WO2021199792A1 - Formulation for preventing or treating pneumonia - Google Patents

Abstract

One formulation 100 for preventing or treating pneumonia, according to the present invention, contains silicon particles and/or silicon fine particles having a hydrogen generation ability. One formulation for preventing or treating pneumonia, according to the present invention, can contribute to the prevention or treatment of pneumonia including various intractable diseases.

Description

Prophylactic or therapeutic preparation for pneumonia

The present invention relates to a pharmaceutical product for the prevention or treatment of pneumonia.

The application of hydrogen is widespread, and there are many expected applications. As an example, there are presentations related to growth and subjects caused by oxidative stress. For example, in the human body, there is active oxygen derived from oxygen produced in the intracellular mitochondria by metabolism and subcutaneously under ultraviolet irradiation and taken in from the lungs. While active oxygen is necessary for life support, it is known to oxidize and damage the cells that make up the living body. In particular, the herodoxyl radical, which has the strongest oxidizing power among active oxygen species, is thought to cause various diseases such as cancer, stroke, myocardial infarction, diabetes and other lifestyle-related diseases, and skin disorders such as skin aging and dermatitis. Therefore, it is desirable to prevent excess active oxygen, especially herodoxyl radicals, which have not been used in reactions beneficial to the living body, from being present in the body as much as possible.

Taking only the oxidative stress in the body, the hydroxyl radical generated in the body disappears by reacting with some substances. As an example of a substance that eliminates hydroxyl radicals, an antioxidant substance in the living body such as polyphenol, vitamin C, α-tocopherol, or glutathione is generally presumed. However, since these substances eliminate not only hydroxyl radicals but also active oxygen having a function in the body such as hydrogen peroxide, there is a possibility of causing adverse effects (side effects) such as a decrease in immunity. It is also known that hydrogen can also extinguish hydroxyl radicals. However, since hydrogen reacts only with hydroxyl radicals in active oxygen, it does not have the above-mentioned adverse effects (side effects). Therefore, a hydrogen water generator containing hydrogen that eliminates hydroxyl radicals in the body has been proposed (for example, Patent Document 1).

However, the solubility of hydrogen (H ₂ ) in water at 25 ° C. is extremely low at 1.6 ppm, and hydrogen in hydrogen water easily diffuses into the air. Therefore, in order to take in the amount of hydrogen required to eliminate hydroxyl radicals into the body, it is necessary to keep the dissolved hydrogen concentration of hydrogen water high. Therefore, it is not possible to take in a sufficient amount of hydrogen into the body to react with the hydroxyl radicals in the body by the method of ingesting hydrogen water. Therefore, in order to facilitate the uptake of hydrogen into the body, a hydrogen-containing composition containing hydrogen and a surfactant has been proposed (Patent Document 2), but the hydrogen concentration cannot be maintained high in the body for a long period of time. .. Hydroxyl radicals are highly reactive, quickly oxidize cells, and are constantly generated in vivo. Therefore, in order to eliminate them, it is necessary to constantly supply a high concentration of hydrogen to the body.

Based on the above background, an orallyable solid preparation containing silicon fine particles as a main component and having a high hydrogen generating ability is disclosed (Patent Document 3). In addition, some of the present inventors have disclosed agents for kidney diseases, which include silicon fine particles capable of generating hydrogen, aggregates of the silicon fine particles, or silicon crystal grains. (Patent Document 4). _{In addition, the silicon microparticles and the silicon suboxide (SiO X} , x in the formula is 1/2, 1, and 3/2) and / or the silicon sub covering at least a part of the surface of the silicon fine particles. A composite material containing a mixed composition of oxide and silicon dioxide is disclosed (Patent Document 4).

