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Production method of insulin oral sustained-release preparation

A technology of oral preparations and insulin, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of subcutaneous fat atrophy, inconvenience and pain of patients, and achieve mild conditions and form Controllable appearance and improved bioavailability

Active Publication Date: 2015-04-08
YANGZHOU UNIV
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Problems solved by technology

However, subcutaneous injection will cause subcutaneous fat atrophy, which will bring inconvenience and pain to patients

Method used

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  • Production method of insulin oral sustained-release preparation
  • Production method of insulin oral sustained-release preparation
  • Production method of insulin oral sustained-release preparation

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Embodiment Construction

[0027] 1. Preparation process

[0028] 1. Synthesis of PEGylated Chitosan

[0029] Weigh 1g CS (CS is chitosan, molecular weight 500000), dissolve it in 6 ml acetic acid, the volume concentration (v / v) of acetic acid is 2%, dilute it with 20 ml TEMED HCL, add it into a three-necked flask, and measure the pH The value is about 5, then add a certain amount of EDC and NHS, after 30 minutes, weigh mPEG-COOH according to the molar ratio of mPEG-COOH:CS=1:1, add it to a three-necked flask, keep the constant temperature water bath at 35°C, and stir for 36 hours. pH 4-6 was controlled during the reaction.

[0030] The obtained crude product was placed in a dialysis bag for dialysis for 4 days, and freeze-dried to obtain PEGylated chitosan.

[0031] 2. Preparation of Insulin-Loaded PEGylated Chitosan Microspheres

[0032] (1) Take a certain amount of PEG-CS (polyethylene glycolated chitosan) and TPP (sodium tripolyphosphate) and dissolve them in distilled water respectively to obtai...

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Abstract

The invention provides a production method of an insulin oral sustained-release preparation and belongs to the technical field of biological medicines. According to the production method, pegylated chitosan (PEG-CS) is taken as an encapsulating material and insulin-loaded pegylated chitosan microspheres are prepared by use of an ionic gel method; in other words, firstly, the PEG-CS solution of a certain concentration is mixed with an insulin solution, low-concentration sodium tripolyphosphate (TPP) of a low concentration is added dropwise under magnetic stirring, the pH is regulated to 5.5 by use of hydrochloric acid, after the reaction is completed, the suspension is centrifuged and then the microspheres are just collected. The production method is simple and mild in conditions; the obtained microspheres are good in biocompatibility, can be stably released in a simulated intestinal fluid for 7 days, and have a sustained-release function; besides, the biological activity of the medicine can be guaranteed, and the oral medication of the insulin is expected to be realized.

Description

technical field [0001] The invention relates to a method for encapsulating insulin, in particular to a preparation method for insulin slow-release oral preparations, and belongs to the technical field of biomedicine. Background technique [0002] Basal insulin is the main drug for the treatment of diabetes, and it plays an important role in the treatment of type 1 and type 2 (including other types) diabetes patients. The evaluation of basal insulin therapy in the guidelines of the American Diabetes Association is "the most effective". Subcutaneous injection of insulin has been the main route of administration for diabetic patients since the technology of recombinant human insulin made the wide application of insulin possible. However, subcutaneous injection can cause subcutaneous fat atrophy, which brings inconvenience and pain to patients. In order to overcome the disadvantages of subcutaneous injection, improve patient compliance, and improve patient quality of life, it i...

Claims

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Application Information

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IPC IPC(8): A61K38/28A61K47/34A61K47/36A61K9/16A61K9/50A61P5/48
Inventor 宋晓丽许春兰闫彩凤朱爱萍郭荣
Owner YANGZHOU UNIV
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