Asiaticoside external use sterile powder and its preparation method

A technology of asiaticoside and asiaticoside total glucoside, which is applied in the field of external use solid sterile preparation of asiaticoside and its preparation field, can solve the problems such as inability to fully exert the medicinal effect, inability to ensure the cleaning of the wound surface, use restriction and the like, and achieves the The effect of reducing drug decomposition products, facilitating storage at room temperature, and improving quality

Inactive Publication Date: 2008-06-11
浙江茵诺邦健康科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets and other preparations are taken orally, which cannot concentrate the drug in a high concentration on the lesion, and cannot fully exert the drug effect; while cream (ointment or cream) is not easy to apply on the wound, even if it can be applied, it cannot guarantee the cleanliness of the wound. It is easy to cause wound infection, and its clinical use is limited

Method used

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  • Asiaticoside external use sterile powder and its preparation method
  • Asiaticoside external use sterile powder and its preparation method
  • Asiaticoside external use sterile powder and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] The composition of the preparation: 62.5g of Centella asiatica total glycosides (reduced pure), 20.0g of sodium lauryl sulfate, and water for injection to 1000ml.

[0012] Preparation method: Weigh the raw material of Centella asiatica total glycosides, add 80% water for injection, heat and stir to dissolve, coarse filter with sand filter, then add sodium lauryl sulfate, stir to dissolve, adjust pH with 1mol / L HCl Value to 6.0, add 0.2% activated carbon for needles, keep at 60℃ for 30 minutes, coarse filter with sand filter rod, make up the solution, filter with 0.45μm membrane, filter with 0.22μm microporous sand core, fill and freeze-dry according to the setting The curve is freeze-dried (see Freeze-Drying Table 1), stoppering, capping, printing and packaging. After the product is fully inspected, it will be put into storage to obtain the freeze-dried asiaticoside for external use. The specification is 0.25g / bottle.

[0013] In the preparation of the present invention, th...

Embodiment 2

[0017] Example 2 Selection of Cosolvent

[0018] The total glycosides of asiatica contains many poorly water-soluble components. When heated, these components can be dissolved in water, and then precipitated out after cooling. Adjusting the pH value to alkaline (pH>9) can also increase the solubility of these ingredients, but considering the irritation of the preparation to the skin, it is difficult to adjust the pH value in the process. Therefore, it is necessary to select an appropriate co-solvent to increase the solubility of these ingredients, especially the effective ingredients.

[0019] A variety of cosolvents have been studied. The research plan and results are shown in Table 2:

[0020] Cosolvent

[0021] It can be seen that sodium lauryl sulfate and urotropine have a certain solubilizing effect on Centella asiatica total glycosides, while other reagents have weak or no solubilizing effect. In further comparison, the solubilizing effect of sodium lauryl sulfate ...

Embodiment 3

[0022] Example 3 Preparation method research

[0023] The composition of the total glucosides of Asiatic asiatica is complex, and the present invention is first dissolved in hot water for injection and then coarsely filtered, which can reduce the difficulty of filtration in subsequent processes. The subsequent steps basically refer to the process of lyophilized powder preparation of traditional Chinese medicine.

[0024] Three batches of samples were prepared according to the selected formulation composition and method, with good reproducibility, consistency between batches, and meeting production requirements. The results are shown in Table 3.

[0025] Main equipment: Lyo-7.5 freeze dryer (Shanghai Dongfulong Technology Co., Ltd.)

[0026] DGS8 / 2 filling and stoppering machine

[0027] ZG-300 Capping Machine

[0028] table 3

[0029] Lot number

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Abstract

An exterior-applied aseptic powder of asiaticoside is prepared through dissolving asiaticoside in the water for injection, filtering, adding cosolvent and activated carbon, filtering for removing carbon, filtering for removing bacteria, adding the water for injection, stirring pouring in sterilized bottles, and vacuum freeze drying.

Description

Technical field [0001] The invention belongs to a pharmaceutical preparation, and relates to an external preparation of Chinese medicine extracts, in particular to a solid sterile preparation of asiaticoside for external use and a preparation method thereof. Background technique [0002] Centella asiatica (Centella asiatica L.Urban) is a commonly used Chinese medicine included in the Chinese Pharmacopoeia. It is a dry whole plant of Centella asiatica, a plant belonging to the Umbelliferae family, Centella asiatica. It was first published in Shennong's Materia Medica and listed as a mid-level product. , Has the effects of clearing heat and dampness, detoxification and swelling, and is clinically used to treat bruises and skin diseases. [0003] Centella asiatica is produced in my country's Jiangsu, Zhejiang, Guangdong, Fujian, Guangxi and other provinces and cities, and its plant resources are extremely rich. Madecassoside is a plant-based active ingredient extracted and refined f...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/704A61K9/19
Inventor 胡钢亮郑伟平邵胜荣吕庆中
Owner 浙江茵诺邦健康科技有限公司
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