Glucocorticoid drug tablet and preparation method thereof

A glucocorticoid and tablet technology, which is applied in the field of glucocorticoid drug tablets and its preparation, can solve the problems of affecting the dissolution rate, low production efficiency, and low yield of tablets, so as to improve the dissolution rate and production efficiency , The effect of reducing equipment energy consumption

Inactive Publication Date: 2019-06-25
JIANGSU SKYRUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, Pfizer's undisclosed product preparation patent; patent CN 101804061 A discloses a preparation method of methylprednisolone tablets, in order to solve the problem of poor fluidity of amorphous methylprednisolone raw materials, poor content uniformity, low production efficiency, and high stability Poor, prone to sticking, pockmarking, breakage when tableting, low tablet yield, this invention has prepared a methylprednisolone crystal form 1, and adopted a wet granulation process, the process added in the product A disintegrant was introduced to solve the problem of slow disintegration, but the invention still has disadvantages such as cumbersome preparation process, chemical reactions of raw materials in hot and humid environment, complex composition of prescription, and influence on dissolution rate.

Method used

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  • Glucocorticoid drug tablet and preparation method thereof
  • Glucocorticoid drug tablet and preparation method thereof
  • Glucocorticoid drug tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Feeding according to 10000 pieces

[0034] Recipe: Methylprednisolone 40g

[0035] Lactose monohydrate 720g

[0036] Cornstarch 210g

[0037] Crospovidone 20g

[0038] Magnesium Stearate 10g

[0039] Preparation Process:

[0040] 1) Raw material crushing: the crushing air flow is 1.0Mpa, the feed rate is 0.6kg / h, the raw material is crushed in batches to D90 and then averaged, and the average D90 is 30~40μm.

[0041] 2) Feed on the basis of preparing 10,000 tablets. The above-mentioned excipients in the prescription amount except crospovidone and magnesium stearate are passed through a 60-mesh sieve respectively, and mixed with the above-mentioned methylprednisolone powder. When mixing, a three-dimensional mixer is used. 10 rpm, mixing for 15 minutes.

[0042] 3) Add the prescribed amount of crospovidone, rotate at 10 rpm, and mix for 10 minutes.

[0043] 4) Add the prescribed amount of magnesium stearate, rotate at 10 rpm, mix for 10 minutes, and perform tablet ...

example 1

[0047] Example 1 Tablet A and the original research sample B have no significant increase in impurities after 30 days of high temperature, and the impurities in tablet C have increased significantly after being placed at high temperature for 30 days, especially impurity D. Therefore, the stability of methylprednisolone tablets prepared by the preparation process in this example is The sex is better, and the quality is consistent with the original research product. The data are shown in Tables 1, 2, and 3.

[0048] Table 1 Example 1 Tablet A high temperature storage 0 days and 30 days related substance results

[0049]

[0050] N.D. means not detected

[0051] Table 2 The results of related substances in the original research sample B placed at high temperature for 0 days and 30 days

[0052]

[0053] N.D. means not detected

[0054] Table 3 Results of related substances in Tablet C stored at high temperature for 0 days and 30 days

[0055]

[0056] N.D. means not ...

Embodiment 2

[0058] Feeding according to 10000 pieces

[0059] formula:

[0060] Methylprednisolone 40g

[0061] Lactose monohydrate 930g

[0062] Low-substituted hydroxypropyl cellulose 20g

[0063] Calcium Stearate 10g

[0064] Preparation Process:

[0065] 1) Raw material crushing: the crushing air flow is 1.0Mpa, the feed rate is 0.6kg / h, the raw material is crushed in batches to D90 and then averaged, and the average D90 is 30~40μm.

[0066] 2) Feed for the preparation of 10,000 tablets, pass the prescribed amount of lactose monohydrate through a 60-mesh sieve, and mix with the above-mentioned methylprednisolone powder. When mixing, use a three-dimensional mixer with a speed of 10 rpm and mix for 15 minutes.

[0067] 3) Add the prescribed amount of low-substituted hydroxypropyl cellulose, rotate at 10 rpm, and mix for 10 minutes.

[0068] 4) Add the prescribed amount of calcium stearate, rotate at 10 rpm, mix for 10 minutes, and perform tablet compression.

[0069] Get above-ment...

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations, and relates to a glucocorticoid drug tablet and a preparation method thereof. The raw material medicine of the tablet is methylprednisolone having a particle size of D90 30-40 [mu]m, and the preparation method comprises the following steps: the raw material medicine is pulverized by air flow, and then uniformly mixed with a filler,a disintegrating agent and a lubricant, and then a mixture compressed to obtain a finished product. The glucocorticoid drug tablet prepared by the method has the advantages of high dissolution rate and high stability, and the preparation process improves preparation efficiency, reduces equipment energy consumption, and is suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a glucocorticoid pharmaceutical tablet and a preparation method thereof. Background technique [0002] Methylprednisolone is a glucocorticoid successfully developed by Upjohn Company of the United States in the 1950s. It is a medium-effect glucocorticoid drug. This product can be used for maintenance treatment of some critically ill patients after emergency treatment. Anti-allergic, anti-shock and other pharmacological effects. The anti-inflammatory effect of the drug is strong, equivalent to 5 times that of hydrocortisone and 1.4 times that of prednisone. Among glucocorticoids, methylprednisolone has the strongest affinity with glucocorticoid receptors, while mineralocorticoid-like effects (such as water and sodium retention) are weak, and the inhibitory effect on the hypothalamus-pituitary-adrenal axis is weak, so the drug is discontinued After that, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/573A61P29/00
Inventor 燕立波王娅金永华
Owner JIANGSU SKYRUN PHARMA CO LTD
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