Ergothioneine compound composition and preparation method thereof

Abstract

According to the ergothioneine compound composition and the preparation method thereof, by preparing the ergothioneine compound preparation, the problems of poor curative effect, poor stability, poor absorption and the like in the prior art are solved, and the composition obtained by the invention not only has good stability and safety, but also improves the dissolution property, and is suitable for industrial production. The anti-oxidation effect of the ergothioneine in an organism is fully exerted.

Description

Technical Field

[0001] This invention belongs to the field of health products, specifically relating to a compound ergothioneine composition and its preparation method. Background Technology

[0002] With economic development, people's demands for quality of life are increasing, and how to improve insomnia and aging issues is attracting more and more attention. Aging is a natural process in which humans slow down their metabolism and decline their abilities as they age. Although aging is irreversible, its process can be slowed down through external factors. Under normal circumstances, free radicals in the human body are in a dynamic balance between production and elimination. Excessive production or slow elimination of free radicals will accelerate the aging process. The body's antioxidant function can maintain the balance between the production and elimination of free radicals, which is of great significance for preventing various diseases and anti-aging. Currently, insomnia has become a global public health problem, and sleep problems are closely related to many other diseases such as depression, cardiovascular and cerebrovascular diseases, endocrine disorders, and Alzheimer's disease.

[0003] Currently, there are numerous combination products on the market that offer antioxidant functions, stress relief, and sleep improvement. Western medicine treats sleep disorders primarily through the rational use of sedative-hypnotic drugs, which induce sleep relatively quickly but have some adverse reactions, such as exacerbating respiratory depression, fatigue, and drowsiness. They can also lead to drug tolerance, addiction, and cause gut microbiota imbalance, affecting gastrointestinal health. While common antioxidants such as vitamin C and vitamin E have some antioxidant capacity, vitamin C is relatively unstable and easily oxidized and decomposed by environmental factors such as light, temperature, and humidity. Its duration of action in the body is relatively short, and its ability to scavenge certain free radicals is insufficient. Traditional natural sleep aids are mostly based on single ingredients or simple formulas, such as melatonin products. Although relatively safe, they only work by regulating circadian rhythms and have limited effectiveness in improving sleep problems caused by complex mechanisms such as neurotransmitter imbalance and mitochondrial dysfunction, making it difficult to meet diverse market demands.

[0004] Ergothioneine is a natural antioxidant. Studies have found that it can cross the blood-brain barrier and exert antioxidant and anti-inflammatory effects in the brain, making it valuable for anti-aging and improving sleep. However, the development of ergothioneine in the market is still limited to using a variety of active ingredients, even combining it with many traditional Chinese medicine ingredients, which cannot fully realize its therapeutic effects, and the stability and absorption of ergothioneine have not been well resolved.

[0005] Therefore, there is an urgent need to develop an ergothioneine compound composition that is convenient to take, has good compliance, excellent bioavailability, good stability, high bioavailability, and significant therapeutic effect. Summary of the Invention

[0006] To address the challenges, this invention provides a compound ergothioneine composition that exhibits good clinical efficacy, excellent bioavailability, good product quality, and superior chemical and physical stability, thus ensuring both safety and effectiveness.

[0007] In a first aspect, the present invention provides a compound ergothioneine composition, wherein the active ingredients of the compound composition include ergothioneine, pyrroloquinoline quinone salt, and coenzyme Q10.

[0008] Optionally, the composition comprises ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10, filler, and lubricant.

[0009] Optionally, in the composition, the pyrroloquinoline quinone salt is selected from pyrroloquinoline quinone monosodium salt, pyrroloquinoline quinone disodium salt, and pyrroloquinoline quinone trisodium salt.

[0010] Optionally, in the composition, ergothioneine includes, but is not limited to, one or more of ergothioneine salts, ergothioneine stereoisomers, hydrates, and solvates.

[0011] Optionally, in the composition, the ergothioneine salt is selected from physiologically acceptable salts.

