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Aspirin-DL-lysine freeze-dried powder injection for injection and preparation method thereof

A technology of freeze-dried powder injection and lysine-pirin, which is applied in the field of lysine-pirin freeze-dried powder for injection and its preparation, can solve problems such as increased irritation and sensitization, muscle necrosis, and allergic reactions, and achieve Improved stability, stable drug properties, and good formability

Inactive Publication Date: 2018-02-23
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the currently clinically used single-component lysine for injection is unstable to humidity, heat and light, causing it to be partially decomposed into free salicylic acid during the storage period, which reduces the drug effect.
Because free salicylic acid is highly irritating and sensitizing to the human body, the irritating and sensitizing properties will increase after medication, and muscle necrosis or severe allergic reactions will occur in severe cases, even life-threatening

Method used

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  • Aspirin-DL-lysine freeze-dried powder injection for injection and preparation method thereof
  • Aspirin-DL-lysine freeze-dried powder injection for injection and preparation method thereof
  • Aspirin-DL-lysine freeze-dried powder injection for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] 1. Prescription

[0030]

[0031] 2. Production process

[0032] 2.1 Control the cleaning and sterilization of antibiotic glass bottles

[0033] Controlled antibiotic glass bottles are removed from the outer packaging, passed into the bottle washing and drying room, cleaned by a bottle washing machine, dried with compressed air, dried and sterilized in a hot air tunnel oven at 350°C for 5 minutes, and cooled.

[0034] 2.2 Cleaning and sterilization of butyl rubber

[0035] The butyl rubber stoppers are removed from the outer packaging and sent to the stopper washing room, cleaned by a stopper washing machine, sterilized by damp heat at 121°C for 40 minutes, and cooled for later use.

[0036] 2.3 Sterilization of aluminum-plastic combination caps

[0037] The aluminum-plastic cover is removed from the outer packaging, and then transferred to the aluminum cover sterilization room, sterilized by dry heat at 110°C for 120 minutes in a drying oven, cooled, and set asid...

Embodiment 2

[0049] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0050]

Embodiment 3

[0052] The difference between the present embodiment and embodiment 1 is that the prescription is different, and the prescription of the present embodiment is as follows:

[0053]

[0054]

[0055] Stability study

[0056] Get the lysine-pirin freeze-dried powder sample that the embodiment of the present invention 1-3 makes and remove outer packaging, place 10 days in room temperature air, take samples respectively in the 1st, 3rd, 5th, 10th days after setting out, investigate relevant Project, all sample properties have no change, it is white crystalline powder, pH value is stable, is 5.6. Clarity, free salicylic acid content, and sterility test all meet the standard (((National Drug Standard)) WS1-XG-015-2001Z, the same below), and the content is greater than 99.2%.

[0057] Take the lysine-pirin freeze-dried powder samples prepared in Examples 1-3 of the present invention, place them at room temperature, and take samples 1, 3, 6, and 11 months after setting out, and ...

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Abstract

The invention provides a lysine-pirin freeze-dried powder for injection, which is formed by freeze-drying a lysine-pirin drug solution, the pH of the lysine-pirin drug solution is 4.5-6.5, and every 2000mL of the lysine Pirin drug solution contains: 80-120g of lysine-pirin, 12-18g of gelatin, 10-15g of albumin, 5-12g of sucrose, 4-6g of glutathione, 2-3g of L-serine, 2-3g of ethylenediaminetetraacetic acid Sodium 6‑10g, appropriate amount of pH regulator, and the balance of water. In the formula of the present invention, an appropriate amount of auxiliary materials such as gelatin, albumin, sucrose, glutathione, L-serine, disodium edetate, etc. are added, which can improve the stability of the drug and reduce the production of salicylic acid. It is convenient for the storage and transportation of medicines. Moreover, the preparation process is simple, the technical requirements are not high, the production cycle is relatively short, the quality of the prepared product is stable and controllable, and it is beneficial to long-term storage.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a lysine-pirin freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Lysinepirin is the double salt of aspirin and lysine. As a derivative of aspirin, it is a new type of antipyretic and analgesic that was first launched by the French Egic pharmaceutical company in the seventies. Because of its low toxic and side effects, safe use, non-addiction, and good curative effect, it is the drug of choice for antipyretic and analgesic in children and secondary and tertiary analgesic for cancer patients. At present, it has been produced by many pharmaceutical companies in China, including Enteric-coated capsules, powders, powder injections, etc. Lyspirin is hydrolyzed in the body to generate aspirin and lysine, and aspirin is further hydrolyzed to generate salicylic acid, so the mechanism of action of lyspirin and aspirin is the sam...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/42A61K47/26A61K47/18A61K31/616A61K31/198A61P29/00
CPCA61K9/19A61K9/0019A61K31/198A61K31/616A61K47/183A61K47/26A61K47/42A61K2300/00
Inventor 杨杰符成龙陈玉珠史秋萍符永红
Owner HAINAN GENERAL & KANGLI PHARMA
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