Meleumycin enteric capsule and preparation method thereof

A technology of mebelamycin and enteric-coated capsules, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, and medical preparations containing active ingredients. It can solve the problems of poor dissolution rate and stability, lack of mebelamycin, The bioavailability is not high, and the effect of good reproducibility, simple process and good enteric effect is achieved

Active Publication Date: 2015-03-11
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the existing mebelamycin in the market mainly includes tablets and capsules. These dosage forms have poor dissolution rate and stability in the gastrointestinal tract, and the bioavailability is not high.
Therefore, there is a lack of relevant enteric-coated preparations about mebelamycin on the market

Method used

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  • Meleumycin enteric capsule and preparation method thereof
  • Meleumycin enteric capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Weigh 40 parts of melemycin, 15 parts of copovidone, 6 parts of magnesium oxide, 800.5 parts of polysorbate, and 210 parts of isopropanol to prepare the coating solution for the coating layer; weigh 15 parts of copovidone, talc 32 parts of powder and 110 parts of purified water were used to prepare the coating solution for the isolation layer; 260 parts of acrylic resin, 6 parts of triethyl citrate, 3 parts of glyceryl monostearate, 800.5 parts of polysorbate, and 160 parts of purified water were weighed respectively. 3 parts of hydroxypropyl methylcellulose, 3 parts of talcum powder, and 60 parts of purified water were weighed to prepare the coating solution of the protective layer;

[0016] Add the blank pellet core into the GPCG30 multifunctional fluidized bed, and apply the above-mentioned coating solutions to the drug layer coating, isolation layer coating, enteric coating layer coating, and protective layer coating respectively. After sieving, Just dry.

[0017] ...

Embodiment 2

[0019] Weigh 45 parts of mebamycin, 16 parts of copovidone, 8 parts of magnesium oxide, 803 parts of polysorbate, and 220 parts of isopropanol to prepare the coating solution for the coating layer; weigh 16 parts of copovidone, talc 40 parts of powder and 120 parts of purified water were used to prepare the coating solution for the isolation layer; 270 parts of acrylic resin, 8 parts of triethyl citrate, 5 parts of glyceryl monostearate, 802 parts of polysorbate, and 170 parts of purified water were weighed respectively. 4 parts of hydroxypropyl methylcellulose, 5 parts of talcum powder, and 70 parts of purified water were weighed to prepare a coating solution for the protective layer; the blank ball core was added to the GPCG30 multifunctional fluidized bed Inside, each of the above-prepared coating solutions is respectively coated with a drug layer, an isolation layer, an enteric layer, and a protective layer, and then dried after sieving.

[0020] Twelve capsules were rando...

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Abstract

The invention relates to a meleumycin enteric capsule. The meleumycin enteric capsule comprises the following components in parts by weight: 40-45 parts of meleumycin, 30-32 parts of PVP / VA, 210-220 parts of isopropyl alcohol, 35-45 parts of talcum powder, 260-270 parts of acrylic resin, 6-8 parts of triethyl citrate, 6-8 parts of magnesium oxide, 1-4 parts of polysorbate 80, 3-5 parts of glyceryl monostearate and glyceryl distearate, 3-4 parts of hydroxy propyl methyl cellulose and 330-360 parts of purified water. The meleumycin enteric capsule is safe and effective, and has a good dissolution effect in the intestinal tract. The invention further discloses a preparation method of the meleumycin enteric capsule, the proportion of all coatings is introduced, and the process is simple and feasible and suitable for industrial production.

Description

technical field [0001] The invention relates to an enteric-coated preparation, in particular to a mebelamycin enteric-coated capsule and a preparation method thereof. Background technique [0002] Mebemycin Tablets is a 16-membered ring macrolide antibiotic with a broad antibacterial spectrum, and is effective against most Gram-positive bacteria, some Gram-negative bacteria and some atypical pathogenic bacteria. [0003] At present, the existing mebelamycins on the market mainly include tablets and capsules. These dosage forms have poor dissolution rate and stability in the gastrointestinal tract, and the bioavailability is not high. Therefore, there is a lack of related enteric-coated preparations about mebelamycin on the market. Contents of the invention [0004] The purpose of the present invention is to overcome the disadvantages of the prior art and provide a mebelamycin enteric-coated capsule preparation, which has high-efficiency dissolution in the intestine. At t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K31/7048A61K47/38A61P31/04
Inventor 苏娜
Owner SUNSHINE LAKE PHARM CO LTD
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