[0012] Optionally, in the composition, ergothioneine salt includes, but is not limited to, one or more of the following: hydrochloride, hydrobromide, hydroiodide, sulfate, phosphate, hydrogen sulfate, and hydrogen phosphate.

[0013] Optionally, in the composition, ergothioneine is selected from one or more of L-ergothioneine or D-ergothioneine.

[0014] Optionally, in the composition, ergothioneine is selected from L-ergothioneine.

[0015] Optionally, the filler of the composition comprises at least one of corn starch, pregelatinized starch, microcrystalline cellulose, and lactose.

[0016] Optionally, the lubricant of the composition comprises at least one of magnesium stearate, sodium stearate fumarate, stearic acid, hydrogenated vegetable oil, and sodium lauryl sulfate.

[0017] Optionally, the composition is a solid dosage form, comprising capsules, tablets, or pills.

[0018] Optionally, the composition is a capsule formulation.

[0019] Optionally, the composition may contain 1.0% to 30.0% ergothioneine by weight percentage.

[0020] Optionally, the composition may contain 1.0% to 20.0% ergothioneine by weight percentage.

[0021] Optionally, the composition may contain 1.0% to 10.0% ergothioneine by weight percentage.

[0022] Optionally, the composition may contain 2.0% to 10.0% ergothioneine by weight percentage.

[0023] Optionally, the composition may contain 0.1% to 6.0% of pyrroloquinoline quinone salt by weight percentage.

[0024] Optionally, the composition may contain 0.1% to 5.0% pyrroloquinoline quinone salt by weight percentage.

[0025] Optionally, the composition may contain 0.2% to 3.0% pyrroloquinoline quinone salt by weight percentage.

[0026] Optionally, the composition may contain 0.5% to 1.5% pyrroloquinoline quinone salt by weight percentage.

[0027] Optionally, the composition may contain 0.3% to 20.0% coenzyme Q10 by weight percentage.

[0028] Optionally, the composition may contain 0.3% to 15.0% coenzyme Q10 by weight percentage.

[0029] Optionally, the composition may contain 0.3% to 10.0% coenzyme Q10 by weight percentage.

[0030] Optionally, the composition may contain 0.1% to 6.0% coenzyme Q10 by weight percentage.

[0031] Optionally, the composition may contain 40.0% to 98.0% filler by weight percentage.

[0032] Optionally, the composition may contain 60.0% to 98.0% filler by weight percentage.

[0033] Optionally, the composition may contain 70.0% to 98.0% filler by weight percentage.

[0034] Optionally, the composition may contain 80.0% to 95.0% filler by weight percentage.

[0035] Optionally, the composition may contain 0.1% to 5.0% lubricant by weight percentage.

[0036] Optionally, the composition may contain 0.1% to 4.0% lubricant by weight percentage.

[0037] Optionally, the composition may contain 0.2% to 3.0% lubricant by weight percentage.

[0038] Optionally, the composition may contain 0.5% to 1.5% lubricant by weight percentage.

[0039] Optionally, the composition comprises, by weight percentage:

[0040] 1.0% to 30.0% ergothioneine;

[0041] 0.1%–6.0% of pyrroloquinoline quinone salts;

[0042] 0.3%–20.0% Coenzyme Q10;

[0043] 40.0% to 98.0% filler;

[0044] 0.1% to 5.0% lubricant.

[0045] Optionally, the composition comprises, by weight percentage:

[0046] 1.0%–20.0% ergothioneine;

[0047] 0.1%–5.0% of pyrroloquinoline quinone salts;

[0048] 3.0%–15.0% Coenzyme Q10;

[0049] 60.0%–98.0% filler;

[0050] 0.1% to 4.0% lubricant.

[0051] Optionally, the composition comprises, by weight percentage: 1.0% to 10.0% ergothioneine;

[0052] 0.2%–3.0% of pyrroloquinoline quinone salts;

[0053] 3.0%–10.0% Coenzyme Q10;

[0054] 70.0%–98.0% filler;

[0055] 0.2% to 3.0% lubricant.

