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Cefditoren pivoxil composition tablets and preparation method thereof

A technology of cefditoren pivoxil and composition, which is applied in the field of cefditoren pivoxil composition tablet and its preparation field, can solve the problem of slow disintegration speed of cefditoren pivoxil tablet, unsuitable for industrial production and poor stability and other problems, to achieve good disintegration effect, good disintegration effect, good compressibility and good compression formability.

Active Publication Date: 2013-10-23
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Yet the cefditoren pivoxil tablet disintegration speed that above-mentioned prescription makes is slow, dissolution rate is low, and stability is poor, is not suitable for industrialized production

Method used

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  • Cefditoren pivoxil composition tablets and preparation method thereof
  • Cefditoren pivoxil composition tablets and preparation method thereof
  • Cefditoren pivoxil composition tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Using cefditoren pivoxil as raw material, the effects of the dosage of various excipients on drug hardness, appearance, disintegration, friability and dissolution were investigated. The dosage of excipients in each prescription is shown in Table 1.

[0034] Sieve the raw materials, sieve other auxiliary materials separately, and set aside; cefditoren pivoxil, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized starch, croscarmellose sodium, carboxymethyl starch Sodium and magnesium stearate were mixed according to the prescription amount, and the results of measuring the angle of repose and outflow velocity are shown in Table 2. After tableting, the hardness, appearance, weight difference, disintegration, friability, and dissolution rate were measured, and the results are shown in Table 3. Among them, the method for measuring the outflow speed is: take a certain amount of sample (10g), put it into a funnel, measure the time required for all th...

Embodiment 2

[0044] Using cefditoren pivoxil as raw material, the effects of the dosage of various excipients on drug hardness, appearance, disintegration, friability and dissolution were investigated. The amount of excipients in each prescription is shown in Table 4.

[0045] Sieve the cefditoren pivoxil and other excipients respectively, grind the cefditoren pivoxil and corresponding auxiliary materials according to the prescription ratio through a pulverizer, sieve, and set aside.

[0046] Mix cefditoren pivoxil and the corresponding prescription auxiliary materials according to the relevant proportion, pass through 2 times of sieve, adopt the dry granulation method to make the above-mentioned mixture into granules, add the magnesium stearate of the prescription amount, mix well, measure the angle of repose, The outflow velocity results are shown in Table 5. The hardness, appearance, weight difference, disintegration, friability, and dissolution rate were measured after tableting, and ...

Embodiment 3

[0054] Embodiment 3: cefditoren pivoxil composition tablet of the present invention

[0055]

[0056] Preparation method: 126g of cefditoren pivoxil and 30g of mannitol were mixed, pulverized and sieved to obtain the first mixture for later use; another remaining 55g of mannitol was pulverized, and then mixed with 55 parts by weight of microcrystalline cellulose, 15 parts by weight of Carboxymethyl starch sodium, 12g croscarmellose sodium are sieved respectively, and it is for subsequent use; the mannitol, microcrystalline cellulose, carboxymethyl starch sodium and croscarmellose sodium obtained by sieving the first mixture are Mix evenly to obtain the second mixture, sieve it twice, then use dry granulation method to make the second mixture into granules, add 1g of magnesium stearate, mix evenly, and press into tablets to obtain.

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Abstract

The invention belongs to the field of medicine preparation, and discloses cefditoren pivoxil composition tablets and a preparation method thereof. The cefditoren pivoxil composition tablets adopt cefditoren pivoxil as a raw material, and are prepared with certain weight parts of auxiliary materials of mannitol, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked sodium carboxymethyl cellulose, and magnesium stearate. The cefditoren pivoxil composition tablets provided by the invention have high disintegration rate, high dissolution rate, good stability, accurate dosage, convenient application, easy-to-obtain raw materials, and low cost. The tablets are easy to carry. The preparation method of the cefditoren pivoxil composition tablets provided by the invention is simple to operate and easy to control. The preparation method is labor-saving and time-saving, such that the method is suitable for large-scale industrialized productions.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a cefditoren pivoxil composition tablet and a preparation method thereof. Background technique [0002] Cefditoren pivoxil (Cefditoren pivoxil) chemical name: (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-amino-4 -thiazolyl)-2-methoxyiminoacetamido]-3-[(Z)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-5-thia- 1-Azabicyclo[4,2,0]oct-2-ene-2-carboxylate, molecular formula C 25 h 28 N 6 o 7 S 3 , the molecular weight is 620.72, and the chemical structural formula is as follows: [0003] [0004] Cefditoren Pivoxil (Cefditoren Pivoxil) is the third-generation cephalosporin developed by Japan Meiji Seika Co., Ltd. It was first launched in Japan on April 1, 1994, and was approved by my country’s drug regulatory department in September 1996. In 2001 It was approved by the US FDA in September. [0005] A large number of clinical studies have shown that cefditoren pi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/30A61K31/546A61K47/38A61K47/36A61K47/26A61P31/04
Inventor 李明杰冯长银刘文文
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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