DE102024109959A1 - Liver-protecting composition - Google Patents

Abstract

The present invention relates to the technical field of traditional Chinese medicine, and more particularly, to a liver-protecting composition and a method for producing the same. The liver-protecting composition contains, by weight, 10 to 25 parts of plantain, 5 to 15 parts of licorice, 5 to 13 parts of turmeric, 2 to 8 parts of ginseng, 2 to 8 parts of Hovenia dulcis Thunb., and a spice adjuvant, wherein the spice adjuvant contains sucrose. The present invention relates to a pure traditional Chinese medicine that is easy to prepare and convenient to take, has beneficial effects for protecting and nourishing the liver, and also has an effect for alleviating the effects of alcohol.

Description

TECHNICAL FIELD

The present invention relates to the technical field of traditional Chinese medicine and, more particularly, to a liver-protective composition and a method for producing the same.

BACKGROUND

The liver is a metabolic organ with diverse functions. The liver can detoxify various metabolites, regulate glycogen storage, synthesize plasma proteins, produce hormones, and manufacture biochemicals that facilitate the breakdown of toxic substances. Patients with liver disease may experience problems with digestion, blood clotting, blood sugar levels, immunity, lipid metabolism, and more. Fat malabsorption can cause symptoms such as indigestion, deficiency of fat-soluble vitamins, gallstones, intolerance to fatty foods, alcohol intolerance, bloating, and nausea.

Regarding the causes of liver disease, viral and parasitic infections are the main causes of liver disease in Africa and Asia. In Europe and the United States, however, a major cause of liver disease is alcoholism, while the number of viral hepatitis infections is constantly increasing.

Although the number of patients suffering from liver disease is increasing, there is currently a lack of medications to treat or protect the liver. Therefore, medical professionals await research into medications that can effectively treat or protect the liver.

Against this background, the present invention is proposed.

SUMMARY OVERVIEW

• 10 bis 25 Teile Wegerich, 5 bis 15 Teile Süßholz, 5 bis 13 Teile Kurkuma, 2 bis 8 Teile Ginseng, 2 bis 8 Teile Hovenia dulcis Thunb. und einen Gewürzadjuvans, wobei der Gewürzadjuvans Saccharose enthält.

The first object of the present invention relates to a liver-protective composition including in parts by weight:

• 10 to 25 parts plantain, 5 to 15 parts licorice, 5 to 13 parts turmeric, 2 to 8 parts ginseng, 2 to 8 parts Hovenia dulcis Thunb. and a spice adjuvant, the spice adjuvant containing sucrose.

The combination of the aforementioned ingredients not only achieves good efficacy, but also avoids obvious toxic effects and side effects. The combination of ingredients can achieve a significant synergistic effect, resulting in beneficial effects for protecting and nourishing the liver.

In some embodiments, the liver-protecting composition contains, by weight, 12 to 23 parts plantain, 7 to 13 parts licorice, 7 to 10 parts turmeric, 4 to 6 parts ginseng, and 4 to 6 parts Hovenia dulcis Thunb.

In some embodiments, the liver-protecting composition contains, by weight, 17 parts plantain, 10 parts licorice, 9 parts turmeric, 5 parts ginseng, and 5 parts Hovenia dulcis Thunb.

In some cases the licorice is roasted licorice.

In some embodiments, the liver-protective composition further contains a pharmaceutically acceptable adjuvant.

In some embodiments, the dosage form of the liver-protective composition comprises a pill, a powder, an ointment, a tablet, a granule (elecarium), a lozenge, a capsule, an aqueous agent, or a tincture.

A preferred dosage form is the aqueous agent or tincture.

The aqueous agent is an aqueous solution of a traditional Chinese medicine composition. The drug is uniformly dispersed in water in the form of ions or molecules. The concentration of the drug depends on the water solubility of the original drug, which is usually the maximum solubility; the drug is then diluted with water before use. To fully release the active ingredients of the drug, the aqueous agent can be prepared by boiling the drug in hot water or by other methods. The boiling can be performed once, twice, or several times.

The tincture is a clear liquid formulation prepared by leaching or dissolving the drug in ethanol at a specific concentration; it can also be prepared by diluting the drug with a liquid extract. The tincture is taken orally or applied topically. The preparation of the tincture does not require heating, the tincture has relatively pure components with a high active ingredient content, and the tincture is administered in precise dosages, is rapidly absorbed, and is suitable for preparing a formulation containing volatile components or heat-labile components. Preferably, the tincture in the present invention is a tincture administered by the oral route.

