Traditional Chinese medicine composition as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition as well as a preparation method and application thereof, the traditional Chinese medicine composition comprises: (1) an extract of a first traditional Chinese medicine composition, the first traditional Chinese medicine composition comprises the following components: 5-20 parts by weight of scutellaria baicalensis; 5-20 parts by weight of sophora flavescens; 2-15 parts by weight of radix pseudostellariae; 2-15 parts by weight of hawthorn; and (2) a second traditional Chinese medicine component, wherein the second traditional Chinese medicine component comprises 3-12 parts by weight of endothelium corneum gigeriae galli. The traditional Chinese medicine composition is extracted and purified to prepare the traditional Chinese medicine extract, and the traditional Chinese medicine extract has unexpected effects of promoting digestion, relieving stasis, clearing heat, clearing heat and the like.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine extract, in particular to a traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] Fever due to food accumulation is one of the common clinical symptoms in children. Because children's constitution is "often excessive yang and insufficient yin", the spleen and stomach are not well developed, and the diet cannot be well controlled. There are often different degrees of food stagnation, which can cause fever over a long period of time. Fever due to food accumulation in children is mostly due to improper feeding, uncontrolled diet or excessive feeding of raw, cold and greasy food, which damages the spleen and stomach, causing the spleen and stomach to malfunction, unable to normally receive and digest food, and the food stagnates and does not digest. The stagnation lasts for a long time, and the heat turns into heat. The heat and stagnation combine to produce internal heat. The internal heat cannot be eliminated in time, and it is externalized to cause fever. Fever due to food accumulation is also accompanied by symptoms such as abdominal distension and pain, belching, sour and smelly stools, and difficulty in defecation. Some are also accompanied by hot palms and abdomen, slippery pulse, red lips, purple fingerprints, loss of appetite, and restlessness at night. Due to the poor ability of children to express themselves, they are often not taken seriously in the early stages of the disease, which leads to aggravation of the disease and adverse effects on their growth and development. The functions of children's internal organs are not yet fully developed, and fever can be lingering and difficult to cure. If not handled properly, it can easily damage the brain meridians, Jueyin meridians, heart and liver, and cause typical complications such as "high fever convulsions."

[0003] Therefore, there is an urgent need to develop drugs, especially traditional Chinese medicines, that can treat fever caused by indigestion in children. Summary of the invention

[0004] The present invention aims to provide a Chinese medicine composition, and specifically relates to a Chinese medicine extract for treating fever caused by indigestion in children, a preparation thereof and a quality control method thereof.

[0005] In a first aspect of the present invention, a Chinese medicine composition is provided, the Chinese medicine composition comprising: (1) an extract of a first Chinese medicine composition, the first Chinese medicine composition comprising the following components:

[0006] 5-20 parts by weight of Scutellaria baicalensis;

[0007] Sophora flavescens 5-20 parts by weight;

[0008] 2-15 parts by weight of Pseudostellaria heterophylla;

[0009] Hawthorn 2-15 parts by weight;

[0010] and (2) a second Chinese medicinal component, wherein the second Chinese medicinal component comprises: 3-12 parts by weight of chicken gizzard lining.

[0011] In another preferred example, the Chinese medicine composition comprises: 10-15 parts by weight of Scutellaria baicalensis, 10-15 parts by weight of Sophora flavescens, 5-12 parts by weight of Pseudostellaria zizi and 5-12 parts by weight of Crataegus pinnatifida; and the second Chinese medicine component comprises 6-9 parts by weight of Chicken Gizzard Stone Endothelial Gizzard.

[0012] In another preferred example, the medicinal composition comprises: 12 parts by weight of Scutellaria baicalensis, 12 parts by weight of Sophora flavescens, 8 parts by weight of Pseudostellaria sibiricum, and 8 parts by weight of Crataegus pinnatifida; and the second Chinese medicinal component comprises 6 parts by weight of Chicken Gizzard Stone Endothelial Gizzard.

