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Preparation method of lansoprazole solid preparation

A lansoprazole solid and a technology for lansoprazole are applied in the field of preparation of lansoprazole solid preparations, can solve problems such as poor product content uniformity, achieve content uniformity and stability control, facilitate operation, simple craftsmanship

Active Publication Date: 2013-06-19
YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But, the contriver finds that the content uniformity of the product made by this method is not good

Method used

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  • Preparation method of lansoprazole solid preparation
  • Preparation method of lansoprazole solid preparation
  • Preparation method of lansoprazole solid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] 1. The composition of the tablet core, as shown in Table 12:

[0080] Table 12 Prescription quantity: 1000 tablets

[0081] Main drug and excipients

Dosage

Lansoprazole

15g

Microcrystalline Cellulose (Imported)

70g

lactose

30g

Croscarmellose Sodium

4g

NaOH

1.6

PVP K30

3.0g

Magnesium stearate

Appropriate amount

Talc powder

Appropriate amount

[0082] 2. Tablet core preparation method:

[0083] ① Dissolve NaOH, PVP K30, and Lansoprazole in the prescribed amount in absolute ethanol in turn, stir to make the solution clear, and use it as an adhesive for later use;

[0084] ②Take the prescribed amount of MCC and CCMC-Na, mix them, and granulate them in one step to control the moisture content below 3%.

[0085] ③Through granulation, pass through a 16-mesh sieve, add appropriate amount of magnesium stearate and talcum powder, mix evenly, and press into t...

Embodiment 2

[0089] 1. The composition of the tablet core, as shown in Table 13:

[0090] Table 13 Prescription quantity: 1000 tablets

[0091] Main drug and excipients

[0092] 2. The tablet core preparation method and coating process are the same as in Example 1.

Embodiment 3

[0094] 1. The composition of the tablet core, as shown in Table 14:

[0095] Table 14 Prescription quantity: 1000 tablets

[0096] Main drug and excipients

[0097] 2. The tablet core preparation method and coating process are the same as in Example 1.

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Abstract

The invention belongs to the field of pharmacy, relating to a preparation method of a lansoprazole solid preparation, and solving the technical problem of providing a preparation method capable of ensuring a favorable content uniformity of the lansoprazole solid preparation. The preparation method comprises the following steps of: A, sequentially dissolving an alkaline material and the lansoproazole into anhydrous ethyl alcohol to obtain a mixed solution for later use; B, dissolving a bulking agent into the mixed solution obtained in the step A, and pelletizing; and C, preparing a solid preparation by processing particles obtained from the pelletizing according to a traditional method. The preparation method of the solid preparation has the advantages of little used auxiliary material, simple process, and convenient operation; and after long-time production practice, the content uniformity and stability of products can be commendably controlled.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a preparation method of lansoprazole solid preparation. Background technique [0002] Compared with the first-generation proton pump inhibitor omeprazole, lansoprazole has the following advantages: [0003] 1. Relieve symptoms quickly and effectively: because fluorine is introduced into the molecular structure, its bioavailability is increased by 25%; chemical stability and fat solubility are also increased, so that its active effect can take effect faster; There are 3 binding points between the drug and the proton pump, so the effect of inhibiting the proton pump is more complete, and the inhibition of gastric acid secretion is faster and more obvious. [0004] 2. High cure rate: the cure rate for duodenal ulcer and reflux esophagitis is over 90%. [0005] 3. Convenience in taking medicine: it can be administered once a day (30mg). [0006] 4. Good cost performance: the cost of treatmen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/48A61K9/16A61K31/4439A61K47/38A61K47/02A61P1/04
Inventor 薛立安李元波袁瑜彭熙琳张强李丛菊
Owner YANGTZE RIVER PHARM GRP SICHUAN HAIRONG PHARM CO LTD
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