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Stable montelukast sodium enteric-coated pellet capsule and preparation method thereof

An enteric-coated pellet and a technology for pellet-coated pellets are applied in the field of montelukast sodium enteric-coated pellet capsules and the preparation thereof, and can solve the problems of a large amount of degraded impurities of the main drug, large local mucosal irritation, and easily fluctuating blood drug concentration. , to achieve the effect of shortening working hours, improving stability, and reducing process

Inactive Publication Date: 2018-05-11
合肥凯石医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

② Ordinary capsules and tablets have limited diffusion area, slow drug absorption, fluctuating blood drug concentration, low bioavailability, and large local mucosal irritation; enteric-coated micropills have large diffusion area in the gastrointestinal tract and good absorption , high bioavailability, stable blood concentration, less irritation to mucous membranes
Another reported patent contains povidone and copovidone excipients that are incompatible with the main drug in the excipient and isolation layer of montelukast sodium coated on the blank core, respectively. The compatibility test of raw materials and excipients It is found that these two excipients are likely to cause a large amount of degraded impurities in the main drug and make the color of the main drug yellow

Method used

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  • Stable montelukast sodium enteric-coated pellet capsule and preparation method thereof
  • Stable montelukast sodium enteric-coated pellet capsule and preparation method thereof
  • Stable montelukast sodium enteric-coated pellet capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

8L

[0047] The preparation method of this enteric-coated micropill capsule comprises the following steps:

[0048] (1) Preparation of pill core

[0049] Respectively take auxiliary materials such as anhydrous sodium carbonate, mannitol, crospovidone and sodium carboxymethylcellulose that have passed through a 80 mesh sieve, and the raw material of montelukast sodium through a 200 mesh sieve, and put them in a mixer and mix evenly. Mix the dry powder in a wet mixing granulator, use the above-mentioned wetting agent to make a soft material by spraying and adding liquid, and put it in an extrusion pelletizing machine to make pellets. The mesh diameter is 24 mesh, and the wet pellets are collected. Dry in a fluidized bed at 50-60°C, and collect dry pellet cores between 20-30 mesh;

[0050] (2) Preparation of isolation layer

[0051] Weigh ethyl cellulose and hypromellose, add an appropriate amount of ethanol with a concentration of 85%, stir evenly, add talcum powder and ...

Embodiment 2

[0055]

[0056]

[0057] The preparation method is the same as in Example 1.

Embodiment 3

8L

[0060] The preparation method is the same as in Example 1.

[0061] 1. Relevant inspection data of enteric-coated pellets and capsules

[0062]

[0063] As can be seen from the above table, all indicators of the prepared montelukast sodium enteric-coated pellets and capsules in the present invention meet the requirements.

[0064] 2. Stability inspection

[0065] The Montelukast Sodium Enteric-coated Pellets of Examples 1 to 3 are loaded according to the content of the intermediate, and sealed with aluminum and plastic after being packed into capsules, at a high temperature of 40°C ± 2°C and a relative humidity of 75% ± 5%. Accelerated 6-month stability investigation under the conditions, the results are shown in the following table:

[0066]

[0067]

[0068] It can be seen from the above table that the montelukast sodium enteric-coated pellets and capsules prepared by the present invention were inspected at a high temperature of 40°C ± 2°C for 6 months,...

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Abstract

The invention relates to the technical field of pharmaceutic preparations, in particular to a stable montelukast sodium enteric-coated pellet capsule and a preparation method thereof. The stable montelukast sodium enteric-coated pellet capsule comprises 50%-65% of a pill-containing core, 10%-20% of an isolation layer and 25%-30% of an enteric coating from inside to outside, wherein the pill-containing core is prepared from montelukast sodium, sodium carboxymethyl cellulose, filler, a disintegrant and a basifier; the isolation layer is prepared from a retardant, an adhesive, an anti-sticking agent and an opacifier; the enteric coating is prepared from an enteric polymer material, a plasticizer, the anti-sticking agent and the opacifier. According to the stable montelukast sodium enteric-coated pellet capsule, the preparation process is simplified, the production cost is reduced, the product quality and stability are improved, and the capsule has better safety and clinical effects and isworth popularizing and applying.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a stable montelukast sodium enteric-coated pellet capsule and a preparation method thereof. Background technique [0002] Micropill is a spherical or spherical preparation with a diameter of 0.5-1.5mm, which can increase the contact area of ​​the drug in the gastrointestinal tract and improve bioavailability; it can be made into slow-release, controlled-release and compound preparations according to clinical needs; the drug release is stable , the drug release law is reproducible; the drug is not affected by the rhythm of the food transported by the digestive tract; the appearance is beautiful, the fluidity is good, and it is not easy to break; Chemical pelleting method, melting high-speed shearing method, spray freezing method, spray drying method and pelletizing in liquid medium, etc. [0003] The preparation method of the present invention adopts extruding...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/47A61K47/38A61P11/06A61P11/08
CPCA61K9/5047A61K9/5042A61K31/47
Inventor 蒋磊朱生良刘亚张世龙王凯
Owner 合肥凯石医药科技有限公司