[0013] In another preferred embodiment, the extract of the first Chinese medicine composition is prepared by the following method:

[0014] (S1) alcohol extraction: using an ethanol solution to heat reflux extract the first traditional Chinese medicine composition to obtain a filtrate;

[0015] (S2) water precipitation: the filtrate obtained in (S1) is concentrated under reduced pressure and then water is added to form a first dispersion, and the dispersion is allowed to stand to form a supernatant and a precipitate;

[0016] (S3) elution: mixing the precipitate obtained in step (S2) with ethanol to form a second dispersion, and eluting and purifying the supernatant of the dispersion to obtain an eluate; and

[0017] (S4) Drying: The eluate in step (S3) is concentrated and dried under reduced pressure to obtain an extract of the first traditional Chinese medicine composition.

[0018] In another preferred example, the extract of the traditional Chinese medicine composition contains ingredients selected from the following group: baicalin, wogonin, baicalein, wogonin, melaleucatin A-7-O-β-D-glucuronide, matrine, sophoridine, oxymatrine, D-anhydrous glucose, and ginsenoside Rb1.

[0019] In another preferred embodiment, the extract of the Chinese medicine composition contains ingredients selected from the following group:

[0020] The content of baicalin is 17.76-19.76%, based on the total weight of the Chinese medicine extract;

[0021] The content of wogonin is 0.86-1.06%, based on the total weight of the Chinese medicine extract;

[0022] The content of baicalein is 1.2-1.5%, based on the total weight of the Chinese medicine extract;

[0023] The content of wogonin is 3-3.5%, based on the total weight of the Chinese medicine extract;

[0024] The content of the melaleuca alternifolia A-7-O-β-D-glucuronide is 1.3-1.5%, based on the total weight of the Chinese medicine extract;

[0025] The content of matrine is 0.1-0.3%, based on the total weight of the Chinese medicine extract;

[0026] The content of sophoridine is 0.1-0.4%, based on the total weight of the Chinese medicine extract;

[0027] The content of oxymatrine is 1.59-1.9%, based on the total weight of the Chinese medicine extract;

[0028] The content of D-anhydrous glucose is 0.3-0.6%, based on the total weight of the Chinese medicine extract;

[0029] The content of ginsenoside Rb1 is 0.08-0.21%, calculated on the total weight of the traditional Chinese medicine extract.

[0030] In another preferred embodiment, the content of baicalin is 18.76%, based on the total weight of the traditional Chinese medicine extract.

[0031] In another preferred embodiment, the content of wogonin is 0.96%, based on the total weight of the traditional Chinese medicine extract.

[0032] In another preferred example, the content of baicalein is 1.37%, based on the total weight of the traditional Chinese medicine extract.

[0033] In another preferred example, the content of wogonin is 3.27%, based on the total weight of the traditional Chinese medicine extract.

[0034] In another preferred embodiment, the content of the melaleuca alternifolia A-7-O-β-D-glucuronide is 1.42%, based on the total weight of the traditional Chinese medicine extract.

[0035] In another preferred embodiment, the content of matrine is 0.28%, based on the total weight of the traditional Chinese medicine extract.

[0036] In another preferred embodiment, the content of sophoridine is 0.23%, based on the total weight of the traditional Chinese medicine extract.

[0037] In another preferred embodiment, the content of oxymatrine is 1.79%, based on the total weight of the traditional Chinese medicine extract.

[0038] In another preferred embodiment, the content of D-anhydrous glucose is 0.49%, based on the total weight of the traditional Chinese medicine extract.

[0039] In another preferred embodiment, the content of ginsenoside Rb1 is 0.11%, based on the total weight of the traditional Chinese medicine extract.

[0040] In a second aspect of the present invention, there is provided a method for preparing the Chinese medicine composition as described in the first aspect, comprising the steps of:

[0041] (S1) alcohol extraction: using an ethanol solution to heat reflux extract the first traditional Chinese medicine composition to obtain a filtrate;

[0042] (S2) water precipitation: the filtrate obtained in (S1) is concentrated under reduced pressure and then water is added to form a first dispersion, and the dispersion is allowed to stand to form a supernatant and a precipitate;

[0043] (S3) elution: mixing the precipitate obtained in step (S2) with ethanol to form a second dispersion, and eluting and purifying the supernatant of the second dispersion to obtain an eluate;

[0044] (S4) drying: concentrating and drying the eluate in step (S3) under reduced pressure to obtain an extract of the first Chinese medicine composition; and

[0045] (s5) mixing the extract and chicken gizzard lining powder to obtain the Chinese medicine composition.