[0056] Optionally, the composition comprises, by weight percentage: 2.0% to 10.0% ergothioneine;

[0057] 0.5%–1.5% of pyrroloquinoline quinone salt;

[0058] 0.1%–6.0% Coenzyme Q10;

[0059] 80.0%–95.0% filler;

[0060] 0.5% to 1.5% lubricant.

[0061] Optionally, the composition comprises, by weight percentage: 8.9% ergothioneine;

[0062] 1.5% pyrroloquinoline quinone salt;

[0063] 5.9% Coenzyme Q10;

[0064] 82.3% filler;

[0065] 1.5% lubricant.

[0066] Optionally, the composition comprises, by weight percentage: 3.0% ergothioneine;

[0067] 0.5% pyrroloquinoline quinone salt;

[0068] 1.0% Coenzyme Q10;

[0069] 95.0% filler;

[0070] 0.5% lubricant.

[0071] Optionally, the composition comprises, by weight:

[0072] 10mg-60mg of ergothioneine;

[0073] 1 mg-15 mg of pyrroloquinoline quinone salt;

[0074] 5mg-40mg of Coenzyme Q10;

[0075] 100mg-1300mg of filler;

[0076] 1mg-10mg of lubricant.

[0077] Optionally, the composition comprises, by weight:

[0078] 20mg-50mg of ergothioneine;

[0079] 3mg-10mg of pyrroloquinoline quinone salt;

[0080] 10mg-30mg of Coenzyme Q10;

[0081] Filler in the range of 150mg-1000mg;

[0082] 1mg-10mg of lubricant.

[0083] Optionally, the composition comprises, by weight:

[0084] 30mg of ergothioneine;

[0085] 5 mg of pyrroloquinoline quinone salt;

[0086] 20mg of Coenzyme Q10;

[0087] 278mg of filler;

[0088] 5mg of lubricant.

[0089] Optionally, the composition comprises, by weight:

[0090] 30mg of ergothioneine;

[0091] 5 mg of pyrroloquinoline quinone salt;

[0092] 10mg of Coenzyme Q10;

[0093] 950mg of filler;

[0094] 5mg of lubricant.

[0095] In a second aspect, the present invention provides a method for preparing the compound ergothioneine composition of the first aspect, which includes the following steps: preparing compound composition granules, mixing the granules, and filling or tableting them.

[0096] Optionally, the preparation method is as follows:

[0097] (1) Weigh out the prescribed amounts of ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10, filler, and lubricant;

[0098] (2) Take the ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10 and filler from step (1) and sieve them respectively;

[0099] (3) Mix the sieved material from step (2) evenly;

[0100] (4) Add lubricant to step (3) and continue mixing until homogeneous;

[0101] (5) Use capsule filler to fill the powder mixture from step (4); or,

[0102] (6) After wet granulation of the mixed powder in step (4), the powder is compressed into tablets;

[0103] Optionally, in step (2), the sieve used for sieving is selected from 1.0 to 2.0 mm.

[0104] Optionally, in steps (3) and (4), the mixing speed is 3 to 20 rpm.

[0105] Optionally, in step (6), the powder is placed in a wet granulator, purified water is added, granulated, sieved, dried, and tableted.

[0106] Optionally, after wet granulation in step (6), the pellets are passed through a 3.0*3.0mm sieve.

[0107] Thirdly, the present invention provides the use of the compound ergothioneine composition of the first aspect and the compound ergothioneine composition obtained by the preparation method of the compound ergothioneine composition of the second aspect in the preparation of health products for use as antioxidants in the body.

[0108] Fourthly, the present invention provides the use of a filler in improving the stability of the active ingredient in the above-mentioned compound ergothioneine composition.

[0109] This invention has discovered that in compound compositions of ergothioneine, coenzyme Q10, and pyrroloquinoline quinone salt, these three components have certain interactions that lead to instability, such as hygroscopicity, degradation, and increased impurities. This invention, through the screening of fillers, has achieved a stabilizing effect on the compound compositions of this invention. In the compositions of this invention, a stable compound composition can be prepared by adding only the aforementioned fillers, without the need for the addition of other complex types of excipients.

