Hydroxychloroquine sulphate solid preparation and preparation method thereof

A technology of hydroxychloroquine sulfate and solid preparation, applied in the field of hydroxychloroquine sulfate solid preparation and preparation thereof, to achieve the effects of improving stability, excellent dissolution and stability

Active Publication Date: 2015-05-06
SHANGHAI ZHONGXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no research report on the preparation of hydroxychloroquine sulfate in the existing literature

Method used

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  • Hydroxychloroquine sulphate solid preparation and preparation method thereof
  • Hydroxychloroquine sulphate solid preparation and preparation method thereof
  • Hydroxychloroquine sulphate solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0042] Example 2: Dissolve citric acid monohydrate and sodium citrate dihydrate in 10 times the mass of water, add starch and mix evenly, pass through a 24-mesh sieve twice, pass through a 80-mesh sieve after drying, and set aside. After the hydroxychloroquine sulfate is pulverized by a pulverizer, it is evenly mixed with the master powder of the buffering auxiliary material, pregelatinized starch and powdery polyethylene glycol 6000.

[0043] (2) Granulation and coating

[0044] Put it in a fast mixer with a jacket temperature of 70-85°C, turn on the agitator of the granulator, discharge when the material temperature reaches 61°C, cool down, and granulate with a 20-mesh sieve. Add magnesium stearate and talcum powder, mix evenly, and compress into tablets to obtain tablet cores. Add Opadry powder while stirring in water, continue to stir for 45 minutes after adding, be made into the coating solution of 19wt% concentration, carry out film coating to tablet core.

Embodiment 3

[0045] Embodiment 3 Hydroxychloroquine sulfate sheet (100mg / sheet)

[0046]

[0047]

[0048] Preparation process: Dissolve disodium hydrogen phosphate and citric acid in water of 10 times the mass, add microcrystalline cellulose and mix evenly, pass through a 24-mesh sieve twice, pass through a 80-mesh sieve after drying, and set aside. Hydroxychloroquine sulfate is pulverized by a pulverizer, mixed evenly with buffered auxiliary material powder, pregelatinized starch and powdered polyethylene glycol 6000, placed in a fast mixer with a jacket temperature of 70-85°C, and the granulator agitator is turned on , when the temperature of the material reaches 63°C, the material is discharged, cooled, and granulated with a 20-mesh sieve. Add magnesium stearate and talcum powder, mix evenly, and compress into tablets to obtain tablet cores. Add Opadry powder while stirring in water, continue to stir for 45 minutes after adding, be made into the coating solution of 19wt% concen...

Embodiment 4

[0049] Embodiment 4 hydroxychloroquine sulfate capsules (100mg / grain)

[0050] Get the granules before tablet compression of Example 3, mix evenly after passing through a 30-mesh sieve, and pack into capsules.

[0051] Embodiment 5 and 6 hydroxychloroquine sulfate sheet (100mg / sheet)

[0052]

[0053]

[0054] Preparation process: disperse hypromellose in hot water at 80°C, add water and stir to dissolve, make hypromellose aqueous solution, add 5% hydrochloric acid, citric acid and sodium hydroxide, stir and dissolve, and prepare buffered Granulating liquid. Hydroxychloroquine sulfate is pulverized by a pulverizer, mixed evenly with starch and pregelatinized starch, added to the above-mentioned granulation solution to stir and granulate, and the wet granules are dried and sized. Add magnesium stearate and talcum powder, mix evenly, and compress into tablets to obtain tablet cores. Add Opadry powder while stirring in water, continue to stir for 45 minutes after addin...

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PUM

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Abstract

The invention discloses a hydroxychloroquine sulphate solid preparation, which contains hydroxychloroquine sulphate or pharmaceutically acceptable salts thereof and an auxiliary material, wherein the auxiliary material comprises a buffer pair; the buffer pair is dissolved in water to form a buffer solution with pH of 4-6.5; and the content of the buffer pair is 0.05-2% in terms of mass percentage. The invention further discloses a preparation method of the hydroxychloroquine sulphate solid preparation. The hydroxychloroquine sulphate solid preparation disclosed by the invention has excellent dissolution property and stability, and particularly, is obviously increased in stability compared with the prior art.

Description

technical field [0001] The invention relates to a hydroxychloroquine sulfate solid preparation and a preparation method thereof. Background technique [0002] Hydroxychloroquine sulfate is a 4-aminoquinoline antimalarial drug, which has been included in major foreign pharmacopoeias for a long time, and is currently included in BP2007 edition and USP32 edition. Hydroxychloroquine is similar to chloroquine in structure, but has different effects and adverse reactions in some aspects. Since the 1950s, with the application of antimalarial drugs in the treatment of systemic lupus erythematosus and rheumatoid arthritis, the efficacy of hydroxychloroquine sulfate has been affirmed. It is currently the main drug for the treatment of lupus erythematosus, and it can improve the condition as a slow response Drugs are widely used to treat rheumatoid arthritis. Rheumatoid arthritis is a multi-system inflammatory autoimmune disease involving the surrounding joints. The incidence of rheu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/48A61K31/4706A61P17/00A61P19/02A61P19/04A61P29/00A61P37/02
Inventor 郑斯骥张胤杰刘潇怡周莹
Owner SHANGHAI ZHONGXI PHARMA
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