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Capsule containing pseudoephedrine and method for preparing the same

A technology for pseudoephedrine and pseudoephedrine hydrochloride, which is applied in directions such as capsule delivery, medical preparations containing active ingredients, and pharmaceutical formulations, can solve problems such as moisture absorption and corrosion of ephedrine-containing capsules that are not involved, and can ensure safety and effectiveness. The effect of reducing packaging costs and preventing moisture absorption and liquefaction

Active Publication Date: 2010-10-13
SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But do not relate to in the prior art the solution that contains ephedrine capsule moisture absorption and erosion problem

Method used

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  • Capsule containing pseudoephedrine and method for preparing the same
  • Capsule containing pseudoephedrine and method for preparing the same
  • Capsule containing pseudoephedrine and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1, pseudoephedrine capsules, specification: 30mg, prescription quantity: 1000 capsules

[0048] 1. Prescription: Pseudoephedrine hydrochloride 30g

[0049] AMBERLITER IRP-69 300g

[0050] Carboxymethyl Starch Sodium 15g

[0051] Micronized silica gel 2g

[0052] 2. Preparation process:

[0053] 1) Preparation of pseudoephedrine-resin complex:

[0054] A: Get pseudoephedrine hydrochloride and prepare a solution with a concentration of 10 g / L with purified water to obtain A solution.

[0055] B Take AMBERLITE IRP-69 ion exchange resin, put it into A solution, the ratio of feed: pseudoephedrine hydrochloride: ion exchange resin = 1:10.

[0056] The temperature of liquid C is 25° C., and the stirring is continued for 1 hour at a rotation speed of 100 rpm.

[0057] D After stopping the stirring, let stand, settle or filter, remove the upper liquid, and wash.

[0058] E50 ℃ hot air drying to get pseudoephedrine resin complex.

[0...

Embodiment 2

[0074] Embodiment 2, pseudoephedrine capsules, specification: 30mg, prescription quantity: 1000 capsules

[0075] 1. Prescription: Pseudoephedrine hydrochloride 30g

[0076] AMBERLITER IRP-69 150g

[0077] Lactose 30g

[0078] Carboxymethyl Starch Sodium 15g

[0079] Micronized silica gel 2g

[0080] 2. Preparation process: the same as in Example 1, the concentration of pseudoephedrine hydrochloride is 20g / L, the mass ratio of feed: pseudoephedrine hydrochloride / ion exchange resin=1 / 5, the rotating speed is 200 rpm, the reaction is 2 hours, the temperature is 25°C, and the resin is measured by HPLC The content of pseudoephedrine (calculated as pseudoephedrine hydrochloride) in the compound is 15.94%, and then the intermediate is prepared according to the prescription, and the capsules are filled after calculating the capsule content.

[0081] 3. Stability test: The experiment was the same as that in Example 1. The results of the hygrosco...

Embodiment 3

[0082] Embodiment 3, pseudoephedrine capsules, specification: 30mg, prescription quantity: 1000 capsules

[0083] 1. Prescription: Pseudoephedrine hydrochloride 30g

[0084] AMBERLITER IRP-69 120g

[0085] Lactose 30g

[0086] Crospovidone 10g

[0087] Micronized silica gel 2g

[0088] 2. Preparation process: the same as in Example 1, the concentration of pseudoephedrine hydrochloride is 25g / L, the mass ratio of feed: pseudoephedrine hydrochloride / resin=1 / 4, the rotating speed is 400 rpm, the reaction is 3h, the temperature is 25°C, and the resin complex pseudoephedrine is determined by HPLC (in terms of pseudoephedrine hydrochloride) 18.94%, then prepare the intermediate by prescription, fill the capsules after calculating the capsule loading.

[0089] 3. Stability test: The experiment was the same as that in Example 1. The results of the hygroscopicity test and 3-month accelerated test of the obtained capsules are listed in Table 3, an...

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Abstract

The invention discloses a capsule containing pseudoephedrine and the preparation method, which solves the problem of hygroscopicity. The capsule containing pseudoephedrine of the invention contains cation exchange resin, which forms pseudoephedrine resin compound with pseudoephedrine hydrochloride or pseudoephedrine sulfate. The preparation procedure is as follows: pseudoephedrine hydrochloride or pseudoephedrine sulfate is proportioned and cation exchange resin is put into the solution for ion exchange reaction to produce drug resin compound; the compound is dried and pseudoephedrine resin compound is produced; the pseudoephedrine resin compound is mixed uniformly with formula components and filled into capsules with a filling engine. Compared with prior art, the invention adopts drug resin compound, which prevents moisture absorption and liquefaction of the drug, maintains the stability of the drug property, reduces the packaging cost of the capsule containing pseudoephedrine and ensures the safety and the effects of the clinical application of the drug.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a pseudoephedrine-containing capsule and a preparation method thereof. Background technique [0002] Pseudoephedrine hydrochloride is a drug commonly used in medical treatment. It mainly promotes the release of norepinephrine and indirectly exerts the sympathomimetic effect; it can selectively shrink the capillaries of the upper respiratory tract, eliminate the congestion and swelling of the nasopharyngeal mucosa, and relieve nasal congestion. Symptoms, it has no obvious contraction effect on the blood vessels of other organs in the whole body, and has no obvious effect on heart rate, blood pressure and central nervous system. It is mainly used to relieve nasal congestion symptoms caused by colds, allergic rhinitis, rhinitis and sinusitis, especially for the treatment of colds And other respiratory diseases, clinical application is extensive. But t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/167A61K9/48A61K47/32A61P11/02A61P11/00A61P37/08A61K31/4402A61K31/4439A61K31/445A61K31/4545A61K31/485A61K31/522
Inventor 闫志刚曾环想王孟黄凯
Owner SINOPHARM ZHIJUN (SHENZHEN) PHARMA CO LTD
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