Japanese Patent No. 5514140 JP-A-2015-113331 International Publication WO2017 / 130709 International Publication WO2019 / 021769 International Publication WO2019 / 211960 International Publication WO2018 / 037752 International Publication WO2018 / 037818 Gazette International Publication WO2018 / 037819

Matsuda et al., "Water Decomposition and Hydrogen Concentration by Silicon Nanoparticles, Proceedings of the 62nd JSAP Spring Meeting, 2015, 12-031 Fujie et al., Hydrogen generation by reaction between silicon nanoparticles and water in the neutral region, Proceedings of the 64th JSAP Spring Meeting, 2015, 15a-421-6

However, even if hydrogen water is ingested, the maximum amount of hydrogen contained in 1 liter of hydrogen water at 25 ° C is only 18 ml in terms of gas. In addition, hydrogen is the smallest molecule, is light, and has a high diffusion rate, so that it cannot be completely stored in a container containing the hydrogen water. To explain an example of use in a living body as an example, most of hydrogen in hydrogen water is gasified in the stomach. Therefore, there is a problem that a sufficient amount of hydrogen is not taken into the body and causes a belching symptom (so-called "belching"). Therefore, according to publicly known information, it is impossible to maintain a high hydrogen concentration in the body for a long period of time by ingesting hydrogen water, and to continuously ingest a large number of times intermittently for a long period of time. On the other hand, when a hydrogen-containing composition containing hydrogen by a surfactant is ingested, it is impossible to take in a sufficient amount of hydrogen into the body by ingesting the hydrogen-containing composition for a long period of time. In addition, the above-mentioned problem that hydrogen is released in the stomach may occur. Furthermore, if it is used on the skin, it will be used in the atmosphere, so it will diffuse and scatter in the atmosphere in a short time due to the diffusion rate of hydrogen, which is much higher than in the body, so it is difficult to absorb it through the skin. It becomes. Further, regarding the generation of hydrogen using the silicon fine particles disclosed so far, there is still room for improvement in at least the amount and rate of hydrogen generation.

In addition, as described above, some of the present inventors have hitherto used a drug for a kidney disease, which comprises silicon fine particles capable of generating hydrogen, an aggregate of the silicon fine particles, or silicon crystals. However, it has not been known or tested that silicon particles or silicon fine particles can serve as a preventive or therapeutic preparation for pneumonia.

The present invention is classified as an intractable disease that has not been realized so far by solving at least one of the above-mentioned technical problems and creating a new utilization method of the hydrogen generating ability of silicon particles or silicon fine particles. It can greatly contribute to the realization of preventive or therapeutic preparations for various pneumonia including idiopathic interstitial pneumonia and pulmonary fibrosis.

The present inventor has conducted extensive studies and analysis toward the realization of a pharmaceutical product for the prevention or treatment of human pneumonia by utilizing a substance having a high hydrogen generating ability (producing ability). Regarding the generation of hydrogen, it is necessary to design a substance in consideration of the total amount of hydrogen generated (total amount of hydrogen produced). Therefore, in order to enhance the hydrogen generation ability, the present inventor has made "silicon fine particles" in which particles having an average crystallite diameter of 1 nm or more and less than 1 μm are the main particles. Without limitation, we proceeded with the study and analysis in search of a substance capable of exhibiting high hydrogen generating ability, including "silicon particles" having an average crystallite diameter of 1 μm or more.

Therefore, the present inventor tried to produce silicon particles or silicon fine particles by using a method different from the production methods adopted so far. As one specific example, the different production method is a production method including a classification step for obtaining silicon particles having a relatively large constant particle size after a step of crushing silicon particles.

As a result of proceeding with the above studies and analysis, the present inventor has found that an effective preventive or therapeutic preparation for pneumonia can be realized by using silicon particles and / or silicon fine particles having a hydrogen generating ability. .. In particular, it has been found that by adopting silicon particles having the following characteristics (1), a higher hydrogen generating ability is generated as compared with the conventional one, and it is also useful as an oral preparation.
(1) The ratio of the silicon fine particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon fine particles to all the silicon particles, the silicon fine particles and their aggregates is 5% by mass or less. (More preferably 3% by mass or less, further preferably 1% by mass or less, further preferably 0.5% by mass or less, still more preferably 0.2% by mass or less).

More specifically, by adopting the above (1), the total amount of hydrogen generated (total amount of hydrogen produced) of the silicon particles is remarkably superior to those of the conventional silicon fine particles. The inventor found.

