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Duck-gallbladder-oil enteric coatal soft capsule preparation, its preparing method and use

A technology for enteric-coated soft capsules and soft-capsule preparations, which are applied in the field of enteric-coated soft capsule preparations containing brucei seed oil and the preparation thereof, can solve the problems of thermodynamic instability, poor patient tolerance, easy oxidative decomposition and the like, and achieve the benefits of biological Availability, improve dissolution and dispersion, reduce decomposition and rancidity

Inactive Publication Date: 2006-10-25
陈世忠
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the process of intravenous emulsion injection is unstable, and the temperature, emulsification time and production equipment all have an impact on product quality, resulting in uneven emulsion particles; oil and water stratification, cracking, phase inversion, flocculation and Corrosion and other phenomena make it unusable; storage conditions need to be protected from light, and the temperature should be kept within the range of 6±2°C; the service life is only 1 year, and the actual use is greatly affected by the environment, and the product often fails or loses its shape within the validity period Unqualified; in clinical use, side effects such as phlebitis, vascular sclerosis, hemangioma, muscle and blood vessel irritation, allergic reaction, etc., are poorly tolerated by patients
Brucea javanica oil oral emulsion is a thermodynamically unstable system. The physical stability of the oral emulsion after sterilization is poor. Its active ingredients are easily oxidized and decomposed during the storage process, resulting in a specific rancid smell, which affects the stability of the drug. In addition, because Brucea javanica oil The fishy smell and greasy feeling of oral preparations, most patients have greasy, nausea, anorexia, vomiting and other gastrointestinal discomfort reactions to oral emulsion of javanica javanica oil, and the compliance of patients is significantly reduced
Its improved dosage form regenerated emulsion has not yet solved the technical problem of the product being unstable to light, humidity and heat, and has not effectively improved the fishy smell and greasy feeling of oral preparations of javanica javanica oil
And studies have shown that even adding a large amount of flavoring agents can not significantly improve the unique fishy smell of Brucea javanica oil
In addition, oral emulsions or granules also have defects such as inaccurate unit quantification and easy contamination.

Method used

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  • Duck-gallbladder-oil enteric coatal soft capsule preparation, its preparing method and use
  • Duck-gallbladder-oil enteric coatal soft capsule preparation, its preparing method and use
  • Duck-gallbladder-oil enteric coatal soft capsule preparation, its preparing method and use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0037] Example 1-3 Preparation of Brucea javanica oil enteric-coated soft capsules

[0038] Example 1-3 Brucea javanica oil enteric-coated soft capsule composition and index inspection results, see Table 1-2.

[0039] The preparation method is:

[0040] 1) Extraction of Brucea javanica oil: Crude Brucea javanica medicinal materials are pulverized into coarse powder, weighed 5kg, placed in an extraction tank, added 6 times the amount of solvent gasoline, refluxed for 1 hour, filtered, and the residue is added 6 times of solvent gasoline, and refluxed for extraction After 1 hour, filter, combine the filtrate, and recover the solvent under reduced pressure until it is exhausted. The extraction rate is between 12.8% and 13.4%. The results are shown in Table 1.

[0041] 2) Preparation of Brucea javanica oil soft capsule: Take 5000ml of Brucea javanica oil, put it in a stainless steel bucket, add 750g of soy phospholipid, stir to dissolve all, and filter to prepare sac fluid. Take the c...

Embodiment 4

[0045] Example 4 Investigation on the long-term stability of Brucea javanica oil enteric-coated soft capsules

[0046] Take the Brucea javanica oil enteric-coated soft capsules obtained in Examples 1-3 and place them at 0, 3, and 6 under the experimental conditions of a temperature (T) of 25°C±2°C and a relative humidity (RH) of 60%±10% , 9 and 12 months later, inspect the following indicators month by month, and compare the inspection results with those before placing them to observe their stability.

[0047] Stability inspection Observe indicators such as traits, identification, inspection, content determination, and microbiological inspection. The test method refers to the method operation under the corresponding item in an appendix of the Pharmacopoeia of the People's Republic of China in 2005. The requirements for each indicator are:

[0048] 1. Properties: This product is a brown enteric-coated soft capsule preparation, the content of which is a yellow and clear liquid; the ...

Embodiment 5

[0064] Example 5 Investigation of accelerated stability of Brucea javanica oil enteric-coated soft capsule

[0065] Take the Brucea javanica oil enteric-coated soft capsules obtained in Examples 1-3 and place them at 0, 1, and 2 under the experimental conditions of a temperature (T) of 40℃±2℃ and a relative humidity (RH) of 75%±5%. , 3 and 6 months later, check the following indicators month by month, and compare the inspection results with those before placing them to observe their stability.

[0066] Stability inspection Observe indicators such as traits, identification, inspection, content determination, and microbiological inspection. The test method refers to the method operation under the corresponding item in an appendix of the Pharmacopoeia of the People's Republic of China in 2005. The requirements for each indicator are:

[0067] 1. Properties: This product is a brown enteric-coated soft capsule preparation, the content of which is a yellow and clear liquid; the gas is p...

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Abstract

The present invention relates to a medicine enteric soft capsule preparation, in particular, it relates to an enteric soft capsule preparation containing brucea fruit oil, its preparation method and application. Its capsule solution is composed of 0.5 portion of brucea fruit oil and 0.075 portion of soya bean lecithin. Said invention is aimed at raising bioavailability of medicine.

Description

Technical field [0001] The invention relates to a pharmaceutical enteric soft capsule preparation, in particular to an enteric soft capsule preparation containing brucea javanica oil, and a preparation method and application thereof. Background technique [0002] Malignant tumor is one of the malignant diseases with the highest morbidity and mortality in the world today. According to statistics from the World Health Organization, there are currently 8.7 million new cancer patients worldwide each year, with 6-7 million deaths, accounting for one-tenth of the total number of deaths in the population, and an annual growth rate of 2-3%. In my country, 2 million new malignant tumor patients are added every year, and more than 1.3 million people die. [0003] In recent years, due to changes in the climate and diet, the incidence of lung cancer, liver cancer, gastric cancer, colon cancer and pancreatic cancer and other malignant solid tumors has shown a rapid increase. Combination of Ch...

Claims

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Application Information

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IPC IPC(8): A61K36/185A61K9/48A61P35/00
Inventor 陈世忠
Owner 陈世忠
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