The present invention also provides a process for producing the aforementioned liver-protective composition.

First, a simple composition is prepared. Another object of the present invention is to provide a process for preparing the above-mentioned liver-protecting composition, which comprises the following step: grinding and mixing the ingredients.

1. (a) Auskochen oder Brühen von Bestandteilen mit Wasser, um eine ausgekochte Lösung zu erhalten, oder Durchführen einer Extraktion unter Verwendung einer wässrigen Ethanollösung, um eine Extraktlösung zu erhalten; und
2. (b) Zubereitung der ausgekochten Lösung oder der Extraktlösung in einer gewünschten Darreichungsform.

Secondly, a more complex preparation method is provided, which includes the following steps:

1. (a) boiling or scalding components with water to obtain a boiled solution or carrying out extraction using an aqueous ethanol solution to obtain an extract solution; and
2. (b) Preparation of the boiled solution or the extract solution in a desired dosage form.

• Zerkleinerung von Wegerich und Süßholz, Zugabe von Wasser zu der entstandenen Mischung, zweimalige Abkochung der entstandenen Mischung für jeweils 1 bis 2 Stunden, Filtrierung der abgekochten Lösung und Vereinigung der Filtrate, um das erste Filtrat zu erhalten;
• Zerkleinern und Mischen von Kurkuma, Ginseng und Hovenia dulcis Thunb., 2- bis 4-malige Zugabe von 60- bis 80-prozentigem Ethanol zur Rückflussextraktion, Vereinigen der Extrakte und Filtrieren der Extrakte, um das zweite Filtrat zu erhalten; und
• Vereinigen des ersten Filtrats und des zweiten Filtrats, Stehenlassen des entstandenen Gemischs für 2 bis 3 Tage, Gewinnen eines Überstands, Gewinnen des Ethanols aus dem Überstand unter vermindertem Druck und Hinzufügen des Gewürzadjuvans.
• Die vorliegende Erfindung betrifft ein reines traditionelles chinesisches Arzneimittel, das einfach zuzubereiten und bequem einzunehmen ist, eine gute Wirkung zum Schutz und zur Nährung der Leber hat und darüber hinaus eine Wirkung zur Linderung der Auswirkungen von Alkohol hat.

In some embodiments, the method for preparing the liver-protective composition comprises:

• Crushing plantain and licorice, adding water to the resulting mixture, boiling the resulting mixture twice for 1 to 2 hours each, filtering the boiled solution and combining the filtrates to obtain the first filtrate;
• Crushing and mixing turmeric, ginseng, and Hovenia dulcis Thunb., adding 60 to 80 percent ethanol 2 to 4 times for reflux extraction, combining the extracts, and filtering the extracts to obtain the second filtrate; and
• Combine the first filtrate and the second filtrate, allow the resulting mixture to stand for 2 to 3 days, obtain a supernatant, extract the ethanol from the supernatant under reduced pressure, and add the spice adjuvant.
• The present invention relates to a pure traditional Chinese medicine which is easy to prepare and convenient to take, has a good effect of protecting and nourishing the liver, and also has an effect of alleviating the effects of alcohol.

DETAILED DESCRIPTION

Reference will be made in detail to embodiments of the present invention, and one or more examples will be described below. Each example is intended to illustrate and not to limit the present invention. Indeed, those skilled in the art may make various modifications and changes to the present invention without departing from the scope or spirit of the present invention. For example, features shown or described as part of one embodiment may be used in another embodiment to create another embodiment.

Unless otherwise specified, all terms (including technical and scientific terms) used to disclose the present invention have the same meaning, as commonly understood by a person of ordinary skill in the art to which the present invention belongs. To facilitate understanding of the principles of the present invention, the following definitions are used. The terms used herein in the description of the present invention are for the purpose of describing particular embodiments only and are not intended to limit the present invention.

The terms "comprise," "include," and "contain" as used herein are synonymous and are integrative or open-ended and do not exclude additional, unstated members, elements, or method steps.

A range of values in the present invention defined by endpoints includes all values, fractions, and said endpoints that fall within the range.

A concentration value, which is the subject of the present invention, can fluctuate within a certain range. For example, the concentration value can fluctuate within a corresponding precision range. For example, a precision range of 2% allows fluctuations within a range of ±0.1%. For a larger value or a value that does not require fine control, a larger fluctuation is also permissible. For example, a precision range of 100 mM can allow fluctuations within a range of ±1%, ±2%, ±5%, etc. For the molecular weight, a fluctuation of ±10% is permissible.