The results of the analysis of the silicon particles of the above (1) by the present inventor will be described in more detail. The silicon fine particles of the above (1) and the aggregates of the silicon fine particles are the silicon particles, the silicon fine particles and the aggregate. Since the abundance ratio of the silicon particles of less than 1 μm and the agglomerates to the whole of the agglomerates is low, the hydrogen generating ability can be maintained high, and the crystallite diameter is kept within a certain range. Stable hydrogen generation ability can be exhibited. In addition, in the case of oral ingestion, deterioration of human texture can be suppressed. In addition, it is possible to prevent the silicon particles from being directly absorbed and invading the blood vessels with high accuracy.

The present invention was created from each of the above viewpoints.

By the way, the "silicon fine particles" in the present application are mainly particles having an average crystallite diameter of 1 nm or more and less than 1 μm. In a narrower sense, the "silicon fine particles" in the present application mainly consist of silicon nanoparticles having an average crystallite diameter of nano-level, specifically, a crystallite diameter of 1 nm or more and 500 nm or less. Further, the "silicon particles" in the present application are mainly particles having an average crystallite diameter of more than 500 nm (more narrowly, 1 μm or more) and 500 μm or less.

Further, in the present application, the "silicon fine particles" are not limited to those in which each silicon fine particles are dispersed, but also have a size of μm order (generally 0.1 μm or more) in which a plurality of silicon fine particles are aggregated. Includes those in the state of forming aggregates. Since each of the above-mentioned numerical ranges of "silicon fine particles" is only an example, the numerical range is not limited. Further, the crystallite diameter is appropriately selected according to the use, usage, required function, etc. of the "silicon fine particles" or "silicon particles".

Further, the "water-containing liquid" in the present application is water or an aqueous solution, and includes, for example, a human digestive tract liquid. The "digestive tract fluid" refers to the fluid in the small intestine and the fluid in the large intestine. Needless to say, the example of the "water-containing liquid" is not limited to the above-mentioned example. Further, the material of the "pH adjuster" in the present application is particularly limited as long as it is a drug (hereinafter, "alkaline agent") capable of adjusting the pH value to an alkaline range of more than 7 (typically, more than 7.4). Not done. It also includes its use on human skin.

When the pharmaceutical product for the prevention or treatment of pneumonia of the present application, which will be described later, is used as a drug for neutralizing active oxygen in vivo, it is preferable to use an alkaline agent approved as a drug (Japanese Pharmacopoeia). Examples of alkaline agents include sodium hydrogen carbonate, sodium carbonate, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium hydrogen carbonate, potassium carbonate, and other medicinal pH adjusters. Among them, sodium hydrogen carbonate, which is the most general-purpose product, is widely used as a pharmaceutical product, and has a plurality of advantages such as a pH value adjusting function required by the present invention and excellent safety and versatility. It is a preferable aspect that any pH adjusting agent has a form that is not decomposed by an acid. In particular, when the pharmaceutical product for the prevention or treatment of pneumonia of the present application is orally ingested, it is preferable to form a form that is not decomposed by gastric acid or is hardly decomposed.

One of the prophylactic or therapeutic formulations for pneumonia of the present invention contains silicon particles capable of generating hydrogen. Then, in a preferred embodiment of the present invention, the ratio of the silicon particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon particles to all the silicon particles, the silicon fine particles, and the aggregates thereof. However, it is 5% by mass or less.

According to the above-mentioned pharmaceutical product for prevention or treatment of pneumonia, the hydrogen generating ability of the silicon particles can contribute to the prevention or treatment of pneumonia including various intractable diseases.

In particular, according to the above-mentioned preferred embodiment of the prophylactic or therapeutic preparation for pneumonia, the following effects (a) and / or (b) can be exhibited.
(A) Increasing the total amount of generation (total amount of production) (b) When taken orally, it is possible to prevent the silicon particles from being directly absorbed and invading blood vessels.

The above-mentioned "pneumonia" includes pneumonia caused by a new coronavirus infection (COVID-19), pneumonia caused by a mutated new coronavirus infection (COVID-19), and a disease designated as an intractable disease in Japan. Includes "idiopathic interstitial pneumonia", drug-induced pneumonia, chronic hypersensitive pneumonia, dust lung, and bacterial pneumonia.

One of the prophylactic or therapeutic formulations of pneumonia of the present invention can contribute to the prevention or treatment of pneumonia including various intractable diseases.

It is a photograph of a tablet showing an example of the preventive or therapeutic preparation for pneumonia of the first embodiment.

