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A kind of injection containing oxytocin pharmaceutical composition and preparation method thereof

A technology for oxytocin and injections, which is applied in the field of injections containing oxytocin-containing pharmaceutical compositions and its preparation, which can solve problems such as exceeding the standard range, unqualified foreign matter, and long freeze-drying time, so as to ensure quality and improve stability , The effect of stable product quality

Active Publication Date: 2018-02-23
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] (3) Existing problems: Oxytocin is a polypeptide biochemical drug with poor stability in aqueous solution, and the quality of the newly produced product is good, but after going through the process of shipping (especially when there are crossovers in the north and south), storage and other processes , during the entire validity period, the content sometimes fluctuates greatly, or even decreases by 8-10%; oxytocin is a polypeptide biochemical drug, and it is prone to abnormalities such as polymerization in aqueous solution. At the same time, oxytocin injection is acidic and prone to visible foreign matter Unqualified phenomenon
[0014] ① Oxytocin is a polypeptide biochemical drug with poor stability in aqueous solution. During the production process of oxytocin freeze-dried preparations, it must first be formulated into an aqueous solution, and then filled until the end of freeze-drying. Oxytocin is in a non- In the dry state, the freeze-drying time is too long, the oxytocin is in the non-dry state for a long time, the product quality is unstable, and the content is reduced. At the same time, the freeze-drying time is long, the energy consumption is greater, and the production cost is higher;
During the preparation process of the medicinal solution, the pH value of the medicinal solution is controlled within the range of 3.0-4.5, but the pH value of the reconstitution of the medicinal solution after freeze-drying is often higher than 4.5, which may be due to the pH regulator glacial acetic acid in the freeze-drying process. It is volatile and causes the pH value of the reconstitution of the drug solution after freeze-drying to increase significantly, so that it exceeds the standard range;
[0016] ③The content of oxytocin injection sometimes fluctuates greatly (sometimes more than 8%) and is prone to visible foreign matter unqualified phenomena during the process of delivery (especially when there is a cross between the northern and southern regions) and storage.
[0017] At present, there is only oxytocin injection (CN201210111807.3) in the drug market. Visible foreign matter inspection also exists through the purchase of samples; although the oxytocin freeze-dried powder injection has a drug registration number, it is not currently sold in the domestic market. It is understood that it may be because the product quality cannot fully meet the national drug standards

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  • A kind of injection containing oxytocin pharmaceutical composition and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: Injection containing oxytocin pharmaceutical composition (batch number 111218; output 10000 bottles)

[0044] 1. Composition of raw materials: equivalent to 100 mg of oxytocin, 100 mg of cysteine ​​hydrochloride, and 10,000 ml of water for injection in terms of potency.

[0045] 2. Preparation method:

[0046] 1) Preparation process operation process:

[0047] Dissolve the prescribed amount of cysteine ​​hydrochloride in a stainless steel barrel, add 5000ml of water for injection, add 2‰ activated carbon, stir for 15 minutes, filter and decarbonize, and cool to below 25°C to obtain solution ①.

[0048] Add the prescribed amount of oxytocin solution to solution ①, and stir for 15 minutes to obtain solution ②.

[0049] Make up the volume of the solution ② to the total amount with cold water for injection, adjust the pH value to 3.5 (the pH regulator is 5% cysteine ​​hydrochloride solution), filter it through a 0.22 μm pore size sterile filter to the storag...

Embodiment 2

[0058] Embodiment 2: Injection containing oxytocin pharmaceutical composition (batch number 111220; output 10000 bottles)

[0059] 1. Composition of raw materials: oxytocin: 250mg; cysteine ​​hydrochloride: 250mg; add water for injection to 10000ml.

[0060] 2. Preparation method:

[0061] 1) Preparation process operation process:

[0062] Dissolve the prescribed amount of cysteine ​​hydrochloride in a stainless steel barrel, add 5000ml of water for injection, add 2‰ activated carbon, stir for 15 minutes, filter and decarbonize, and cool to below 25°C to obtain solution ①.

[0063] Add the prescribed amount of oxytocin solution to solution ①, and stir for 15 minutes to obtain solution ②.

[0064] Make up the volume of the solution ② to the total amount with cold water for injection, adjust the pH value to 3.8 (the pH regulator is 5% cysteine ​​hydrochloride solution), filter it through a 0.22 μm pore size sterile filter to the storage tank, and pass the inspection of the sem...

Embodiment 3

[0073] Embodiment 3: Injection containing oxytocin pharmaceutical composition (batch number 111222; output 10000 bottles)

[0074] 1. Raw material composition: oxytocin: 500mg; cysteine ​​hydrochloride 500mg; water for injection to 10000ml.

[0075] 2. Preparation method:

[0076] 1) Preparation process operation process:

[0077] Dissolve the prescribed amount of cysteine ​​hydrochloride in a stainless steel barrel, add 5000ml of water for injection, add 2‰ activated carbon, stir for 15 minutes, filter and decarbonize, and cool to below 25°C to obtain solution ①.

[0078] Add the prescribed amount of oxytocin solution to solution ①, and stir for 15 minutes to obtain solution ②.

[0079] Make up the volume of the solution ② with cold water for injection to the total amount, adjust the pH value to 4.0 (the pH regulator is 5% cysteine ​​hydrochloride solution), filter it through a 0.22 μm pore size sterile filter to the storage tank, and pass the inspection of the semi-finishe...

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Abstract

The invention relates to an injection of a pharmaceutical composition containing oxytocin and a preparation method thereof. The raw materials of the injection contain the following components: oxytocin, cysteine ​​hydrochloride and water for injection. In the production process of injections, in addition to active ingredients, the less auxiliary materials are selected, the better. Cysteine ​​hydrochloride is used in the liquid preparation process of the present invention as a freeze-drying excipient to make freeze-drying shape, and as an antioxidant Oxytocin plays a protective role, thereby improving product stability and ensuring product quality.

Description

technical field [0001] The invention relates to a preparation of oxytocin, in particular to an injection containing a pharmaceutical composition of oxytocin and a preparation method thereof. Background technique [0002] Oxytocin, also known as oxytocin, oxytocin acetate, oxytocin tartrate, synthetic oxytocin, 3-isoleucine-8-leucine, its active ingredient is extracted from the posterior pituitary gland of pigs or cattle or Chemically synthesized nonapeptide. The chemical structural formula is a peptide chain composed of 9 amino acids containing disulfide bonds, H-Cys-Tyr-Ile-Glu (NH 2 )-Asp(NH 2 )-Cys-Pro-Leu-Gly-NH 2 . [0003] Oxytocin is a uterotonic drug. It can stimulate the contraction of uterine smooth muscle, simulating the uterine contraction of normal childbirth, resulting in dilation of the cervix. Breast discharge, but does not increase mammary gland milk secretion. It is mainly used for uterine bleeding caused by induction of labor, oxytocin, postpartum a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/08A61K47/18A61P15/04A61J3/02
Inventor 尹双青吉民刘永宏
Owner MAANSHAN BBCA PHARMA