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Method for preparing injection of oleum functus brucease

A technology of bruce chinensis oil emulsion and bruce chinensis oil, which is applied in the directions of emulsion delivery, medical preparations containing active ingredients, pharmaceutical formulations, etc. It can prevent cancer metastasis, improve anti-cancer efficacy, and enhance anti-cancer effect.

Inactive Publication Date: 2006-05-17
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the volume of Brucea javanica oil emulsion injection is added to normal saline, it will also cause demulsification
[0004] 2. The directional distribution of the emulsion for injection cannot be exerted
Shenyang javanica oil emulsion was diluted with normal saline and injected intravenously, which significantly weakened the directional distribution of viscera and lymphatic directivity, and reduced the concentration of drugs in lung, liver, lymph nodes and other tissues, thus weakening the anticancer effect and the effect on metastatic cancer cells. Killing effect
[0005] 3. The energy provided by intravenous infusion of Shenyang Brucea javanica oil emulsion diluted with 250ml of normal saline is limited, and the body cannot make full use of it.
[0006] 4. In the past, the purity of pure javanica javanica oil used as the main ingredient was not high, which affected the safety of the use of javanica javanica oil emulsion
[0007] Chinese patent application CN1368268 discloses a nano javanica javanica oil preparation drug, which is prepared in proportion with 60-150 parts of nano javanica javanica oil and 10-25 parts of nano soybean lecithin, and is extracted by microwave, concentrated under reduced pressure, supersonic Jet technology, spray drying and other steps are used to make pharmaceutical preparations, and then according to the quality standards of the second part of the Chinese Pharmacopoeia in 2000, they are made into pills, tablets, granules, injections, etc. It is characterized by the application of modern material technology to make nano-medicines, but The patent only provides a kind of material technology, and the pharmacological effects of Brucea javanica oil preparations cannot be explained by data.
The safety and effectiveness are unknown; there is no isotonic agent that must be added to intravenous breast milk in its formula, and the formula is also unreasonable
[0008] In summary, the root causes of the defects of the javanica javanica oil emulsion injection in the prior art are: 1. the production of impurities is not controlled during the preparation of the javanica javanica oil emulsion injection; 2. the prepared emulsion particles are too thick, making it difficult for the human body to accept, And cause demulsification; 3. The extraction and purification technology of pure javanica javanica oil as a raw material is unreasonable, and the water-soluble components are not thoroughly removed, thereby bringing the toxic toxic components in the javanica javanica into the preparation

Method used

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  • Method for preparing injection of oleum functus brucease
  • Method for preparing injection of oleum functus brucease
  • Method for preparing injection of oleum functus brucease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Embodiment 1 prepares pure javanica oil

[0054] One, prepare according to the following steps:

[0055] A. Pulverize: select the fruit of Brucea javanica that is ripe and dry, even in size, after cutting off the stem impurity, the fruit of Brucea javanica is pulverized into coarse powder with pulverizer, weighs 45kg;

[0056] b. Petroleum ether extraction: Add 8 times the volume of petroleum ether 60-90°C AR 360L according to the weight of Brucea javanica coarse powder, soak in a closed container for 9 hours, fully stir twice per hour, filter, and collect the filtrate. Take the filter residue, add 6 times the volume of petroleum ether 60-90°C AR 270L, repeat the above steps, and combine the filtrate twice;

[0057] c. Preparation of crude oil: distill the above-mentioned filtrate at atmospheric pressure, recover petroleum ether at 60-90°C AR at 80°C-100°C, until no liquid drops flow out, and obtain 11.25L of dark green Brucea javanica crude oil;

[0058] d. Refining:...

Embodiment 2

[0075] Preparation of brucea javanica oil emulsion injection 30L with a content of 100mg / ml

[0076] Prepare as follows:

[0077] Get pure javanica javanica oil 3kg prepared by embodiment 1, lecithin 0.36kg as emulsifying agent, medicinal glycerin 0.75kg as isotonic agent, comprise the following steps:

[0078] a. Oil phase preparation: take the pure javanica javanica oil and lecithin of the prescription amount, heat and stir to make it completely mixed, blow nitrogen to defoam, and keep warm at 70°C;

[0079] b. Preparation of water phase: Take another prescribed amount of medicinal glycerin and water for injection to 30L, heat to the same temperature as the oil phase, inject into the homogenizer, increase the pressure to 5000psi, and mix the water phase evenly;

[0080] c. Slowly add the oil phase to the water phase to make colostrum, homogenize, repeat the homogenization 6 times, take a little to measure the particle size of the emulsion, until the particle size reaches 10...

Embodiment 3

[0083] The preparation content is 10000ml of javanica javanica oil emulsion injection of 50mg / ml

[0084] Prepare as follows:

[0085] Get pure javanica javanica oil 500g prepared by embodiment 1, soybean lecithin 80g as emulsifying agent, sorbitol 500g as isotonic agent, comprise the following steps:

[0086] a. Preparation of the oil phase: take the pure javanica javanica oil and soybean lecithin in the prescribed amount, heat and stir to completely mix, pass nitrogen gas to defoam, and keep warm at 65°C;

[0087] b. Preparation of water phase: take another prescribed amount of sorbitol and add water for injection to 10000ml, heat to the same temperature as the oil phase at 65°C, inject into the homogenizer, increase the pressure to 7000psi, and mix the water phase evenly;

[0088] c. Slowly add the oil phase to the water phase to make colostrum, homogenize, repeat the homogenization 6 times, take a little to measure the particle size of the emulsion until the particle size r...

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Abstract

A preparation method of javanica javanica oil emulsion injection, the javanica javanica oil emulsion injection contains 5-20g of pure javanica javanica oil per 100ml emulsion, 0.75-2.5g of a medicinally acceptable emulsifier, and an isotonic dose of medicine With an acceptable isotonic agent, the balance is water. The main preparation feature is to dissolve the oil phase components and the water phase separately, prevent the generation of impurities as much as possible during the preparation process, emulsify at a certain temperature to make colostrum, and then homogenize until the particle size of the emulsion reaches 50-300nm. Brucea Brucea Oil Emulsion Injection prepared by this method is being declared as a new drug under the trade name of An Ti Kang Injection. This Brucea Brucea Oil Emulsion Injection can ensure that the preparation can be directly injected intravenously, and improve the safe dosage of the drug, giving full play to the injection. The directional distribution of the emulsion and the directional effect of the lymphatic system are used to fully exert its therapeutic effect on cancer.

Description

(1) Technical field [0001] The invention relates to an anti-malignant traditional Chinese medicine intravenous oil emulsion injection, in particular to an oil emulsion injection with pure javanica javanica oil as the main component, which can be directly injected intravenously and has the functions of anti-cancer and killing metastatic cancer cells. . (2) Background technology [0002] Brucea javanica is the fruit of Brucea javanica, a plant of the bitter wood family. Its main functions are to clear away heat, dry out dampness, kill insects, detoxify, and corrode chelicer warts. Brucea javanica is poisonous, and its toxic components exist in the water-soluble bitter part, and its fixed oil is almost non-toxic. Since 1950, many scholars have used javanica oil to treat external auditory canal papilloma, laryngeal papilloma, cervical cancer, etc., and have obtained certain signs of anti-cancer. Since 1976, Shenyang Institute of Pharmacy has developed Brucea javanica oil-in-wa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K36/185A61K131/00A61P35/00
Inventor 卞如廉卞力
Owner 卞力
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