An embodiment of the present invention will be described in detail with reference to the accompanying drawings. In this description, common reference numerals are given to common parts throughout the drawings unless otherwise specified. Further, in the figure, the elements of the present embodiment are not necessarily shown according to the scale. In addition, some reference numerals may be omitted in order to make each drawing easier to see.

[1] A preparation for preventing or treating pneumonia and a method for producing the same <first embodiment>
The method for producing the preventive or therapeutic preparation 100 for pneumonia and the preventive or therapeutic preparation 100 for pneumonia according to the present embodiment will be described in detail. FIG. 1 is a photograph of a tablet showing an example of the pharmaceutical product 100 for preventing or treating pneumonia according to the present embodiment. The formulation 100 for the prevention or treatment of pneumonia of the present embodiment is formed so as to be a solid formulation using silicon particles and / or silicon fine particles having a hydrogen generating ability as a starting material. The outer diameter of the prophylaxis or therapeutic preparation 100 for pneumonia of the present embodiment is not limited as long as it has a size that can be adopted as a human oral tablet. An example of a typical outer diameter is a cylindrical mass having a diameter of about 8 mm and a height of about 5 mm.

Further, in a preferred embodiment of the preparation 100 for preventing or treating pneumonia, the silicon fine particles containing silicon particles and / or silicon fine particles and having a crystallite diameter of less than 1 μm and an aggregate of the silicon fine particles. The ratio of all the silicon particles, the silicon fine particles and their aggregates to the aggregates is 5% by mass or less (more preferably 3% by mass or less, still more preferably 1% by mass or less, still more preferably 0. 5% by mass or less, more preferably 0.2% by mass or less).

[Manufacturing method of pharmaceutical product 100 for prevention or treatment of pneumonia]
Next, a method for producing the pharmaceutical product 100 for preventing or treating pneumonia according to the present embodiment will be described.

<Crushing process>
In the present embodiment, for example, commercially available high-purity silicon particle powder (particle size 300 μm or less, purity 99.999%, i-type silicon) is used as a part of the raw material of the pharmaceutical product 100 for the prevention or treatment of pneumonia. In another aspect of the present embodiment, silicon particle powder having a purity higher or lower than the above-mentioned purity can be adopted.

First, a crushing step (first crushing step) is performed on the above-mentioned high-purity silicon particle powder by a crushing process using a cutter by a jet mill method. As one modification of the present embodiment, after the above-mentioned first pulverization step, an additional pulverization step (second pulverization step) using 0.5 mmφ zirconia beads in ethanol is performed in the bead mill method. It is also an embodiment that it is possible to obtain silicon fine particles (silicon nanoparticles) having a typical crystallite diameter) of less than 500 nm. Further, instead of the first pulverization step, a roller mill method, a high-speed rotary pulverization method, or a container-driven mill method is used to form silicon particles having a crystallite diameter of 1 μm or more and 60 μm or less, or a typical crystallite diameter of 500 nm. It is also an aspect that it can be adopted to obtain silicon fine particles (silicon nanoparticles) having a diameter of less than.

In each of the above-mentioned pulverization steps, when the wet treatment is performed, 99% or more ethanol (for example, 99.5 wt%) and a small amount of water (for example, 0.1 wt% or more and 10 wt% or less, more preferably 1 wt%). Adopting a mixed solution with (% more than% 2 wt% or less) is a preferable embodiment from the viewpoint of enhancing the hydrogen generating ability of the finally produced preparation 100 for preventing or treating pneumonia containing silicon particles.

<Classification process>
In a preferred embodiment of the present embodiment, a pulverization step (first pulverization step or second pulverization step) is followed by a classification step. Specifically, the ratio of the silicon fine particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon fine particles to all the silicon particles, the silicon fine particles and their aggregates is 5% by mass or less. (More preferably 3% by mass or less, further preferably 1% by mass or less, further preferably 0.5% by mass or less, still more preferably 0.2% by mass or less) using the air flow method. As a result, silicon particles having a crystallite diameter of less than 1 μm and aggregates of the silicon particles are substantially removed. In addition, unlike the term "crystallite diameter" used for silicon particles, "crystal grain size" is used as a term for the overall diameter of agglomerates of silicon particles.