[0046] In another preferred embodiment, the volume ratio of the ethanol solution to the traditional Chinese medicine composition in step (s1) is 5-20:1.

[0047] In another preferred embodiment, the alcohol content in the ethanol solution in step (s1) is 50-98% (v / v), preferably 80-96% (v / v).

[0048] In another preferred embodiment, the concentration in step (s1) is to concentrate the filtrate to a relative density of 1.02 to 1.12.

[0049] In another preferred embodiment, the alcohol content in the ethanol solution in step (s2) is 50-98% (v / v), preferably 80-96% (v / v).

[0050] In another preferred embodiment, the elution solution in step (s3) is an ethanol aqueous solution.

[0051] In another preferred embodiment, in the step (s3), the elution is to elute and purify the supernatant of the second dispersion through a macroporous adsorption resin column;

[0052] Preferably, the macroporous adsorption resin is a styrene-type weakly polar macroporous adsorption resin column.

[0053] In another preferred embodiment, the macroporous adsorption resin is an AB-8 type styrene type weakly polar macroporous adsorption resin column.

[0054] In another preferred embodiment, the diameter-to-height ratio of the macroporous adsorption resin column is 1:2-3.5.

[0055] In another preferred embodiment, the volume of the macroporous adsorption resin column is 8-12L.

[0056] In another preferred embodiment, the elution process of the macroporous adsorption resin includes: first eluting and removing impurities with 0.2-1.2 times BV of purified water, discarding the water elution and impurity removal liquid, then eluting with 2-6 times BV of 55-65% ethanol aqueous solution in turn, collecting the eluate, eluting again with 6-8 times BV of 90-98% ethanol, continuing to collect the eluate until the elution is completed, combining the eluate, and concentrating to obtain extract A.

[0057] In the third aspect of the present invention, there is provided a use of the Chinese medicine composition as described in the first aspect and / or the second aspect for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for: (i) preventing and / or treating food stagnation; (ii) preventing and / or treating fever caused by food stagnation.

[0058] In another preferred embodiment, the pharmaceutical composition or preparation is used for: digesting food, eliminating accumulation, relieving fever, and clearing away heat.

[0059] In another preferred embodiment, the food accumulation is food accumulation in children.

[0060] In the fourth aspect of the present invention, a pharmaceutical composition is provided, which comprises the Chinese herbal extract as described in the first aspect and / or the second aspect; and a pharmaceutically acceptable carrier; preferably, the pharmaceutical composition is selected from the following group: granules, capsules, tablets.

[0061] In another preferred embodiment, the pharmaceutical composition is used to prevent and / or treat food accumulation; preferably, the food accumulation is food accumulation in children.

[0062] In another preferred embodiment, the carrier is selected from the following group: conventional excipients for granules, conventional excipients for capsules, and conventional excipients for tablets.

[0063] In another preferred embodiment, in the pharmaceutical composition, the content of the traditional Chinese medicine extract is 0.1-99.9wt%, preferably 1-99wt%, more preferably 5-95wt%, more preferably 10-90wt%, more preferably 20-80wt%, and optimally 30-70wt%, based on the weight of the pharmaceutical composition.

[0064] The fifth aspect of the present invention provides a method for preventing and / or treating food stagnation, and / or preventing and / or treating fever caused by food stagnation, by administering the Chinese herbal extract as described in the first aspect to a subject in need.

[0065] In another preferred embodiment, the subject is a human or non-human mammal.

[0066] It should be understood that within the scope of the present invention, the above-mentioned technical features of the present invention and the technical features specifically described below (such as embodiments) can be combined with each other to form a new or preferred technical solution. Due to space limitations, they will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS DETAILED DESCRIPTION

[0067] After long and extensive research, the inventor unexpectedly discovered a Chinese medicine composition or Chinese medicine extract and its use, which is used to prevent and / or treat food accumulation, and / or prevent and / or treat fever caused by food accumulation; the Chinese medicine composition includes one or more medicinal materials selected from the following group: Scutellaria baicalensis, Sophora flavescens, Radix Pseudostellariae, Crataegus pinnatifida; the Chinese medicine extract is extracted from the Chinese medicine composition and Gallus gallus tuber. The experimental results of the present invention show that the Chinese medicine extract of the present invention has unexpected effects such as digestion, relieving fever, and clearing away heat. Therefore, the Chinese medicine composition or Chinese medicine extract of the present invention has an excellent therapeutic effect on children's food accumulation or fever caused by children's food accumulation. On this basis, the present invention was completed.

