Traditional Chinese medicine composition for clearing heat, eliminating dampness, relieving spasm and stopping diarrhea as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine. The invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for clearing heat, resolving dampness, relieving spasm and stopping diarrhea and a preparation method and application thereof. The invention provides a traditional Chinese medicine composition, which is prepared from the following raw materials in parts by weight: 4 to 12 parts of herba andrographitis, 2 to 8 parts of rhizoma coptidis, 2 to 8 parts of quassia wood, 1 to 6 parts of radix aucklandiae, 2 to 8 parts of radix pulsatillae, 2 to 8 parts of radix paeoniae alba, 2 to 8 parts of semen plantaginis, 2 to 8 parts of red-knees herb and 1 to 6 parts of liquorice root. Researches show that the traditional Chinese medicine composition has a remarkable treatment effect on model mice with acute enteritis induced by escherichia coli, can play a remarkable curative effect after being administrated once, takes effect quickly, and meets the clinical treatment requirements of relieving urgency and stopping diarrhea. According to the traditional Chinese medicine composition, the specific types and proportions of the medicines are controlled, the synergistic effect of the components is improved, pathogenic microorganism infection can be inhibited, the intestinal function can be adjusted, the effect of treating both symptoms and root causes is achieved, and the traditional Chinese medicine composition has remarkable social benefits and clinical application value.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and more specifically relates to a traditional Chinese medicine composition for clearing away heat and dampness, relieving acute diarrhea, and its preparation method and application. Background Art

[0002] Diarrhea is a common digestive system disorder characterized by increased bowel movement frequency and changes in stool consistency (such as loose or watery stools), often accompanied by abdominal pain, anal burning, and fever. Damp-heat diarrhea is a common syndrome in Traditional Chinese Medicine (TCM) and is often caused by exogenous damp-heat pathogens or unclean diet. Its pathogenesis is characterized by downward movement of damp-heat, dysfunction of the spleen and stomach, and intestinal conduction disorders. In modern medicine, infectious diseases such as acute enteritis and bacillary dysentery can present as damp-heat diarrhea.

[0003] At present, the main means of treating diarrhea in Western medicine include antibiotic treatment, such as the use of rifaximin antibiotics to control intestinal infections. However, long-term use of antibiotics can easily lead to the development of drug resistance, and may disrupt the balance of normal intestinal flora, affecting patient recovery. In the field of traditional Chinese medicine, clearing away heat and dampness, and relieving and stopping diarrhea are the basic principles for treating damp-heat type diarrhea. Studies have shown that a variety of Chinese medicines have anti-inflammatory, antibacterial, immune-regulating and intestinal function-improving effects. Compared with some Western medicines (such as antibiotics and antidiarrheal drugs) that may bring about drug resistance, intestinal flora disorders, dependence and other problems, Chinese medicines are mostly natural plant medicines with relatively small toxic side effects, and are suitable for long-term or repeated use.

[0004] Therefore, it is of great significance to find a safe and effective Chinese medicine composition with few side effects, high safety and the ability to quickly relieve symptoms for the treatment of diarrhea. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the existing defects and deficiencies and provide a traditional Chinese medicine composition.

[0006] The first object of the present invention is to provide a Chinese medicine composition.

[0007] The second object of the present invention is to provide a Chinese medicine preparation.

[0008] The third object of the present invention is to provide the application of the above-mentioned Chinese medicine composition or Chinese medicine preparation.

[0009] The above-mentioned purpose of the present invention is achieved through the following technical solutions:

[0010] The present invention uses Andrographis paniculata, Coptis chinensis, Quassima, Costus root, Pulsatilla chinensis, White Peony Root, Plantago seed, Polygonum hydropiper, and Licorice root to prepare a traditional Chinese medicine composition. This traditional Chinese medicine composition can treat acute enteritis, significantly reduce the frequency and rate of diarrhea, and has a rapid onset of action. Therefore, the present invention claims protection for the following technical solutions:

[0011] The invention provides a traditional Chinese medicine composition, which contains the following raw materials in parts by weight: 4-12 parts of Andrographis paniculata, 2-8 parts of Coptis chinensis, 2-8 parts of Quassinus officinalis, 1-6 parts of Costus root, 2-8 parts of Pulsatilla scabra, 2-8 parts of White Peony Root, 2-8 parts of Plantago seed, 2-8 parts of Polygonum hydropiper, and 1-6 parts of Licorice root.

[0012] As an optional embodiment, the Chinese medicine composition contains the following raw materials in parts by weight: 4-6 parts of Andrographis paniculata, 2-4 parts of Coptis chinensis, 2-4 parts of Quassinus officinalis, 1-3 parts of Costus root, 2-4 parts of Pulsatilla scabra, 2-4 parts of White Peony Root, 2-4 parts of Plantago seed, 4-6 parts of Polygonum hydropiper, and 1-3 parts of Licorice.

[0013] As an optional embodiment, the Chinese medicine composition contains the following raw materials in parts by weight: 5 parts of Andrographis paniculata, 3 parts of Coptis chinensis, 3 parts of Quassinus officinalis, 2 parts of Costus root, 3 parts of Pulsatilla scabra, 3 parts of White Peony Root, 3 parts of Plantago seed, 5 parts of Polygonum hydropiper, and 2 parts of Licorice.