The hydrogen-generating pneumonia preventive or therapeutic formulation 100 of the present embodiment contains silicon particles and / silicon fine particles, and the silicon fine particles having a crystallite diameter of less than 1 μm and an aggregate of the silicon fine particles. The ratio of all the silicon particles, the silicon fine particles and their aggregates to the aggregates is 5% by mass or less (more preferably 3% by mass or less, still more preferably 1% by mass or less, still more preferably 0. 5% by mass or less, more preferably 0.2% by mass or less) has the effect that the accuracy is higher and the safety can be enhanced by preventing the silicon particles from passing through the cell membrane of the intestinal tract and between the cells. Can play.

By the way, as long as it has the ability to generate hydrogen, the upper limit of the crystallite diameter of silicon particles and aggregates of silicon particles is not limited. However, in addition to the above-mentioned classification step, it is also possible to adopt a classification step of substantially removing silicon particles having a crystallite diameter of more than 60 μm, or more preferably more than 45 μm, and agglomerates of silicon particles. More specifically, all the silicon particles, the silicon fine particles, and their aggregates of the silicon particles having a crystallite diameter of more than 60 μm (more preferably more than 45 μm). The ratio to the agglomerates is 5% by mass or less (more preferably 3% by mass or less, further preferably 1% by mass or less, still more preferably 0.5% by mass or less, still more preferably 0.2% by mass). The classification process for classifying so as to be (below) can be adopted. By substantially removing silicon particles having a crystallite diameter of more than 60 μm, or more preferably more than 45 μm, and aggregates of silicon particles, the hydrogen generating ability can be maintained high and the crystallite diameter can be kept in a certain range. By staying inside, more stable hydrogen generation ability can be exhibited. In addition, in the case of oral ingestion, deterioration of human texture can be suppressed. In addition, it is possible to prevent the silicon particles from being directly absorbed and invading the blood vessels with high accuracy.

As a result, as an example, the ratio of the silicon fine particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon fine particles to all the silicon particles, the silicon fine particles and their aggregates is 5% by mass. The following (more preferably 3% by mass or less, further preferably 1% by mass or less, still more preferably 0.5% by mass or less, still more preferably 0.2% by mass or less) of silicon particles and coagulation of silicon particles. A collection is obtained. In another aspect, silicon particles having a crystallite diameter of 1 μm or more and 60 μm or less (more preferably 1 μm or more and less than 45 μm) and an agglomerate of silicon particles can be obtained.

As a result of comparing the pharmaceutical product 100 for the prevention or treatment of pneumonia of the present embodiment with the silicon particles which have not undergone the classification step of the present embodiment, as described above, the realization of stable hydrogen generation ability and oral ingestion The pharmaceutical product 100 for preventing or treating pneumonia of the present embodiment is excellent from the viewpoint of suppressing deterioration of human texture or reducing the possibility of silicon particles invading blood vessels.

In addition, the amount of hydrogen generated in the comparative example in which the silicon particles not subjected to the classification step and the aqueous sodium hydrogen carbonate solution (pH 8.3) at 37 ° C. were reacted for 48 hours, and the prevention or prevention of pneumonia under the same conditions as described above. The results of the hydrogen generation amount of the therapeutic preparation 100 are shown in Table 1.

As shown in Table 1, it can be seen that the hydrogen generating ability of the prophylaxis or therapeutic formulation 100 of the present embodiment is remarkably excellent.

<Example>
[Effect of preventive or therapeutic preparations for pneumonia on pneumonia]
In this example, a tester (male in his 60s) who had a disease of interstitial pneumonia and participated in this example on his own initiative took 1 g / day of the preventive or therapeutic preparation 100 for pneumonia every day. Ingested orally. Since the above-mentioned 1 g means the mass of silicon particles, the mass of a material other than silicon particles (for example, excipients) is not included. The same applies to each of the following examples.

