Cefaclor film-controlled slow-release pellet capsule

A technology of slow-release pellets and Clorox membrane, which is applied in the field of pharmaceutical preparations and can solve the problems of membrane aging and release decline

Active Publication Date: 2013-07-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the problem of release decline caused by film aging of cefaclor film-controlled sustained-release pellets prepared by water dispersion coating, the present invention provides a film-controlled film-controlled pellet that can maintain stable release performance througho

Method used

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  • Cefaclor film-controlled slow-release pellet capsule
  • Cefaclor film-controlled slow-release pellet capsule
  • Cefaclor film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] The cefaclor sustained-release pellet capsule of embodiment 1 common ball core

[0029] 1. Prescription

[0030] 1. Pill core prescription (1000 capsules)

[0031]

[0032] 2. Prescription of sustained-release film coating solution

[0033]

[0034]3. 00el ordinary stomach-soluble gelatin capsule shell 1000 capsules

[0035] Second, the preparation process:

[0036] 1. Ball core preparation process:

[0037] (1) Pass cefaclor through a 60-mesh sieve.

[0038] (2) Weigh the cefaclor, microcrystalline cellulose PH101 and lactose in the prescribed amount, put them in a wet granulator and mix them evenly.

[0039] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0040] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0041] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0042] (6) Sieve, and take ball cores between 16 and 30 mesh.

...

Embodiment 2

[0066] Example 2 Cefaclor Sustained-release Pellet Capsules Containing 5% Carboxymethyl Starch Sodium

[0067] 1. Prescription

[0068] 1. Pill core prescription (1000 capsules)

[0069]

[0070] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0071] 3. 00el ordinary stomach-soluble gelatin capsule shell 1000 capsules

[0072] Second, the preparation process:

[0073] 1. Ball core preparation process:

[0074] (1) Cefaclor is passed through a 60-mesh sieve;

[0075] (2) Take cefaclor, microcrystalline cellulose PH101, lactose, carboxymethyl starch sodium of prescription quantity, put in the wet granulator and mix uniformly;

[0076] (3) make soft material with 2% carboxymethylcellulose sodium 10% ethanol solution;

[0077] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0078] (5) Put it on the spheronizer for spheronization, the spheronization speed is 900~1000rpm, and dry in the fl...

Embodiment 3

[0097] Example 3 Cefaclor Sustained-release Pellet Capsules Containing 10% Carboxymethyl Starch Sodium

[0098] 1. Prescription

[0099] 1. Pill core prescription (1000 capsules)

[0100]

[0101] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0102] 3. 00el ordinary stomach-soluble gelatin capsule shell 1000 capsules

[0103] Second, the preparation process:

[0104] 1. Ball core preparation process: the same as in Example 2

[0105] 2. Preparation process of sustained-release film coating solution:

[0106] Same as Example 1

[0107] 3. Coating (sustained release film):

[0108] The ball core is placed in a fluidized bed for coating, and the weight gain of the coating film is controlled, and the weight gain of the coating is 26.5% and 30.7%.

[0109] 4, heat treatment: with embodiment 1

[0110] 5. Pellet filling: same as Example 1

[0111] 3. Release, content determination and results

[0112] Measuring method: see table 5 with...

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PUM

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Abstract

The invention relates to a cefaclor film-controlled slow-release pellet capsule. A slow-release film of the cefaclor film-controlled slow-release pellet utilizes a mixture of aqueous dispersion Eurdragit RL 30D and Eurdragit RS 30D as a film-formation material, wherein a weight ratio of Eurdragit RL 30D to Eurdragit RS 30D in the mixture is 4: 1. A pellet core of the cefaclor film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains pharmaceutically-acceptable common excipients for the slow-release pellet, wherein preferably, the excipients comprise microcrystalline cellulose and lactose, and the pellet core comprises 5 to 20wt% of the sodium carboxymethyl starch. The slow-release film comprises the mixture of Eurdragit RL 30D and Eurdragit RS 30D, triethyl citrate as a plasticizer, and talcum powder as an antiplastering aid, wherein preferably, a ratio of Eurdragit RL 30D to Eurdragit RS 30D to triethyl citrate to talcum powder is 24: 6: 2: 4 and a film weight increasing ratio is in a range of 23 to 40%. The cefaclor film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the cefaclor film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the cefaclor film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to a cefaclor membrane-controlled sustained-release pellet capsule, in particular to a cefaclor membrane-controlled sustained-release pellet capsule whose core contains sodium carboxymethyl starch, belonging to the field of pharmaceutical preparations. Background technique [0002] Cefaclor is a cephalosporin antibiotic, which plays an antibacterial effect by inhibiting the synthesis of bacterial cell walls and has bactericidal properties. It can quickly sterilize bacteria at low concentrations, and is used for respiratory system, urinary system, otolaryngology, skin and soft tissue infections caused by sensitive bacteria. [0003] Cefaclor is slightly soluble in water, and the earliest common preparation on the market needs to be taken 3 times a day, the blood concentration fluctuates greatly, the peak concentration is too high, and the adverse reactions are serious. [0004] Cefaclor Sustained Release Tablets (trade name: Cefac...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/16A61K31/545A61K47/36A61P31/04
Inventor 姜庆伟狄媛吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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