[0068] the term

[0069] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0070] As used herein, the terms "comprise", "include", and "contain" are used interchangeably and include not only closed definitions, but also semi-closed and open definitions. In other words, the terms include "consisting of", "consisting essentially of".

[0071] In the present invention, the term "prevention" means a method of preventing the onset of a disease and / or its attendant symptoms or protecting a subject from acquiring a disease. "Prevention" as used herein also includes delaying the onset of a disease and / or its attendant symptoms and reducing the risk of a subject getting a disease.

[0072] The "treatment" described in the present invention includes delaying and stopping the progression of the disease, or eliminating the disease, and does not require 100% inhibition, elimination and reversal. In some embodiments, the composition or pharmaceutical composition of the present invention reduces, inhibits and / or reverses diabetes and its complications by, for example, at least about 10%, at least about 30%, at least about 50%, or at least about 80%, compared to the levels observed when the composition, medicine kit, food kit or health product kit, active ingredient combination described in the present invention is not present.

[0073] As used herein, the term "effective amount" refers to an amount that produces a function or activity in humans and / or animals and is acceptable to humans and / or animals. It should be understood by those skilled in the art that the "effective amount" may vary depending on the form of the pharmaceutical composition, the severity of the disease, and the combination of other drugs.

[0074] As used herein, the terms "parts by weight" and "parts by weight" are used interchangeably, and the parts by weight may be any fixed weight expressed in milligrams, grams or kilograms (such as 1 mg, 1 g, 2 g or 1 kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b may be a composition consisting of 1 gram of component a + 9 grams of component b, or 10 grams of component a + 90 grams of component b, etc. In the composition, the percentage content of a component = (parts by weight of the component / sum of the parts by weight of all components) × 100%. Therefore, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10%, and the content of component b is 90%.

[0075] As used herein, the term "Chinese medicine composition" refers to the Chinese medicine used as the active medicinal material in the present invention, and the medicinal material may include various forms, for example, the medicinal material includes (but is not limited to) dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, or a combination thereof. In addition, when the pharmaceutical composition or preparation of the present invention contains a certain Chinese medicine extract, the term also includes the raw medicinal materials corresponding to the Chinese medicine extract or the corresponding Chinese medicine composition used to prepare the extract.

[0076] Pharmaceutical composition

[0077] In a preferred embodiment of the present invention, the raw medicinal materials Scutellaria baicalensis, Sophora flavescens, Radix Pseudostellariae, Crataegus pinnatifida, Gallus gallus tuber can be directly added to the composition or added to the pharmaceutical composition after being crushed. In addition, those skilled in the art can also directly use the Chinese medicine extract of the present invention for processing to prepare a pharmaceutical composition. In addition, those skilled in the art can extract active ingredients from each raw medicine and mix them into the pharmaceutical composition. In a preferred embodiment of the present invention, the pharmaceutical composition of the present invention is prepared by mixing the raw medicinal material extract with a carrier, and the medicinal material extract can be mixed by extracts of each raw medicinal material.

[0078] There is no particular limitation on the dosage form of the pharmaceutical composition of the present invention, and it can be any dosage form suitable for mammals. Preferably, the dosage form can include tablets, capsules, granules, pills, powders, oral liquids, buccal tablets, or aerosols; most preferably, tablets, capsules, or granules. From the standpoint of ease of preparation, administration or taking, the preferred composition is a solid composition. Oral administration is preferred.

[0079] The composition of the present invention may be added with various conventional carriers and / or auxiliary materials required for preparing different dosage forms, such as fillers (such as starch, cellulose, dextrin), disintegrants (sodium carboxymethyl starch), lubricants (magnesium stearate), solvents (purified water), cosolvents (ethanol), and coating materials. Conventional methods for preparing traditional Chinese medicine preparations may be used to prepare any commonly used dosage form, such as tablets, capsules, granules, capsules, pills, and powders.

