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Somatostat in prepn. for injection use, and its prepn. method

A technology of somatostatin and preparation process, which is applied in the direction of endocrine system diseases, active ingredients of esters, pharmaceutical formulas, etc., can solve problems affecting the health of infusion people, pollution particles, allergies, pyrogens, tumor-like reactions, etc. Achieve the effects of easy production operation and control, guaranteed stability, simple prescription and production process

Inactive Publication Date: 2005-01-05
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The Chinese patent document "Somatostatin Freeze-dried Powder Injection and Its Preparation Technology" (publication number: CN1415378A) provides a technology for preparing somatostatin freeze-dried powder injection using activated carbon adsorption and membrane filtration technology, which has the following defects : 1. Since the activated carbon is charged, it can pass through the filter rod and filter membrane, and after entering the infusion, it is dispersed in the water for injection to form a colloidal solution, so that the preparation is polluted with new particulate impurities, which cannot be metabolized in the body, so it can cause Granuloma, pulmonary edema, phlebitis, thrombosis, tissue necrosis, allergies, pyrogens, tumor-like reactions and other reactions seriously affect the health of the infusion population

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The whole preparation process is carried out under the partial 100-level clean area in the 10,000-level clean area.

[0042] Accurately weigh 250 mg of somatostatin acetate raw material and 5000 mg of mannitol according to the formulation prescription, place the mannitol in a sterilized beaker, stir thoroughly with 800 ml of water for injection to dissolve it, and use an ultrafilter with a molecular cut-off value of 10,000. Perform ultrafiltration to remove substances above 10,000 molecular weight. Add somatostatin acetate to the resulting ultrafiltrate, stir to fully dissolve it, then adjust the pH to 5.5 with a pH regulator, add water for injection to 1000ml, and then use it. The 0.22μm sheet filter of bacteria is filtered and sterilized. After sampling, the filtrate is sampled, and after all indicators are qualified, the filtrate is divided into 2ml vials at 1ml / piece, and a total of 1000 bottles are obtained, and then put into a freeze dryer for freeze-drying ( See belo...

Embodiment 2

[0054] The whole preparation process is carried out under the partial 100-level clean area in the 10,000-level clean area.

[0055]Accurately weigh 3000mg of somatostatin acetate raw material and 5000mg of lactose according to the formulation prescription, place the lactose in a sterilized beaker, stir thoroughly with 800ml of water for injection to dissolve it, and perform ultrafiltration with an ultrafilter with a molecular cut-off value of 10000 , To remove substances above 10,000 molecular weight, the resulting ultrafiltrate is adjusted to pH 5.5 with a pH regulator, and water for injection is added to 1000ml, and then filtered and sterilized with a sterilized 0.22μm sheet filter. The filtrate is sampled and inspected. After the index is qualified, 1ml / piece, divided into 2ml vials, a total of 1000 bottles, and then put into the freeze dryer for freeze-drying (see below for the freeze-drying curve), freeze and dry for about 24 hours, then press the cap. Got.

[0056] The freez...

Embodiment 3

[0067] The whole preparation process is carried out under the local level of 100 in the 10,000-level clean area.

[0068] Accurately weigh 250 mg of somatostatin acetate raw material and 5000 mg of dextran according to the preparation prescription, place the dextran in a sterilized beaker, stir it with 800 ml of water for injection to dissolve it, and use a molecular cut-off value of more than 10,000 molecular weight The ultrafilter is used for ultrafiltration to remove substances above 10,000 molecular weight. The resulting ultrafiltrate is adjusted to pH 6.0 with a pH regulator, and water for injection is added to 1000ml, and then sterilized by filtration with a sterilized 0.22μm sheet filter. After sampling the filtrate, after all the indicators are qualified, it is divided into 2ml vials at 1ml / cylinder, a total of 1,000 bottles are obtained, and then put into a freeze dryer for freeze-drying (see the freeze-drying curve below), freeze and dry about 24 After ~36 hours, the cap...

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PUM

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Abstract

A somatostatin injection is prepared by ultrafilter technique and features high purity, solubility and stability.

Description

Technical field [0001] The invention relates to the field of medicine and pharmacy, in particular to a somatostatin preparation for injection and a preparation process thereof. Background technique [0002] Somatostatin (Somatostatin), namely growth hormone release inhibitor (SRLF, GH-RIF), is an endogenous regulatory hormone that exists in the human body. Somatostatin is composed of two kinds of fourteen peptides or twenty eight peptides in the body. Exist in the form, both have physiological activity, mainly for a wide range of inhibitory effects on a variety of physiological functions, such as inhibition of exocrine, gastrointestinal motility, visceral bleeding, etc., and can go through a variety of ways, including endocrine, paracrine and autocrine Play its role. Because of the potentially important medical value of somatostatin, it is quite difficult to extract endogenous somatostatin from the human body. Therefore, the design and synthesis of somatostatin and its analogues ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/22A61P5/00
Inventor 赵晨刘伟强
Owner 上海华源药业(宁夏)沙赛制药有限公司
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