Medicine composition of alprostadil and Chuanhuning/Yanhuning liposome and its prepn

A technology of alprostadil and Yanhuning, applied in the field of alprostadil and Chuanhuning/Yanhuning liposome combination medicine and preparation thereof, can solve the problems of pyrogen-like reaction, allergic reaction, liver function damage, etc. Use dose, improve the therapeutic index, and promote the effect of hepatocyte regeneration

Inactive Publication Date: 2007-08-22

江苏德伦生物制药有限公司

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AI-Extracted Technical Summary

Problems solved by technology

The existing Chuanhuning and Yanhuning drugs have liver fun...

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Abstract

The present invention relates to medicine composition of alprostadil and Chuanhuning/Yanhuning liposome and its preparation process. The nanometer liposome medicine contains the mixture of alprostadil and Chuanhuning/Yanhuning in the weight ratio of 0.1-1.0 to 50-300 in 10.1-80.2 weight portions, the mixture of soybean lecithin and yolk lecithin in the weight ratio of 4 to 1 in 88-440 weight portions, the mixture of cholesterol and beta-sitosterol n the weight ratio of 9 to 1 in 40-200, polyethylene glycol in 4000 15-40 weight portions, sodium glucuronate in 100 -280 weight portions and vitamin C in 160-800 weight portions. The medicine of the present invention may be used in antagonizing pneumonia adenovirus and influenza virus.

Application Domain

Powder deliveryOrganic active ingredients +7

Technology Topic

PediatricsLiposome +15

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Examples

Experimental program(5)

Example Embodiment

[0029] Example 1:

[0030] This embodiment provides a kind of nano liposome drug, comprising alprostadil and Chuanhuning/Yanhuning, comprising the following raw materials in parts by weight:

[0031] Alprostadil and Chuanhuning/Yanhuning

[0032] Mixture 80.2 in a weight ratio of 0.1:300;

[0033] 4:1 mixture of soybean lecithin and egg yolk lecithin in weight ratio 440;

[0034] Cholesterol and β-sitosterol weight ratio 9: 1 mixture 200;

[0035] Macrogol 4000 40;

[0036] Sodium Glucuronate 280;

[0037] Vitamin C 800.

[0038] The Chuanhuning/Yanhuning refers to the mixture of Chuanhuning and Yanhuning in a weight ratio of 3:1 or Chuanhuning alone.

[0039] The preparation method of above-mentioned medicine, the steps are as follows:

[0040] (1) Get the mixture of Alprostadil and Chuanhuning/Yanhuning weight ratio 0.1: 300, soybean lecithin and egg yolk lecithin mixture, cholesterol and β-sitosterol weight ratio 9: 1 mixture dissolved in ethanol or ether In, make a solution;

[0041] (2) Get the solution prepared in step (1) and evaporate to dryness in a rotary evaporator to make a phospholipid film;

[0042] (3) hydrating the phospholipid film prepared in step (2) with 0.01M, pH6.0-7.0 phosphate buffer solution to obtain a phospholipid film suspension, the optimal concentration of phospholipid is 0.02M;

[0043] (4) Dissolve polyethylene glycol 4000, sodium glucuronate, and vitamin C in a 0.01M, pH6.0-7.0 phosphate buffer, ultrafilter with an ultrafiltration membrane with a molecular weight cut-off of 5000 Daltons, take the filtrate, and remove Bacterial endotoxin;

[0044] (5) The phospholipid film suspension prepared in step (3) is made into a liposomal drug carrier with an average particle diameter of 100nm with a mini-extruder micro-extruder, and added to the filtrate prepared in step (4), in a water bath After ultrasonic treatment of 4-50W/L for 5-10 minutes, filter through a 220nm filter membrane, and take the filtrate;

[0045] (6) Making the filtrate prepared in step (5) into a pharmaceutically acceptable dosage form.

[0046] Specifically, the pharmaceutically acceptable dosage forms are freeze-dried powder injections, enteric-coated capsules, enteric-coated tablets, sprays, and nasal drops.

