Chinese herbal extract preparations

Abstract

To provide a Chinese medical preparation that can suppress the formation of a precipitate when dissolved in water.SOLUTION: A Chinese medical extract preparation contains a Chinese medical extract containing a hydroxy ketone flavor component and is dissolved in water for drinking. Such a Chinese medical extract preparation can suppress the formation of a precipitate when dissolved in water.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to a herbal extract preparation, more specifically, to a herbal extract preparation that is inhibited from sedimenting when dissolved in water and consumed. [Background technology]

[0002] Commonly available herbal medicine extract powders are produced by extracting a specific herbal medicine mixture, concentrating the resulting extract, and then drying it. The drying process is usually carried out using a spray-drying method using hot air spray (Non-Patent Document 1).

[0003] For example, Patent Document 1 describes the production of an extract powder from a herbal preparation containing predetermined proportions of Angelica acutiloba, Cnidium rhizome, Peony root, Rehmannia glutinosa, Anemone rhizome, Scutellaria baicalensis, Scutellaria baicalensis, Scutellaria baicalensis, Cassia japonica, pearl powder, and Corydalis chinensis, which was spray-dried at an intake temperature of approximately 185°C. Patent Document 2 describes the production of an extract powder from a herbal preparation of Bofutsushosan by spray-drying it with hot air at 150°C. Patent Document 3 describes the production of an extract powder from a herbal preparation of Daisaikoto by spray-drying it with hot air at 150°C. Patent Document 4 describes the production of an extract powder from a herbal preparation of Bojiogito by spray-drying it with hot air at 150°C.

[0004] Generally available herbal medicines are prepared by granulating the extract powder produced in this way. However, since herbal medicines are essentially decoctions with a distinct smell and taste, the appropriate way to take them is to dissolve them in about 100 ml of hot water (Non-Patent Document 2). [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] "Validation Concept and Examples, Examples (Appendix), Explanation of Validation of Herbal Medicines, Kampo Preparations and Kampo Extract Preparations," Pharmaceutical Affairs Division, Health and Medical Department, Osaka Prefecture, March 2015 [Non-patent document 2] Organ Biology VOL.23NO.1 p.46-52, 2016 [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-505991 [Patent Document 2] International Publication No. 2009 / 041698 [Patent Document 3] Japanese Patent Application Publication No. 2019-085348 [Patent Document 4] Japanese Patent Publication No. 2020-114807 Summary of the Invention [Problem to be solved by the invention]

[0007] Generally, herbal medicines are available in the form of dried extracts for storage stability and ease of distribution, but as mentioned above, it is desirable to take herbal medicines in a form as close as possible to the original smell and taste of a decoction. However, even if a dried extract is dissolved in water (hot water), the scent is actually different from that of a decoction, and the extract does not dissolve or disperse well in water, resulting in a large amount of sediment, making it impossible to take in the ideal form.

[0008] Therefore, an object of the present invention is to provide a herbal preparation that can suppress the formation of precipitates when dissolved in water. [Means for solving the problem]

[0009] The present inventors have conducted extensive research and found that by preparing a concentrated extract liquid or a herbal extract powder containing a specific aroma component, the formation of precipitates when dissolved in water is suppressed. Based on this finding, the present invention was completed through further research.

[0010] That is, the present invention provides the following aspects. Item 1. A herbal extract preparation containing a herbal extract containing hydroxyketone-based aromatic components, which is dissolved in water and taken as a drink. Item 2. The herbal extract formulation according to Item 1, wherein the hydroxyketone-based aroma component is selected from the group consisting of hydroxyacetone, furaneol, and maltol. Item 3. The herbal extract formulation according to Item 1 or 2, wherein the content of the hydroxyketone aromatic component in the herbal extract is 10 μg or more per 1 g of the dried extract of the herbal extract. Item 4. The herbal extract preparation according to any one of Items 1 to 3, wherein the herbal extract has not been subjected to a heat history of 110°C or higher. Item 5. The herbal extract preparation according to any one of Items 1 to 4, wherein the herbal extract is dokkatsu-kakkonto extract, shimotsu-to extract, and / or yokukansan extract. [Effects of the Invention]

[0011] According to the present invention, there is provided a herbal preparation that can suppress the formation of precipitates when dissolved in water. [Brief explanation of the drawings]

[0012] [Figure 1] The figure shows the content of hydroxyketone-based aroma components (hydroxyacetone) in the herbal extract. In the figure, FD represents freeze-dried product, and SD represents spray-dried product. The same applies to Figures 2 and 3. [Figure 2] The content of hydroxyketone-based aroma component (furaneol) in the herbal extract is shown. [Figure 3] The content of hydroxyketone-based aroma component (maltol) in the herbal extract is shown. DETAILED DESCRIPTION OF THE INVENTION

[0013] The herbal extract preparation of the present invention is characterized by containing a herbal extract containing a hydroxyketone-based aromatic component and being dissolved in water for drinking. The herbal extract preparation of the present invention will be described in detail below.