Then, before starting oral intake, when 2 months have passed since the start of ingestion, 4 months after the start of ingestion, and 5.5 months after the start of ingestion, the KL-6 in the blood of the examiner By quantitative measurement, the concentration of "KL-6" (unit: "U / mL") at each time was examined. "KL-6" is a glycoprotein antigen and is one of the glycoproteins belonging to MUC1 mucin, which is a transmembrane non-secretory mucin. In addition, serum "KL-6" is known to be an effective index of interstitial pneumonia. For the measurement of serum "KL-6", for example, Shuko Kono et al., "Diagnostic Ability for Interstitial Pneumonia of KL-6 Measurement Kit ED066 by Electrochemiluminescent Immunoassay", Clinical and Research, 1998, 75, p. This can be done by reference to 1167-1172. An example of the normal range of a healthy person is 500 U / mL or less. (Another example is 105-401 U / mL. (Keiko Hasegawa, "Clinical Significance of Serum Marker KL-6 for Interstitial Pneumonia", National Hospital Clinical Laboratory Engineers Association Bulletin No. 58, p. .107-115)))

As shown in Table 2, it was confirmed that the index value of "KL-6" decreased remarkably and continuously as the days passed from the start of ingestion of the preventive or therapeutic preparation for pneumonia. Was done. Then, 5.5 months after the start of ingestion of the preventive or therapeutic preparation for pneumonia, "KL-6" decreased to about 670. At this point, the value is higher than the upper limit of the normal range of healthy subjects mentioned above, but considering that it was more than twice the upper limit of the normal range before ingestion, it is a preparation for the prevention or treatment of pneumonia. It is worth noting that ingestion revealed a significant improvement in idiopathic interstitial pneumonia, which is classified as an intractable disease.

Since it has been reported that KL-6 is useful for differentiating between interstitial pneumonia and other disease groups between the interstitial pneumonia group and the non-interstitial pneumonia group (Kikuchi et al.) , "Examination of basic performance and clinical usefulness of new KL-6 measurement reagent" LZ test'Eiken'KL-6 "", Medical Examination, Vol. 66 (2017) No. 1), especially in this example, " The remarkable decrease in the value of "KL-6" in a short period of time indicates that the therapeutic preparation of the first embodiment is particularly useful for the treatment of interstitial pneumonia.

In addition, the preparation 100 for preventing or treating pneumonia is not only for idiopathic interstitial pneumonitis, but also for pneumonia caused by a new coronavirus infection (COVID-19) and a mutated new coronavirus infection (COVID-19). It can also contribute as a prophylactic or therapeutic formulation against the resulting pneumonia, drug-induced pneumonia, chronic hypersensitivity pneumonitis, dust lung, or bacterial pneumonia.

<Modified example (1) of the first embodiment>
After the pulverization step is performed in the first embodiment described above, it is also preferable to carry out a modification step of modifying the surface of the silicon particles by further contacting the surface with hydrogen peroxide solution. This is one aspect. This modification step allows the silicon nanoparticles to be made hydrophilic when viewed macroscopically. For example, the silicon particles are immersed in a hydrogen peroxide solution (for example, about 10 ° C. to about 80 ° C., about 20 ° C. to about 50 ° C. from the viewpoint of realizing lower cost) contained in a known container. Thereby, the reforming step can be performed.

Further, the same modification can be realized by immersing the silicon particles in ozone water and / or sodium percarbonate instead of the hydrogen peroxide solution. Alternatively, similar modification can be achieved by contacting the silicon particles with at least one selected from the group of hydrogen peroxide solution, ozone water, and sodium percarbonate.

Further, as described above, it is also preferable to carry out the reforming step using hydrogen peroxide solution at about room temperature from the viewpoint of realizing low cost and safe treatment. In addition, the adoption of hydrogen peroxide solution in the reforming process of this variant generates hydrogen by using a safer and more secure material (for example, less affecting the human body), as with ethanol. From the viewpoint of being able to make it, it is a preferable aspect.

<Modified example (2) of the first embodiment>
Further, in this modified example, 500 mg of the preparation 100 for preventing or treating pneumonia according to the first embodiment or the modified example (1) of the first embodiment is added to sodium hydrogen carbonate powder (manufactured by Wako Pure Chemical Industries, Ltd.). Purity 99.5%) Mix with about 500 mg. This mixture is kneaded and tableted using a tableting method to form a cylindrical mass having a diameter of about 10 mm and a height of about 1.5 mm as shown in FIG. 1 (for example, for pharmaceuticals or quasi-drugs). Tablets) can be obtained. The tablet is an example of a lumpy preparation. In addition, nanocapsules, microcapsules, usually, which do not dissolve the preventive or therapeutic preparation 100 for pneumonia having a stable silicon suboxide and the pH adjuster such as sodium hydrogen carbonate separately under acidic conditions but dissolve under basic conditions. Capsule or coating of the above is a preferred embodiment. By adopting the above-described embodiment, the reaction in the presence of water under acidic conditions is avoided, and the reaction between the preventive or therapeutic preparation 100 for pneumonia and water reacts with each other in the presence of water in a basic manner. It becomes possible to encourage that.

