Acetaminophen injection and manufacturing process thereof

A technology for acetaminophen and injections, applied in the field of preparations and preparations of injections, which can solve the problems of increasing the incidence of acute renal tubular necrosis, etc., and achieve the effects of good stability and feasible preparation process

Inactive Publication Date: 2018-08-10
彭进洪 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Domestic small needles usually use polyethylene glycol 300 or polyethylene glycol 400 as a stabilizer. Although polyethylene glycol is one of the few synthetic polymers approved by the FDA that can be used as medicine for internal injection, there are constantly According to clinical case reports, the application of polyethylene glycol 300 or polyethylene glycol 400 in injection can increase the incidence of acute tubular necrosis; in addition, acetaminophen is slightly soluble in water, and is easily oxidized and decomposed in aqueous solution, so it is harmful to The selection of excipients for acetaminophen injection is worthy of careful study

Method used

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  • Acetaminophen injection and manufacturing process thereof
  • Acetaminophen injection and manufacturing process thereof
  • Acetaminophen injection and manufacturing process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: the preparation of paracetamol injection (every bottle 100ml, containing paracetamol 1000mg)

[0026]

[0027] It is prepared as follows:

[0028] 1) According to the ingredient list, receive qualified medicinal raw materials such as acetaminophen, mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous) and sodium metabisulfite;

[0029] 2) Add water for injection with a batch volume of 50% in the batching tank, and after cooling down to below 50°C, fill the water with nitrogen for 10 minutes;

[0030] 3) Add mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous), sodium metabisulfite in sequence, stir for 10 minutes, then add acetaminophen, stir and dissolve for 20 to 25 minutes;

[0031] 4) Add water for injection to the full amount, keep stirring, and adjust the pH value of the solution in the tank to 5.5-6.5 with 10% sodium hydroxide solution or dilute acetic acid;

[0032] 5) Carry out the intermediate tes...

Embodiment 2

[0036] Embodiment 2: the preparation of paracetamol injection (every bottle 50ml, containing paracetamol 500mg)

[0037]

[0038] It is prepared as follows:

[0039] 1) According to the ingredient list, receive qualified medicinal raw materials such as acetaminophen, mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous) and sodium metabisulfite;

[0040] 2) Add water for injection with a batch volume of 60% in the batching tank, and after cooling down to below 50°C, fill the water with nitrogen for 10 minutes;

[0041] 3) Add mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous), sodium metabisulfite in sequence, stir for 10 minutes, then add acetaminophen, stir and dissolve for 20 to 25 minutes;

[0042] 4) Add water for injection to the full amount, keep stirring, and adjust the pH value of the solution in the tank to 5.4-6.5 with 10% sodium hydroxide solution or dilute acetic acid;

[0043] 5) Carry out the intermediate testi...

Embodiment 3

[0047] Embodiment 3: the preparation of paracetamol injection (every bottle 100ml, containing paracetamol 1000mg)

[0048]

[0049] It is prepared as follows:

[0050] 1) According to the ingredient list, receive qualified medicinal raw materials such as acetaminophen, mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous) and sodium sulfite;

[0051] 2) Add water for injection with a batch volume of 70% in the batching tank, and after cooling down to below 50°C, fill the water with nitrogen for 10 minutes;

[0052] 3) Add mannitol, cysteine ​​hydrochloride, disodium hydrogen phosphate (anhydrous), and sodium sulfite in sequence, stir for 10 minutes, then add acetaminophen, and stir to dissolve for 20 to 25 minutes;

[0053]4) Add water for injection to the full amount, keep stirring, and adjust the pH value of the solution in the tank to 5.3-6.5 with 10% sodium hydroxide solution or dilute acetic acid;

[0054] 5) Carry out the intermediate testing o...

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PUM

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Abstract

The invention discloses a prescription and a process of acetaminophen injection. The injection has two kinds of package: 50 ml and 100 ml, but the acetaminophen concentration is 10 mg / ml. The invention relates to the prescription which comprises one of antioxidants cysteine hydrochloride, sodium pyrosulfite, sodium sulfite and sodium hydrogen sulfite or two of the above antioxidants. The process provided by the invention comprises the following steps: 1) cooling water for injection and then filling with nitrogen; 2) adding mannitol and a disodium hydrogen phosphate (anhydrous) and an antioxidant, and then putting acetaminophen; 3) adding all the water for injection and adjusting the pH value of the solution to 5.0 to 6.5; 4) after in-process inspection is qualified, filtering, filling withnitrogen and filling; 5) performing moist heat sterilization; and 6) packaging and putting into a storage. The injection provided by the invention is proved to be safe, effective and stable through acceleration test, abnormal toxicity test and clinical trial.

Description

technical field [0001] The invention belongs to the field of manufacturing pharmaceutical products, and relates to a preparation of an injection with acetaminophen as the main active ingredient and a preparation method thereof. Background technique [0002] Acetaminophen was first approved as a drug in the United States in 1951, and has now become a commonly used antipyretic and analgesic drug. One or several combinations of butalbital and other drugs can be used to make antitussive with good sedative effect. Analgesia with acetaminophen is peripheral rather than central. After more than 60 years of development, up to now, medicines with acetaminophen as the main ingredient include tablets, oral suspensions, capsules, suppositories, injections and other dosage forms. [0003] Among the injections with acetaminophen as the single main ingredient, China currently only has two small-volume injections of 1ml and 2ml approved for marketing. The administration method is intramus...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/167A61K47/18A61K47/26A61P29/00
CPCA61K47/183A61K47/26A61P29/00A61K9/0019A61K9/08A61K31/167
Inventor 彭真彭进洪
Owner 彭进洪
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