[0080] As used herein, the term "pharmaceutically acceptable carrier" refers to a substance that is suitable for human and / or animal use without excessive adverse side effects (such as toxicity, irritation and allergic reactions), that is, a substance with a reasonable benefit / risk ratio. Some examples of pharmaceutically acceptable carriers include cellulose and its derivatives (such as methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, etc.), gelatin, talc, solid lubricants (such as stearic acid, magnesium stearate), calcium sulfate, vegetable oils (such as soybean oil, sesame oil, peanut oil, olive oil, etc.), polyols (such as propylene glycol, glycerol, mannitol, sorbitol, etc.), emulsifiers (such as Tween), wetting agents (such as sodium lauryl sulfate), buffers, chelating agents, thickeners, pH adjusters, transdermal enhancers, colorants, flavoring agents, stabilizers, antioxidants, preservatives, antibacterial agents, pyrogen-free water, etc.

[0081] Dosage and treatment methods

[0082] The Chinese medicine composition and Chinese medicine extract of the present invention can be used to prepare a pharmaceutical composition or preparation for preventing and / or treating food stagnation, and / or preventing and / or treating fever caused by food stagnation. The pharmaceutical composition or preparation of the present invention may also contain other optional medicinal materials or extracts thereof or other drugs effective for treating and / or preventing food stagnation and / or symptoms caused by food stagnation.

[0083] The pharmaceutical composition or preparation is matched with the mode of administration. When using the pharmaceutical composition or preparation, a safe and effective amount of the drug is applied to the desired object (such as a human or non-human mammal). Usually, the pharmaceutical composition or preparation of the present invention is administered at a dose of 0.001-20g / kg of animal body weight per day, preferably 1-4 times a day in separate doses, or in a sustained-release form. For most mammals, the total daily dose is 0.05-600g. Of course, the specific dose will also vary with the mode of administration, dosage form and severity of the disease being treated, and the route of administration, which are all within the skill of a skilled physician. Administration can be carried out by conventional routes, including (but not limited to): oral, intramuscular, dermal, or topical administration. Oral administration is preferred.

[0084] The present invention also provides a method for preventing and / or treating food stagnation, and / or preventing and / or treating fever caused by food stagnation, by administering the Chinese medicine composition and / or the Chinese medicine extract of the present invention to a subject in need thereof.

[0085] In another preferred embodiment, the subject is a human or non-human mammal (eg, dog, pig, cat, monkey, sheep, horse, cow, etc.).

[0086] The main advantages of the present invention include:

[0087] 1. The preparation method of the Chinese medicine composition / Chinese medicine extract of the present invention only uses the processes of alcohol extraction, water precipitation and elution, and the amount of the extract obtained is far less than the water extract of the traditional process. The extract yield of the present invention is reduced from 42.11% to 20.54%, and some solid particles, proteins and other macromolecules in the water extract are removed to purify the extract.

[0088] 2. The contents of flavonoids and alkaloids in the Qinji Fang extract of the present invention are greatly improved compared with those in the Qinji Fang water extract, with the highest baicalin content increased by 15 times and the lowest oxymatrine increased by more than 1 times.

[0089] 3. The Chinese medicine composition or Chinese medicine extract of the present invention can effectively treat children's food accumulation or fever caused by children's food accumulation, can play the role of clearing away heat and eliminating accumulation, and has a significant therapeutic effect on fever caused by food accumulation.

[0090] 4. The extract of the Qinji prescription of the present invention can promote the secretion of gastrin and cholinesterase in mice with food accumulation, reduce the content of nitric oxide in serum, thereby regulating gastrointestinal activity and playing a role in digestion and regulating the stomach.

[0091] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples without specifying specific conditions are usually based on conventional conditions or the conditions recommended by the manufacturer. Unless otherwise stated, percentages and parts are by weight.

[0092] Example 1: Preparation of Qinjifang Extract

[0093] 1. Drug preparation method

[0094] Dry extract powder A

[0095] Alcohol extraction: provide a mixture of 12g of Scutellaria baicalensis, 12g of Sophora flavescens, 8g of Pseudostellaria heterophylla, and 8g of Crataegus pinnatifida, add 50% ethanol 10 times the volume of the mixture, heat and reflux to extract twice, each time for 2 hours, filter, and collect the filtrate.

[0096] Water precipitation: The filtrate is concentrated under reduced pressure to a concentrated solution with a relative density of 1.02 to 1.12 (50 to 60°C), and the concentrated solution is diluted with purified water to form a first dispersion (containing 0.05 kg / L of crude drug). After standing, the dispersion forms a supernatant and a precipitate.

