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Insulin nanoparticle and preparation method thereof

An insulin and nanoparticle technology, applied in the field of medicine, can solve the problems of low drug encapsulation rate and drug load, and achieve the effects of increasing drug bioavailability, increasing stability, and mild preparation conditions

Active Publication Date: 2014-12-17
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in order to prepare pharmaceutical preparations that can be applied clinically, the problem of low drug encapsulation efficiency and drug loading must be solved.

Method used

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  • Insulin nanoparticle and preparation method thereof
  • Insulin nanoparticle and preparation method thereof
  • Insulin nanoparticle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] Example 1: Preparation of recombinant human insulin-sodium deoxycholate complex

[0122] Dissolve 100 mg of recombinant human insulin in HCl solution with a pH value of 2.5 to obtain a recombinant human insulin solution with a concentration of 6.8 mg / ml; another 60 mg of DOC is dissolved in water to obtain a DOC with a concentration of 2.5 mg / ml Solution, according to the molar ratio of DOC and recombinant human insulin is 4:1, add the DOC solution to the recombinant human insulin solution, slowly add it dropwise and shake continuously, and then white precipitate will be precipitated as recombinant human insulin-sodium deoxycholate ion to the complex. The white precipitate obtained above was left to stand, and after the combination was complete, the solution was centrifuged, the precipitate was taken, washed with an appropriate amount of water to remove the free drug and anionic surfactant that might be adsorbed, and the recombinant human insulin complex powder was obta...

Embodiment 2

[0123] Embodiment 2: Preparation of insulin-sodium deoxycholate complex

[0124] Dissolve 100 mg of insulin in HCl solution with a pH value of 2.5 to obtain an insulin solution with a concentration of 8.4 mg / ml, and dissolve another 60 mg of DOC in water to obtain a DOC solution with a concentration of 0.7 mg / ml. Add the DOC solution to the insulin solution at a molar ratio of 8:1, slowly add it dropwise and shake continuously, and a white precipitate will be precipitated as an insulin-sodium deoxycholate ion-pair complex; The precipitate is left standing, and after the combination is complete, the solution is centrifuged, the precipitate is taken, washed with an appropriate amount of water to remove the free drug and anionic surfactant that may be adsorbed, and the insulin complex powder is obtained by freeze-drying.

Embodiment 3

[0125] Embodiment 3: the preparation of insulin-sodium lauryl sulfate complex

[0126] Take 100 mg insulin and 35 mg SDS and dissolve them in HCl solution with a pH value of 2.5 to prepare an insulin solution with a concentration of 9.1 mg / ml and an SDS solution with a concentration of 2.1 mg / ml. According to the molar ratio of SDS to insulin is 6 Add the SDS solution to the insulin solution at a ratio of 1:1, add it dropwise slowly and shake continuously, and a white precipitate will be precipitated as an insulin-sodium dodecyl sulfate ion-pair complex. Afterwards, the solution was centrifuged, and the precipitate was collected with 0.01 mol·l -1 Wash with an appropriate amount of hydrochloric acid solution to remove the free drug and anionic surfactant that may be adsorbed, and freeze-dry to obtain the insulin complex powder.

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Abstract

The invention relates to the technical field of drugs, and especially relates to an insulin nanoparticle and a preparation method thereof. The preparation method comprises the following steps: preparation of an insulin ion pair compound and preparation of the insulin nanoparticle. According to the insulin nanoparticle of the invention, the entrapment rate and the drug loading are high, the particle size distribution is uniform, and a certain slow releasing effect is possessed, so drugs can be effectively prevented from being degraded by proteases, the stability of the drugs can be increased, and a case that the drugs permeate a biomembrane is promoted, thereby curative effects of the drugs are improved, the toxicity of the drugs is reduced, the biological utilization degree of the drugs is increased, and the insulin nanoparticle is suitable for various administration approaches of the drugs; preparation conditions are mild, no violent conditions of high temperature, and high speed shearing force or the like are needed, so the biological activities of the drugs can be guaranteed; and a surfactant Cremophor EL used in the preparation process can inhibit P-glycoprotein, so the permeability of the drugs going through cell membranes is improved, and the absorption of the drugs going through intestinal tract walls to enter blood is increased.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to an insulin nanoparticle and a preparation method thereof. Background technique [0002] Diabetes is a common chronic metabolic disease caused by insulin deficiency or resistance in the human body. Diabetes is very harmful to human health and can lead to serious complications such as cardiovascular disease, dyslipidemia, blindness, renal failure and amputation. It has become the fourth leading cause of death in the global population. According to the estimates of the International Diabetes Federation (IDF), the number of diabetic patients in my country was about 39.8 million in 2007, most of whom were type II diabetic patients, accounting for about 90% to 95% of the diagnosed cases of diabetes. [0003] Insulin is one of the most effective drugs for diabetes treatment. For patients with type I diabetes (about 10% of all diabetes), insulin is the only drug for treatment; for pati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/00A61K47/34A61K47/48A61P3/10A61K9/14
Inventor 徐雄良张洪宇梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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