[0110] Optionally, the filler is selected from at least one of corn starch, pregelatinized starch, microcrystalline cellulose, and lactose.

[0111] Optionally, the composition may contain 40.0% to 98.0% filler by weight percentage.

[0112] Optionally, the composition may contain 60.0% to 98.0% filler by weight percentage.

[0113] Optionally, the composition may contain 70.0% to 98.0% filler by weight percentage.

[0114] Optionally, the composition may contain 80.0% to 95.0% filler by weight percentage.

[0115] Optionally, the stability is physical stability, chemical stability, and / or light stability.

[0116] Optionally, the stability of the active ingredient is the physical stability, chemical stability, and / or photostability of pyrroloquinoline quinone disodium salt, coenzyme Q10, and / or ergothioneine.

[0117] Optionally, the stability of the active ingredient is the physical and / or chemical stability of pyrroloquinoline quinone disodium salt and / or coenzyme Q10.

[0118] Optionally, the stability of the active ingredient is the chemical stability and / or photostability of coenzyme Q10 and / or ergothioneine.

[0119] The compound ergothioneine composition of the present invention has the following excellent effects:

[0120] 1. The composition of the present invention has excellent bioavailability and drug metabolism capacity in vivo, and can be fully absorbed and effectively utilized by the human body after administration.

[0121] 2. By screening excipients, especially fillers, the composition of this invention has good stability, effectively overcomes the degradation problem of ergothioneine, fully ensures the stability of the active ingredients in the composition, reduces the generation of impurities, and can still ensure good product quality under harsh environments such as high temperature and high humidity, effectively ensuring the safety of consumption.

[0122] 3. The composition of the present invention has significantly improved hygroscopicity, which is beneficial for storage and transportation.

[0123] 4. The composition of the present invention has excellent dissolution and disintegration properties, and can be rapidly absorbed by the human body after administration to exert its medicinal effect.

[0124] 5. The composition of the present invention has a simple preparation process, requires no additional special equipment, greatly reduces production costs, reduces quality control points, and shortens the production cycle; Detailed Implementation

[0125] To better illustrate the present invention, numerous specific details are set forth below. Those skilled in the art will understand that the present invention can be practiced even without certain specific details. Therefore, in some embodiments, methods, means, apparatus, and steps well known to those skilled in the art are not described in detail in order to highlight the spirit of the invention.

[0126] Unless otherwise stated, all units used in this specification are international standard units; and all numerical values ​​and / or ranges appearing in this invention should be understood to include systematic errors that are unavoidable in industrial production.

[0127] In this specification, the word "may" has two meanings: to perform a certain process and not to perform a certain process.

[0128] In this specification, the range of values ​​referred to as "value A to value B" refers to the range including the endpoint values ​​A and B.

[0129] In this specification, "physiologically acceptable salt" means a salt of the parent compound that is physiologically acceptable (as defined above) and has the desired activity (pharmacological, cosmetic, food, or health product activity). The salts comprise: (1) acid addition salts formed with inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid and the like; or acid addition salts formed with organic acids such as acetic acid, benzenesulfonic acid, benzoic acid, camphorsulfonic acid, citric acid, ethanesulfonic acid, fumaric acid, glucoheponic acid, gluconic acid, glutamic acid, glycolic acid, hydroxynaphthoic acid, 2-hydroxyethanesulfonic acid, lactic acid, maleic acid, malic acid, mandelic acid, methanesulfonic acid, mucoconic acid, 2-naphthalenesulfonic acid, propionic acid, salicylic acid, succinic acid, dibenzoyl-L-tartaric acid, tartaric acid, p-toluenesulfonic acid, trimethylacetic acid, trifluoroacetic acid and the like; or (2) salts formed when an acidic proton present in the parent compound is replaced by a metal ion (e.g., an alkali metal ion, an alkaline earth metal ion or an aluminum ion), or when it is combined with an organic or inorganic base. Acceptable organic bases include diethanolamine, ethanolamine, N-methylglucosamine, triethanolamine, tromethamine, and the like. Acceptable inorganic bases include aluminum hydroxide, calcium hydroxide, potassium hydroxide, sodium carbonate, and sodium hydroxide.

