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Pulsatilla chinensis total saponin oral emulsion and preparation method thereof

A technology of total saponin oral emulsion and total saponin emulsion, which is applied in the field of medicine, can solve the problems of gastrointestinal tract irritation, poor absorption, and low solubility of total saponins of Pulsatilla grandis, so as to promote drug absorption, improve in vivo absorption, and improve gastrointestinal tract. The effect of mucosal properties

Inactive Publication Date: 2014-04-02
JIANGXI HERBFINE HI TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no research on the preparation of total saponins of Pulsatillae Radix in China. Due to the low solubility, poor absorption and irritation to the gastrointestinal tract, the total saponins of Pulsatillae Radix will inevitably limit its clinical application.

Method used

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  • Pulsatilla chinensis total saponin oral emulsion and preparation method thereof
  • Pulsatilla chinensis total saponin oral emulsion and preparation method thereof
  • Pulsatilla chinensis total saponin oral emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Pulsatilla total saponins (b) 1.3% (g / 100 ml)

[0036] Phospholipids (c) 5.4% (g / 100 ml)

[0037] Vitamin E (d) 0.1% (g / 100 ml)

[0038] Poloxamer 188 (e) 0.54% (g / 100 ml)

[0039] Glycerin (f) 2.5% (g / 100 ml)

[0040] Water (g) 70% (g / 100ml)

[0041] (a), (b), (c), (d) and other oil-soluble ingredients are mixed evenly to obtain the oil phase, and kept warm at 40-80 ℃ for later use; mix and dissolve (e), (f) and (g) and add Add to the oil phase, stir magnetically at 40-80°C for 10-60 minutes, cut with a high-speed shear for 1-30 minutes, potting, and sterilizing to obtain the product.

[0042] Example 2

Embodiment 2

[0044] Pulsatilla total saponins (b) 6.5% (g / 100 ml)

[0045] Phospholipids (c) 10% (g / 100 ml)

[0046]Vitamin E (d) 1% (g / 100 ml)

[0047] Poloxamer 188 (e) 2% (g / 100 ml)

[0048] Glycerin (f) 3% (g / 100 ml)

[0049] Water (g) 80% (g / 100ml)

[0050] (a), (b), (c), (d) and other oil-soluble ingredients are mixed evenly to prepare the oil phase for later use; (e), (f) and (g) are mixed and dissolved, then added to the oil phase, and after Ultrasonic emulsifier dispersion, 100 W ~ 1000 W, 1 ~ 5 min, repeat three times, potting, sterilization, the product is obtained.

[0051] Example 3

Embodiment 3

[0053] Pulsatilla total saponins (b) 13% (g / 100 ml)

[0054] Phospholipids (c) 15% (g / 100 ml)

[0055] Vitamin E (d) 2% (g / 100ml)

[0056] Poloxamer 188 (e) 4% (g / 100 ml)

[0057] Glycerin (f) 5% (g / 100 ml)

[0058] Water (g) 90% (g / 100ml)

[0059] (a), (b), (c), (d) and other oil-soluble components are mixed evenly, and preheated at 40-80 ℃ to prepare the oil phase for later use; under slow stirring, the 40-80 ℃ The preheated purified water containing (e) and (f) is added to the preheated oil phase to form a stable O / W emulsion, potted and sterilized to obtain the product.

[0060] Test example 1

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Abstract

The invention belongs to the technical field of medicine, and relates to a pulsatilla chinensis total saponin oral emulsion and a preparation method thereof. The emulsion comprises the following components: 0.13%-13.5% of pulsatilla chinensis total saponins, 5%-50% of medicinal oil, 1%-30% of emulsifiers, 0-10% of auxiliary emulsifiers, 0.1%-15% of anti-oxidants, and the balance of purified water. The emulsion can be prepared by methods such as phase inversion emulsification method, PIT emulsification method, alternate liquid feeding emulsification method, ultrasonic wave emulsification method, low-energy emulsification method, micro-fluidization method, and the like. The pulsatilla chinensis total saponins provided by the invention are indissolvable drugs, and have irritation to gastrointestinal tracts. The dispersity of emulsion droplets in the emulsion is great, which facilitates drug absorption and increases bioavailability; the emulsion enables the drugs to be located in oil-water interfacial films or oil drop nuclei, which prevents direct contact of the drugs with gastrointestinal tracts, and thus reduces the gastrointestinal tract irritation of the drugs. The emulsion is a good carrier of pulsatilla chinensis total saponins; the addition of the auxiliary emulsifiers solves the problem of poor stability of common emulsions; when the emulsion is centrifuged at a rotating speed of 4000 r / min for 30 min, no layering phenomenon is caused; the bioavailability is high; and the stability is good.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an oral emulsion of total saponins of pulsatillae and a preparation method thereof. Background technique [0002] Cancer is one of the serious diseases that endanger human life and health. Statistics from the World Health Organization show that there are more than 10 million new cases of cancer in the world every year, and cancer accounts for more than 12% of the total death toll in the world, and it is increasing year by year. 60% are lung cancer, liver cancer, gastric cancer, breast cancer, colorectal cancer, oral cancer, cervical cancer and esophageal cancer. Malignant tumors are major diseases that threaten human life. It is urgent to find anti-tumor drugs with high efficiency and low toxicity. [0003] Pulsatilla is "bitter, warm, and non-toxic. It is mainly warm, malaria, prone to cold and heat, accumulation of lumps, ringworm gas, expelling blood to relieve pain, and golden...

Claims

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Application Information

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IPC IPC(8): A61K36/71A61K9/107A61K47/44A61K47/38A61K47/36A61P35/00
Inventor 杨世林罗晓健李翔刘薇简晖范玫玫王琦
Owner JIANGXI HERBFINE HI TECH
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