thereof, wherein the furosemide tablet comprises furosemide, a filler, an adhesive, a lubricant, an anti-adhesion agent and a glidant, wherein the filler is selected from one or more of lactose and sucrose, the adhesive is pregelatinized starch, the lubricant is selected from one or more of magnesium stearate, stearic acid and calcium stearate, the anti-adhesion agent is selected from talcum powder, and the glidant is selected from one or more of colloidal silicon dioxide and silicon dioxide. Further, the weight ratio of the components is 25.00% of furosemide, 40% to 45% of filler, 27% to 33% of adhesive, 0.5% to 1.5% of lubricant, 1.0% to 2.0% of anti-adhesion agent and 0.5% to 1.5% of glidant. Further, the particle size D90 of the crude drug of the furosemide is controlled to be 20-80 mu m. A method for preparing a furosemide tablet, the preparation method of the furosemide tablet comprises the following steps: (1) Firstly, putting the furosemide, the adhesive and the filler into a wet mixing granulator for mixing for 3-10 min, and then adding purified water for granulating. (2) And after granulating, carrying out fluidization drying, and drying until the moisture is lower than 3.0%. (3) And after the drying, granulating the dried materials, adding a glidant and a lubricant, and carrying out total mixing for 5-15 min. (4) Tabletting, wherein the tablet weight is controlled to be 100% +/-5%, and the hardness is 20-80N. Further, the amount of purified water added in the step (1) accounts for 25-28% of the proportion of the granulating prescription. Compared with the prior art, the furosemide tablet prepared by the invention is prepared by directly adding purified water without preparing an adhesive, adopts a wet granulation process, adopts granulation liquid as purified water, is easy to obtain, is simple to operate, can finish granulation in one step in wet granulator equipment, has uniform particle size, reduces production process steps, shortens preparation time, reduces complex process of preparing the adhesive by starch, is easy to cause scalding safety accidents, has high controllability of production process parameters, reduces artificial influence of operation of a plurality of process steps, effectively improves quality stability of medicines, is favorable for commercial mass production, and has similar dissolution curves to those of a reference preparation, and has similar in-vitro dissolution behavior as the reference preparation, sta