[0014] The prescription of the Chinese medicine composition of the present invention is explained as follows:

[0015] Andrographis paniculata: Bitter, cold. Entries the Heart, Lung, Large Intestine, and Bladder meridians. Clears heat and detoxifies, cools the blood, and reduces swelling. Used for colds and fevers, sore throats, mouth sores, sudden coughs, diarrhea, dysentery, painful stranguria caused by heat, carbuncles, ulcers, and snake and insect bites.

[0016] Coptis chinensis: Bitter, cold. Entries the Heart, Spleen, Stomach, Liver, Gallbladder, and Large Intestine meridians. It has the effects of relieving heat and dampness, purging fire and detoxifying. It is used for damp-heat, fullness in the abdomen, vomiting and acid regurgitation, diarrhea, jaundice, high fever and coma, hyperactive heart fire, restlessness and insomnia, palpitations, vomiting and bleeding due to blood heat, red eyes, toothache, thirst, carbuncles, and furuncles; it is also used externally for eczema, eczema, and auricular discharge. Coptis chinensis in wine is good for clearing heat from the upper burner. It is used for red eyes and mouth sores. Coptis chinensis in ginger clears the stomach and soothes vomiting. It is used for the combination of cold and heat, damp-heat in the middle, fullness in the abdomen and vomiting. Coptis chinensis in cornus officinalis soothes the liver and soothes the stomach. It is used for liver-stomach disharmony and vomiting and acid regurgitation.

[0017] Kusambar formosana: Bitter, cold, and slightly toxic. It enters the lung and large intestine meridians. It clears heat, detoxifies, and dispels dampness. It is used for wind-heat colds, sore throats, damp-heat diarrhea, eczema, boils, and snake and insect bites.

[0018] Costus root: Pungent, bitter, and warm. It enters the spleen, stomach, large intestine, triple burner, and gallbladder meridians. It promotes qi circulation, relieves pain, strengthens the spleen, and aids digestion. It is used for chest, flank, and abdominal distension and pain, heaviness after diarrhea, indigestion, and loss of appetite. Simmered costus root astringes the intestines and stops diarrhea. It is used for abdominal pain caused by diarrhea.

[0019] Pulsatilla: Bitter, cold. Enters the stomach and large intestine meridians. Clears heat and detoxifies, cools blood and stops dysentery. Used for heat-induced bloody dysentery, and vaginal itching and leucorrhea.

[0020] White Peony Root: Bitter, sour, and slightly cold. It enters the Liver and Spleen meridians. It nourishes blood and regulates menstruation, astringes Yin and stops sweating, softens the liver and relieves pain, and calms Liver Yang. It is used for sallow complexion due to blood deficiency, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, and headaches and dizziness.

[0021] Plantago seed: Sweet, cold. Enters the liver, kidney, lung, and small intestine meridians. It clears heat, promotes urination, relieves stranguria, dissipates dampness and stops diarrhea, improves eyesight, and eliminates phlegm. It is used for painful stranguria caused by heat, edema, diarrhea caused by summer heat, red and swollen eyes, and coughs caused by phlegm and heat.

[0022] Polygonum hydropiper: Warm in nature, pungent in flavor. It enters the spleen, stomach, and large intestine meridians. It has the effects of removing dampness and resolving stagnation. It is used for dysentery, enteritis, and indigestion; it can also be used externally to treat itchy skin and eliminate maggots.

[0023] Licorice: Sweet, neutral. It enters the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears away heat and detoxifies, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal properties. It is used for spleen and stomach deficiency, fatigue, palpitations, shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncles, sores, and to alleviate drug toxicity and potency.

[0024] The present invention provides a traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition.

[0025] As an optional embodiment, the above-mentioned traditional Chinese medicine preparation contains a flavoring agent, and the flavoring agent is at least one of sucrose, sucralose, citric acid, and aspartame.

[0026] As an optional embodiment, the above-mentioned traditional Chinese medicine preparation contains pharmaceutically acceptable excipients.

[0027] As an optional embodiment, the pharmaceutical excipient includes any one or a combination of at least two of a carrier, a diluent, an excipient, a filler, a binder, a wetting agent, an emulsifier, a solubilizer, a surfactant or a buffer.

[0028] As an optional embodiment, the dosage form of the above-mentioned traditional Chinese medicine preparation is decoction, ointment, pill, lozenge, tablet, granule, powder, capsule or patch.

[0029] As an optional embodiment, the dosage form of the above-mentioned traditional Chinese medicine preparation is a decoction or an ointment.

[0030] As an optional embodiment, the traditional Chinese medicine preparation is prepared from the above-mentioned traditional Chinese medicine composition by water extraction or water extraction and alcohol precipitation.

[0031] As an optional embodiment, the preparation method of the traditional Chinese medicine preparation is to boil the above-mentioned traditional Chinese medicine composition with water, concentrate the decoction, add ethanol, let it stand for 12-36 hours, filter and recover the ethanol, and concentrate and dry it.

