A traditional Chinese medicine composition and application thereof

Abstract

The present application relates to a kind of traditional Chinese medicine composition and its application, the traditional Chinese medicine composition is made of the following mass parts of raw medicinal materials: loquat leaf 0.5~8 parts;Mace 0.5~4 parts;And optionally, xuanfuhua 0.1~1.8 parts.The traditional Chinese medicine composition can relieve the nausea and / or vomiting caused by alcohol intake.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for relieving nausea and vomiting symptoms caused by alcohol intake and its application. Background Technology

[0002] Nausea and vomiting caused by alcohol consumption are common acute alcohol-related health problems in modern society. With the increasing prevalence of social drinking and work-related social events, the incidence of acute alcohol poisoning and post-drinking discomfort continues to rise. According to a report released by the World Health Organization (WHO) in June 2024, approximately 2.6 million people worldwide die each year from alcohol-related causes, accounting for 4.7% of all deaths. Among these, severe nausea and vomiting caused by acute alcohol poisoning has become one of the important reasons for patients seeking medical attention.

[0003] Currently, modern medical treatments for alcoholic nausea and vomiting mainly include: gastric mucosal protectants, such as sucralfate and bismuth potassium citrate; antiemetics, including dopamine receptor antagonists (such as metoclopramide) and 5-HT3 receptor antagonists (such as ondansetron); and drugs that promote alcohol metabolism, such as metadoxine. However, these Western medicine treatments have significant limitations. Although some antiemetics have a rapid onset of action, they are often accompanied by adverse reactions such as drowsiness, extrapyramidal reactions, and arrhythmias; long-term use may also lead to drug resistance or even drug dependence, affecting patient compliance and safety.

[0004] Therefore, there is an urgent clinical need for a treatment plan that is effective, safe, has few side effects, and has a clear mechanism of action. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for relieving nausea and vomiting symptoms caused by alcohol consumption. The composition of this invention significantly improves discomfort symptoms such as nausea and vomiting after drinking alcohol, and has a high safety profile.

[0006] This invention provides a traditional Chinese medicine composition, which is made from the following raw materials in parts by weight: Loquat leaf 0.5-8 parts; nutmeg 0.5-4 parts; and optionally, Inula japonica 0.1-1.8 parts.

[0007] In some embodiments, the loquat leaves are 0.5 to 6 parts by weight; and / or The mass fraction of Inula japonica is 0.3 to 1.8 parts, preferably 0.5 to 1.5 parts; and / or The nutmeg content is 0.5 to 4 parts by weight, preferably 0.8 to 3.5 parts by weight.

[0008] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials: Loquat leaves, Inula japonica, and nutmeg; The mass ratio of loquat leaves, inula flowers, and nutmeg is (0.5~8):(0.5~1.8):(0.5~4). Preferably, the mass ratio of loquat leaf, inula flower and nutmeg is (0.5~6):(0.5~2):(0.5~3), more preferably (1~5):(0.5~1.5):(1~2), and even more preferably 1:1:1, 2:1:1, 1:1:2, 5:1:1.

[0009] In some embodiments, the traditional Chinese medicine composition is prepared by mixing loquat leaves, inula flowers and nutmeg, then decocting and concentrating the mixture. Preferably, the preparation method of the traditional Chinese medicine composition is to mix loquat leaves, inula flowers and nutmeg, soak them in water, decoct, concentrate and filter.

[0010] In some embodiments, the mass-to-volume ratio of the total active pharmaceutical ingredient to water is 30-250 g / L, preferably 180-230 g / L, and even more preferably 150-200 g / L.

[0011] In some embodiments, the simmering time is 20 to 120 minutes, preferably 30 to 60 minutes, and more preferably 40 minutes.

[0012] In some embodiments, the ratio of the total mass of the active pharmaceutical ingredient to the volume of the concentrated drug is 3.5 to 15 g / mL, preferably 4 to 14 g / mL, and even more preferably 6 to 12 g / mL.