<Modified example (3) of the first embodiment>
The pharmaceutical product 100 for preventing or treating pneumonia according to the above-mentioned first embodiment or modified examples (1) to (2) of the first embodiment can be utilized as, for example, a pharmaceutical product (medicinal product). In addition, the application examples are not limited to tablets. For example, even when a capsule containing the preventive or therapeutic preparation 100 for powdery pneumonia is used instead of the tablet, the same effect as described above can be achieved. The pharmaceutical product 100 for the prevention or treatment of pneumonia can generate more hydrogen when it is in the form of a powder having a large surface area rather than in the form of a lump. It will be easier. In addition, by making tablets or capsules, they remain lumpy to some extent in the stomach, but after passing through the stomach, they disintegrate and become powdery. Therefore, in the stomach where the hydrogen generation reaction is desired to be suppressed, the small intestine and / or the large intestine where the preventive or therapeutic preparation 100 for pneumonia is exposed to gastric juice and / or the contents of the stomach to promote the hydrogen generation reaction. The surface area exposed to the water-containing liquid can be increased.

Further, the prophylaxis or therapeutic preparation 100 for pneumonia may be a granule preparation. Granule preparations are powdery at an earlier stage after ingestion or anal ingestion compared to tablets and capsules. However, in the case of oral ingestion, gastric juice has a low pH value (about 1.5), so even if it reaches the stomach and immediately becomes powdery, it hardly generates hydrogen, and in the presence of water after passing through the stomach. To generate hydrogen. In addition, the prophylaxis or therapeutic preparation 100 for pneumonia may be a powder.

An example of a coating layer applicable to a tablet is a known poorly soluble gastrointestinal enteric material, which is a coating agent covering the outermost layer of a tablet. An example of a coating layer applicable to a capsule is the capsule itself produced from a known poorly soluble gastrointestinal enteric material containing the prophylaxis or therapeutic formulation 100 for pneumonia.

As described above, an example of a suitable formulation as an example of utilization of the preventive or therapeutic formulation 100 for pneumonia is a tablet or powdery pneumonia which is a lumpy formulation which is easy to take in a sufficient amount orally or through the anus. A capsule containing a prophylactic or therapeutic preparation 100 (which may include an aggregated form) in a capsule. When tablets are used, a disintegrant may be further contained. Further, as the disintegrant, a known material can be adopted. In addition, a more preferred example of a disintegrant is an organic acid, the most preferred example is citric acid. Here, the organic acid can also function as a binder that agglomerates the silicon particles.

<Modified example (4) of the first embodiment>
In addition, the pneumonia preventive or therapeutic preparation 100 of the above-mentioned first embodiment or modifications (1) to (3) of the first embodiment is brought into contact with, for example, the pneumonia preventive or therapeutic preparation 100. By using the "medium", hydrogen can be taken into the body (including the skin itself or the mucous membrane itself) percutaneously or transmucosally. The medium of this modification is not particularly limited to materials or products. Any physiologically acceptable medium can produce the effects of this variant. Therefore, a product provided with the prophylaxis / therapeutic preparation 100 for pneumonia and the medium in contact with the prophylaxis / therapeutic preparation 100 for pneumonia can exert a function as a hydrogen supply material.

As one specific example, in a daily life, a human part comes into contact with water (or a water-containing liquid) or a medium containing the water (or a water-containing liquid) (hereinafter, collectively referred to as "medium"). From the perspective of increasing opportunities, examples of suitable vehicles are at least one selected from the liquid, gel, cream, paste, emulsion, and mousse groups. An example of another suitable medium is bath water (preferably alkaline bath water). Therefore, in one example of this modification, the production of the bath water is the method for producing the medium.