[0032] As an optional embodiment, the preparation method of the traditional Chinese medicine preparation comprises the following steps:

[0033] S1. Weigh the above Chinese medicine composition, add water and boil 2-4 times, and filter the combined decoction;

[0034] S2. Concentrating the filtrate obtained in step S1 to obtain the traditional Chinese medicine preparation.

[0035] As an optional embodiment, in step S2, the filtrate obtained in step S1 is concentrated, ethanol is added to the concentrate with stirring, and the concentrate is allowed to stand for 12-36 hours. The ethanol is filtered to recover and concentrated to dryness to obtain the traditional Chinese medicine preparation.

[0036] As an optional implementation scheme, in step S1, the adding of water is 4-15 times the amount of water, and the decocting time is 1-3 hours.

[0037] As an optional implementation scheme, in step S1, the adding of water is 6-10 times the amount of water, and the decocting time is 1-2 hours.

[0038] As an optional embodiment, the preparation method of the traditional Chinese medicine preparation comprises the following steps:

[0039] S1. Weigh the above Chinese medicine composition, add 8 times the amount of water and boil twice, each time for 1.5 hours, filter the combined decoction, and concentrate the filtrate to a relative density of 1.15 to 1.20 extract;

[0040] S2. Add ethanol to the extract obtained in step S1, stir, let stand for 12-36h, filter, recover the ethanol and concentrate to an extract with a relative density of 1.15 to 1.20, dry it to obtain a dry extract, and obtain the traditional Chinese medicine preparation.

[0041] As an optional embodiment, in step S2, the amount of ethanol added is such that the content of ethanol in the extract is 50-70% (preferably 60%).

[0042] As an optional embodiment, in step S2, the drying is carried out under reduced pressure at 60-80°C (preferably 70°C).

[0043] As an optional embodiment, the preparation method of the traditional Chinese medicine preparation comprises the following steps:

[0044] S1. Weigh the above Chinese medicine composition, add 8 times the amount of water and boil twice, each time for 1.5 hours, filter the combined decoction, and concentrate the filtrate to a relative density of 1.15 to 1.20 extract;

[0045] S2. Add ethanol to the extract obtained in step S1 until the ethanol content of the extract is 60%, stir well, let stand for 24 hours, then filter, recover the ethanol and concentrate to an extract with a relative density of 1.15 to 1.20, and dry to obtain a dry extract to obtain the traditional Chinese medicine composition.

[0046] The present invention provides use of the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine preparation in preparing a medicine for preventing or treating diarrhea and related symptoms caused by diarrhea.

[0047] Specifically, the diarrhea is diarrhea caused by damp heat or infectious diarrhea.

[0048] The present invention provides use of the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine preparation in preparing medicine for preventing or treating acute enteritis and related symptoms caused by acute enteritis.

[0049] Specifically, the symptoms caused by acute enteritis include diarrhea, abdominal pain, abdominal distension, nausea and vomiting, and dehydration.

[0050] The present invention provides use of the above-mentioned traditional Chinese medicine composition or the above-mentioned traditional Chinese medicine preparation in preparing a medicine for preventing or treating relevant symptoms caused by Escherichia coli infection.

[0051] Specifically, the Escherichia coli is Escherichia coli.

[0052] The present invention has the following beneficial effects:

[0053] The present invention is based on the principle of combining traditional Chinese medicine theory with modern pharmacological research. It uses Andrographis paniculata, Coptis chinensis, Quassima, Aucklandia lappa, Pulsatilla chinensis, White Peony Root, Plantago seed, Polygonum hydropiper, and Licorice to prepare a traditional Chinese medicine composition. By controlling the specific types and proportions of the drugs, the present invention enhances the synergistic effect between the components, resulting in a significant effect in treating diarrhea. Through multi-target, multi-pathway synergistic effects, the traditional Chinese medicine composition can inhibit pathogenic microbial infection and regulate intestinal function, achieving the effect of treating both the symptoms and the root cause. It is particularly suitable for treating acute enteritis and infectious diarrhea caused by damp-heat.

[0054] Research conducted in this paper demonstrates that this traditional Chinese medicine composition has a significant therapeutic effect on mice with an acute enteritis model induced by Escherichia coli: it significantly prolongs the incubation period of diarrhea and reduces the frequency of diarrhea; improves stool characteristics and reduces diarrhea rates; and increases animal survival rates, surpassing or approaching those of traditional anti-infective drugs (such as berberine hydrochloride and rifaximin). Furthermore, the composition exhibits significant therapeutic effects with a single administration and rapid onset, meeting the clinical need for "relieving acute diarrhea."

[0055] In addition, the present invention provides two preparation process routes: water decoction and water decoction + alcohol precipitation. Experimental data show that the dry paste powder prepared by the water extraction and alcohol precipitation method is superior to the simple water extraction method in improving the number of diarrhea, diarrhea rate, and survival rate.

[0056] In summary, the present invention provides a traditional Chinese medicine composition with clear efficacy, good safety, convenient administration, and easy large-scale production. It is an important supplement and optimization of existing drugs for treating damp-heat type diarrhea, and has significant social benefits and clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0057] Figure 1 The effects of compositions 1 to 15 on the latent period of diarrhea in mice with acute enteritis.

