Promethazine hydrochloride tablet and preparation method thereof

A promethazine hydrochloride tablet and a promethazine hydrochloride technology are applied in the directions of anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc., which can solve the problem of uneven content uniformity of active ingredients, save dosage and cost, and achieve compressibility. Good, compliance-increasing effect

Active Publication Date: 2015-06-03
常州康普药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is: in the common promethazine hydrochloride tablet in the prior art, the active ingredient content uniformity is not high

Method used

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  • Promethazine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] (1) Preparation of solid dispersion carrier: Add 20 g of Poloxamer 407 and 85 g of PEG6000 into 60% (ml / ml) ethanol of 1 / 3 of the prescription amount, heat and stir until Poloxamer 407 and PEG6000 are completely dissolved That is, the auxiliary material solution is obtained;

[0018] Promethazine hydrochloride (dry, pure) 250g is dissolved in 60% (ml / ml) ethanol of recipe quantity 1 / 3 to obtain main drug solution; Gained adjuvant solution and main drug solution are mixed uniformly to obtain mixed solution; Gained mixing The solution is dried in vacuum until the water content is less than 1% (mass percentage);

[0019] (2) Preparation of tablet: pulverize the material obtained in step (1) to 100 mesh to obtain a solid dispersion powder; put the gained solid dispersion powder, starch 180g, and microcrystalline cellulose 360g into a granulator, and dry mix Evenly, add 60% (ml / ml) ethanol of the remaining 1 / 3 of the prescription amount as a binder, set the shearing knife f...

Embodiment 2

[0021] (1) Preparation of solid dispersion carrier, add poloxamer 407 25g and PEG6000 80g into 60% (ml / ml) ethanol of 1 / 3 of the prescription amount, heat and stir until poloxamer and PVPk30 are completely dissolved Yes, excipient solution;

[0022] Promethazine hydrochloride (dry, pure) 250g is dissolved in 60% (ml / ml) ethanol of recipe quantity 1 / 3 to obtain main drug solution; Gained adjuvant solution and main drug solution are mixed uniformly to obtain mixed solution; Gained mixing The solution is dried in vacuum until the water content is less than 1% (mass percentage);

[0023] (2) Preparation of tablet: pulverize the material obtained in step (1) to 120 mesh to obtain solid dispersion powder; put the gained solid dispersion powder, starch 180g, and microcrystalline cellulose 360g into a granulator, and dry mix Evenly, add 60% (ml / ml) ethanol of the remaining 1 / 3 of the prescription amount as a binder, set the frequency of the shearing knife as 30 Hz, and shear and gran...

Embodiment 1、2

[0034] Embodiment 1, 2, and the outward appearance of product in each comparative example, content uniformity are as shown in table 1 (check by Chinese Pharmacopoeia 2010 editions)

[0035] Table 1

[0036]

[0037] (Dissolution is tested according to the standards in Appendix XC of Part Two of the Chinese Pharmacopoeia 2010 Edition).

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PUM

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Abstract

The invention belongs to the field of medicine preparation, and in particular relates to a promethazine hydrochloride tablet and a preparation method thereof. The preparation method comprises the following steps: firstly, weighing poloxamer and PEG6000 to prepare an auxiliary solution, further preparing a main medicine solution from an effective component promethazine hydrochloride, and uniformly mixing the auxiliary solution and the main medicine solution, thereby obtaining a mixed solution; performing vacuum drying on the mixed solution; crushing the obtained solid material, adding other excipient, putting into a granulator for shearing and granulation, and putting into a boiling dryer for drying; screening and shaping the dried granules, mixing the obtained granules and a lubricant of the formula, and subsequently tabletting.

Description

technical field [0001] The invention belongs to the field of medicine preparation, in particular to a preparation method of promethazine hydrochloride tablet. Background technique [0002] Promethazine hydrochloride tablet is a tablet-type drug with promethazine hydrochloride as the main component. Applicable symptoms ① Skin and mucous membrane allergy: long-term, seasonal allergic rhinitis, vasomotor rhinitis, contact with allergens or food Allergic conjunctivitis, urticaria, angioneurotic edema, allergic reaction to blood or plasma products, skin scratches; ② Motion sickness: motion sickness, seasickness, and airplane sickness. ③Sedation and hypnosis: suitable for preoperative, postoperative and obstetrics. In addition, it can also be used to reduce the fear of adults and children, showing a light sleep state. ④Treatment of nausea and vomiting: It is suitable for nausea and vomiting after some anesthesia and surgery, and is also used to prevent radiation sickness or drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/5415A61K47/10A61P37/08A61P11/02A61P27/02A61P17/00A61P9/00A61P1/08A61P25/20A61P29/00
Inventor 王苏南汤金春
Owner 常州康普药业有限公司
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