[0097] Elution: Take the precipitate in the first dispersion and add 95% ethanol to form a second dispersion. The alcohol content in the dispersion is greater than or equal to 80%, and the supernatant of the dispersion is eluted together with 95% ethanol. Specifically, a styrene-type weakly polar macroporous adsorption resin column (AB-8 type) is used to elute the supernatant of the dispersion. The resin column has a diameter-to-height ratio of 1:2.7 and a volume BV of 10.8L. After loading, 0.5 times BV of purified water is used to elute and remove impurities, and the water elution and impurity removal liquid is discarded; after the water washing and impurity removal is completed, first elute with 4 times BV of 60% ethanol, collect the eluate, and after the elution is completed, elute with 7 times BV of 95% ethanol, continue to collect the eluate until the elution is completed, and combine the eluate.

[0098] Post-treatment: the eluate is concentrated under reduced pressure, ethanol is recovered, and the mixture is concentrated to extract A with a relative density of 1.05 to 1.20 (50 to 60° C.). Extract A is dried under reduced pressure (-0.07 to -0.1 MPa, ≤60° C.), crushed, and passed through a 60-mesh sieve to obtain dry extract powder A.

[0099] Qinjifang Extract

[0100] Weigh 6g of chicken's gizzard lining and grind it, sieve it through 80 mesh to get the chicken's gizzard lining fine powder. Mix the dry extract powder A and the chicken's gizzard lining fine powder to get the Qinji Fang extract.

[0101] 2. Preparation method

[0102] 1) Granules

[0103] The prepared Qinji Fang extract is added with conventional auxiliary materials for granules, mixed and granulated by a wet method, and dried and granulated to obtain Qinji granules.

[0104] 2) Capsules

[0105] The prepared Qinji Fang extract is added with conventional capsule excipients for wet mixing and granulation, and then dried, granulated, and filled into capsules to obtain Qinji capsules.

[0106] 3) Tablets

[0107] The prepared Qinji Fang extract is added with conventional tablet auxiliary materials, and wet-mixed granulation is performed, dried, granulated, and tableted to obtain Qinji tablets.

[0108] 3. Prescription and dosage

[0109] Oral, one prescription per day, one course of treatment for three days

[0110] 4. Chemical composition of the drug

[0111] 4.1 Instruments and reagents

[0112] 4.1.1 Instruments

[0113] Table 1 lists the instruments used in this experiment.

[0114] Table 1: Instruments

[0115]

[0116] 4.1.2 Drug testing

[0117] The test drugs for this experiment are shown in Table 2

[0118] Table 2: Test drugs

[0119]

[0120]

[0121] 4.2 Flavonoids in the Qinji Fang extract

[0122] 4.2.1 Preparation of test solution

[0123] Take about 0.5g of Qinjifang extract, weigh accurately, put it in a 25ml volumetric flask, add 20ml of 50% methanol, treat it with ultrasound (power: 250W, frequency: 53kHz) for 20 minutes, cool it, add 50% methanol to the scale, shake it well, and set aside.

[0124] 4.2.2 Preparation of mixed reference solution

[0125] Take appropriate amount of baicalin, baicalin, wogonin, wogonin, and melaleuca alternifolia A-7-O-β-D-glucuronide reference substances, add methanol to dissolve, and obtain reference substance stock solutions; take appropriate amount of each stock solution into a 25 ml volumetric flask, and make up to volume with 50% methanol so that each 1 ml contains 43.04, 33.27, 69.02, 65.47, and 19.01 μg of baicalin, baicalin, wogonin, wogonin, and melaleuca alternifolia A-7-O-β-D-glucuronide, respectively.

[0126] 4.2.3 Chromatographic conditions

[0127] Chromatographic column: Waters XBridge Shield RP 18; mobile phase: A-acetonitrile, B-0.05% phosphoric acid, gradient elution, elution gradient see Table 3; flow rate: 0.8 mL / min; column temperature: 30°C; detection wavelength: 270 nm.

[0128] Table 3: Elution gradient

[0129]

[0130] 4.2.4 Determination method

[0131] 10 μl of the test solution and the mixed reference solution were respectively filtered through a 0.45 μm microporous filter membrane, injected into a liquid chromatograph, and measured to obtain the result.

