阅读说明：本技术 一种止血粉末及其制备方法 (Hemostatic powder and preparation method thereof ) 是由 昝兴杰 史鹏忠 于 2020-04-29 设计创作，主要内容包括：本发明公开了一种止血粉末及其制备方法,其以碳酸盐、多酚为原料制备多酚掺杂碳酸钙颗粒,再通过与凝血酶溶液孵育,用超纯水洗涤、离心、冻干,制得止血粉末。本发明制得的止血粉末,其粒径为0.5-15μm的微米球状颗粒,生物相容性良好,用于外科手术的止血过程,止血效果快速,而且本发明的原材料简单易得,工艺简便,生产成本低,适合于工业化生产,具有广阔的应用前景。(The invention discloses a hemostatic powder and a preparation method thereof, wherein carbonate and polyphenol are used as raw materials to prepare polyphenol-doped calcium carbonate particles, and then the particles are incubated with thrombin solution, washed by ultrapure water, centrifuged and freeze-dried to prepare the hemostatic powder. The hemostatic powder prepared by the invention has micron spherical particles with the particle size of 0.5-15 mu m, good biocompatibility, quick hemostatic effect when being used in the hemostatic process of surgical operation, simple and easily obtained raw materials, simple and convenient process, low production cost, suitability for industrial production and wide application prospect.)

1. A hemostatic powder, comprising: comprises the following components: polyphenols, calcium carbonate and thrombin.

2. Hemostatic powder according to claim 1, wherein: the hemostatic powder has particle size of 0.5-15 μm.

3. Hemostatic powder according to claim 1 or 2, wherein: the polyphenol is one or more of tannic acid, procyanidin, epigallocatechin gallate or gallic acid.

4. A method for preparing a hemostatic powder, comprising: the method comprises the following steps:

(1) mixing a calcium salt solution with the concentration of 0.1-1M and a polyphenol solution with the concentration of 2-50 mg/mL at the temperature of 0-40 ℃, uniformly stirring, then placing under the condition of violent stirring or ultrasonic shaking, quickly adding a carbonate solution with the same molar weight as the calcium salt solution, continuously stirring or ultrasonically treating for 30-60 s, standing the solution for 10-30 min, centrifuging, washing with ultrapure water for three times, and collecting polyphenol-doped calcium carbonate particles;

(2) and (2) moving the particles obtained in the step (1) into a centrifugal tube, adding 0.1-10 kU thrombin solution at the temperature of 0-10 ℃, incubating for 0.5-12 h, centrifuging, washing with ultrapure water for three times, and freeze-drying to obtain the hemostatic powder.

5. The hemostatic powder preparation method of claim 4, wherein: the volume ratio of the calcium salt to the solution of the polyphenol to the solution of the carbonate in the step (1) is as follows: (0.5-1.5): (1-3): (2-4).

6. The hemostatic powder preparation method of claim 4, wherein: the calcium salt in the step (1) is calcium chloride or calcium nitrate; the carbonate is ammonium bicarbonate, sodium carbonate or potassium carbonate.

7. The hemostatic powder preparation method of claim 4, wherein: the violent stirring speed in the step (1) is 450-1500 rpm/min; the frequency of the ultrasonic frequency is 20-60 kHz.

Technical Field

The invention relates to a hemostatic powder and a preparation method thereof, belonging to the technical field of medicines.

Background

The uncontrolled hemorrhage of large blood vessels and the extensive bleeding of wounded tissues in soft tissue wounds in war and peace periods are one of the important causes of death of wounded people. Timely and effective first-aid hemostasis can win precious time for the wounded, and the death rate and disability rate of the wounded are reduced. Therefore, the development of a hemostatic material which is highly effective, can be rapidly absorbed, and can effectively complete hemostasis in a short time is a research and development hotspot of the current hemostatic materials.