In the present invention, terms such as “multiple” and “different” refer to two or more than two unless otherwise specified.

In the context of the present invention, the technical features in the open-ended descriptions include both closed technical solutions consisting of the listed features and open-ended technical solutions containing the listed features.

In the present invention, "preferred", "better", "advantageous" and "suitable" are intended only to describe embodiments or examples having better effect and should not be construed as limiting the scope of the present invention.

The embodiments of the present invention are described in detail below using examples. It should be understood that these examples are used only to illustrate the present invention and are not intended to limit the scope of the present invention. In the following examples, for a test method for which a specific condition is not specified, reference is preferably made to the instructions in the present invention, a test manual or a condition conventional in the art, another test method known in the art, or a condition from a manufacturer.

In the following specific examples, a measurement parameter related to an ingredient may exhibit slight deviation within a weighing accuracy range unless otherwise specified. For temperature and time parameters, an acceptable deviation is permitted due to the instrument's testing accuracy or operating accuracy.

Example 1

Weight: 10 g plantain, 15 g licorice, 5 g turmeric, 8 g ginseng, 2 g Hovenia dulcis Thunb. and 13 g sucrose.

Preparation: Plantain and licorice were ground, the resulting mixture was added to water, boiled twice for 1 hour each, the boiled solution was filtered and the filtrates were combined to obtain the first filtrate;

Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 80% ethanol was added twice for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and

The first filtrate and the second filtrate were combined and stood for 2 days, then a supernatant was withdrawn, ethanol was obtained from the supernatant under reduced pressure and sucrose was added.

Example 2

Weight: 25 g plantain, 5 g licorice, 13 g turmeric, 2 g ginseng, 8 g Hovenia dulcis Thunb. and 5 g sucrose.

Preparation: Plantain and licorice were ground, the resulting mixture was added to water and boiled twice for 2 hours each, the boiled solution was filtered and the filtrates were combined to obtain the first filtrate;

Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 60% ethanol was added four times for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and

The first filtrate and the second filtrate were combined and stood for 3 days, then a supernatant was withdrawn, ethanol was obtained from the supernatant under reduced pressure and sucrose was added.

Example 3

Weight: 12 parts plantain, 13 parts licorice, 7 parts turmeric, 6 parts ginseng, 4 parts Hovenia dulcis Thunb., and 10 parts sucrose.

Preparation: Plantain and licorice were ground, the resulting mixture was added to water, boiled twice for 1 to 2 hours, the boiled solution was filtered and the filtrates were combined to obtain the first filtrate;

Crushing and mixing turmeric, ginseng, and Hovenia dulcis Thunb., adding 60 to 80 percent ethanol 2 to 4 times for reflux extraction, combining the extracts, and filtering the extracts to obtain the second filtrate; and

The first filtrate and the second filtrate were combined and allowed to stand for 2 to 3 days, a supernatant was withdrawn, ethanol was obtained from the supernatant under reduced pressure and sucrose was added.

Example 4

Weight: 17 g plantain, 10 g licorice, 9 g turmeric, 5 g ginseng, 5 g Hovenia dulcis Thunb. and 9 g sucrose.

Preparation: Plantain and licorice were ground, the resulting mixture was added to water and boiled twice for 2 hours each, the boiled solution was filtered and the filtrates were combined to obtain the first filtrate;

Turmeric, ginseng, and Hovenia dulcis Thunb. were ground and mixed, 70% ethanol was added three times for reflux extraction, and the extracts were combined and filtered to obtain the second filtrate; and

The first filtrate and the second filtrate were combined and stood for 3 days, then a supernatant was withdrawn, ethanol was obtained from the supernatant under reduced pressure and sucrose was added.

Test example

• 60 Mäuse wurden nach dem Zufallsprinzip in 4 Gruppen mit 15 Mäusen in jeder Gruppe aufgeteilt, jede Gruppe wurde über eine Schlundsonde behandelt, eine Blanko-Gruppe und eine Modellierungsgruppe erhielten sauberes Wasser, eine Testgruppe erhielt die in Beispiel 4 hergestellte Formulierung, und einer positiven Gruppe wurde eine wirksame Menge von Sonnenblumen-Leberschutztabletten verabreicht, um als Kontrollgruppe verwendet zu werden. Die Dosierung wurde für Mäuse gemäß dem „Chinesischen Arzneibuch“ berechnet, die Dosierung für die positive Gruppe betrug 560 mg/kg und die Dosierung für die Testgruppe 420 mg/kg.