[0058] Figure 2 The effects of compositions 1 to 15 on the frequency of diarrhea in mice with acute enteritis are shown.

[0059] Figure 3 The effects of compositions 1 to 15 on stool characteristics scores of mice with acute enteritis are shown.

[0060] Figure 4 The effects of compositions 1 to 15 on the diarrhea rate of mice with acute enteritis are shown.

[0061] Figure 5 The effects of compositions 1 to 15 on the survival rate of mice with acute enteritis are shown. DETAILED DESCRIPTION

[0062] The present invention is further described below in conjunction with the accompanying drawings and specific examples. The embodiments described below are some embodiments of the present invention, rather than all embodiments. They are only used to illustrate the present invention and should not be regarded as limiting the scope of the present invention. The embodiments do not limit the present invention in any form. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. If specific conditions are not specified in the examples, they are carried out according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, the reagents, methods and equipment used in the present invention are conventional reagents, methods and equipment in this technical field.

[0063] Unless otherwise specified, the reagents and materials used in the following examples are commercially available conventional products.

[0064] In the following examples, the temperature standard for decocting is boiling.

[0065] Sodium carboxymethyl cellulose was purchased from the market (CMC-Na) with a CAS number of 9004-32-4.

[0066] In the following examples, the nutrient agar medium used was purchased from Guangdong Huankai Biotechnology Co., Ltd. with batch number: 240713A10.

[0067] Example 1

[0068] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 5 parts of Andrographis paniculata, 3 parts of Coptis chinensis, 3 parts of Quassinus officinalis, 2 parts of Aucklandia lappa, 3 parts of Pulsatilla scutellariae, 3 parts of White Peony Root, 3 parts of Plantago seed, 5 parts of Polygonum hydropiper, and 2 parts of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 5).

[0069] Example 2

[0070] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 4 parts of Andrographis paniculata, 2 parts of Coptis chinensis, 2 parts of Quassinus officinalis, 1 part of Costus root, 2 parts of Pulsatilla scabra, 2 parts of White Peony Root, 2 parts of Plantago seed, 2 parts of Polygonum hydropiper, and 1 part of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 11).

[0071] Example 3

[0072] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 12 parts of Andrographis paniculata, 8 parts of Coptis chinensis, 8 parts of Quassinus officinalis, 6 parts of Aucklandia lappa, 8 parts of Pulsatilla scutellariae, 8 parts of White Peony Root, 8 parts of Plantago seed, 8 parts of Polygonum hydropiper, and 6 parts of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 12).

[0073] Example 4

[0074] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 8 parts of Andrographis paniculata, 5 parts of Coptis chinensis, 5 parts of Quassinus officinalis, 3.5 parts of Costus root, 5 parts of Pulsatilla scabra, 5 parts of White Peony Root, 5 parts of Plantago seed, 5 parts of Polygonum hydropiper, and 3.5 parts of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 13).

[0075] Example 5

[0076] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 4 parts of Andrographis paniculata, 2 parts of Coptis chinensis, 2 parts of Quassinus officinalis, 1 part of Costus root, 2 parts of Pulsatilla scabra, 2 parts of White Peony Root, 2 parts of Plantago seed, 4 parts of Polygonum hydropiper, and 1 part of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 14).

[0077] Example 6

[0078] The traditional Chinese medicine composition provided in this embodiment is composed of the following raw materials in parts by mass: 6 parts of Andrographis paniculata, 4 parts of Coptis chinensis, 4 parts of Quassinus officinalis, 3 parts of Costus root, 4 parts of Pulsatilla scabra, 4 parts of White Peony Root, 4 parts of Plantago seed, 6 parts of Polygonum hydropiper, and 3 parts of Licorice (see Table 1 for details of the composition ratio and dosage of the traditional Chinese medicine combination, Composition 15).

[0079] Comparative Example 1

[0080] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that costus root is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, composition 1).

[0081] Comparative Example 2

[0082] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that no Plantago seed is added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, Composition 2).

[0083] Comparative Example 3

[0084] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that Pulsatilla scabra is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, composition 3).

[0085] Comparative Example 4

[0086] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that Rhizoma Coptidis is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, Composition 4).

[0087] Comparative Example 5

[0088] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that Polygonum hydropiper is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, composition 6).

[0089] Comparative Example 6

[0090] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that white peony root is not added (see composition 7 in Table 1 for details of the composition ratio and dosage of the Chinese medicine combination).

[0091] Comparative Example 7

[0092] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that Quassinus rubra is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, composition 8).

[0093] Comparative Example 8

[0094] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that licorice is not added (see Table 1 for details of the composition ratio and dosage of the Chinese medicine combination, composition 9).