[0130] In this specification, "stereoisomer" refers to both diastereomers and enantiomers. Therefore, it is an optical isomer. Stereoisomers that are not mirror images of each other are called "diastereomers," and stereoisomers that are mirror images of each other but cannot be superimposed are called "enantiomers."

[0131] The embodiments of the present invention will be described in detail below with reference to examples. However, those skilled in the art will understand that the following examples are only for illustrating the present invention and should not be regarded as limiting the scope of the present invention.

[0132] Unless otherwise specified in the examples, the procedures should be performed under standard conditions or conditions recommended by the manufacturer. Reagents or instruments whose manufacturers are not specified are all commercially available standard products.

[0133] Example 1

[0134] The compound ergothioneine composition has the formulation composition shown in the table below.

[0135] Table 1. Prescription composition of Example 1

[0136]

[0137] Preparation method:

[0138] (1) Weigh out the prescribed amounts of ergothioneine, disodium pyrroloquinoline quinone, coenzyme Q10, corn starch, and magnesium stearate;

[0139] (2) Add the weighed ergothioneine, disodium pyrroloquinoline quinone, coenzyme Q10 and corn starch to the granulator in sequence for dispersion, with a round hole screen of 1.0-2.0 mm.

[0140] (3) Mix the sieved materials using a mixer, setting the mixing speed to 10 rpm;

[0141] (4) Add magnesium stearate to the mixture after step (3) and continue mixing. Set the mixing speed to 5 rpm.

[0142] (5) Fill the mixture from step (4) into capsules;

[0143] The capsules obtained in Example 1 have clean and smooth shells with uniform color, no cracks or deformation, clear separation between the capsule body and the capsule cap without mechanical damage, and the powder inside the capsule is light yellow, uniform in color, dry and loose, without lumps.

[0144] Example 2

[0145] The compound ergothioneine composition has the formulation as shown in Table 1.

[0146] Preparation method:

[0147] (1) Weigh out the prescribed amounts of ergothioneine, disodium pyrroloquinoline quinone, coenzyme Q10, corn starch, and magnesium stearate;

[0148] (2) Add the weighed ergothioneine, disodium pyrroloquinoline quinone, coenzyme Q10 and corn starch to the granulator in sequence for dispersion, with a round hole screen of 1.0-2.0 mm.

[0149] (3) Mix the sieved materials using a mixer, setting the mixing speed to 10 rpm;

[0150] (4) Add magnesium stearate to the mixture after step (3), continue mixing, set the mixing speed to 5 rpm, and obtain light yellow granules;

[0151] (5) Place the mixed powder from step (4) into a wet granulator, add purified water and granulate, pass through a 3.0*3.0mm sieve, dry and compress into tablets.

[0152] The tablets obtained in Example 2 have a clean and smooth appearance, neat edges, consistent shape, and uniform color.

[0153] Example 3

[0154] The compound ergothioneine composition has the prescription composition shown in the table below, and the preparation process is the same as in Example 1.

[0155] Table 2. Prescription composition of Example 3

[0156]

[0157] Example 4

[0158] The compound ergothioneine composition has the prescription composition shown in the table below, and the preparation process is the same as in Example 1.

[0159] Table 3. Prescription composition of Example 4

[0160]

[0161] Example 5

[0162] The compound ergothioneine composition has the prescription composition shown in the table below, and the preparation process is the same as in Example 1.

[0163] Table 4. Prescription composition of Example 5

[0164]

[0165] Comparative Example 1

[0166] The compound ergothioneine composition has the prescription composition shown in the table below, and the preparation method is the same as in Example 1.

[0167] Table 5. Prescription composition of Comparative Example 1

[0168]

[0169] Comparative Example 2

[0170] The compound ergothioneine composition has the prescription composition shown in the table below, and the preparation method is the same as in Example 1.

