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Amoxicillin sulbactam pivoxil capsule and preparation method thereof

A technology of amoxicillin-sulbactam pivoxil and sulbactam pivoxil, which is applied in the field of pharmaceutical preparations, can solve the problems of large filling volume, poor patient compliance, poor dissolution effect of amoxicillin-sulbactam pivoxil capsules, etc. problem, to achieve the effect of simple preparation method, convenient taking, and enhanced compliance

Inactive Publication Date: 2012-10-03
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when this method is specifically applied to amoxicillin-sulbactam pivoxil preparations, due to the large differences in physical properties such as particle size and density between amoxicillin and sulbactam raw powder, the product prepared according to the general dry granulation method Large filling volume, poor patient compliance
In addition, the dissolution effect of amoxicillin-sulbactam pivoxil capsules prepared by the existing dry method is not good

Method used

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  • Amoxicillin sulbactam pivoxil capsule and preparation method thereof
  • Amoxicillin sulbactam pivoxil capsule and preparation method thereof
  • Amoxicillin sulbactam pivoxil capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Amoxicillin-sulbactam pivoxil capsule Specification: 250mg

[0029] (1) Weigh 3 kg of amoxicillin, 3.866 kg of sulbactam pivoxil, and 34 g of sodium lauryl sulfate.

[0030] Croscarmellose sodium 136g, magnesium stearate 49g.

[0031] The sulbactam pivoxil raw material, magnesium stearate, and sodium lauryl sulfate were passed through an 80-mesh sieve respectively and weighed, and amoxicillin, sulbactam pivoxil, and 1 / 2 amount of cross-linked carboxymethyl fiber Sodium plain is placed in a mixer, stirred and mixed, the mixed material is extruded in an extruder, and crushed to obtain dry granules, and the prepared dry granules are mixed with the remaining croscarmellose sodium, ten Dialkyl sodium sulfate and magnesium stearate are placed in a mixer and mixed to obtain a mixed powder. The mixed powder is inspected and filled into No. 1 capsule after passing the test. The filling amount is 0.345g / grain, and the drug content is 36.5% (calculated as amoxicillin.) The fill...

Embodiment 2

[0033] Amoxicillin-sulbactam pivoxil capsules Specification: 625mg

[0034] (1) Weigh 12kg of amoxicillin, 3.866kg of sulbactam pivoxil, and 79g of sodium lauryl sulfate.

[0035] Croscarmellose sodium 316g, magnesium stearate 111g.

[0036] The sulbactam pivoxil raw material, magnesium stearate, and sodium lauryl sulfate were passed through an 80-mesh sieve respectively and weighed, and amoxicillin, sulbactam pivoxil, and 1 / 2 amount of cross-linked carboxymethyl fiber Put plain sodium in a mixer to mix and stir to make it fully mixed, put the mixed material in an extruder to squeeze and crush to obtain dry granules, and mix the prepared dry granules with the remaining croscarmellose sodium , Sodium Lauryl Sulfate, and Magnesium Stearate are mixed in a mixer to obtain mixed powder. The mixed powder is inspected and filled into No. 0 capsules after passing the test. The filling amount is 0.77g, and the drug content is 65% (calculated as amoxicillin.) The filled capsules are ...

Embodiment 3

[0047] Stability study

[0048] Objects of investigation: the product manufactured in Example 1 of the present invention and the product manufactured in Comparative Example 1.

[0049] Inspection method: Accelerated test is carried out under the conditions of relative humidity of 75%±5% and temperature of 40°C±2°C.

[0050] Inspection project: According to the "Standard YBHO1472007 of the State Food and Drug Administration", the product's properties, related substances, content, and dissolution rate were inspected.

[0051]The results are detailed in Table 1 and Table 2:

[0052] Table 1: Relevant data of the product made in embodiment 1

[0053]

[0054] Table 2: Relevant data of the product made in comparative example 1

[0055]

[0056] As can be seen from the data comparison of Table 1 and Table 2, in the accelerated test, after placing 2 months according to the product manufactured by wet method, its related substances are obviously higher than the product manufa...

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Abstract

The invention discloses an amoxicillin sulbactam pivoxil capsule and a preparation method thereof. The preparation method comprises the following steps of: (a) weighing up the following raw materials by mass ratio: 3000 parts of amoxicillin, 3866 parts of sulbactam pivoxil, 32-36 parts of lauryl sodium sulfate, 130-14 parts of crosslinking sodium carboxymethylcellulose and 40-50 parts of magnesium stearate; (b) mixing the amoxicillin, the sulbactam pivoxil and one-second amount of the crosslinking sodium carboxymethylcellulose and uniformly stirring; (c) placing uniformly mixed materials in an extruder for extruding and crushing to obtain dry granules, and mixing the dry granules with the rest crosslinking sodium carboxymethylcellulose, the lauryl sodium sulfate and the magnesium stearatein a mixer to obtain mixed powder; and (d) testing the mixed powder and encapsulating the mixed powder if qualified. The invention adopts less auxiliary materials, has short technological process andsimple preparation method, avoids affects of high-temperature and high-humidity to the quality of the products, and increases the stability of the product quality.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations. It specifically relates to amoxicillin-sulbactam pivoxil capsules and a preparation method thereof. technical background [0002] Amoxicillin-sulbactam pivoxil capsules are a mixed preparation composed of amoxicillin and sulbactam (calculated as sulbactam) at a ratio of 1:1. Among them, amoxicillin is a β-lactam antibiotic, which is effective against aerobic Gram-positive cocci such as Streptococcus pneumoniae and hemolytic Streptococcus, non-penicillinase-producing Staphylococcus, Enterococcus faecalis, Escherichia coli, mirabilis, etc. Proteus, Salmonella, Haemophilus influenzae, Neisseria gonorrhoeae and other aerobic Gram-negative bacteria that do not produce β-lactamase and Helicobacter pylori have good antibacterial activity. Amoxicillin exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and can rapidly dissolve and rupture bacteria into spheroids....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/43A61K9/48A61K47/38A61K47/20A61K47/12A61P31/04
Inventor 蔡丽红陈素婥王志良刘书睿单金海赵霞路玉锋
Owner NORTH CHINA PHARMA COMPANY
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