[0095] Comparative Example 9

[0096] The composition of the Chinese medicine composition provided in this comparative example is substantially the same as that of Example 1, except that Andrographis paniculata is not added. (See Table 1 for details of the composition ratio and dosage of the Chinese medicine combination composition 10)

[0097] Experimental Example 1

[0098] 1. Preparation of dry paste powder of Chinese medicine composition

[0099] The present invention has been studied extensively and clinical medication experience has been summarized. It has been found that Andrographis paniculata, Coptis chinensis, Atractylodes macrocephala, Costus root, Pulsatilla chinensis, White Peony Root, Plantago seed, Polygonum hydropiper, and Licorice root have the effect of treating diarrhea and acute enteritis through reasonable compatibility. According to the Chinese medicine combination component ratio and dosage in Table 1, the Chinese medicine combination medicinal materials are weighed and decocted to prepare a dry paste powder. The specific preparation method is as follows: weigh 2 parts of the whole prescription medicinal materials or slices, 30 times the daily prescription amount is 1 part, add 8 times the amount of water and decoct twice, each time for 1.5 hours, combine the decoctions, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.15-1.20 (60° C.), cool, add ethanol to make the alcohol content reach 60%, stir evenly, let stand for 24 hours, filter, recover ethanol from the filtrate and concentrate it to an extract with a relative density of 1.15-1.20 (60° C.), dry under reduced pressure at 70° C. to obtain a dry extract, crush, and set aside.

[0100] Table 1: Ratio and dosage of Chinese medicine combination

[0101]

[0102]

[0103] 2. Determination of the efficacy of each composition in treating diarrhea

[0104] 1. Experimental methods

[0105] SPF-grade BALB / c mice, half male and half female, were randomly divided into 18 groups according to body weight, namely normal control group, model control group, rifaximin control group, and experimental groups 1 to 15, with 8 mice in each group. Except for the normal control group, 0.5 ml of nutrient broth was injected intraperitoneally, and the other groups were injected intraperitoneally with 1×10 7Modeling was performed with 0.5 ml of a CFU / ml Escherichia coli suspension. After modeling, each group of animals was immediately gavaged with purified water, rifaximin tablets (at a dose of 0.15 g / kg, a clinically equivalent dose for mice), and drug suspensions of compositions 1 to 15 (at doses of 5.05, 4.86, 4.86, 4.86, 5.42, 4.49, 4.86, 4.86, 5.05, 4.49, 3.37, 13.47, 8.42, 3.7, and 7.07 g crude drug / kg, respectively, all clinically equivalent doses for mice, and the solvent for the suspension was purified water. The administration volume was 10 ml / kg, and the drug was administered again 24 hours later, for a total of two doses. 1.5-3 h after modeling and drug administration, the time of onset of the first diarrhea symptom, the number of diarrhea episodes, and the stool characteristics score of each group of animals were recorded, and the diarrhea incubation period and diarrhea rate were calculated. On the second day (D2) and third day (D3) after modeling and drug administration, the number of surviving animals in each group was recorded, and the survival rate was calculated.

[0106] The incubation period of diarrhea is the time from the start of the measurement to the first onset of diarrhea.

[0107] Scoring criteria for stool characteristics: normal stool 0 points; soft stool 1 point; mushy loose stool 2 points; unformed watery stool 3 points.

[0108] Diarrhea rate = number of animals with diarrhea / total number of animals. Survival rate = number of surviving animals / total number of animals.

[0109] 2. Experimental results

[0110] (1) Diarrhea incubation period: The results of the effects of compositions 1 to 15 on the diarrhea incubation period in mice with acute enteritis are as follows: Figure 1 As shown in the figure, compared with the normal control group, the diarrhea incubation period of mice in the model control group was reduced, with statistical significance (P<0.01); compared with the model control group, the diarrhea incubation period of mice in the drug groups except experimental groups 3, 4, 7, and 10 was increased, among which the rifaximin control group, experimental group 2, experimental group 5, experimental group 12, and experimental group 14 were statistically different (P<0.05 or 0.01), and the mean values ​​from high to low were: rifaximin control group > experimental group 5 > experimental group 12 > experimental group 14 > experimental group 2 > experimental group 13 > experimental group 11 > experimental group 15 > experimental group 9 > experimental group 8 > experimental group 1 > experimental group 6 > experimental group 7, experimental group 3 > experimental group 4, and experimental group 10.

[0111] (2) Diarrhea frequency: The results of the effects of compositions 1 to 15 on the diarrhea frequency in mice with acute enteritis are as follows: Figure 2As shown in the figure, compared with the normal control group, the diarrhea frequency of mice in the model control group increased, which was statistically significant (P<0.01); compared with the model control group, the diarrhea frequency of mice in each drug group was reduced, among which the rifaximin control group, experimental group 2, experimental group 5, experimental group 6, experimental group 7, experimental group 9, experimental group 11, experimental group 12, experimental group 13, experimental group 14, and experimental group 15 all had statistically significant differences (P<0.05 or 0.01), and their means from low to high were: experimental group 5 < experimental group 12 < rifaximin control group, experimental group 13, experimental group 15 < experimental group 11, experimental group 14 < experimental group 9 < experimental group 6 < experimental group 2 < experimental group 7 < experimental group 3 < experimental group 1 < experimental group 8 < experimental group 4 < experimental group 10.