Research until now, a number of hemostatic materials have been developed, including fibrin-based glues and sealants, zeolite based dispersions, cross-linked gelatin mechanisms, and the like. They have their own limitations in application, such as the high cost and low mechanical strength of fibrin products, the susceptibility of zeolite minerals to severe burns and not to degradation, and the ability of the cross-linked gelatin matrix to stop bleeding within minutes only when combined with high doses of thrombin. Thrombin is an active hemostatic material, and the principle of hemostasis is to activate the final stage of the physiological coagulation cascade in vivo to form fibrin clot so as to promote blood coagulation. The protease is a prothrombin proteolytic enzyme extracted from human or animal blood, can directly act on fibrinogen in blood plasma, promotes the conversion of the fibrinogen into fibrin, accelerates the blood coagulation on the surface of a wound, and plays a role in stopping bleeding. At present, thrombin hemostasis is widely used for bleeding conditions caused by surgical, digestive and gynecological bleeding. The following problems still remain: (1) the adhesion performance is weak, and thrombin is easily washed away by blood flow under the condition of arterial bleeding or large-area wound bleeding, so that the hemostatic process is difficult to complete quickly; (2) thrombin needs to be preserved in a freezing way and has potential virus source; (3) local or systemic vascular embolism is easily caused during the use process.

As an effective hemostatic material, thrombin needs to be combined with other materials to better exert the advantage that thrombin can rapidly stop bleeding as an active hemostatic material. The calcium carbonate is a very important novel inorganic material, and has the advantages of easily available material sources, low price, safety, no toxicity, no odor, environmental friendliness, wide application, good material dispersibility and the like. Therefore, the prepared calcium carbonate porous material is combined with thrombin to obtain the hemostatic material which can rapidly stop bleeding, can be naturally degraded, is safe to use and has high water absorption.

Disclosure of Invention

The invention aims to provide a hemostatic powder capable of rapidly stopping bleeding, which comprises the components of polyphenol, calcium carbonate and thrombin. The powder has good biocompatibility, is safe and degradable, and can efficiently complete hemostasis within one minute.

It is further set that the particle size of the hemostatic powder is 0.5-15 μm.

Further provided that the polyphenol is one or more of tannic acid, procyanidins, epigallocatechin gallate or gallic acid.

It is another object of the present invention to provide a method for preparing a powder that rapidly stops bleeding.

The method specifically comprises the following steps:

(1) mixing a calcium salt solution with the concentration of 0.1-1M and a polyphenol solution with the concentration of 2-50 mg/mL at the temperature of 0-40 ℃, uniformly stirring, then placing under the condition of violent stirring or ultrasonic shaking, quickly adding a carbonate solution with the same molar weight as the calcium salt solution, continuously stirring or ultrasonically treating for 30-60 s, standing the solution for 10-30 min, centrifuging, washing with ultrapure water for three times, and collecting polyphenol-doped calcium carbonate particles;

(2) and (2) moving the particles obtained in the step (1) into a centrifugal tube, adding 0.1-10 kU thrombin solution at the temperature of 0-10 ℃, incubating for 0.5-12 h, centrifuging, washing with ultrapure water for three times, and freeze-drying to obtain the hemostatic powder.

Further setting the volume ratio of the calcium salt, the polyphenol and the carbonate in the step (1) as follows: (0.5-1.5): (1-3): (2-4).

Further setting the calcium salt in the step (1) as calcium chloride or calcium nitrate; the carbonate is ammonium bicarbonate, sodium carbonate or potassium carbonate.

Further setting that the violent stirring speed in the step (1) is 450-1500 rpm/min; the frequency of the ultrasonic frequency is 20-60 kHz.

The hemostatic powder provided by the invention has good biocompatibility, is used for the hemostatic process of surgical operation, has a quick hemostatic effect, and has a wide application prospect. Meanwhile, the preparation method has the advantages of simple and easily-obtained raw materials and simple process steps, and is suitable for industrial production.

The invention is further described with reference to the drawings and the detailed description.

Drawings

FIG. 1 is a scanning electron micrograph of the hemostatic powder of example 1.

Detailed Description

The present invention is described in detail below with reference to examples, which are intended to be illustrative only and not to be construed as limiting the scope of the invention, and many insubstantial modifications and variations of the invention can be made by an engineer skilled in the art based on the teachings of the invention.