Metronidazole tablet and preparation method thereof

Abstract

The invention provides a metronidazole tablet and a preparation method thereof, and particularly relates to the field of medicines. The metronidazole composition is prepared from metronidazole, anhydrous calcium hydrogen phosphate, microcrystalline cellulose and magnesium stearate. The preparation method comprises the following steps: S1, crushing the raw material medicines and sieving with a 70- S2, mixing metronidazole and anhydrous calcium hydrogen phosphate according to the prescription dosage for 5-15 minutes; s3, adding microcrystalline cellulose according to the prescription dosage, and mixing for 5-15 minutes; s4, finally adding magnesium stearate according to the prescription dosage, and mixing for 3-7 minutes; s5, tabletting is conducted through a 10mm shallow concave circular stamping tablet die; and S6, carrying out film coating on the tablets to increase the weight by 2-4%. The method has simple steps, reduces the production cost, can prevent the materials from being in a humid and hot condition, and reduces the generation of impurities.

Description

Technical Field

[0001] The invention belongs to the field of medicine, and particularly relates to a metronidazole tablet and a preparation method thereof. Background Art

[0002] Metronidazole tablets belong to the nitrimiazole class of drugs. They not only have good anti-trichomoniasis and anti-amoeba effects, but also have strong anti-anaerobic activity. They are now widely used in clinical practice. The clinical indications of metronidazole are intestinal and extraintestinal amebiasis (such as amoebic liver abscess, pleural amebiasis, etc.), vaginal trichomoniasis, balantidiasis and cutaneous leishmaniasis, guinea worm infection, etc. Most of the current metronidazole tablets adopt the wet granulation method, which has a complex preparation method, many process steps, and high cost. Therefore, the existing technology needs to be developed.

[0003] In view of the deficiencies in the prior art, the purpose of the invention is to provide metronidazole tablets and a preparation method thereof. The metronidazole tablets are prepared by a powder direct compression method, which not only simplifies the method steps and reduces production costs, but also avoids the material being in a wet and hot condition and reduces the generation of impurities. Summary of the invention

[0004] The purpose of the present invention is to provide a metronidazole tablet and a preparation method thereof, which not only simplifies the method steps and reduces the production cost, but also avoids the material being in a wet and hot condition and reduces the generation of impurities.

[0005] The present invention provides the following technical solutions:

[0006] The invention discloses a metronidazole tablet, which consists of metronidazole, anhydrous calcium hydrogen phosphate, microcrystalline cellulose and magnesium stearate.

[0007] Preferably, metronidazole 40-60%, microcrystalline cellulose 20-40%, anhydrous calcium hydrogen phosphate 10-40%, and magnesium stearate 0.1-1%.

[0008] Preferably, metronidazole 50%, microcrystalline cellulose 30%, anhydrous calcium hydrogen phosphate 25%, and magnesium stearate 0.5%.

[0009] A method for preparing metronidazole tablets, the specific steps are as follows:

[0010] S1. Grind the raw material through a 70-90 mesh sieve;

[0011] S2, then mixing the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 5 to 15 minutes;

[0012] S3, adding the prescribed amount of microcrystalline cellulose and mixing for 5 to 15 minutes;

[0013] S4. Finally, add the prescribed amount of magnesium stearate and mix for 3 to 7 minutes;

[0014] S5, tabletting through a 10 mm shallow concave circular punching die;

[0015] S6. Film-coating the tablets to increase weight by 2-4%.

[0016] Preferably, the raw drug is crushed and passed through an 80-mesh sieve;

[0017] Preferably, the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate are mixed for 10 minutes; then the prescribed amount of microcrystalline cellulose is added and mixed for 10 minutes; finally, the prescribed amount of magnesium stearate is added and mixed for 5 minutes.

[0018] Preferably, the compressed tablets are film coated to a weight gain of 3%.

[0019] Beneficial effects of the present invention:

[0020] The invention adopts a powder direct compression method to prepare the metronidazole tablets, which not only simplifies the method steps and reduces the production cost, but also avoids the material being in a wet and hot condition and reduces the generation of impurities. DETAILED DESCRIPTION

[0021] Embodiment 1:

[0022] A metronidazole tablet is composed of 40% of metronidazole, 20% of microcrystalline cellulose, 10% of anhydrous calcium hydrogen phosphate and 0.1% of magnesium stearate.

