Prepn. of self-emulsion of glossy ganoderma spore oil, and its prepn. method

A self-emulsification technology of Ganoderma lucidum spore oil, which is applied in the fields of pharmaceutical formula, emulsion delivery, medical preparations containing active ingredients, etc., can solve the problems of unqualified disintegration, unstable thermodynamics, unstable product quality, etc., and achieve improvement Effects of drug bioavailability, discoloration and deterioration inhibition, and excellent storage stability

Active Publication Date: 2007-01-31
江苏海王健康生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the temperature, emulsification time and production equipment of the intravenous emulsion injection process are likely to affect the product quality and cause uneven emulsion particles; the product quality is unstable, and oil and water stratification, cracking, phase inversion, and flocculation are prone to occur during storage and spoilage; the storage conditions are relatively harsh, and they should be kept away from light, filled with nitrogen, and stored at a lower temperature; the service life is short, only 1 to 1 and a half years, and it is greatly affected by the environment in actual use, often within the validity period That is, failure or unqualified properties, etc.
Ganoderma lucidum spore oil oral emulsion is also a thermodynamically unstable system, especially after undergoing the same sterilization process as the injection, its physical stability is poor, the process and product quality are not stable, and the taste of Ganoderma lucidum spore oil oral emulsion is poor, fishy smell and greasiness
What is particularly unfavorable is that chemotherapy and radiotherapy usually induce vomiting in patients, and taking oral emulsion of ganoderma lucidum spore oil will further aggravate this pain and significantly reduce the patient's treatment compliance, which is not conducive to the smooth development of clinical treatment.
[0004] Due to the physicochemical properties of Ganoderma lucidum spore oil, it is very suitable to be made into soft capsules, yet some difficulties need to be overcome when making Ganoderma lucidum spore oil into soft capsules, such as disintegration during storage becomes unqualified, material migration and Stability issues such as leakage of oily components, increased acid value and oxidation value

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1: Ganoderma lucidum spore oil self-emulsifying soft capsule preparation

[0020] Ganoderma lucidum spore oil 700g

[0021] Tween-85 300g

[0022] Soft capsule capsule material: Add gelatin into the sol tank, add water at 60-80°C, add preservatives, sunscreens and colorants if necessary, seal and heat at the same time, stir until melting and swelling are complete, add glycerin, seal the glue tank, close Stir, turn on the vacuum pump, evacuate, and wait for the air bubbles to be removed to obtain the gelatin solution. Keep warm at 50-70°C for later use.

[0023] Take Ganoderma lucidum spore oil and Tween-85 in the same container and ultrasonically stir and mix evenly to form a homogeneous solution, that is, the self-emulsifying drug release liquid of Ganoderma lucidum spore oil. The soft capsule material and the self-emulsifying medicinal solution of ganoderma lucidum spore oil are put on a soft capsule machine to prepare soft capsules, dried, washed, dried ag...

Embodiment 2

[0025] Embodiment 2: Ganoderma lucidum spore oil self-emulsifying soft capsule preparation

[0026] Ganoderma lucidum spore oil 500g

[0027] Soy Lecithin 175g

[0028] Glycerin 50g

[0029] Sorbitol 75g

[0030] Vitamin E 50g

[0031] Polyethylene Glycol-400 150g

[0032] Soft capsule capsule material embodiment 1 is identical.

[0033] Mix soybean lecithin, glycerin, sorbitol, vitamin E and polyethylene glycol-400, use a shearing machine (8000 rpm), stir twice, the first time for 5 minutes, the second time for 2 minutes, to disperse Evenly, add 100m of warm Ganoderma lucidum spore oil, stir 3 times for 2 minutes each time to make colostrum, then transfer to a high-pressure homogenizer for homogenization 3 times, filter to form a uniform solution that is the content of Ganoderma lucidum spore oil Self-emulsifying drug release solution. The soft capsule capsule material and the self-emulsifying medicinal solution of ganoderma lucidum spore oil are put on a soft capsule ...

Embodiment 3

[0035]Embodiment 3: Ganoderma lucidum spore oil self-emulsifying liquid capsule preparation

[0036] Lingzhi Spore Oil 650g

[0037] Lecithin 100g

[0038] Polyoxyethylene Nonylphenol Ether 200g

[0039] Glycerin 50g

[0040] Take emulsifier-OP (polyoxyethylene nonylphenol ether, molecular weight 648.85), add lecithin and glycerin, stir to mix evenly, then add Ganoderma lucidum spore oil, stir at high speed to mix evenly, and obtain Ganoderma lucidum spore oil self-emulsifying concentrate . The self-emulsifying concentrate of ganoderma lucidum spore oil is directly filled in the liquid capsule shell to prepare liquid capsules, which are sorted and packaged to obtain finished products.

[0041] Take 0.5ml of the self-emulsifying concentrate of Ganoderma lucidum spore oil, add it to 10ml of artificial gastric juice, stir gently with a glass rod, and a blue opalescent emulsion can be formed rapidly. The particle size of the emulsion was measured with a TSM ultrafine particle...

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Abstract

A self-emulsified ganoderma spore oil in the form of soft capsule, liquid soft capsule, capsule, particle, etc is prepared from ganoderma spore oil, carrier, emulsifier, emulsifying assistant and/or adsorbent. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine preparations, in particular to a self-emulsifying preparation of ganoderma lucidum spore oil and a preparation method thereof. Background technique [0002] Ganoderma lucidum spore oil is a hydrophobic oily substance extracted from Ganoderma lucidum spores. Ganoderma lucidum spores are the spores released from the cap of Ganoderma lucidum during the mature period. Since the 1980s, there have been more basic researches on the anti-tumor aspects of Ganoderma lucidum and its spores; in the 1990s, the United States, Japan and other countries have applied Ganoderma lucidum to Clinically, it is used in the treatment of cancer and AIDS (AIDS), and has received extensive attention from international research scholars. In recent years, more studies and applications have been made on artificially cultivated ganoderma lucidum spores and their extracts. The main components of ganoderma lucidum spo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/074A61K9/107A61K9/16A61K9/48A61P35/00
Inventor 李颖吴敏黄光华
Owner 江苏海王健康生物科技有限公司
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