[0047] The curative effect verification of the medicine prepared in the present embodiment is as follows:

[0048] Induce pneumonia model mice with A1 type influenza virus, 18-20 grams in weight, with 25μg/kg alprostadil/80mg/kg Yanhuning/Chuanhuning (treatment group 1) or 25μg/kg alprostadil/80mg/kg Chuanhuning (Treatment group 2) Dosage: Tail vein injection, once a day, for 7 days, 50 rats in the treatment group. The first positive control group and the second positive control group used Yanhuning and Chuanhuning alone, the dose was 80 mg/kg, and the others were the same as those in the treatment group.

[0049] The survival rate, pyrogenic reaction rate, vomiting and diarrhea rate were counted.

[0050] The test results are as follows:

Example Embodiment

[0051] Example 2:

[0052] This embodiment provides a kind of nano liposome drug, comprising alprostadil and Chuanhuning/Yanhuning, comprising the following raw materials in parts by weight:

[0053] Alprostadil and Chuanhuning/Yanhuning

[0054] Mixture 10.1 in a weight ratio of 0.1:500;

[0055] 4:1 mixture of soybean lecithin and egg yolk lecithin by weight 88;

[0056] 9:1 mixture of cholesterol and β-sitosterol by weight 40;

[0057] Polyethylene glycol 4000 15;

[0058] Sodium Glucuronate 100;

[0059] Vitamin C 160.

[0060] The Chuanhuning/Yanhuning refers to the mixture of Chuanhuning and Yanhuning in a weight ratio of 2:1 or Chuanhuning alone.

[0061] The preparation method of above-mentioned medicine refers to embodiment 1.

[0062] The curative effect verification of the medicine prepared in the present embodiment is as follows:

[0063] Induce pneumonia model mice with A1 type influenza virus, 18-20 grams in weight, with 20μg/kg alprostadil/10mg/kg Yanhuning/Chuanhuning (treatment group 1) or 20μg/kg alprostadil/10mg/kg Chuanhuning (Treatment group 2) Dosage: Tail vein injection, once a day, for 7 days, 50 rats in the treatment group. The drugs of the first positive control group and the second positive control group were Yanhuning and Chuanhuning respectively, the dosage was 10 mg/kg, and the others were the same as those of the treatment group.

[0064] The survival rate, pyrogenic reaction rate, vomiting and diarrhea rate were counted.

[0065] The test results are as follows:

Example Embodiment

[0066] Example 3:

[0067] This embodiment provides a kind of nano liposome drug, comprising alprostadil and Chuanhuning/Yanhuning, comprising the following raw materials in parts by weight:

[0068] Alprostadil and Chuanhuning/Yanhuning

[0069] Mixture 80.2 in weight ratio 1.0:266;

[0070] 4:1 mixture of soybean lecithin and egg yolk lecithin by weight 88;

[0071] Cholesterol and β-sitosterol weight ratio 9: 1 mixture 200;

[0072] Polyethylene glycol 4000 15;

[0073] Sodium Glucuronate 100;

[0074] Vitamin C 800.

[0075] The Chuanhuning/Yanhuning refers to the mixture of Chuanhuning and Yanhuning in a weight ratio of 3:1 or Yanhuning alone.

[0076] The preparation method of above-mentioned medicine refers to embodiment 1.

[0077] The curative effect verification of the medicine prepared in the present embodiment is as follows:

[0078] Induce pneumonia model mice with A1 type influenza virus, 18-20 grams in weight, with 300μg/kg alprostadil 80mg/kg Yanhuning/Chuanhuning (treatment group 1) or 300μg/kg alprostadil 80mg/kg Yanhuning (Treatment group 2) Dosage: Tail vein injection, once a day, for 7 days, 50 rats in the treatment group. The drugs of the first positive control group and the second positive control group were Yanhuning and Chuanhuning respectively, the dosage was 80 mg/kg, and the others were the same as those of the treatment group.

[0079] The survival rate, pyrogenic reaction rate, vomiting and diarrhea rate were counted.

[0080] The test results are as follows:

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Classification and recommendation of technical efficacy words

Lower dose
Improve curative effect

Medicine composition of alprostadil and Chuanhuning/Yanhuning liposome and its prepn

AI-Extracted Technical Summary

Problems solved by technology

Abstract

Image

Examples

Example Embodiment

Example Embodiment

Example Embodiment

PUM

Description & Claims & Application Information

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