[0013] The present invention also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition as described above and pharmaceutically acceptable excipients.

[0014] In some embodiments, the dosage form of the pharmaceutical preparation is an oral liquid, granules, capsules, or tablets.

[0015] The present invention also provides the use of the traditional Chinese medicine composition or pharmaceutical preparation as described above in the preparation of a medicament for relieving nausea and / or vomiting symptoms; preferably, the nausea and / or vomiting is caused by alcohol intake.

[0016] The composition of the present invention significantly improves discomfort symptoms such as nausea and vomiting after drinking alcohol, and has high safety. Attached Figure Description

[0017] Figure 1 Schematic diagram of an odor avoidance test induced by intraperitoneal injection of alcohol in mice; Figure 2 Results of an experiment on inducing conditioned odor avoidance behavior in mice by intraperitoneal injection of ethanol solution; Figure 3 Comparison of the effects of different compositions on odor avoidance behavior; Figure 4 The effect of different concentration gradients of the composition on odor avoidance behavior; Figure 5 The effect of different proportions of the formulation on the odor avoidance behavior of the composition. Detailed Implementation

[0018] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. The specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention in any way.

[0019] This invention provides a traditional Chinese medicine composition, which is made from the following raw materials in parts by weight: Loquat leaf 0.5-8 parts; nutmeg 0.5-4 parts; and optionally, Inula japonica 0.1-1.8 parts.

[0020] In some embodiments, the loquat leaves are in the form of 0.5 to 6 parts by weight, for example, 0.8 parts, 1 part, 1.5 parts, 2 parts, 3 parts, 4 parts, 5 parts, or 6 parts.

[0021] In some embodiments, the mass fraction of Inula japonica is 0.3 to 1.8 parts, preferably 0.5 to 1.5 parts, for example 0.8 parts, 1 part, or 1.2 parts.

[0022] In some embodiments, the nutmeg is in the form of 0.5 to 4 parts by weight, preferably 0.8 to 3.5 parts, for example 0.8 parts, 1 part, 1.5 parts, 2 parts, 3 parts, or 4 parts.

[0023] Loquat leaves are slightly cold in nature and excel at clearing heat from the lungs and stomach, making them suitable for nausea and cough caused by stomach or lung heat. Inula japonica is slightly warm in nature, light in texture, and good at descending, earning it the reputation of "all flowers ascend, but Inula japonica descends alone." It can effectively lower lung qi to eliminate phlegm and lower stomach qi to stop vomiting, and is especially good at treating phlegm-dampness stagnation and stomach qi rebellion. Nutmeg is warm in nature and functions to warm the middle jiao, promote qi circulation, astringe the intestines, and stop diarrhea. It can warm the spleen and stomach in the middle jiao, and resolve dampness and promote circulation. Loquat leaves, being slightly cold in nature, can clear heat from the lungs and stomach, and are especially suitable for nausea and vomiting caused by stomach heat (such as after drinking alcohol or food stagnation turning into heat) and cough with yellow phlegm caused by lung heat.

[0024] This invention, through in-depth research, has discovered that single medicinal herbs often only act on a specific aspect of nausea and vomiting symptoms caused by alcohol intake. Through scientific combination, the lung-clearing and phlegm-resolving properties of loquat leaf and the phlegm-reducing and qi-regulating properties of inula flower can produce a synergistic anti-nausea effect. In addition, the warming, qi-regulating, dampness-resolving, and stagnation-relieving properties of nutmeg not only offset some of the cold properties of the herbs to protect the spleen and stomach, but also synergistically improve the stimulation of the digestive and nervous systems by alcohol through multiple pathways and targets, thus achieving a more significant and comprehensive anti-nausea and anti-vomiting effect than single herbs.

[0025] In some embodiments, the traditional Chinese medicine composition is made from the following raw materials: Loquat leaves, Inula japonica, and nutmeg; The mass ratio of loquat leaves, inula flowers, and nutmeg is (0.5~8):(0.5~1.8):(0.5~4).