[0014] Chinese herbal extract The herbal extract used in the present invention contains hydroxyketone-based aroma components, which are aromatic compounds having a hydroxyl group (more specifically, an α-hydroxyl group) and a carbonyl group.

[0015] Hydroxyketone-based aroma components include acyclic compounds and oxygen-containing heterocyclic compounds, and the herbal extract may contain either or both of these.

[0016] Examples of acyclic compounds include hydroxyacetone (monohydroxyacetone) and dihydroxyacetone. A Kampo extract may contain one of these acyclic compounds alone or in combination with multiple compounds. Examples of oxygen-containing heterocyclic compounds include furan compounds such as sotolon and furaneol, and pyran compounds such as maltol and ethylmaltol. A Kampo extract may contain one of these oxygen-containing heterocyclic compounds alone or in combination with multiple compounds.

[0017] In the present invention, from the viewpoint of further enhancing the precipitation-inhibiting effect, the hydroxyketone-based aroma component preferably contains both an acyclic compound and an oxygen-containing heterocyclic compound, or is selected from the group consisting of hydroxyacetone, furaneol, and maltol, and more preferably contains all of hydroxyacetone, furaneol, and maltol.

[0018] The content (total amount) of hydroxyketone aroma components contained in a Kampo extract is not particularly limited and can be determined appropriately depending on the desired precipitation-inhibiting effect, but from the viewpoint of further improving the precipitation-inhibiting effect, it is preferably 10 μg or more, more preferably 50 μg or more, even more preferably 100 μg or more, even more preferably 140 μg or more, and even more preferably 150 μg or more per 1 g of dried Kampo extract. The upper limit of the range of the content (total amount) of hydroxyketone aroma components contained in a Kampo extract is not particularly limited, but examples include 300 μg or less, 250 μg or less, or 200 μg or less per 1 g of dried Kampo extract.

[0019] The hydroxyacetone contained in the herbal extract is not particularly limited and can be appropriately determined depending on the desired precipitation-inhibiting effect, but from the viewpoint of further improving the precipitation-inhibiting effect, it is preferably 7 μg or more, more preferably 35 μg or more, even more preferably 50 μg or more, even more preferably 60 μg or more, and even more preferably 68 μg or more per 1 g of the dried extract equivalent of the herbal extract. The furaneol contained in the herbal extract is not particularly limited and can be appropriately determined depending on the desired precipitation-inhibiting effect, but from the viewpoint of further improving the precipitation-inhibiting effect, it is preferably 6 μg or more, more preferably 30 μg or more, even more preferably 50 μg or more, even more preferably 70 μg or more, 85 μg or more, or 100 μg or more per 1 g of the dried extract equivalent of the herbal extract. The amount of maltol contained in the herbal extract is not particularly limited and can be determined appropriately depending on the desired precipitation-inhibiting effect. However, from the viewpoint of further improving the precipitation-inhibiting effect, the amount is preferably 0.5 μg or more, more preferably 3 μg or more, and even more preferably 5 μg or more, 8 μg or more, or 10 μg or more per 1 g of dried extract equivalent of the herbal extract.

[0020] The type of herbal extract is not particularly limited as long as it contains a hydroxyketone-based aroma component. From the viewpoint of further enhancing the precipitation-inhibiting effect, examples of the herbal extract include dokkatsu-kakkonto extract, shimotsu-to extract, yokukansan extract, etc., and more preferably shimotsu-to extract and yokukansan extract.

