Insulin nanoparticle and preparation method thereof

A technology of insulin and nanoparticles, which is applied in the field of medicine, can solve the problems of low drug encapsulation efficiency and drug loading, and achieve the effects of increasing drug bioavailability, absorption, and stability

Active Publication Date: 2012-08-01
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Therefore, in order to prepare pharmaceutical preparations that can be applied clin...

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
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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 solution with a concentration of 2.5 mg / ml. Add the DOC solution to the recombinant human insulin solution according to the molar ratio of DOC to recombinant human insulin of 4:1, add slowly and shake continuously, and a white precipitate will precipitate out as recombinant human insulin-sodium deoxycholate ion pair complex things. 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 obtained by free...

Embodiment 2

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

[0124] Dissolve 100mg of insulin in HCl solution with a pH value of 2.5 to obtain an insulin solution with a concentration of 8.4mg / ml, and dissolve another 60mg of DOC in water to obtain a DOC solution with a concentration of 0.7mg / ml. The molar ratio of the DOC solution was added to the insulin solution at a ratio of 8:1, slowly added dropwise and constantly shaken, and a white precipitate was precipitated as an insulin-sodium deoxycholate ion-pair complex; the white precipitate obtained above was statically 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 100mg insulin and 35mg SDS and dissolve them in HCl solution with a pH value of 2.5 to prepare an insulin solution with a concentration of 9.1mg / ml and an SDS solution with a concentration of 2.1mg / ml. The molar ratio of SDS to insulin is 6:1 Add the SDS solution to the insulin solution, add it dropwise slowly and shake it continuously, and the white precipitate is precipitated as insulin-sodium dodecyl sulfate ion-pair complex. The white precipitate obtained above is left to stand. Centrifuge the solution, take the precipitate, and use 0.01mol·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 diabetes treatment drugs. For patients with type I diabetes (accounting for about 10% of all diabetes), insulin is the only treatment drug; f...

Claims

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Application Information

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