[0026] In some embodiments, the mass ratio of loquat leaf, inula flower, and nutmeg is (0.5~6):(0.5~2):(0.5~3), preferably (1~5):(0.5~1.5):(1~2), even more preferably (1~5):(0.5~1):(1~2), and even more preferably 1:1:1, 2:1:1, 1:1:2, or 5:1:1. This invention has found that although nutmeg alone does not significantly improve conditioned odor avoidance caused by alcohol, it plays an important auxiliary role in compound formulations: nutmeg is warm in nature and pungent in taste, possessing the functions of warming the middle jiao, promoting qi circulation, resolving dampness, and eliminating stagnation. By improving the overall damage of alcohol to the spleen and stomach function, it assists and enhances the qi-regulating and nausea-relieving effects of loquat leaf and inula flower, thereby improving the overall efficacy.

[0027] In some embodiments, the traditional Chinese medicine composition is prepared by mixing loquat leaves, inula flowers, and nutmeg, then decocting and concentrating the mixture.

[0028] In some embodiments, the traditional Chinese medicine composition is prepared by mixing loquat leaves, inula flowers and nutmeg, adding water and decocting, concentrating and filtering.

[0029] In some embodiments, the traditional Chinese medicine composition is prepared by mixing loquat leaves, inula flowers and nutmeg, soaking in water, decocting, concentrating and filtering.

[0030] In some embodiments, the mass-to-volume ratio of the total active pharmaceutical ingredient to water is 30-250 g / L, for example 40 g / L, 50 g / L, 70 g / L, 90 g / L, 100 g / L, 120 g / L, 150 g / L, 180 g / L, 200 g / L, preferably 180-230 g / L, and even more preferably 150-200 g / L.

[0031] In some embodiments, the simmering time is 20 to 120 minutes, preferably 30 to 60 minutes, and more preferably 40 minutes.

[0032] In some embodiments, the ratio of the total mass of the active pharmaceutical ingredient to the volume of the concentrated drug is 3.5 to 15 g / mL, preferably 4 to 14 g / mL, and even more preferably 6 to 12 g / mL.

[0033] The present invention also provides a pharmaceutical preparation comprising the traditional Chinese medicine composition as described above and pharmaceutically acceptable excipients.

[0034] In some embodiments, the dosage form of the pharmaceutical preparation is an oral liquid, granules, capsules, or tablets.

[0035] The present invention also provides the use of the traditional Chinese medicine composition or pharmaceutical preparation as described above in the preparation of a medicament for relieving nausea and / or vomiting symptoms.

[0036] In some embodiments, the nausea and / or vomiting are caused by alcohol intake.

[0037] The present invention also provides a method for relieving nausea and / or vomiting symptoms in an individual, the method being to administer an effective amount of the traditional Chinese medicine composition or pharmaceutical preparation as described above to the individual.

[0038] In some embodiments, the nausea and / or vomiting are caused by alcohol intake.

[0039] In some embodiments, the administration method is oral.

[0040] The sources of experimental materials and the experimental environment used in the following examples are described below: Mice: 10-week-old male SPF-grade C57BL6J mice, purchased from Vital Rivers.

[0041] The mouse rearing conditions were set as follows: the ambient temperature was maintained at 22±0.5℃, and a 12-hour / 12-hour light-dark cycle was used. During the pre-experiment rearing stage, the mice were allowed free access to food and water; after entering the experimental stage, the same temperature, humidity, and light conditions were maintained, but the mice were restricted from drinking water.

[0042] Preparation Method of Loquat Leaf Concentrate (Example 1) Take 100g of loquat leaves, add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting liquid to 50mL, and filter through a 400-mesh sieve to obtain loquat leaf concentrate.

[0043] Preparation Method of Inula japonica Concentrate (Example 2) Take 100g of Inula japonica, add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting liquid to 50mL, and filter through a 400-mesh sieve to obtain Inula japonica concentrate.