[0023] The method steps are as follows: S1, crushing the raw material drug through a 70-mesh sieve; S2, then mixing the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 5 minutes; S3, adding the prescribed amount of microcrystalline cellulose and mixing for 5 minutes; S4, finally adding the prescribed amount of magnesium stearate and mixing for 3 minutes; S5, tableting through a 10mm shallow concave circular stamping tablet mold; S6, film coating the tablets to increase the weight by 2%.

[0024] Embodiment 2:

[0025] A metronidazole tablet is composed of 50% of metronidazole, 30% of microcrystalline cellulose, 25% of anhydrous calcium hydrogen phosphate and 0.5% of magnesium stearate.

[0026] The method steps are as follows: S1, crushing the raw material drug through an 80-mesh sieve; S2, then mixing the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 10 minutes; S3, adding the prescribed amount of microcrystalline cellulose and mixing for 10 minutes; S4, finally adding the prescribed amount of magnesium stearate and mixing for 5 minutes; S5, tableting through a 10mm shallow concave circular stamping tablet mold; S6, film coating the tablets to increase the weight by 3%.

[0027] Embodiment 3:

[0028] A metronidazole tablet is composed of 60% metronidazole, 40% microcrystalline cellulose, 40% anhydrous calcium hydrogen phosphate, and 1% magnesium stearate.

[0029] The method steps are as follows: S1, crushing the raw material drug through a 90-mesh sieve; S2, then mixing the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 15 minutes; S3, adding the prescribed amount of microcrystalline cellulose and mixing for 15 minutes; S4, finally adding the prescribed amount of magnesium stearate and mixing for 7 minutes; S5, tableting through a 10mm shallow concave circular stamping die; S6, film coating the tablets to increase the weight by 4%.

[0030] Experimental data:

[0031] Products purchased randomly from the market were used as control preparations; dissolution tests were performed on Examples 1, 2, 3 prepared by the present invention and the control preparations, respectively. The specific experimental data are as follows:

[0032]

[0033] Products purchased randomly from the market were used as control preparations; high temperature tests and light irradiation experiments were performed on Examples 1, 2, 3 prepared by the present invention and the control preparations, respectively. The specific experimental data are as follows:

[0034]

[0035]

[0036]

[0037]

[0038] From the dissolution results, it can be seen that the dissolution rates of Example 1, Example 2, and Example 3 using the powder direct compression method are consistent with the dissolution effect of the control preparation and have good similarity with the control preparation.

[0039] The experimental data show that the control preparation shows obvious changes under high temperature, high humidity and light conditions, but the contents and related substances of Examples 1, 2 and 3 do not change significantly, indicating that the preparation method is better.

[0040] The above are only preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art can still modify the technical solutions described in the aforementioned embodiments or replace some of the technical features therein by equivalents. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. Metronidazole tablets, characterized in that: It is composed of metronidazole, anhydrous calcium hydrogen phosphate, microcrystalline cellulose and magnesium stearate.

2. The metronidazole tablet according to claim 1, characterized in that: Metronidazole 40-60%, microcrystalline cellulose 20-40%, anhydrous calcium hydrogen phosphate 10-40%, magnesium stearate 0.1-1%.

3. The metronidazole tablet according to claim 2, characterized in that: Metronidazole 50%, microcrystalline cellulose 30%, anhydrous calcium hydrogen phosphate 25%, magnesium stearate 0.5%.

4. The metronidazole tablet according to claim 1, wherein the preparation method is characterized in that: The specific steps are as follows: S1. Grind the raw material through a 70-90 mesh sieve; S2, then mixing the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 5 to 15 minutes; S3, adding the prescribed amount of microcrystalline cellulose and mixing for 5 to 15 minutes; S4. Finally, add the prescribed amount of magnesium stearate and mix for 3 to 7 minutes; S5, tabletting through a 10 mm shallow concave circular punching die; S6. Film-coating the tablets to increase weight by 2-4%.

5. The method for preparing metronidazole tablets according to claim 4, characterized in that: Preferably, the raw drug is crushed and passed through an 80-mesh sieve.

6. The method for preparing metronidazole tablets according to claim 4, characterized in that: Mix the prescribed amount of metronidazole and anhydrous calcium hydrogen phosphate for 10 minutes; then add the prescribed amount of microcrystalline cellulose and mix for 10 minutes; finally, add the prescribed amount of magnesium stearate and mix for 5 minutes.

7. The method for preparing metronidazole tablets according to claim 4, characterized in that: The compressed tablets were film coated to a weight gain of 3%.

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