Hydrogen-containing enteric drug and preparation method thereof

Abstract

The invention relates to the technical field of medicine, in particular to a hydrogen-containing enteric drug and a preparation method thereof.The hydrogen-containing enteric drug comprises an inner drug core and an outer enteric coating, the outer enteric coating enables the porous starch drug core adsorbing a large number of hydrogen molecules to completely pass through the stomach, and the porous starch drug core disintegrates or dissolves and releases a large number of hydrogen molecules until the porous starch drug core enters the intestine, so that the hydrogen-containing enteric drug is prepared. Due to the fact that the whole hydrogen release process is slow, hydrogen adsorbed in gaps of the porous starch can effectively enter intestinal juice, the hydrogen utilization rate and the single-time hydrogen release amount are greatly increased, then the hydrogen concentration of blood and the hydrogen concentration of the liver are increased, the manufacturing process is simple, and the cost is low.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technologies, and specifically provides a hydrogen-containing enteric-coated drug and a preparation method thereof. Background Art

[0002] Hydrogen biomedicine has also been highly recognized in the global medical field. Hydrogen therapy belongs to etiological treatment rather than symptomatic treatment, and it solves problems fundamentally from the root cause of disease occurrence. Hydrogen therapy has broad application prospects. Currently, the main ways for the human body to absorb hydrogen molecules mainly include two ways: inhaling hydrogen and drinking hydrogen water. However, research shows that the metabolism of hydrogen molecules and their therapeutic effects on the human body are likely to be achieved after being absorbed by the intestine and entering the blood and liver. Obviously, it is difficult to achieve the above hydrogen molecule absorption process by inhaling hydrogen. When drinking hydrogen water, it first enters the stomach. Due to the acidic environment in the stomach, it is easy to cause the release of dissolved hydrogen, and hydrogen molecules are not easily transported to the intestine. Patent 202110015201.9 provides a hydrogen-containing capsule and a preparation method thereof. This patent uses a capsule shell to encapsulate hydrogen as a whole, and claims to have the advantages of controllable hydrogen content, high stability, convenient dosage use, and suitability for large-scale production. The invention content part of this patent mentions that this technology uses gelatin, hydroxypropyl methylcellulose, seaweed polysaccharide, pectin, or carboxymethyl cellulose as the main components of the capsule shell. Obviously, the above main components are the main components of gastric-soluble capsule shells. Therefore, the main goal of this technology is to directly transport hydrogen to the stomach and release hydrogen in the stomach by encapsulating hydrogen with a capsule structure. However, as analyzed above, hydrogen molecules reaching the stomach are not easily transported to the intestine. In addition, due to hydrogen supply by capsules, after the hydrogen capsules enter the stomach, the capsule shell quickly dissolves and breaks, and the internal hydrogen quickly releases in the form of gas and cannot be dissolved in gastric juice, and then is quickly discharged through "hiccupping". The absorption rate of hydrogen is even lower than quickly drinking high-concentration hydrogen-rich water.

[0003] In view of this, the present invention provides a hydrogen-containing enteric-coated drug and a preparation method thereof. Through external enteric coating, the porous starch drug core adsorbed with a large number of hydrogen molecules can completely pass through the stomach and only disintegrate or dissolve until it reaches the intestine, releasing a large number of hydrogen molecules. Since the entire hydrogen release process is slow, the hydrogen adsorbed in the pores of the porous starch can effectively enter the intestinal fluid, greatly improving the hydrogen utilization rate and the single hydrogen release amount, thereby increasing the hydrogen concentration in the blood and liver, and the production process is simple and the cost is low. Summary of the Invention

[0004] The purpose of the present invention is to provide a hydrogen-containing enteric-coated drug and a preparation method thereof to solve the problems raised in the above background art.

[0005] To achieve the above purpose, the present invention provides the following technical solutions:

[0006] A hydrogen-containing enteric-coated drug and its preparation method, characterized in that it comprises an internal drug core and an external enteric coating;

[0007] Among them, the internal drug core is porous starch; the external enteric coating is one or a combination of several of acrylic resin, cellulose acetate phthalate, and hydroxypropyl methylcellulose phthalate, and its function is to enable the internal drug core to pass through the stomach intact and only disintegrate or dissolve until it reaches the intestine;

[0008] Among them, the internal drug core of the hydrogen-containing enteric-coated drug is prepared by ultrasonic irradiation method, spraying method, drum method, extrusion method, alcohol denaturation method, acid hydrolysis method, and enzymatic hydrolysis method, and the internal drug core is placed in an environment with a hydrogen partial pressure > 0.05 MPa after preparation;

[0009] Among them, the coating process of the hydrogen-containing enteric-coated drug is to spray the atomized coating solution onto the surface of the drug core in a rotating cavity. The rotating cavity is provided with an air inlet and an air outlet; a gas with a temperature > 40 °C and a hydrogen partial pressure > 0.05 Mpa enters the rotating cavity through the air inlet and then exits the rotating cavity through the air outlet to dry the surface of the drug core until the enteric coating thickness on the surface of the drug core > 2 μm;

[0010] Furthermore, the surface of the porous starch is covered with small holes with a diameter of 1 μm - 500 μm, and the total volume of the voids accounts for a proportion > 10% of the particle volume.

[0011] Furthermore, when hydrogen needs to be released in the stomach, enteric coating can be performed on the surface of the drug core.