[0112] (3) Stool Character Scoring: The results of the effects of Compositions 1 to 15 on the stool character scoring of mice with acute enteritis are as follows: Figure 3 As shown in the figure, compared with the normal control group, the stool character scores of the mice in the model control group were increased, with statistical significance (P<0.01); compared with the model control group, the stool character scores of the mice in each drug group were decreased, among which the rifaximin control group, experimental group 2, experimental group 5, experimental group 6, experimental group 7, experimental group 9, experimental group 11, experimental group 12, experimental group 13, experimental group 14, and experimental group 15 were statistically different (P<0.05 or 0.01), and their means from low to high were: experimental group 5, experimental group 12, experimental group 13 < rifaximin control group, experimental group 15 < experimental group 9, experimental group 11 < experimental group 14 < experimental group 6 < experimental group 2, experimental group 3 < experimental group 7 < experimental group 8 < experimental group 10 < experimental group 1 < experimental group 4.

[0113] (4) Diarrhea rate: The results of the effects of compositions 1 to 15 on the diarrhea rate in mice with acute enteritis are shown in the following table. Figure 4 As shown, the diarrhea rate of mice in the normal control group was 0, and that of mice in the model control group was 100% diarrhea; the diarrhea rates of each drug group from low to high were: experimental group 5 (50%) < experimental group 12 (62.5%) < rifaximin control group, experimental group 2, experimental group 11, experimental group 13, experimental group 14, experimental group 15 (75.0%) < experimental group 7, experimental group 9 (87.5%) < experimental group 1, experimental group 3, experimental group 4, experimental group 6, experimental group 8, experimental group 10 (100%).

[0114] (5) Mouse survival rate: The effects of compositions 1 to 15 on the survival rate of mice with acute enteritis are shown in the following table. Figure 5As shown, on D2 and D3, the comprehensive comparison of animal survival rates among the groups is as follows, from high to low: experimental group 2, experimental group 3, experimental group 5, experimental group 6, experimental group 9, experimental group 12, experimental group 13, experimental group 14, experimental group 15 (D3, 100%) > rifaximin control group, experimental group 1, experimental group 7 (D3, 87.5%) > experimental group 4, experimental group 8, experimental group 10, experimental group 11 (D3, 75%) > model control group (D3, 50%).

[0115] 3. Conclusion

[0116] The effects of compositions 1 to 15 on mice with acute enteritis are shown in Table 2. The results indicate that compositions 2, 5, 6, 7, 9, 11, 12, 13, 14, and 15 all have a significant improvement effect on infectious acute enteritis caused by Escherichia coli, can reduce the frequency and rate of diarrhea in model animals, improve stool characteristics, and increase animal survival rate, and a single dose is effective; at the same dose, the comprehensive efficacy is ranked as follows: composition 5 > composition 12 > composition 13 > composition 15 > composition 14 > composition 11 > composition 9 > composition 6 > composition 2 > composition 7 > composition 3 > composition 1 > combination 8 > composition 4 > composition 10.

[0117] Table 2 Effects of Compositions 1 to 15 on Acute Enteritis in Mice ( n=8)

[0118]

[0119] Note: vs normal control group, ##P<0.01; vs model control group, **P<0.01, *P<0.05.

[0120] Example 7 Process Route Study

[0121] 1. Process Route 1 (Water Extraction Group)

[0122] According to the Chinese medicine composition provided in Example 1, 2 parts of the whole prescription or decoction pieces were weighed according to the mass ratio, 30 times the daily prescription amount was 1 part, 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60°C), dried under reduced pressure at 70°C to obtain a dry extract, crushed, and set aside.

[0123] 2. Process Route 2 (Water Extraction and Alcohol Precipitation)

[0124] According to the Chinese medicine composition provided in Example 1, 2 parts of the whole prescription or decoction pieces were weighed according to the mass ratio, 30 times the daily prescription amount was 1 part, and 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60°C), cooled, ethanol was added to make the alcohol content reach 60%, stirred, allowed to stand for 24 hours, filtered, and the filtrate was recovered. Ethanol was concentrated to an extract with a relative density of 1.15 to 1.20 (60°C), dried under reduced pressure at 70°C to obtain a dry extract, crushed, and set aside.

[0125] 3. Dry paste powder preparation data

[0126] The dry paste powder preparation data are shown in Table 3. The results show that both process routes can complete the preparation of the corresponding dry paste powder. Among them, the dry paste powder prepared by process route 1 (water extraction group) has poorer solubility than that prepared by process route 2 (water extraction and alcohol precipitation group), and a small amount of precipitation is produced.

[0127] Table 3 Dry paste powder preparation data table

[0128]

[0129]

[0130] 4. Determination of the efficacy of each process route in treating diarrhea