[0044] Preparation Method of Nutmeg Concentrate (Example 3) Take 100g of nutmeg, crush it appropriately, add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting liquid to 50mL, filter through a 400-mesh sieve to obtain nutmeg concentrate.

[0045] Preparation Example 4: Preparation method of loquat leaf + inula flower concentrate Take 100g each of loquat leaves and Inula japonica (total medicinal material 200g), add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting mixed medicinal liquid under reduced pressure to 50mL, filter through a 400-mesh sieve to obtain loquat leaf + Inula japonica concentrated liquid.

[0046] Preparation Example 5: Preparation method of loquat leaf + nutmeg concentrate Take 100g each of loquat leaves and nutmeg (total medicinal material 200g), crush the nutmeg appropriately, add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting mixed medicinal liquid under reduced pressure to 50mL, filter through a 400-mesh sieve to obtain loquat leaf + nutmeg concentrate.

[0047] Preparation Example 6: Preparation method of Inula japonica + Myristica fragrans concentrate Take 100g each of Inula japonica and nutmeg (total medicinal material 200g), crush the nutmeg appropriately, add 1L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes; filter out the dregs, concentrate the resulting mixed medicinal liquid under reduced pressure to 50mL, filter through a 400-mesh sieve to obtain Inula japonica + nutmeg concentrated liquid.

[0048] Preparation Example 7: Preparation method of a 1:1:1 concentrated extract of loquat leaf, inula flower, and nutmeg. Take 100g of loquat leaves, 100g of inula flowers, and 100g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs and concentrate the resulting mixed liquid to 50mL. Filter through a 400-mesh sieve to obtain a 1:1:1 concentrated solution of loquat leaves, inula flowers, and nutmeg.

[0049] Preparation Method of Example 8: 2x Concentrated Loquat Leaf + Inula Flower + Nutmeg Solution Take 100g of loquat leaves, 100g of inula flowers, and 100g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs and concentrate the resulting mixed liquid to 25mL. Filter through a 400-mesh sieve to obtain a 2x concentrated solution of loquat leaves, inula flowers, and nutmeg.

[0050] Preparation Method of 2-fold Diluted Loquat Leaf + Inula Flower + Nutmeg Solution (Example 9) Take 100g of loquat leaves, 100g of inula flowers, and 100g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed liquid to 100mL, and filter through a 400-mesh sieve to obtain a 2-fold diluted solution of loquat leaves, inula flowers, and nutmeg.

[0051] Preparation Example 10: Preparation method of a 4-fold dilution of loquat leaf + inula flower + nutmeg Take 100g of loquat leaves, 100g of inula flowers, and 100g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed liquid to 200mL, and filter through a 400-mesh sieve to obtain a 4-fold diluted solution of loquat leaves, inula flowers, and nutmeg.

[0052] Preparation Example 11: Preparation method of concentrated extract of loquat leaf + inula flower + nutmeg 2:1:1 Take 150g of loquat leaves, 75g of Inula japonica, and 75g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs and concentrate the resulting mixed liquid to 50mL. Filter through a 400-mesh sieve to obtain a 2:1:1 concentrated solution of loquat leaves, Inula japonica, and nutmeg.

[0053] Preparation Example 12: Preparation method of a concentrated extract of loquat leaf + inula flower + nutmeg 1:2:1 Take 75g of loquat leaves, 150g of inula flowers, and 75g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed liquid to 50mL, and filter through a 400-mesh sieve to obtain a 1:2:1 concentrated solution of loquat leaves, inula flowers, and nutmeg.

[0054] Preparation Example 13: Preparation method of a concentrated extract of loquat leaf + inula flower + nutmeg in a 1:1:2 ratio Take 75g of loquat leaves, 75g of inula flowers, and 150g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed liquid to 50mL, and filter through a 400-mesh sieve to obtain a 1:1:2 concentrated solution of loquat leaves, inula flowers, and nutmeg.

