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Ginkgo leaf sustained-release tablet with stable release performance

A technology of ginkgo biloba and sustained-release preparations, applied in the field of medicine, can solve the problems of large dosage, complicated process, high cost, etc., and achieve the effects of less administration times, simple process, and small fluctuation of blood drug concentration.

Inactive Publication Date: 2014-12-24
BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the complex active ingredients of the extract, low content and large dosage, the difficulty of dosage form design is large.
The complexity of the active ingredients brings challenges to the purification of a single active ingredient, the process is complicated and the cost is expensive

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Composition (its proportioning quantity is in parts by weight, and it is also the same when expressing proportioning quantity below):

[0048] Ginkgo biloba extract 120 parts

[0049] Sodium Lauryl Sulfate 15 parts

[0050] Poloxamer 25 parts

[0051] Hypromellose (K4M CR) 55 parts

[0052] Lactose 85 parts

[0053] Microcrystalline cellulose 80 parts

[0054] Micropowder silica gel 20 parts

[0055] Magnesium stearate 6 parts.

[0056] Preparation Process:

[0057] Mix ginkgo biloba extract with sodium lauryl sulfate and poloxamer, then mix with lactose, microcrystalline cellulose, and hypromellose, then add magnesium stearate, micronized silica gel, and mix well. The whole powder is directly compressed into tablets to obtain tablets, each containing 120 mg of ginkgo biloba extract.

[0058] In vitro release test: get this product, according to the release assay method (Chinese Pharmacopoeia version two appendix XD first method in 2000), adopt the first method ...

Embodiment 2

[0063] Element:

[0064] Ginkgo biloba extract 120 parts

[0065] Tween 80 makes 15 servings

[0066] Hypromellose (K15M CR) 25 parts

[0067] Lactose 100 parts

[0068] Microcrystalline cellulose 100 parts

[0069] Micropowder silica gel 20 parts

[0070] Magnesium stearate 6 parts.

[0071] Preparation process: after the Ginkgo biloba extract and Tween 80 are evenly mixed, other excipients are added, mixed evenly, and compressed into tablets to obtain tablets, each containing 120 mg of Ginkgo biloba extract.

[0072] The in vitro release testing method is the same as in Example 1.

[0073] The cumulative release rate of the sustained-release preparation obtained in the present embodiment is as follows:

[0074] time (hours)

Embodiment 3

[0076] Element:

[0077] Ginkgo biloba extract 120 parts

[0078] Docusate sodium 5 parts

[0079] Tween 80 measures 5 servings

[0080] Hypromellose (K4M) 35 parts

[0081] Hypromellose (K15M) 10 parts

[0082] Lactose 125 parts

[0083] Microcrystalline cellulose 130 parts

[0084] Micropowder silica gel 20 parts

[0085] Magnesium stearate 6 parts.

[0086] The preparation process is the same as in Example 2, and the in vitro release test method is the same as in Example 1.

[0087] The cumulative release rate of the sustained-release preparation obtained in the present embodiment is as follows:

[0088] time (hours)

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Abstract

The invention relates to ginkgo leaf sustained-release tablets with the stable release performance, particularly to a ginkgo leaf sustained-release tablet. The ginkgo leaf sustained-release tablet is a tablet and comprises 120 parts of ginkgo leaf extract, 5 to 50 parts of at least one pharmaceutical acceptable surfactant, 20 to 80 parts of at least one pharmaceutical acceptable hydrophilic gel frame materials and 50 to 400 parts of at least one pharmaceutical acceptable excipient. According to the ginkgo leaf sustained-release tablets with the stable release performance, a dissolution determination method first method namely the blue method device is adopted according to a Chinese pharmacopeia 2010 edition appendix XD first method, 500 ml of water serves as a release medium, the release degree is determined with the rotating speed as 100 rotations per minute, the release amount of 2 hours, 6 hours and 12 hours of ginkgo leaf total flavonoids and ginkgo leaf terpene lactones is within the range of 20 to 40%, within the range of 40 to 70% and more than 80% such as within the range of 80 to 90% respectively, and the release stable performance is excellent.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a preparation made of ginkgo leaf extract, in particular to a ginkgo leaf sustained-release tablet, more particularly to a ginkgo leaf sustained-release tablet with stable release performance. The invention also relates to a preparation method of the preparation. Background technique [0002] Ginkgo biloba is a deciduous tree that can be as high as 40m. The trunk is erect and the bark is grayish white. There are two types of branches, long and short. The leaves are clustered on the short branches and alternate on the long branches. The leaves are fan-shaped, 4-8cm long, 5-10cm wide, 2-lobed in the middle of the apex, cuneate at the base, with parallel veins and divergent forks; the petiole is 2.5-7cm long. The flowering period is from April to May, and the fruiting period is from July to October. Harvest from September to October and dry in the sun. [0003] Ginkgo biloba is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/16A61K9/22A61K9/24A61K47/38A61K127/00
Inventor 高永良汲守信陈登建王学智
Owner BEIJING HUMANWELL JUNWEI PHARM TECH CO LTD