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Method for producing roxithromycin capsules

A technology of roxithromycin and a production method, which is applied in the field of preparation of medicinal compounds, can solve problems such as low dissolution rate of capsules, poor process quality stability, etc., and achieve the effects of simplifying production procedures, shortening production cycles, and improving process efficiency

Inactive Publication Date: 2010-03-10
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the quality stability of the process of directly filling capsules is poor at present, and the dissolution rate of capsules is low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The original prescription for the production of roxithromycin capsules (specification 150mg) 1000 is:

[0036] Roxithromycin 0.15kg Sodium Carboxymethyl Starch (Swelling Speed ​​King) 0.0085kg

[0037] Soluble starch 0.052kg Magnesium stearate 0.002kg

[0038] Micropowder silica gel 0.01575kg

[0039] Mix the above raw and auxiliary materials in a mixing tank for 10 minutes, pass through a 40-mesh sieve, and mix for another 5 minutes. It is filled with the Italian IMA capsule filling machine, and the metering needle should have no impact pressure on the powder. The filled capsules are sampled and assayed, and the dissolution rate is greater than 90%.

[0040] In the above formula, the main function of the micropowdered silica gel is as a flow aid to promote the fluidity of the powder. Micronized silica gel is micronized silica with a specific surface area of ​​170-210m2 / g and a particle size of 3-5μm.

Embodiment 2

[0042] The preparation process is the same as in Example 1.

[0043] The recipe uses the following ingredients by weight:

[0044] Roxithromycin 0.15kg Sodium Carboxymethyl Starch (Swelling Speed ​​King) 0.0080kg

[0045] Soluble starch 0.053kg Magnesium stearate 0.001kg

[0046] Micropowder silica gel 0.0165kg

[0047] The filled capsules are sampled and assayed, and the dissolution rate is greater than 90%.

Embodiment 3

[0049] The preparation process is the same as in Example 1.

[0050] The recipe uses the following ingredients by weight:

[0051] Roxithromycin 0.15kg Sodium Carboxymethyl Starch (Swelling Speed ​​King) 0.0090kg

[0052] Soluble starch 0.051kg Magnesium stearate 0.003kg

[0053] Micropowder silica gel 0.0150kg

[0054] The filled capsules are sampled and assayed, and the dissolution rate is greater than 90%.

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Abstract

The invention discloses a method for producing roxithromycin capsules. The production method comprises the following steps: fully mixing raw materials, then sieving the mixture, mixing the sieved materials, and finally filling the mixture with a filling machine to obtain the roxithromycin capsules. The raw materials adopts the following weight proportion: 15 portions of roxithromycin, 0.80 to 0.90portion of sodium carboxymethyl starch, 5.1 to 5.3 portions of soluble starch, 0.1 to 0.3 portion of magnesium stearate and 1.50 to 1.65 portions of superfine silica powder. The method can avoid thecondition that the dissolution rate is usually not quantified during the production of the roxithromycin capsules. The method simplifies the production process and shortens the production period by directly filling the capsules.

Description

technical field [0001] The invention relates to a preparation method of medicinal compounds, in particular to a production method of roxithromycin capsules. Background technique [0002] Roxithromycin is a macrolide antibiotic with certain viscosity and hygroscopicity. Its preparation, roxithromycin capsules, is mostly granulated with raw and auxiliary materials and filled, especially the Italian Ima capsule filling machine. When using the Italian IMA capsule filling machine, because the metering of the gun barrel machine produces a certain extrusion force on the powder when filling the powder, the powder is generally bonded together into a column, which is not conducive to the dissolution of the raw materials in the capsule. [0003] If the raw and auxiliary materials of roxithromycin capsules adopt the process of making wet granules, steam for drying needs to be used, resulting in an additional process, resulting in waste of manpower and material resources. [0004] To s...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7048A61P31/04
Inventor 刘振文焦玉举
Owner 山东淄博新达制药有限公司
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