[0171] Table 6. Prescription composition of Comparative Example 2

[0172]

[0173] Experimental Example 1

[0174] The compound ergothioneine compositions of Examples 1 and 3, and Comparative Examples 1 and 2 were taken and, in accordance with the "Basic Technical Guidelines for Research on Chemical Drug Preparations", were placed under 75% RH for 10 days, and the changes in the content of pyrroloquinoline quinone disodium salt in the compound ergothioneine compositions were detected.

[0175] Table 7. Stability of Compound Ergothioneine Compositions

[0176]

[0177] As shown in the table above, the compound ergothioneine composition of the present invention remains stable under high humidity conditions, without any moisture absorption or weight gain, and the content of pyrroloquinoline quinone disodium salt remains almost unchanged. In contrast, the compound ergothioneine compositions of Comparative Examples 1 and 2, using different fillers, exhibited poor stability under high humidity conditions. Comparative Example 1 showed severe moisture absorption and clumping, while Comparative Example 2 showed significant degradation.

[0178] Experimental Example 2

[0179] The compound ergothioneine compositions of Examples 1, 2, 4 and Comparative Example 1 were taken and, referring to the "Basic Technical Guidelines for Research on Chemical Drug Preparations", were placed under 75% RH for 10 days, and the changes in the coenzyme Q10 content in the compound ergothioneine compositions were detected.

[0180] Table 8. Stability of Compound Ergothioneine Compositions

[0181]

[0182] As shown in the table above, the compound ergothioneine composition of the present invention is stable in high humidity environments, and no moisture absorption or weight gain occurred after 10 days of storage, with almost no change in its coenzyme Q10 content. In contrast, the compound ergothioneine composition of Comparative Example 1, which used different fillers, showed poor stability after being placed in a high humidity environment, and severe moisture absorption and clumping occurred.

[0183] Experimental Example 3

[0184] Take the compound ergothioneine composition of Example 1 and Comparative Examples 1 and 2, and refer to the "Basic Technical Guidelines for Research on Chemical Drug Preparations". Place the composition of Example 1 and Comparative Examples 1 and 2 under 75% RH for 10 days and observe the appearance changes of the compound composition.

[0185] Table 9 Appearance of the compound ergothioneine composition

[0186]

[0187] As shown in the table above, the compound ergothioneine composition of Example 1 of this invention showed almost no change in appearance after being placed under high humidity conditions, remaining a pale yellow powder. However, the compositions of Comparative Examples 2 and 3 both changed color; Comparative Example 2 changed from a pale yellow powder to a yellow powder, and Comparative Example 1 changed from a pale yellow powder to a red powder, indicating that moisture absorption caused a change in product quality. Furthermore, both Comparative Examples 1 and 2 showed varying degrees of moisture absorption and clumping.

[0188] Test Example 4

[0189] The compound ergothioneine compositions of Example 1 and Comparative Example 1 were used. Referring to the "Basic Technical Guidelines for Research on Chemical Drug Preparations", the compositions of Example 1 and Comparative Example 1 were placed under 4500 lx light for 11 days, and the changes in the content of ergothioneine and coenzyme Q10 in the compound ergothioneine compositions were detected.

[0190] Table 10 Stability of Compound Ergothioneine Compositions

[0191]

[0192] As shown in the table above, the compound ergothioneine composition of the present invention is stable under light conditions. After 11 days of exposure, ergothioneine did not degrade, and its content changed very little. In the compound ergothioneine composition of the present invention, the content of coenzyme Q10 remained almost unchanged after 11 days of light exposure. Therefore, the composition of the present invention is stable under light conditions, effectively overcoming the defects of photodegradation of active ingredients such as ergothioneine. In contrast, the compound ergothioneine composition of Comparative Example 1, using different fillers, showed significant degradation of both ergothioneine and coenzyme Q10 after exposure to light, with a marked decrease in content, indicating that Comparative Example 1 has poor stability under light conditions.