[0021] Dokkatsu-kakkonto is a mixed herbal medicine consisting of Pueraria lobata (pueraria root), cinnamon bark, peony root, ephedra root, dokkatsu rhizome (flower root), ginger root, rehmannia root, taiso (flower root), and licorice root. The mixing ratio of the herbs constituting the herbal preparation used to produce Dokkatsu-kakkonto extract is not particularly limited, but examples include 2.5 to 5 parts by weight of Pueraria lobata, 1.5 to 3 parts by weight of cinnamon bark, 1.5 to 3 parts by weight of peony root, 1 to 2 parts by weight of ephedra root, dokkatsu rhizome (flower root), 0.25 to 1 part by weight of ginger root, 2 to 4 parts by weight of rehmannia root, 0.5 to 2 parts by weight of taiso (flower root), and 0.5 to 2 parts by weight of licorice root. Shimotsu-to is a mixed herbal medicine consisting of peony root, rehmannia root, cnidium root, and dongqi (flower root). The mixing ratio of the herbs constituting the herbal preparation used to produce Shimotsuto extract is not particularly limited, but examples include 1.5 to 5 parts by weight of Peony Root, 1.5 to 5 parts by weight of Rehmannia Root, 1.5 to 5 parts by weight of Cnidium Rhizome, and 1.5 to 5 parts by weight of Angelica Root. Yokukansan is a mixed herbal medicine consisting of Angelica Root, Chotoukou, Cnidium Rhizome, Byaku Atractylodes Rhizome, Poria Coccinea, Bupleurum Root, and Licorice. The mixing ratio of the herbs constituting the herbal preparation used to produce Yokukansan extract is not particularly limited, but examples include 1.5 to 3 parts by weight of Angelica Root, 1.5 to 3 parts by weight of Chotoukou, 1.5 to 3 parts by weight of Cnidium Rhizome, 2 to 4 parts by weight of Byaku Atractylodes Rhizome, 2 to 4 parts by weight of Poria Coccinea, 1 to 5 parts by weight of Bupleurum Root, and 0.75 to 1.5 parts by weight of Licorice.

[0022] Concentrated solutions of herbal extracts can be obtained by extracting a herbal preparation according to a herbal prescription and concentrating the resulting extract. The extraction solvent used in the extraction is not particularly limited, and examples include water or aqueous ethanol, preferably water. Extraction methods include adding approximately 10 to 20 times the amount of extraction solvent to the herbal preparation and stirring for approximately 1 to 3 hours at 40 to 100°C, 50 to 100°C, 60 to 100°C, 80 to 100°C, or 90 to 100°C. Concentration methods are not particularly limited, and examples include vacuum concentration, membrane concentration, and heat concentration. Dried herbal extracts can be obtained by drying concentrated solutions of herbal extracts. The drying method is not particularly limited, and examples include freeze-drying, adding an appropriate adsorbent (e.g., silicic anhydride, starch, etc.) to a soft extract with a high extract concentration to obtain an adsorbed powder, and spray-drying.

[0023] In the herbal extract preparation of the present invention, the herbal extract may be contained in the form of a concentrated solution of the herbal extract or in the form of a dried herbal extract. A concentrated herbal extract refers to a herbal extract containing a solvent (e.g., the extraction solvent used to extract the herbal extract), in which the concentration of the herbal extract (equivalent to the dried extract) in the concentrated extract is higher than that in the decoction of the herbal extract (equivalent to the dried extract) or is increased to such an extent that dilution is required before administration. A dried herbal extract may be obtained by removing the solvent used to extract the herbal extract.

[0024] In the herbal extract preparation of the present invention, the herbal extract is preferably one that has not been subjected to a heat history of at least 110°C or higher, from the viewpoint of suppressing the loss of hydroxyketone-based aroma components during the preparation process and further enhancing the precipitation-inhibiting effect. For example, the herbal extract is preferably one obtained by extracting the extract at the above-mentioned temperature, followed by concentration or drying at a temperature below 90°C, preferably below 80°C, more preferably below 60°C, even more preferably below 50°C, and even more preferably below 40°C. In particular, when the herbal extract is contained in the form of a concentrated liquid, the concentrated liquid is preferably a product concentrated under reduced pressure, and when the herbal extract is contained in the form of a dried product, the dried product is preferably a freeze-dried product.

[0025] In addition, in the herbal extract preparation of the present invention, from the viewpoint of suppressing the loss of the above-mentioned aroma components during the preparation process and further enhancing the precipitation suppression effect, it is also preferable that the herbal extract is one that has not undergone the process of microparticulating the herbal extract liquid and rapidly evaporating the solvent.From this viewpoint, when the herbal extract is contained in the form of a concentrated liquid, the concentrated liquid is preferably a product concentrated under reduced pressure, and when the herbal extract is contained in the form of a dried product, the dried product is preferably a freeze-dried product.