[0055] Preparation Example 14: Preparation method of a concentrated extract of loquat leaf + inula flower + nutmeg in a 5:1:1 ratio Take 214.3g of loquat leaves, 42.86g of Inula japonica, and 42.86g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed medicinal liquid to 50mL, and filter through a 400-mesh sieve to obtain a 5:1:1 concentrated solution of loquat leaves, Inula japonica, and nutmeg.

[0056] Preparation Example 15: Preparation method of concentrated extract of loquat leaf + inula flower + nutmeg 1:5:1 Take 42.86g of loquat leaves, 214.3g of Inula japonica, and 42.86g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed medicinal liquid to 50mL, and filter through a 400-mesh sieve to obtain a 1:5:1 concentrated solution of loquat leaves, Inula japonica, and nutmeg.

[0057] Preparation Example 16: Preparation method of a concentrated extract of loquat leaf + inula flower + nutmeg in a 1:1:5 ratio Take 42.86g of loquat leaves, 42.86g of Inula japonica, and 214.3g of nutmeg (total medicinal material 300g). After crushing the nutmeg appropriately, add 2L of double-distilled water and soak for 30 minutes, then decoct for 40 minutes. Filter out the dregs, concentrate the resulting mixed medicinal liquid to 50mL, and filter through a 400-mesh sieve to obtain a 1:1:5 concentrated solution of loquat leaves, Inula japonica, and nutmeg.

[0058] Example 1: Conditioned odor avoidance experiment induced by intraperitoneal injection of alcohol in mice Healthy 10-week-old C57BL / 6J mice were randomly divided into a saline group and an ethanol group. A water restriction protocol (23.5 hours of water deprivation daily, with 30-minute timed drinking sessions at fixed intervals) was implemented throughout the experiment. During the first three-day acclimatization period, mice were transferred to test cages equipped with two water bottles, during which they could freely drink the flavorless water in the bottles for 30 minutes each day for three consecutive days. After the acclimatization period, on the fourth day, both bottles were filled with a single-flavor solution containing 0.2% saccharin, selected from either grape or cherry flavor (e.g., if grape flavor was chosen, both bottles contained 0.2% saccharin grape-flavored water; if cherry flavor was chosen, both bottles contained 0.2% saccharin cherry-flavored water). Mice were allowed free access to this flavored saccharin water for 30 minutes. After the drinking water was administered, the ethanol group was injected intraperitoneally with a sterile saline solution containing 20% ​​(v / v) ethanol at a dose of 2 g ethanol / kg; the saline group was injected intraperitoneally with sterile saline at a dose of 10 µL / g based on the mice's body weight. On day 5, both water bottles were refilled with tasteless water, and the mice were given a 30-minute drinking time.

[0059] On day 6, two bottles were filled with cherry-flavored and grape-flavored solutions containing 0.2% saccharin, respectively. Mice were given free access to water for 30 minutes, and the volume of each mouse consuming the two flavored solutions was recorded. V 葡萄 and V 樱桃 Examples of modeling methods Figure 1 As shown.

[0060] Odor Preference Index (OPI) is .

[0061] Here, "conditional flavor" refers to the flavor used on day 4 (i.e., if grape flavor is used on day 4, then V...). 条件化风味 =V 葡萄 If using cherry flavor, then V 条件化风味 =V 樱桃 ).

[0062] The results are as follows Figure 2 As shown.

[0063] according to Figure 2 The results showed that mice treated with intraperitoneal injection of 2 g / kg ethanol had a significantly lower odor preference index compared to mice that received only saline injection. This suggests that the method can effectively induce conditioned avoidance behavior of mice towards specific odors.

[0064] Example 2 Conditional Odor Avoidance Test of Different Compositions Healthy 10-week-old C57BL6J mice were randomly divided into: control group, single-herb group (loquat leaf group, inula flower group, nutmeg group), two-herb combination group (loquat leaf + inula flower group, loquat leaf + nutmeg group, inula flower + nutmeg group), and three-herb group (loquat leaf + inula flower + nutmeg 1:1:1 combination group).