[0012] Compared with the prior art, the beneficial effects of the present invention are: through the external enteric coating, the porous starch drug core adsorbed with a large number of hydrogen molecules can pass through the stomach intact and only disintegrate or dissolve until it reaches the intestine, releasing a large number of hydrogen molecules. Since the entire hydrogen release process is slow, the hydrogen adsorbed in the pores of the porous starch can effectively enter the intestinal juice, greatly improving the hydrogen utilization rate and the single hydrogen release amount, thereby enhancing the hydrogen concentration in the blood and liver, and the production process is simple and the cost is low. Description of the Drawings

[0013] Figure 1 It is a schematic diagram of the coating process of the present invention.

[0014] Reference numerals in the figure: 1 is the rotating cavity, 2 is the air inlet, 3 is the air outlet, 4 is the drug core, and 5 is the coating solution spray nozzle. Detailed Embodiments

[0015] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0016] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be understood as a limitation to the present invention.

[0017] In the description of this patent, it should be noted that unless otherwise clearly specified and limited, the terms "installation", "connection", "connection", "setting" should be understood in a broad sense. For example, it can be fixedly connected and set, or detachably connected and set, or integrally connected and set. For those of ordinary skill in the art, the specific meanings of the above terms in this patent can be understood according to specific circumstances. In the description of the present invention, the meaning of "plurality" is two or more, unless otherwise clearly specifically limited.

[0018] Please refer to Figure 1 as shown, Example 1 of a hydrogen-containing enteric-coated drug and its preparation method provided by the present invention:

[0019] Each 300 mg of porous starch drug core to be coated is taken out from a hydrogen storage tank with a purity of 99.9% and a pressure of 0.15 Mpa (it has been placed for 30 minutes). Each porous starch drug core reaches an adsorption equilibrium with hydrogen in the hydrogen storage tank, and each can adsorb about 6 mg of hydrogen, which is equivalent to drinking 3.75 L of saturated hydrogen-rich water (1.6 mg / L).

[0020] The above-mentioned porous starch drug core is placed into the slowly rotating rotating cavity 1; hydrogen with a purity of 99.9%, a temperature of 45 °C, and a pressure of 0.15 Mpa enters the rotating cavity 1 from the air inlet 2 and then exits the rotating cavity 1 through the air outlet 3; the hydroxypropyl methylcellulose phthalate solution is atomized by the coating solution spray nozzle 5 and then sprayed onto the surface of the drug core 4. The hydroxypropyl methylcellulose phthalate gradually dries on the surface of the drug core 4 until the thickness of the enteric coating on the surface of the drug core reaches 20 μm, and the hydrogen-containing enteric-coated drug is prepared.

[0021] When taking the above-mentioned hydrogen-containing enteric-coated drug, the drug enters the gastric juice. Due to the existence of the surface enteric coating, the drug can pass through the stomach intact and does not disintegrate until it reaches the intestine. During the disintegration process, the hydrogen molecules dissolved in the pores of the inner porous starch drug core are slowly released. Due to the large surface area of the gas-liquid interface during the slow release process, hydrogen can be dissolved in the intestinal juice, enabling the human body to effectively absorb and utilize hydrogen.

[0022] Compared with the prior art, the beneficial effects of the present invention are as follows: The porous starch drug core adsorbed with a large number of hydrogen molecules can pass through the stomach intact through the external enteric coating and does not disintegrate or dissolve until it reaches the intestine, releasing a large number of hydrogen molecules. Since the entire hydrogen release process is slow, the hydrogen adsorbed in the pores of the porous starch can effectively enter the intestinal juice, greatly improving the hydrogen utilization rate and the single hydrogen release amount, thereby increasing the hydrogen concentration in the blood and liver. Moreover, the production process is simple and the cost is low.

[0023] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. The above embodiments and the descriptions in the specification are only preferred examples of the present invention and are not used to limit the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of the present invention claimed is defined by the appended claims and their equivalents.

Claims

1. A hydrogen-containing enteric-coated drug and its preparation method, characterized in that, It includes an internal drug core and an external enteric coating; Among them, the internal drug core is porous starch; the external enteric coating is a combination of one or more of acrylic resin, cellulose acetate phthalate, and hydroxypropyl methylcellulose phthalate, and its function is to enable the internal drug core to pass through the stomach intact and only disintegrate or dissolve until it reaches the intestine; Among them, the internal drug core of the hydrogen-containing enteric drug is prepared by ultrasonic irradiation method, spraying method, drum method, extrusion method, alcohol denaturation method, acid hydrolysis method, and enzymatic hydrolysis method, and the internal drug core is placed in an environment with a hydrogen partial pressure > 0.05 MPa after preparation; Among them, the coating process of the hydrogen-containing enteric drug is to spray the atomized coating solution onto the surface of the drug core in the rotating cavity. The rotating cavity is provided with an air inlet and an air outlet; a gas with a temperature > 40 °C and a hydrogen partial pressure > 0.05 Mpa enters the rotating cavity through the air inlet and then exits the rotating cavity through the air outlet to dry the surface of the drug core until the enteric coating thickness on the surface of the drug core > 2 μm.

2. The hydrogen-containing enteric-coated drug and its preparation method according to claim 1, characterized in that, The surface of the porous starch is covered with small holes with a diameter of 1 μm - 500 μm, and the total volume of the voids accounts for a proportion > 10% of the particle volume.

3. The hydrogen-containing enteric-coated drug and its preparation method according to claim 1, characterized in that: When hydrogen needs to be released in the stomach, enteric coating can be performed on the surface of the drug core.

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