[0026] The herbal extract preparations of the present invention do not exclude herbal extracts that have been subjected to a heat history of 110°C or higher and / or herbal extracts that have been prepared by microparticulating a herbal extract liquid and rapidly evaporating the solvent. In these cases, the above-mentioned hydroxyketone aroma components can be added as additives to the herbal extract that has been prepared by a heat history of 110°C or higher and / or the herbal extract that has been prepared by microparticulating a herbal extract liquid and rapidly evaporating the solvent.

[0027] The content of the herbal extract in the herbal extract preparation of the present invention (equivalent to the amount of dried extract) is not particularly limited and may vary depending on the dosage form of the herbal extract preparation, but may be, for example, 20 to 100% by weight, preferably 25 to 100% by weight.

[0028] Other ingredients The herbal extract preparation of the present invention may consist solely of the herbal extract, or may contain additives and bases appropriate for the formulation. Such additives and bases are not particularly limited as long as they are pharmaceutically acceptable. Examples include excipients, binders, disintegrants, lubricants, isotonicity agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, stabilizers, suspending agents, adhesives, coating agents, glossing agents, water, oils and fats, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymers, surfactants, metal soaps, lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV protection agents, preservatives, flavoring agents, fragrances (such as the above-mentioned hydroxyketone-based fragrance components), powders, thickeners, pigments, and chelating agents. These additives may be used alone or in combination of two or more. The content of these additives and bases is appropriately determined depending on the type of additives and bases used and the formulation of the herbal extract preparation.

[0029] In addition, the herbal extract preparation of the present invention may contain other nutritional components or pharmacological components in addition to the herbal extract as needed. Such nutritional components and pharmacological components are not particularly limited as long as they are pharmaceutically acceptable. Examples include antacids, stomachics, digestive aids, intestinal regulators, antispasmodics, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, anti-inflammatory enzymes, sedatives, hypnotics, antihistamines, caffeine, cardiac diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal extracts, vitamins, and menthols. These nutritional components and pharmacological components may be used alone or in combination of two or more. The content of these components is appropriately determined depending on the type of components used.

[0030] Formulation The formulation of the herbal extract preparation of the present invention is not particularly limited as long as it can be dissolved in water and consumed.Specific formulation forms include, for example, solid preparations such as powders, fine granules, and granules (including dry syrups); semi-solid preparations such as jellies; and liquid preparations such as solutions, suspensions, and syrups.To prepare the herbal extract preparation of the present invention into these formulations, the active ingredient of the herbal extract, and additives, bases, and pharmacological ingredients added as needed, can be formulated according to conventional formulation methods.

[0031] How to take The herbal extract preparation of the present invention is dissolved in water and consumed. The dosage per dose is, in terms of the amount of dried herbal extract, for example, 0.5 to 5 g, preferably 0.75 to 2 g, and more preferably 1 to 1.5 g. The temperature of the water is not particularly limited, and examples include 10 to 80°C, preferably 20 to 75°C, more preferably 30 to 65°C, and more preferably 35 to 40°C. Dissolving in water does not require complete dissolution in water, and also includes dispersing in water. The amount of water used is, for example, such that the total volume of the herbal extract preparation dissolved in water is 80 to 150 ml, preferably 90 to 120 ml. [Example]

[0032] The present invention will be specifically described below with reference to examples, but the present invention is not limited to these examples.

[0033] (1) Preparation of herbal extracts (1-1) Preparation of concentrated solution and spray-dried product of Dokkatsu-Kakkonto extract The raw herbs used were 1.5g of Pueraria root, 1.5g of Cinnamon bark, 1.5g of Peony root, 1.0g of Ephedra root, 1.0g of Dokkatsu Root, 0.167g of Ginger root, 1.0g of Rehmannia root, 0.5g of Taiso root, and 0.5g of Licorice root. After chopping, the herbs were extracted with 15 times their weight of water at approximately 100°C for 1 hour and centrifuged to obtain an extract. The extract was concentrated under reduced pressure to obtain a concentrate of Dokkatsu-Kakkonto extract. The concentrate was then dropped into an atomizer rotating at 10,000 rpm and dried with hot air at 150°C to obtain a spray-dried Dokkatsu-Kakkonto extract. The single dose of the concentrate was 5g, and the single dose of the spray-dried product was 1.25g (both equivalent to 1.25g of dried Kampo extract).