[0131] 1. Experimental methods

[0132] BALB / c mice of SPF grade (half male and half female) that had passed quarantine for 6-8 weeks were randomly divided into a normal control group (administered 0.5% CMC-Na), a model control group (administered 0.5% CMC-Na), a water extraction group (administered water extraction dry powder at a dose of 0.930 g dry powder / kg), a water extraction alcohol precipitation group (administered water extraction alcohol precipitation dry powder at a dose of 0.660 g dry powder / kg), a berberine hydrochloride control group (administered berberine hydrochloride tablets at a dose of 0.17 g / kg), and a rifaximin control group (administered rifaximin tablets at a dose of 0.15 g / kg). Except for the normal control group, which consisted of 6 mice per group, the remaining groups consisted of 8 mice per group. The normal group was intraperitoneally injected with 0.5 ml of nutrient broth medium, while the remaining groups were intraperitoneally injected with 0.5 ml of 1×10 7 The model was established with a suspension of Escherichia coli containing 500 CFU / ml. After model establishment, each group of animals was immediately gavaged with each drug at a volume of 10 ml / kg. The drug was administered again 24 hours later, for a total of 2 doses. 1.5-3 hours after model establishment and drug administration, the time of onset of the first diarrhea symptom, the number of diarrhea episodes, and stool characteristics of each group of animals were recorded. The diarrhea incubation period and diarrhea rate were calculated. On the second and third days after model establishment and drug administration, the number of surviving animals in each group was recorded, and the survival rate was calculated. Diarrhea rate = number of animals with diarrhea / total number of animals. Survival rate = number of surviving animals / total number of animals.

[0133] 2. Experimental results

[0134] (1) Diarrhea incubation period: Compared with the normal control group, the diarrhea incubation period of mice in the model control group was decreased, with statistical significance. Compared with the model control group, the diarrhea incubation period of animals in the water extraction group, water extraction alcohol precipitation group, berberine hydrochloride group, and rifaximin control group were all increased, among which the rifaximin control group had statistical significance.

[0135] (2) Diarrhea frequency: Compared with the normal control group, the model control group had an increased diarrhea frequency, which was statistically significant. Compared with the model control group, the diarrhea frequency of mice in each drug-treated group was decreased, which was statistically significant. This suggests that the water extraction and alcohol precipitation group can improve the diarrhea frequency in mice, and a single dose is effective. At the same dose, this effect is equivalent to that of rifaximin tablets and slightly better than that of berberine hydrochloride tablets. The improvement effect of the water extraction and alcohol precipitation group is better than that of the water extraction group.

[0136] (3) Stool characteristics score: Compared with the normal control group, the stool characteristics score of the mice in the model control group was increased, with statistical significance. Compared with the model control group, the stool characteristics scores of the mice in each drug-treated group were decreased, among which the water extraction and alcohol precipitation group and the rifaximin control group had statistical significance. This suggests that water extraction and alcohol precipitation can improve the stool characteristics score of mice, and a single dose is effective. At the same dose, this effect is equivalent to that of rifaximin tablets and slightly better than that of berberine hydrochloride tablets. The improvement effect of the water extraction and alcohol precipitation group is better than that of the water extraction group.

[0137] (4) Diarrhea rate: The diarrhea rate of mice in the normal control group was 0, and 100% of mice in the model control group had diarrhea. In this experiment, the diarrhea rate in the water extraction group did not improve. The diarrhea rates of the other groups were as follows: water extraction and alcohol precipitation group < berberine hydrochloride control group < rifaximin control group. This suggests that the water extraction and alcohol precipitation group can reduce the diarrhea rate of mice. At the same dose, this effect is slightly better than that of berberine hydrochloride tablets and rifaximin tablets. The improvement effect of the water extraction and alcohol precipitation group is better than that of the water extraction group.

[0138] (5) Mouse survival rate: Compared with the normal control group, the survival rate of the model control group was lower on the second and third days after modeling. Compared with the model control group, the survival rate of the mice in each drug group was higher. The survival rate of each drug group was ranked from high to low as follows: water extraction group, water extraction and alcohol precipitation group > berberine hydrochloride control group, rifaximin control group. This suggests that both the water extraction group and the water extraction and alcohol precipitation group can improve the survival rate of mice. At the same dose, this effect is slightly better than that of berberine hydrochloride tablets and rifaximin tablets.

[0139] 3. Conclusion

[0140] The results of the effects of different process routes on acute enteritis in mice are shown in Table 4. Under the experimental conditions, the water extraction group and the water extraction and alcohol precipitation group both had a significant improvement effect on infectious acute enteritis caused by Escherichia coli, reducing the number of diarrhea and diarrhea rate of model animals, improving stool characteristics, and increasing animal survival rate. A single dose was effective. At the same dose, the improvement effect of the water extraction and alcohol precipitation group was better than that of the water extraction group, slightly better than berberine hydrochloride tablets, rifaximin tablets or equivalent, with good drugability, and had certain advantages in improving the diarrhea rate and survival rate of animals within 3 days.

[0141] Table 4 Effects of different process routes on acute enteritis mice ( n=8)

[0142]

[0143]

[0144] Note: vs normal control group, ##P<0.01; vs model control group, **P<0.01, *P<0.05.

[0145] Example 8

[0146] Take by weighing full prescription medicinal material or decoction piece by the Chinese medicine composition proportioning among the embodiment 1, add 8 times of water gagings and decoct twice, each 1.5 hours, merge decoction, filter, filtrate decompression is concentrated to the extractum that relative density is 1.15~1.20 (60 ℃), put cool, add ethanol and make to contain alcohol amount and reach 60%, stir evenly, left standstill 24 hours, filter, filtrate recovery ethanol and be concentrated into the extractum that relative density is 1.15~1.20 (60 ℃), add water approximately to fixed capacity, stir evenly, refrigerate (4~7 ℃) 36~48 hours, filter. Separately get sucrose and add water and boil and make syrup and add in the above-mentioned filtrate, add sodium benzoate and sodium cyclamate, add water to fixed capacity, stir evenly, sterilize, fill, promptly get oral liquid.

