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Stable cefeclor dispersible tablet and preparation method thereof

A technology for cefaclor and dispersible tablets, applied in the field of stable cefaclor dispersible tablets and their preparation, can solve the problems of decreased content, decreased drug bioavailability, unstable light, high temperature, high humidity, etc. Faster time, small difference in tablet weight, good press formability

Active Publication Date: 2010-12-15
BEIJING JINGFENG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, cefaclor dispersible tablets have the characteristics of convenient taking, fast absorption, early onset of effect and high bioavailability compared with conventional dosage forms, and are especially suitable for children, the elderly and patients who have difficulty swallowing solids. However, cefaclor itself is sensitive to light , high temperature, and high humidity are not very stable, so the current preparations need to be stored away from light and sealed. The content of the accelerated test and room temperature storage for 6 months has decreased significantly, especially after two years. The reduction in potency is faster, while the content of The decrease will inevitably directly bring about the decrease of drug bioavailability

Method used

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  • Stable cefeclor dispersible tablet and preparation method thereof
  • Stable cefeclor dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1 cefaclor dispersible tablet

[0038] Raw material name dosage

[0039] Cefaclor 25g

[0040] Microcrystalline Cellulose 11.5g

[0041] Hypromellose 7g

[0042] 2% hypromellose 40% ethanol solution appropriate amount

[0043] Pregelatinized starch 5g

[0044] Crospovidone 2.8g

[0045] Silica 1.2g

[0046] Magnesium Lauryl Sulfate 1g

[0047] Flavor 0.12g

[0048]

[0049] Makes 100 pieces

[0050] Preparation:

[0051] 1) Handling of raw and auxiliary materials

[0052] Cefaclor is crushed through a 100-mesh sieve, microcrystalline cellulose, hydroxypropyl cellulose, pregelatinized starch, crospovidone, silicon dioxide, magnesium lauryl sulfate, and essence are sieved separately, and set aside.

[0053] 2) Making glue

[0054] Calculate the feeding amount of hypromellose, ethanol and water in the mucilage according to the prescription. Weigh the hypromellose, first add ethanol and stir to disperse evenly, the...

Embodiment 2

[0069]Embodiment 2 Cefaclor Dispersible Tablets

[0070] Raw material name dosage

[0071] Cefaclor 25g

[0072] Microcrystalline Cellulose 11.5g

[0073] Hypromellose 5g

[0074] 2% hypromellose 40% ethanol solution appropriate amount

[0075] Pregelatinized starch 5g

[0076] Crospovidone 3g

[0077] Silica 1.2g

[0078] Magnesium Lauryl Sulfate 1.5g

[0079] Flavor 0.12g

[0080]

[0081] Makes 100 pieces

[0082] Preparation method: prepare with reference to the method of Example 1

Embodiment 3

[0083] Embodiment 3 cefaclor dispersible tablet

[0084] Raw material name dosage

[0085] Cefaclor 25g

[0086] Microcrystalline Cellulose 11.5g

[0087] Hypromellose 5g

[0088] 2% hypromellose 40% ethanol solution appropriate amount

[0089] Pregelatinized starch 5g

[0090] Crospovidone 4

[0091] Silica 1.2g

[0092] Magnesium Lauryl Sulfate 2g

[0093] Flavor 0.12g

[0094]

[0095] Makes 100 pieces

[0096] Preparation method: refer to the method of Example 1.

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Abstract

The invention belongs to the technical field of medicament preparations, and particularly relates to a cefeclor dispersible tablet which is characterized by being prepared from the following components in parts by weight: 25g of cefeclor, 11.5g of microcrystalline cellulose, 5-7g of hydroxypropyl cellulose, a proper amount of 2-percent hydroxypropyl methylcellulose 40-percent ethanol solution, 5g of pregelatinized starch, 2.8-4g of cross-linked polyvidone, 1.2g of silicon dioxide, 1-2g of magnesium laurylsulfate and 0.12g of essence. Because the magnesium laurylsulfate is used in the dispersible tablet, the preparation stability is markedly improved, the content is basically not changed after long-time placement, and the service time of the medicament is prolonged.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a stable cefaclor dispersible tablet and a preparation method thereof. Background technique [0002] Cefaclor (cephalexin) is a semi-synthetic second-generation cephalosporin, which is mainly used for the treatment of respiratory tract, urinary tract, skin and soft tissue infections. Its antibacterial effect is better than that of cephalexin. [0003] Cefaclor is white or slightly yellow crystalline powder, slightly soluble in water, developed by Eli Lilly and Company in 1975, approved by FDA in 1979, and recorded in the XXI edition of the US Pharmacopoeia, Japan Shionogi Pharmaceutical Co., Ltd. It was developed in 1976 and approved in 1981. At present, various dosage forms such as ordinary tablets, capsules, granules, and dispersible tablets are available. Among them, cefaclor dispersible tablets have the characteristics of convenient taking, fast absorption, early onset of...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/545A61K47/38A61K47/32A61K47/20A61P31/04
Inventor 陈成龙张洪范辉张信忠
Owner BEIJING JINGFENG PHARMA GRP
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