[0193] Experimental Example 5

[0194] The compositions of Example 1 and Comparative Example 1 were tested according to the second method of the dissolution and release determination method in Section 0931 of Part IV of the Chinese Pharmacopoeia 2025, with water as the medium. The samples were tested by HPLC as specified in General Chapter 0512 of Part IV of the Chinese Pharmacopoeia 2025. The dissolution data are shown in Table 12.

[0195] Table 11 Dissolution of Compound Ergothioneine Composition

[0196]

[0197] As shown in the table, the dissolution rate of the composition in Example 1 gradually increases as the capsule shell dissolves, and the overall dissolution curve is relatively stable. It does not exhibit the unstable release curve seen in Comparative Example 1, which showed a slow release at 10-15 minutes followed by a sudden complete release at 20 minutes due to the dextrin filler. The composition of this invention ensures the stability of blood drug concentration and the safety of administration, achieving complete dissolution and stable release within 30 minutes, demonstrating excellent rapid-release effect.

[0198] Experimental Example 6

[0199] The disintegration time of the compositions of Example 1 and Comparative Example 1 was determined according to the method of General Chapter 0921, Part IV, Chinese Pharmacopoeia 2025 Edition, at a temperature of 37±1℃, with water as the medium and a baffle. The disintegration data are shown in Table 13.

[0200] Table 12 Disintegration time of compound ergothioneine compositions

[0201]

[0202] As shown in the table above, Example 1 exhibits a better disintegration time than Comparative Example 1, rapidly disintegrating within 5 minutes, which fully meets the requirements for administration. Comparative Example 1, on the other hand, has a much longer disintegration time than Example 1, failing to meet the requirement for rapid disintegration.

Claims

1. A compound ergothioneine composition, said composition comprising ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10, filler, and lubricant.

2. The compound ergothioneine composition according to claim 1, wherein the filler of the composition comprises at least one of corn starch, pregelatinized starch, microcrystalline cellulose, lactose, and mannitol.

3. The compound ergothioneine composition according to claim 1 or 2, wherein the lubricant of the composition comprises at least one of magnesium stearate, sodium stearate fumarate, stearic acid, hydrogenated vegetable oil, and sodium lauryl sulfate.

4. The compound ergothioneine composition according to any one of claims 1-3, wherein the composition is a solid dosage form, comprising capsules, tablets, or pills.

5. The compound ergothioneine composition according to any one of claims 1-4, characterized in that, The composition contains 1.0% to 30.0% ergothioneine, preferably 1.0% to 20.0% ergothioneine; the composition contains 0.1% to 6.0% pyrroloquinoline quinone salt, preferably 0.1% to 5.0% pyrroloquinoline quinone salt; the composition contains 0.3% to 20.0% coenzyme Q10, preferably 0.3% to 15.0% coenzyme Q10.

6. The compound ergothioneine composition according to any one of claims 1-5, characterized in that, The composition contains 40.0% to 98.0% of filler, preferably 60.0% to 98.0% of filler.

7. The compound ergothioneine composition according to any one of claims 1-6, characterized in that, The composition contains 0.5% to 5.0% lubricant.

8. A method for preparing the compound ergothioneine composition according to any one of claims 1-6, characterized in that, The method includes the following steps: preparing compound composition granules, mixing the granules, and filling or tableting them.

9. The method according to claim 8, characterized in that, The method includes the following steps: (1) Weigh out the prescribed amounts of ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10, filler, and lubricant; (2) Take the ergothioneine, pyrroloquinoline quinone salt, coenzyme Q10 and filler from step (1) and sieve them respectively; (3) Mix the sieved material from step (2) evenly; (4) Add lubricant to step (3) and continue mixing until homogeneous; (5) Use capsule filler to fill the powder mixture from step (4); or, (6) The mixed powder from step (4) is granulated by wet granulation and then compressed into tablets.

10. Use of the compound ergothioneine composition according to any one of claims 1-7 in the preparation of health products for use as antioxidants in the body.

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