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Cefuroxime axetil capsule and preparation method thereof

A technology of cefuroxime axetil and capsules, which is applied in the field of cefuroxime axetil capsules and its preparation, can solve problems affecting product quality and clinical application, unqualified drug content uniformity, excessive content of drug degradation products, etc., and achieve time reduction , low dissolution rate and improved dissolution rate

Pending Publication Date: 2022-01-21
NINGXIA MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] However, because cefuroxime axetil is sensitive to external conditions such as humidity and heat, problems such as excessive drug degradation product content and unqualified drug content uniformity often occur in the research and production process, which affect product quality and clinical application. Therefore, cefuroxime There is still room for improvement in the stability and bioavailability of furoctyl ester preparations
In addition, cefuroxime axetil is mostly an amorphous powder in medicine, and in the process of dry granulation and tablet compression, if a certain crystal form is formed by crystal transformation, it will also have an adverse effect on the absorption of the drug in vivo

Method used

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  • Cefuroxime axetil capsule and preparation method thereof
  • Cefuroxime axetil capsule and preparation method thereof
  • Cefuroxime axetil capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 (1000 grains)

[0035] Prepare according to the formula in Table 1

[0036] Table 1 Embodiment 1 formula

[0037] raw material Weight (g) mass percentage cefuroxime axetil 150.25 66.85％ Lactose SuperTab11SD 15 6.67％ Carboxymethyl Starch Sodium 50 22.25％ Sodium dodecyl sulfate 1 0.44％ Micropowder silica gel 8 3.56％ Magnesium stearate 0.5 0.22％

[0038] The preparation method is as follows:

[0039] 1. Material pretreatment: pass sodium lauryl sulfate, micropowder silica gel, and magnesium stearate through an 80-mesh sieve; pass cefuroxime axetil and lactose through a 60-mesh sieve, and set aside;

[0040] 2. Pre-mixing: Weigh sodium lauryl sulfate, micropowder silica gel, and magnesium stearate and mix for 5 minutes, pass through a 60-mesh sieve, and sieve three times to obtain mixture A;

[0041] 3. Mixing: Add cefuroxime axetil to mixture A, mix for 5 minutes, add sodium starch glycolate and lac...

Embodiment 2

[0043] Embodiment 2 (1000 grains)

[0044] Prepare according to the formula in Table 2

[0045] Table 2 Example 2 formula

[0046] raw material Weight (g) mass percentage cefuroxime axetil 150.25 66.85％ β-cyclodextrin 15 6.67％ Carboxymethyl Starch Sodium 50 22.25％ Sodium dodecyl sulfate 1 0.44％ Micropowder silica gel 8 3.56％ Magnesium stearate 0.5 0.22％

[0047] The preparation method is as follows:

[0048] 1. Material pretreatment: pass sodium lauryl sulfate, micropowder silica gel, and magnesium stearate through a 80-mesh sieve; pass cefuroxime axetil and β-cyclodextrin through a 60-mesh sieve; set aside;

[0049] 2. Pre-mixing: Weigh sodium lauryl sulfate, micropowder silica gel, and magnesium stearate and mix for 5 minutes, pass through a 60-mesh sieve, and sieve three times to obtain mixture A;

[0050] 3. Mixing: Add cefuroxime axetil to mixture A, mix for 5 minutes, add sodium starch glycolate and β-cyclodextr...

Embodiment 3

[0052] Embodiment 3 (1000 grains)

[0053] Prepare according to the formula in Table 3

[0054] Table 3 Example 3 formula

[0055] raw material Weight (g) mass percentage cefuroxime axetil 150.25 71.29％ Microcrystalline Cellulose PH301 28 13.29％ Lactose SuperTab11SD 15 7.12％ Croscarmellose Sodium 10 4.74％ Sodium dodecyl sulfate 1 0.47％ Micropowder silica gel 6 2.85％ Magnesium stearate 0.5 0.24％

[0056] The preparation method is as follows:

[0057] 1. Material pretreatment: pass sodium lauryl sulfate, micropowder silica gel, and magnesium stearate through an 80-mesh sieve; pass cefuroxime axetil, lactose, and microcrystalline cellulose through a 60-mesh sieve; set aside;

[0058] 2. Pre-mixing: Weigh sodium lauryl sulfate, micropowder silica gel, and magnesium stearate and mix for 5 minutes, pass through a 60-mesh sieve, and sieve three times to obtain mixture A;

[0059] 3. Mixing: Add cefuroxime axetil to ...

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Abstract

The invention discloses a cefuroxime axetil capsule and a preparation method thereof. The preparation method comprises the following steps: (1) raw material pretreatment: sieving a solubilizer, a flow aid and a lubricant with a 60-100-mesh sieve; sieving the cefuroxime axetil and the filling agent with a 60-100-mesh sieve for later use; (2) premixing: mixing the solubilizer, the flow aid and the lubricant, and sieving with a 60-100-mesh sieve to obtain a mixture A; (3) mixing: uniformly mixing the cefuroxime axetil and the mixture A, then adding the filling agent and the disintegrating agent, and uniformly mixing to obtain intermediate powder; and (4) capsule filling: filling a capsule shell with the intermediate powder according to a filling amount requirement, and then packaging to obtain the cefuroxime axetil capsule. According to the invention, after cefuroxime axetil and auxiliary materials are uniformly mixed, the capsule is directly filled by adopting a full-powder process without a granulation process. The stability of the cefuroxime axetil is improved, and the bioavailability is improved; the production period is shortened and the cost is reduced.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefuroxime axetil capsule and a preparation method thereof. Background technique [0002] Cefuroxime Axetil is a second-generation cephalosporin antibiotic. After oral administration and absorption through the gastrointestinal tract, it is rapidly hydrolyzed into cefuroxime under the action of esterase to exert antibacterial effect. The activity against Gram-positive cocci is similar to or slightly worse than that of the first-generation cephalosporins, but it is quite stable against the β-lactamase produced by Staphylococcus and Gram-negative bacilli. Except for methicillin-resistant Staphylococcus, Enterococcus and Listeria, other positive cocci (including anaerobic cocci) are sensitive to this product. [0003] At present, the dosage forms of cefuroxime axetil preparations in China mainly include tablets, capsules, dry suspensions and the like. There a...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/546A61K47/38A61K47/36A61K47/26A61K47/02A61P31/04
CPCA61K31/546A61K9/4866A61K9/4858A61K9/485A61P31/04
Inventor 侯延辉
Owner NINGXIA MEDICAL UNIV
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