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A kind of melelamycin enteric-coated capsule and its preparation method

A technology of mebelamycin and enteric-coated capsules, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of lack of mebelamycin and low bioavailability , Dissolution and poor stability, etc., to achieve the effect of simple process, good enteric effect and good reproducibility

Active Publication Date: 2018-01-23
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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  • A kind of melelamycin enteric-coated capsule and its preparation method
  • A kind of melelamycin enteric-coated capsule and its preparation method

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 melelamycin enteric-coated capsule, which comprises the following components in parts by weight: 40-45 parts of melemycin, 30-32 parts of copovidone, 210-220 parts of isopropanol, and 35 parts of talcum powder 45 parts, 260‑270 parts of acrylic resin, 6‑8 parts of triethyl citrate, 6‑8 parts of magnesium oxide, 801‑4 parts of polysorbate, 3‑5 parts of glyceryl monostearate, hydroxypropyl 3-4 parts of methyl cellulose, 330-360 parts of purified water. The mebamycin capsule of the invention is safe and effective, and has a good dissolution effect in the intestinal tract. The invention also discloses a preparation method of the mebelamycin enteric-coated capsule, and introduces the proportion of each coating layer. The process is simple and feasible, and is 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 Patents(China)
IPC IPC(8): A61K9/62A61K31/7048A61K47/38A61P31/04
Inventor 苏娜
Owner SUNSHINE LAKE PHARM CO LTD
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