[0147] Example 9

[0148] According to the ratio of the Chinese medicine composition in Example 1, the whole prescription medicinal materials or decoction pieces were weighed, 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60°C), cooled, ethanol was added to make the alcohol content reach 60%, stirred, allowed to stand for 24 hours, filtered, and the filtrate was recovered. Ethanol was concentrated to an extract with a relative density of 1.20 to 1.35 (60°C), and an appropriate amount of auxiliary materials was added to form granules, dried, granulated, mixed, and packaged to obtain granules.

[0149] Example 10

[0150] According to the ratio of the Chinese medicine composition in Example 1, the whole prescription medicinal materials or decoction pieces were weighed, 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60°C), cooled, ethanol was added to make the alcohol content reach 60%, stirred, allowed to stand for 24 hours, filtered, and the filtrate was recovered. Ethanol was concentrated to an extract with a relative density of 1.20 to 1.35 (60°C), an appropriate amount of excipients was added, and wet pills were made, dried, pills were selected, and packaged to obtain concentrated pills.

[0151] Example 11

[0152] According to the ratio of the Chinese medicine composition in Example 1, the whole prescription medicinal materials or decoction pieces were weighed, 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60°C), cooled, ethanol was added to make the alcohol content reach 60%, stirred, allowed to stand for 24 hours, filtered, the filtrate was recovered and ethanol was concentrated to an extract with a relative density of 1.20 to 1.35 (60°C), dried under reduced pressure at 70°C to obtain a dry extract, crushed, added with an appropriate amount of excipients, made into granules, dried, tableted, and packaged to obtain tablets.

[0153] Example 12

[0154] According to the ratio of the Chinese medicine composition in Example 1, the whole prescription medicinal materials or decoction pieces were weighed, 8 times the amount of water was added and decocted twice, each time for 1.5 hours, the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to an extract with a relative density of 1.15 to 1.20 (60° C.), cooled, ethanol was added to make the alcohol content reach 60%, stirred, allowed to stand for 24 hours, filtered, the filtrate was recovered with ethanol and concentrated to an extract with a relative density of 1.20 to 1.35 (60° C.), dried under reduced pressure at 70° C. to obtain a dry extract, crushed, added with an appropriate amount of excipients, made into granules, filled in capsules, and packaged to obtain capsules.

[0155] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be considered as equivalent replacement methods and are included in the scope of protection of the present invention.

Claims

1. A Chinese medicine composition, characterized in that The invention contains the following raw materials in parts by weight: 4-12 parts of Andrographis paniculata, 2-8 parts of Coptis chinensis, 2-8 parts of Quassinus officinalis, 1-6 parts of Costus root, 2-8 parts of Pulsatilla scabra, 2-8 parts of White Peony Root, 2-8 parts of Plantago seed, 2-8 parts of Polygonum hydropiper, and 1-6 parts of Licorice root.

2. The Chinese medicine composition according to claim 1, characterized in that The invention contains the following raw materials in parts by weight: 4-6 parts of Andrographis paniculata, 2-4 parts of Coptis chinensis, 2-4 parts of Quassinus officinalis, 1-3 parts of Costus root, 2-4 parts of Pulsatilla scabra, 2-4 parts of White Peony Root, 2-4 parts of Plantago seed, 4-6 parts of Polygonum hydropiper, and 1-3 parts of Licorice root.

3. The Chinese medicine composition according to claim 1, characterized in that The invention contains the following raw materials in parts by weight: 5 parts of Andrographis paniculata, 3 parts of Coptis chinensis, 3 parts of Quassinus officinalis, 2 parts of Aucklandia lappa, 3 parts of Pulsatilla scutellariae, 3 parts of White Peony Root, 3 parts of Plantago seed, 5 parts of Polygonum hydropiper, and 2 parts of Licorice.

4. A Chinese medicine preparation, characterized in that The composition is prepared from the Chinese medicine composition according to any one of claims 1 to 3.

5. The Chinese medicine preparation according to claim 4, characterized in that The Chinese medicine composition according to any one of claims 1 to 3 is prepared by water extraction or water extraction and alcohol precipitation.

6. The Chinese medicine preparation according to claim 5, characterized in that The preparation method of the traditional Chinese medicine preparation comprises the following steps: boiling the traditional Chinese medicine composition according to any one of claims 1 to 3 with water, concentrating the decoction, adding ethanol, standing for 12 to 36 hours, filtering to recover the ethanol, and concentrating to dryness.

7. The Chinese medicine preparation according to claim 4, characterized in that The dosage form of the preparation is decoction, ointment, pill, lozenge, tablet, granule, powder, capsule or patch.

8. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine preparation according to any one of claims 4 to 7 in the preparation of a medicament for preventing or treating diarrhea and related symptoms caused by diarrhea.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine preparation according to any one of claims 4 to 7 in the preparation of a medicament for preventing or treating acute enteritis and related symptoms caused by acute enteritis.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine preparation according to any one of claims 4 to 7 in the preparation of a medicament for preventing or treating symptoms related to Escherichia coli infection.

Images