The formulation prepared in Example 4 was used for a test on mice with acute liver damage caused by CCl ₄ :

• 60 mice were randomly divided into four groups, each with 15 mice in each group. Each group was treated via gavage. A blank group and a modeling group received clean water. A test group received the formulation prepared in Example 4. A positive group was administered an effective amount of sunflower liver-protecting tablets to serve as a control group. The dosage for mice was calculated according to the Chinese Pharmacopoeia. The dosage for the positive group was 560 mg/kg, and the dosage for the test group was 420 mg/kg.

In the present invention, olive oil was used to prepare a solution containing 1% _CCl4 . The solution was injected intraperitoneally at 10 ml/kg body weight into each mouse separately to create a model, and only the blank group did not require modeling. One week after the intragastric administration, the mice in the _CCl4 modeling group, the test group, and the positive group were again injected intraperitoneally with the 0.1% _CCl4 oil solution to create the model. Subsequently, blood samples were collected from each mouse within 18 hours using an orbital blood sampling method, and liver function indicators (AST and ALT) were determined using conventional methods. The results are shown in Table 1. Table 1 group Number of animals ALT (U/L) AST (U/L) Blanko group 10 37.2±7.4** 30.64+4.33** Modeling group 10 397.5±81.6 141.6±32.7 test group 10 154.2±29.8** 82.90±10.75** Positive group 10 234.55±52.01 ** 98.73±12.93**

Note: Compared with the modeling group, *P<0.05 and **P<0.01.

From the above results, it can be seen that the drug of the present invention could significantly reduce ALT activity, and there was a very significant difference (P<0.01) compared with the model group; and

Samples at all three doses were able to reduce ALT activity, and there was a highly significant difference (P<0.01) between the three dose groups and the modeling group. The test results show that the sample has a significant protective effect on liver injury and exhibits a significant liver-protective effect.

The above embodiments describe only a few examples of the present invention. These descriptions are relatively detailed and specific, but should not be construed as limiting the scope of the present invention. It should be understood that a person skilled in the art could make various variations and improvements without departing from the concept of the present invention. These variations and improvements are all within the scope of the present invention.

Claims (9)

A liver-protective composition containing, by weight: 10 to 25 parts plantain, 5 to 15 parts licorice, 5 to 13 parts turmeric, 2 to 8 parts ginseng, 2 to 8 parts Hovenia dulcis Thunb., and a spice adjuvant, wherein the spice adjuvant contains sucrose. The liver-protecting composition according to Claim 1 , comprising in parts by weight: 12 to 23 parts plantain, 7 to 13 parts liquorice, 7 to 10 parts turmeric, 4 to 6 parts ginseng and 4 to 6 parts Hovenia dulcis Thunb. The liver-protecting composition according to Claim 2 , comprising in parts by weight: 17 parts plantain, 10 parts liquorice, 9 parts turmeric, 5 parts ginseng and 5 parts Hovenia dulcis Thunb. The liver-protecting composition according to one of the Claims 1 until 3 , where the licorice is roasted licorice. The liver-protecting composition according to Claim 4 which also contains a pharmaceutically acceptable adjuvant. Liver protection agents according to Claim 4 , where the dosage form is a pill, powder, ointment, tablet, granule, lozenge, capsule, aqueous preparation or tincture. Process for the preparation of the liver-protective composition according to one of the Claims 1 until 6 , comprising the following step: grinding and mixing the ingredients. Process for the preparation of the liver-protective composition according to one of the Claims 1 until 6 , comprising the following step: (a) decoction or brewing of components with water to obtain a decocted solution, or extraction using an aqueous ethanol solution to obtain an extract solution, and (b) preparation of the decocted solution or the extract solution in a desired dosage form. Process for the preparation of the liver-protective composition according to Claim 8 , comprising: crushing plantain and licorice, adding water to the resulting mixture, decocting the resulting mixture twice for 1 to 2 hours each, filtering the decocted solution, and combining the filtrates to obtain the first filtrate; crushing and mixing turmeric, ginseng, and Hovenia dulcis Thunb., adding 60 to 80% ethanol 2 to 4 times for reflux extraction, combining the extracts, and filtering the extracts to obtain the second filtrate; and combining the first filtrate and the second filtrate, allowing the resulting mixture to stand for 2 to 3 days, obtaining a supernatant, recovering the ethanol from the supernatant under reduced pressure, and adding the spice additive.