Preparation process of zedoary oil submicron emulsion

A technology of zedoary oil and oleic acid, which is applied in the field of preparation of new formulations of submicron emulsions from zedoary oil, which can solve problems such as local inflammation and adverse reactions

Inactive Publication Date: 2013-06-05
QINGDAO VLAND BIOTECH INC
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Problems solved by technology

Clinical reports that Tween-80 may cause

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Embodiment Construction

[0007] Taking the average particle size, particle size distribution, potential and other parameters as indicators, it is determined that 2.0 g of zedoary oil, 2.0 g of soybean oil, 1.2 g of refined egg yolk phospholipids, 0.04 g of oleic acid, 0.8 g of poloxamer 188, and water for injection to 100 mL Prescription. Weigh turmeric oil, soybean oil for injection, refined egg yolk phospholipids, and oleic acid in a beaker according to the prescription ratio, stir and mix well in a 60℃ water bath to prepare a clear and stable oil phase, and keep it at 60℃ for standby use. Then weigh poloxamer 188 according to the prescription ratio, heat and stir to disperse evenly to prepare an aqueous phase, which is kept at 60°C for later use. Then the oil phase is added dropwise to the water phase, placed in a high-shear dispersing emulsifier, mixed to make a coarse emulsion, and water for injection is added to make the whole amount. Then homogenize the crude emulsion with a two-step high-press...

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Abstract

The invention relates to a preparation process of zedoary oil submicron emulsion; by using parameters such as average particle diameter, particle size distribution, potential and the like as indexes, the preparation process determines a formula containing 2.0 g of zedoary oil, 2.0 g of soybean oil, 1.2 g of refined yolk phospholipid, 0.04 g of oleic acid, 0.8 g of poloxamer 188, and 100 mL of injection water. The preparation process comprises the following steps: weighing zedoary oil, soybean oil for injection, refined yolk phospholipid, and oleic acid in a beaker according to the proportions in the formula, stirring and well mixing in a water bath at 60 DEG C, preparing a clarified stable oil phase to keep in reserve at 60 DEG C; weighing poloxamer 188 according to the proportion in the formula, heating, stirring to uniformly disperse to obtain a water phase to keep in reserve at 60 DEG C; then dropwisely adding the oil phase into the water phase, putting into a high-shear dispersion emulsifying machine, mixing to prepare crude emulsion, adding injection water to reach a whole amount; homogenizing the crude emulsion by a two-step high-pressure homogenizer, adjusting the pH to 7.5-8.0, filling into ampoules, and sealing. The product is autoclaved. The product is basically stable after stored at room temperature for 6 months.

Description

Technical field [0001] The invention relates to a process for preparing a new dosage form of submicroemulsion from zedoary turmeric oil, and belongs to the technical field of traditional Chinese medicine. Background technique [0002] Curcuma oil is derived from the dried rhizomes of Curcuma kwangsinensis SGLee et CFLiang, Curcuma wenyujin YHChen et C.Ling, Curcuma sp, and Curcuma aeruginous roxb. Steam distillation or supercritical fluid CO 2 Fat-soluble ingredients extracted by extraction method. [0003] Zedoary oil has significant pharmacological activities in anti-tumor, anti-thrombotic, and anti-viral aspects. It also has anti-early pregnancy, anti-bacterial, hepatoprotective, and anti-psoriatic effects. Anti-tumor is the most important pharmacological effect of turmeric oil, and its main active ingredients are curcumol and elemene. Liver stellate cell experiments show that turmeric oil can effectively inhibit hepatocarcinoma cells HepG by regulating cell proliferation, apo...

Claims

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Application Information

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IPC IPC(8): A61K36/9066A61K9/107A61P35/00A61P7/02A61P31/12A61P15/18A61P31/04A61P1/16A61P17/06A61P25/00A61P9/10
Inventor 郝智慧钟英杰王艳玲
Owner QINGDAO VLAND BIOTECH INC
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