To explain the bathing water in more detail, tap water is typically stored as bathing water in a general bathtub (including a public bathtub, a public bathtub, and an indoor or outdoor bathtub installed by an inn). Before and after storing the bath water, hydrogen (by placing or putting the above-mentioned hydroxyl radical inhibitor in the bathtub and performing a contact step of contacting the bath water as a medium with the preparation 100 for preventing or treating pneumonia). H ₂ ) is generated. Therefore, the prophylaxis or therapeutic preparation 100 for pneumonia of this variant can be adopted as a so-called bath agent.

_{Therefore, hydrogen (H 2} ) generated by the above-mentioned contact step can be brought into contact with the human skin and / or mucous membrane to be bathed via bath water as a physiologically acceptable medium. As a result, according to this variant, it may be possible to take hydrogen (H ₂ ) into the human body (including the skin itself or the mucous membrane itself) by means different from ingestion or ingestion from the anus. ..

<Other Embodiments (1)>
In addition, the prophylaxis or therapeutic formulation 100 of each of the above-mentioned first embodiment or each modification of the first embodiment has a diameter of μm level (for example, several tens of μm or more) by aggregating in a natural state. Can constitute an agglomerate of the size of. By artificially assembling the preventive or therapeutic preparation 100 for pneumonia by adding or compressing the aggregate or the binder, a lumpy solid preparation having a size that can be pinched by a human finger is prepared. Can be formed.

<Other Embodiments (2)>
By the way, regarding the pharmaceutical product 100 for preventing or treating pneumonia in each of the first embodiment or the first embodiment described above, for example, in the first contact step (first contact step), the pH value is less than 7. It can be brought into contact with one water-containing liquid, and in the subsequent contact step (second contact step), it is brought into contact with a second water-containing liquid having a pH value of 7 or more, and hydrogen can be generated in the second contact step. The pharmaceutical product 100 for preventing or treating pneumonia according to each of the above-described embodiments is remarkable when it comes into contact with a water-containing liquid having a pH value of 7 or more (more preferably more than 7 and more preferably 8.2 or more). It may have the ability to generate hydrogen.

Further, the temperature conditions of the second water-containing liquid for hydrogen generation described above are not limited. Although it may depend on the pH of the second water-containing liquid, if the temperature of the second water-containing liquid is 80 ° C. or lower, the accuracy is high and hydrogen generation can be promoted. However, the upper limit of the temperature of the second water-containing liquid is not originally limited. For example, when the pharmaceutical product 100 for preventing or treating pneumonia in each of the above-described embodiments and variants thereof is used as an industrial drug, the temperature may exceed 50 ° C. However, the higher the temperature, the higher the heat resistance of the equipment (including the container) is required, and there are problems that care must be taken in handling. Therefore, even when used as an industrial chemical, it is preferably used at 100 ° C. or lower.

As described above, the disclosure of each of the above-described embodiments and modifications thereof is described for the purpose of explaining the embodiments or modifications thereof, and is not described for the purpose of limiting the present invention. In addition, other modifications that exist within the scope of the invention, including each embodiment and other combinations thereof, are also within the scope of the claims.

The prophylactic or therapeutic preparation for pneumonia of the present invention can be widely used in the pharmaceutical and medical industries utilizing hydrogen.

100 Prophylactic or therapeutic preparation for pneumonia

Claims (5)

Contains silicon particles capable of generating hydrogen and / or silicon fine particles,
A prophylactic or therapeutic preparation for pneumonia. The ratio of the silicon fine particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon fine particles to all the silicon particles, the silicon fine particles and their aggregates is 5% by mass or less.
The pharmaceutical product for the prevention or treatment of pneumonia according to claim 1. The ratio of the silicon fine particles having a crystallite diameter of less than 1 μm and the aggregates of the silicon fine particles to all the silicon particles, the silicon fine particles and their aggregates is 1% by mass or less.
The pharmaceutical product for the prevention or treatment of pneumonia according to claim 1. Using KL-6 as an index,
The pharmaceutical product for preventing or treating pneumonia according to any one of claims 1 to 3. The pneumonia is interstitial pneumonia, pneumonia caused by a new coronavirus infection (COVID-19), or pneumonia caused by a mutated new coronavirus infection (COVID-19).
The pharmaceutical product for preventing or treating pneumonia according to any one of claims 1 to 4.

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