Sterile and freeze dried hypophysin preparation for injection and its preparing process

A technique of vasopressin and freeze-dried preparations, applied to the dosage form of vasopressin and preparation thereof, the sterile lyophilized preparation of vasopressin for injection and the field of preparation thereof, can solve the problem of not seeing vasopressin Sterile freeze-dried preparation patents and research reports, etc., to achieve the effect of improving stability and bioavailability, facilitating storage and transportation, and promoting further expansion

Inactive Publication Date: 2004-12-29
刘红 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there are few reports on the development of new formulations of pituitrin, and so far, there are no patents and research reports on the aseptic freeze-dried preparation of pituitrin

Method used

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  • Sterile and freeze dried hypophysin preparation for injection and its preparing process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 specification 5U / bottle, the formula of 1000 bottles of pituitrin sterile freeze-dried preparation for injection is:

[0030] Posterior pituitary powder (vasopressin) 50g, mannitol 70g, appropriate amount of citric acid

[0031] Add water for injection to 2000ml, make 1000 bottles in total

[0032] Preparation:

[0033] a) Preparation of pituitrin solution for injection

[0034] Weigh each component according to the above formula, add 50 g of the posterior pituitary leaf powder into 5 times the amount (w / v) of 0.25% acetic acid aqueous solution, stir continuously, extract at 50°C for 15 minutes, filter, and use the filter residue twice The amount (w / v) of acetic acid with a concentration of 0.25% was extracted once more in the same way, and the filtrates were combined twice; the filtrate was quickly heated to 100°C, maintained for 15 minutes, and the concentration of 0.5% chlorotert-butyl was added by volume immediately Alcohol, quickly cooled to below 3...

Embodiment 2

[0045] Example 2 Specification 10U / bottle, the formula of 1000 bottles of vasopressin sterile freeze-dried preparation for injection is:

[0046] Posterior pituitary powder (vasopressin) 100g, mannitol 70g, appropriate amount of citric acid

[0047] Add water for injection to 2000ml, make 1000 bottles in total

[0048] Preparation:

[0049] a) Prepare pituitrin solution for injection

[0050] Weigh each component according to the above formula, add 100 g of the posterior pituitary leaf powder into 0.25% acetic acid aqueous solution with 5 times the amount (w / v), stir continuously, extract at 50°C for 15 minutes, filter, and use the filter residue twice The amount (w / v) of acetic acid with a concentration of 0.25% was extracted once more in the same way, and the filtrates were combined twice; the filtrate was quickly heated to 100°C, maintained for 15 minutes, and the concentration of 0.5% chlorotert-butyl was added by volume immediately Alcohol, quickly cooled to below 30°C, ...

Embodiment 3

[0060] Embodiment 3 Specification 20U / bottle, the formula of 1000 bottles of pituitrin sterile freeze-dried preparation for injection is:

[0061] Posterior pituitary powder (vasopressin) 200g, mannitol 200g, acetic acid amount

[0062] Add water for injection to 3000ml, make 1000 bottles in total

[0063] Preparation:

[0064] a) Preparation of pituitrin solution for injection

[0065] Weigh each component according to the above formula, add 200 g of the posterior pituitary leaf powder into 0.25% acetic acid aqueous solution with 5 times the amount (w / v), stir continuously, extract at 50°C for 15 minutes, filter, and use the filter residue twice The amount (w / v) of acetic acid with a concentration of 0.25% was extracted once more in the same way, and the filtrates were combined twice; the filtrate was quickly heated to 100°C, maintained for 15 minutes, and the concentration of 0.5% chlorotert-butyl was added by volume immediately Alcohol, quickly cooled to below 30°C, then...

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Abstract

The freeze dried bacteria-free hypophysin preparation for injection consists of hypophysin, excipient, acidity regulator, and injection water. The preparation process includes preparing hypophysin solution, adding excipient, fixing volume, packing the solution in bacteria-free freeze drying bottle, and freeze drying. The freeze dried bacteria-free hypophysin preparation thus prepared may be used in intramuscular injection or intravenous transfusion to raise the hypophysin level clinically, and has high light and heat stability, high bioavailability and less oxidation and reduction degradation.

Description

technical field [0001] The invention relates to a dosage form of pituitrin and a preparation method thereof, in particular to a sterile freeze-dried preparation of pituitrin for injection and a preparation method thereof, belonging to the field of biopharmaceuticals. Background technique [0002] Pituitrin is an effective polypeptide biochemical drug for vasoconstriction and anti-diuresis. Oxytocin in it has a strong contraction effect on smooth muscle, especially on blood vessels and the base layer of the uterus. Due to different doses, it can cause uterine Rhythmic contraction to tetanic contraction can be used as an oxytocin drug in obstetrics and gynecology. Pituitrin can also increase the tension of the intestinal tract and bladder, causing them to contract and inhibit urination. It is used as an antidiuretic. Because it contains vasopressin, it can directly excite vascular smooth muscle, shrink capillaries, small arteries, and small veins, reduce circulating blood vol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/17A61P15/04
Inventor 刘红马小歧
Owner 刘红
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