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A kind of preparation method of flucloxacillin sodium amoxicillin capsule

A technology of flucloxacillin sodium and amoxicillin, which is applied in the field of preparation of flucloxacillin sodium and amoxicillin capsules, can solve the problems of the dissolution rate of flucloxacillin sodium and the reduction of the labeled amount, and achieve improved stability, avoiding degradation, good stability effect

Active Publication Date: 2018-07-20
HUNAN KELUN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prepared flucloxacillin sodium amoxicillin capsules are found after accelerated stability investigation under the conditions of temperature 40°C ± 2°C and humidity 75±5%, the dissolution rate and labeled amount of flucloxacillin sodium are large after one month. A reduction in magnitude, below the legal limit

Method used

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  • A kind of preparation method of flucloxacillin sodium amoxicillin capsule
  • A kind of preparation method of flucloxacillin sodium amoxicillin capsule
  • A kind of preparation method of flucloxacillin sodium amoxicillin capsule

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preparation example Construction

[0023] The invention provides a kind of preparation method of flucloxacillin sodium amoxicillin capsule, comprises the following steps:

[0024] A) After mixing flucloxacillin sodium and pregelatinized starch, carry out dry granulation and sieve the whole grain to obtain mixture granules;

[0025] B) mixing the mixture granules, amoxicillin, pregelatinized starch, magnesium stearate and talc to obtain the total mixture;

[0026] C) filling the total mixture into capsules to obtain flucloxacillin sodium amoxicillin capsules.

[0027] The flucloxacillin sodium amoxicillin capsule provided by the present invention is a composite preparation composed of equal amounts of amoxicillin and flucloxacillin, preferably prepared according to the following formula:

[0028] Each 1000 capsules contains 125g of flucloxacillin sodium, 125g of amoxicillin, 40-60g of pregelatinized starch, 4-6g of talcum powder and 1-2g of magnesium stearate.

[0029] Before the flucloxacillin sodium is granu...

Embodiment 1

[0046] 1. Prepare the raw and auxiliary materials of flucloxacillin sodium and amoxicillin capsules according to the following table, wherein, flucloxacillin sodium and amoxicillin are the dry equivalents

[0047] Name of raw material

Dosage

Flucloxacillin sodium (calculated as flucloxacillin)

150000g

Amoxicillin

150000g

[0048] pregelatinized starch

60000g

talcum powder

6000g

Magnesium stearate

1500g

Co-made

1.2 million tablets

[0049]2. Crushing and screening of raw and auxiliary materials: first put amoxicillin, flucloxacillin sodium, pregelatinized starch, talcum powder, and magnesium stearate into a universal pulverizer; pass amoxicillin through a 20-mesh vibrating sieve, Sodium cillin, pregelatinized starch, talcum powder, and magnesium stearate are passed through an 80-mesh vibrating sieve.

[0050] 3. Weighing preparation: Accurately weigh crushed and sieved amoxicillin, flucloxaci...

Embodiment 2

[0058] 1. Prepare the raw and auxiliary materials of flucloxacillin sodium and amoxicillin capsules according to the following table, wherein, flucloxacillin sodium and amoxicillin are the dry equivalents

[0059] Name of raw material

Dosage

flucloxacillin sodium

125000g

Amoxicillin

125000g

pregelatinized starch

50000g

talcum powder

5000g

Magnesium stearate

1250g

Co-made

1 million tablets

[0060] 2. Crushing and screening of raw and auxiliary materials: first put amoxicillin, flucloxacillin sodium, pregelatinized starch, talcum powder, and magnesium stearate into a universal pulverizer; pass amoxicillin through a 20-mesh vibrating sieve, Sodium cillin, pregelatinized starch, talcum powder, and magnesium stearate are passed through an 80-mesh vibrating sieve.

[0061] 3. Weighing preparation: Accurately weigh crushed and sieved amoxicillin, flucloxacillin sodium, pregelatinized starch, talcum powder...

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Abstract

The invention provides a preparation method of flucloxacillin sodium amoxicillin capsules. The method comprises the following steps: (A) mixing flucloxacillin sodium with pregelatinized starch, and then performing dry granulation and whole grain sieving to obtain mixture particles; (B) mixing the mixture particles, amoxicillin, the pregelatinized starch, magnesium stearate and talc powder to obtain a total mixture; and (C) filling the total mixture into capsules to obtain the flucloxacillin sodium amoxicillin capsules. According to the preparation method provided by the invention, the stability of flucloxacillin is improved by performing dry granulation on flucloxacillin. Moreover, the method adopts an isolating agent namely the pregelatinized starch to separate flucloxacillin sodium from amoxicillin, so that flucloxacillin sodium is prevented from being in contact with amoxicillin to cause degradation of flucloxacillin sodium, and the obtained flucloxacillin sodium amoxicillin capsules are good in stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of flucloxacillin sodium amoxicillin capsules. Background technique [0002] Flucloxacillin Sodium Amoxicillin Capsules is a compound preparation composed of equal amounts of amoxicillin and flucloxacillin, which can learn from each other's strengths, expand the antibacterial spectrum, have strong antibacterial activity, and play a synergistic effect. It is suitable for treating acute infection of the respiratory system. It is used to treat mixed infections or severe infections with unknown pathogenic bacteria, and has obvious advantages over single drug use, and has better safety. [0003] Currently commercially available flucloxacillin sodium and amoxicillin capsules are usually prepared by blending flucloxacillin sodium and amoxicillin. See the specific process figure 1 , figure 1 It is a flow chart of the preparation process of flucloxaci...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/431A61K9/48A61K47/36A61P31/04
Inventor 李全学彭建廖孝曙逯佩荣彭朝晖刘志军刘思川程志鹏万阳浴葛均友
Owner HUNAN KELUN PHARMA
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