[0065] A water restriction protocol (23.5 hours of water restriction per day, with a fixed 30-minute drinking time limit) was used throughout the experiment. During the first three days of acclimatization, mice were transferred to test cages equipped with two water bottles, during which they could freely drink the flavorless water in the bottles for 30 minutes each day for three consecutive days. After the acclimatization period, on the fourth day, both water bottles were filled with a single-flavor solution containing 0.2% saccharin, selected from either grape or cherry flavor (e.g., if grape flavor was chosen, both bottles contained 0.2% saccharin grape-flavored water; if cherry flavor was chosen, both bottles contained 0.2% saccharin cherry-flavored water). Mice were allowed free access to the saccharin-flavored water for 30 minutes. After the water intake, the treatment group was administered the corresponding concentrated solution (Preparation Examples 1-7) by gavage at a volume based on the mouse's body weight (10 µL / g); the control group was administered double-distilled water by gavage at a volume based on the mouse's body weight (10 µL / g). Twenty minutes later, all groups received an intraperitoneal injection of a sterile saline solution containing 20% ​​(v / v) ethanol at a dose of 2 g ethanol / kg. On day 5, both water bottles were refilled with tasteless water, and participants were given 30 minutes to drink the water.

[0066] On day 6, two bottles were filled with cherry-flavored and grape-flavored solutions containing 0.2% saccharin, respectively. Mice were given free access to water for 30 minutes, and the volume of each mouse consuming the two flavored solutions was recorded. V 葡萄 and V 樱桃 The method for calculating the Odor Preference Index (OPI) is as described in Example 1.

[0067] The improvement effects of different combinations were evaluated based on the results of the conditioned odor avoidance test on day 6. The results are as follows: Figure 3 As shown.

[0068] Depend on Figure 3 It can be seen that the single herbs (loquat leaf and inula flower) can only produce partial improvement, while the relief effect of the combination of the two is better than that of the single components. The odor preference index of mice in the loquat leaf + nutmeg group and the loquat leaf + inula flower + nutmeg 1:1:1 combination group were significantly improved, which can relieve nausea and vomiting, demonstrating a clear synergistic effect.

[0069] Example 3: Odor Avoidance Behavior Experiment with Different Concentration Gradients of the Composition Except for the different drug administration groups, the experimental methods are the same as in Example 2.

[0070] The experiment was set up with different concentration groups: a 2-fold concentrated group, a stock solution group (i.e., a combination of loquat leaf + inula flower + nutmeg 1:1:1), a 2-fold dilution group, and a 4-fold dilution group, with a control group also included. Mice in each of the treatment groups were given the corresponding concentrated composition via gavage 20 minutes before intraperitoneal injection of 20% (v / v) ethanol in sterile saline solution (Preparation Examples 8, 7, 9, and 10). The control group was given double-distilled water via gavage at a dose of 10 µL / g of mouse body weight 20 minutes before intraperitoneal injection of 2 g / kg ethanol. Simultaneously, to assess the safety of this traditional Chinese medicine composition (verifying whether it has irritant / adverse reactions), a saline control group was included. The stock solution or double-distilled water was administered 20 minutes before intraperitoneal injection of sterile saline. The degree of improvement in conditioned odor avoidance behavior in each group was measured, and the results are as follows: Figure 4 As shown.

[0071] Depend on Figure 4 It can be seen that both the undiluted solution group and the 2x concentrated solution group showed excellent relief effects. When the undiluted solution was diluted 2 times, the effect was relatively weakened, and after being diluted 4 times, there was no significant relief effect on nausea.

[0072] Example 4 Conditional odor avoidance test of three-component compositions with different ratios Except for the different drug administration groups, the experimental methods are the same as in Example 2.