[0034] (1-2) Preparation of concentrated solution and spray-dried product of Shimotsuto extract The raw herbs used were 1.5g of Peony Root, 1.5g of Rehmannia Root, 1.5g of Cnidium Rhizome, and 1.5g of Angelica Root. These were chopped and extracted with 15 times their weight of water at approximately 100°C for 1 hour, followed by centrifugation to obtain an extract. The extract was concentrated under reduced pressure to obtain a concentrate of Shimotsuto extract. The concentrate was then dropped into an atomizer rotating at 10,000 rpm and dried with hot air at 150°C to obtain a spray-dried product of Shimotsuto extract. The single dose of the concentrate was 5g, and the single dose of the spray-dried product was 1.25g (both equivalent to 1.25g of dried Kampo extract).

[0035] (1-3) Preparation of concentrated solution, freeze-dried product, and spray-dried product of Yokukansan extract The raw herbs used were 1.5 g of Angelica acutiloba, 1.5 g of Chotokou, 1.5 g of Cnidium Root, 2.0 g of Atractylodes Rhizome, 2.0 g of Poria Coccinea, 1.0 g of Bupleurum Root, and 0.75 g of Licorice. These were chopped and extracted with 15 times their weight of water at approximately 100°C for 1 hour, followed by centrifugation to obtain an extract. The extract was concentrated under reduced pressure to obtain a concentrate of yokukansan extract. The concentrate was then dried at -30°C or below to obtain a freeze-dried product of yokukansan extract. The concentrate was then dropped into an atomizer rotating at 10,000 rpm and dried with hot air at 150°C to obtain a spray-dried product of yokukansan extract. The single dose of the concentrate was 5 g, the single dose of the spray-dried product was 1.25 g, and the single dose of the freeze-dried product was 1.25 g (each equivalent to 1.25 g of dried Kampo extract).

[0036] (2) Measurement of hydroxyketone-based aroma components The content of hydroxyketone aroma compounds in Kampo extracts was measured using GC / MS. A DB-WAX column (film thickness 0.25 μm, length 30 m, inner diameter 0.25 mm) was used. The column temperature was increased at 10°C / min from 60°C to 150°C, 10°C / min from 45°C to 160°C, 15°C / min from 100°C to 160°C, and 20°C / min from 160°C to 240°C. The detector temperature was maintained at 300°C throughout the analysis. Quantitation was performed using calibration curves calculated from each standard. For the concentrate, 0.5 μL of the original solution was injected. For the spray-dried product, 5 g of the spray-dried product was mixed with purified water to make a 20 g solution, and 0.5 μL was injected. For the freeze-dried product, 5 g of the freeze-dried product was mixed with purified water to make a 20 g solution, and 0.5 μL was injected. The results are shown in Figures 1 to 3.

[0037] (3) Evaluation of precipitation suppression effect The resulting Kampo extracts (5 g of concentrated liquid, 1.25 g of freeze-dried product, and 1.25 g of spray-dried product; each equivalent to 1.25 g of dried Kampo extract) were mixed with 37°C water to bring the total volume to 100 ml, stirred with a glass rod for 30 seconds, and then allowed to stand for 30 seconds. After standing, the supernatant was removed and dried, and the amount of sediment (mg) per 1.25 g of dried extract was measured. The results are shown in Table 1.

[0038] [Table 1]

[0039] As shown in Table 1, the herbal extract preparations (Comparative Examples 1 to 3) that did not contain hydroxyketone-based aromatic components such as hydroxyacetone, furaneol, and maltol produced a large amount of precipitate, whereas the herbal extract preparations (Examples 1 to 4) that contained the hydroxyketone-based aromatic components produced significantly less precipitate.

Claims

1. A herbal extract preparation containing a Shimotsuto extract that has not been subjected to a heat history of 110°C or higher, and which contains a hydroxyketone-based aromatic component selected from the group consisting of hydroxyacetone, furaneol, and maltol, and which is dissolved in water and taken as a drink.

2. 2. The herbal extract preparation according to claim 1, wherein the content of the hydroxyketone-based aroma components in the Shimotsuto extract is 10 μg or more per 1 g of the dried extract of the Shimotsuto extract.

3. A herbal extract preparation as described in claim 1 or 2, wherein the Shimotsuto extract that has not been subjected to a thermal history of 110°C or higher is a concentrate concentrated under reduced pressure or a freeze-dried product.

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