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Butylbenzene phthalein tablet and preparation method thereof

A technology of butylphthalide tablets and butylphthalide, which is applied in the direction of medical formula, medical preparations containing active ingredients, pill delivery, etc., and can solve problems such as no formula given

Active Publication Date: 2009-01-14
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although it is mentioned in this invention that dosage forms such as tablets and capsules can be made, no detailed formula is given.
[0006] CN200410075068.2 applied by our company discloses a self-emulsifying drug release system composed of butylphthalide and an emulsifier. Examples 6 and 7 of this invention disclose two kinds of butylphthalide tablets, but there are certain limitations for large-scale production

Method used

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  • Butylbenzene phthalein tablet and preparation method thereof
  • Butylbenzene phthalein tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Prescription composition (5000 tablets)

[0053] Tablet core weight (g) weight percentage (%)

[0054] Butylphthalide 100.0 7.79

[0055]Poloxamer 0.1 0.01

[0056] β-cyclodextrin 899.9 70.03

[0057] Starch 100.0 7.78

[0058] Croscarmellose Sodium 150.0 11.67

[0059] Talc 23.0 1.79

[0060] Magnesium stearate 12.0 0.93

[0061] Aqueous solution of hydroxypropyl methylcellulose (2%) Appropriate amount

[0062] Total 1285.0 100

[0063] Preparation method: Weigh butylphthalide raw material and emulsifier poloxamer, add a small amount of water to stir and mix evenly, weigh β-cyclodextrin, add water to dissolve, mix the two solutions, stir rapidly for 1 hour, and refrigerate in the refrigerator ( 5°C) for 12 hours, take out and filter, and dry the obtained solid at 60°C to obtain solid powder of butylphthalide.

[0064] Weigh an appropriate amount of butylphthalide solid powder, add lactose and partly crosslinked carmellose sodium, mix well, granulate with hydro...

Embodiment 2

[0067] Prescription composition (5000 tablets)

[0068] Tablet core weight (g) weight percentage (%)

[0069] Butylphthalide 100.0 7.97

[0070] Poloxamer 1.0 0.08

[0071] β-cyclodextrin 899.0 71.63

[0072] Starch 120.0 9.56

[0073] Croscarmellose Sodium 100.0 7.97

[0074] Micropowder silica gel 23.0 1.83

[0075] Magnesium stearate 12.0 0.96

[0076] Appropriate amount of water

[0077] Total 1255.0 100

[0078] The preparation method is the same as in Example 1.

Embodiment 3

[0080] Prescription composition (5000 tablets)

[0081] Tablet core weight (g) weight percentage (%)

[0082] Butylphthalide 250.0 19.98

[0083] Polyethylene glycol-12-hydroxystearate 0.42 0.03

[0084] Hydroxypropyl-β-cyclodextrin 750.0 59.95

[0085] Lactose 165.6 13.24

[0086] Crospovidone 62.5 5.00

[0087] Talc 15.0 1.20

[0088] Magnesium stearate 7.5 0.60

[0089] Proper amount of povidone aqueous solution (5%)

[0090] Total 1251.02 100

[0091] Preparation method: Add butylphthalide and polyethylene glycol-12-hydroxystearate into water, stir and mix evenly; weigh hydroxypropyl-β-cyclodextrin and dissolve in water. The above two solutions are mixed, stirred rapidly, and the liquid medicine is dried by a spraying method to obtain a solid powder of butylphthalide.

[0092] Weigh an appropriate amount of butylphthalide solid powder, add pregelatinized starch and crospovidone, mix evenly, granulate with 5% povidone aqueous solution, dry, granulate, add magnesium...

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PUM

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Abstract

The invention relates to a butyl phthalide tablet and a preparation method thereof. The butyl phthalide tablet is composed of butyl phthalide solid powders and other medical troche auxiliary materials; wherein, the butyl phthalide solid powders are composed of the components with the following weight percentage: 9 percent to 30 percent of butyl phthalide, 0.01 percent to 1.2 percent of emulsifiers and 70 percent to 90 percent of cyclodextrin or cyclodextrin ramification. The troche which is made with the invention has favorable forming, stable product quality and high dissolution rate.

Description

technical field [0001] The invention relates to a butylphthalide tablet and a preparation method thereof. Background technique [0002] Racemic butylphthalide (dl-3-n-butylphthalide) and its two enantiomers developed in later stage: D-butylphthalide (d-3-n-butylphthalide), L-butylphthalide (1-3 -n-butylphthalide) all three are a kind of volatile oil which is insoluble in water. [0003] Because the volatile oil is easy to volatilize at room temperature, it is easy to volatilize and lose during the conventional preparation process, so it is difficult to effectively control the content, and the migration of active ingredients can easily cause uneven content, and it is easy to have stains or oil leakage during tablet compression, making it difficult to control the content. Preparation of stable and high oil content formulations. Therefore, a series of explorations have been carried out for the preparation technology of butylphthalide. [0004] As early as CN93117148.2 (Examp...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/365A61K47/40A61K47/42A61P7/02
Inventor 周桂荣李云立郭文敏刘海丽高玉清梁亚丽
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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