[0073] The experiment was set up with drug treatment groups and control groups with different ratios. For the drug treatment groups, while keeping the total amount of the three plants constant, the ratios of loquat leaf, inula flower, and nutmeg were changed to 1:1:1, 2:1:1, 1:2:1, 1:1:2, 5:1:1, 1:5:1, and 1:1:5. Twenty minutes before intraperitoneal injection of a sterile saline solution containing 20% ​​(v / v) ethanol, mice in each drug treatment group were administered the corresponding concentrated solution of the drug treatment group via gavage (Preparation Examples 7, 11-16). The control group was administered double-distilled water via gavage at a dose of 10 µL / g based on mouse body weight 20 minutes before intraperitoneal injection of 2 g / kg ethanol. The degree of improvement in conditioned odor avoidance behavior in each group was assessed, and the results are as follows: Figure 5 As shown.

[0074] Depend on Figure 5 It was found that different ratios of the three-component composition showed significant differences in conditioned odor avoidance. When the weight ratios of loquat leaf, inula flower, and nutmeg were 1:1:1, 1:1:2, 2:1:1, and 5:1:1, the odor preference index of mice was significantly improved, demonstrating a stable and excellent effect in alleviating nausea and vomiting. In contrast, combined with Figure 5 and Figure 3 It can be seen that when the weight ratio of loquat leaf, inula flower, and nutmeg is 1:2:1, 1:5:1, and 1:1:5, its medicinal effect is significantly weakened, and its aroma preference index is comparable to or worse than that of the two-herb combination group with lower medicinal content (loquat leaf + inula flower group, inula flower + nutmeg group).

[0075] The technical solutions of this invention are not limited to the specific embodiments described above. It should be understood that any modifications and changes can be made without departing from the spirit of this invention. All technical variations made according to the technical solutions of this invention fall within the protection scope of this invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Loquat leaf 0.5-8 parts; nutmeg 0.5-4 parts; and optionally, Inula japonica 0.1-1.8 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The loquat leaf contains 0.5 to 6 parts by weight; and / or The mass fraction of Inula japonica is 0.3 to 1.8 parts, preferably 0.5 to 1.5 parts; and / or The nutmeg content is 0.5 to 4 parts by weight, preferably 0.8 to 3.5 parts by weight.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials: Loquat leaves, Inula japonica, and nutmeg; The mass ratio of loquat leaves, inula flowers, and nutmeg is (0.5~8):(0.5~1.8):(0.5~4). Preferably, the mass ratio of loquat leaf, inula flower and nutmeg is (0.5~6):(0.5~2):(0.5~3), more preferably (1~5):(0.5~1.5):(1~2), and even more preferably 1:1:1, 2:1:1, 1:1:2, 5:1:

1.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition is to mix loquat leaves, inula flowers and nutmeg, decoct and concentrate the mixture; Preferably, the preparation method of the traditional Chinese medicine composition is to mix loquat leaves, inula flowers and nutmeg, soak them in water, decoct, concentrate and filter.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The mass-to-volume ratio of the total active pharmaceutical ingredient to water is 30-250 g / L, preferably 180-230 g / L, and even more preferably 150-200 g / L.

6. The traditional Chinese medicine composition according to claim 4, characterized in that, The simmering time is 20 to 120 minutes, preferably 30 to 60 minutes, and more preferably 40 minutes.

7. The traditional Chinese medicine composition according to claim 4, characterized in that, The ratio of the total mass of the active pharmaceutical ingredient to the volume of the concentrated drug is 3.5~15 g / mL, preferably 4~14 g / mL, and even more preferably 6~12 g / mL.

8. A pharmaceutical preparation comprising the traditional Chinese medicine composition as described in any one of claims 1-7 and pharmaceutically acceptable excipients.

9. The pharmaceutical preparation according to claim 8, characterized in that, The dosage form of the pharmaceutical preparation is oral liquid, granules, capsules or tablets.

10. The use of a traditional Chinese medicine composition as described in any one of claims 1-7 or a pharmaceutical preparation as described in any one of claims 8-9 in the preparation of a medicament for relieving nausea and / or vomiting symptoms; preferably, the nausea and / or vomiting is caused by alcohol intake.

Images