[0132] Each gram of this product contains 6.86 mg of baicalin, 93.78 mg of baicalin, 4.81 mg of wogonin, 16.34 mg of baicalin and 7.10 mg of melaleuca alternifolia A-7-O-β-D-glucuronide, respectively.

[0133] 4.3 Alkaloid components in the extract of Qinji Fang

[0134] 4.3.1 Preparation of test solution

[0135] Take 0.5 g of Qinjifang extract, place it in a 25 ml volumetric flask, add 20 ml of 50% methanol, ultrasonically treat for 20 minutes, cool, add 50% methanol to the scale, shake well, and set aside.

[0136] 4.3.2 Preparation of mixed reference solution

[0137] Take appropriate amount of matrine, sophoridine and oxymatrine reference substances, place them in a 25 ml volumetric flask, add methanol to dissolve and dilute to the scale to obtain reference substance stock solution, take appropriate amount of each stock solution in a 25 ml volumetric flask, and make up to volume with 50% methanol so that each 1 ml contains 24.69, 22.96 and 22.73 μg of matrine, sophoridine and oxymatrine, respectively.

[0138] 4.3.3 Chromatographic conditions

[0139] Chromatographic column:; Mobile phase: anhydrous ethanol-acetonitrile-3% phosphoric acid (11:81:8), isocratic elution; Flow rate: 1 mL / min; Column temperature: 30°C; Detection wavelength: 210 nm.

[0140] 4.3.4 Determination method

[0141] 10 μl of the test solution and the mixed reference solution were respectively filtered through a 0.45 μm microporous filter membrane, injected into a liquid chromatograph, and measured to obtain the result.

[0142] The extract of Qinji Fang in this product contains 1.42 mg, 1.14 mg and 8.96 mg of matrine, sophoridine and oxymatrine per gram respectively.

[0143] 4.4 Total polysaccharides in the extract of Qinji Fang

[0144] 4.4.1 Preparation of reference solution

[0145] Take an appropriate amount of D-anhydrous glucose reference substance dried to constant weight at 105°C, accurately weigh it, and add water to make a solution containing 150 μg of D-anhydrous glucose per ml.

[0146] 4.4.2 Preparation of standard curve

[0147] Accurately measure 0.1mL, 0.2mL, 0.4mL, 0.6mL, 0.8mL and 1ml of the reference solution and place them in 10ml EP tubes respectively. Add water to 1.0mL each, accurately add 1.0mL 5% phenol solution (prepared temporarily), shake well, then accurately add 5mL sulfuric acid, shake well, heat in a boiling water bath for 20 minutes, take out and cool in an ice water bath for 5 minutes, use the corresponding reagent as blank, measure the absorbance at a wavelength of 490nm according to the UV-Vis spectrophotometry, and draw a standard curve with the absorbance value as the ordinate and the content as the abscissa.

[0148] 4.4.3 Test sample determination method

[0149] Take about 0.5g of Qinjifang extract, weigh it accurately, put it in a stoppered test tube, accurately add 10ml of water, ultrasonically treat for 20 minutes, centrifuge, accurately measure 2ml of supernatant, put it in a 10ml EP tube, accurately add 8ml of anhydrous ethanol, shake well, overnight (4℃), take out, centrifuge (4000r / min, 5 minutes), discard the supernatant, wash the precipitate with 5ml of 80% ethanol, centrifuge, discard the supernatant, evaporate the washing liquid, add 1ml of hot water to dissolve the precipitate, put it in a 10ml EP tube, and determine the absorbance according to the method under the standard curve preparation item from "accurately add 1ml of 5% phenol solution", read the amount of D-anhydrous glucose in the test solution from the standard curve, and calculate.

[0150] This product contains 2.46 mg of total polysaccharides per gram.

[0151] 4.5 Total saponins in the extract of Qinji Fang

[0152] 4.5.1 Preparation of reference solution

[0153] Take an appropriate amount of ginsenoside Rb1 reference substance, weigh it accurately, and add methanol to make a solution containing 100 μg of ginsenoside Rb1 per ml.

[0154] 4.5.2 Preparation of standard curve

[0155] Accurately measure 0.25mL, 0.5mL, 0.1mL, 1.5mL, and 2mL of the reference solution, place them in stoppered test tubes respectively, evaporate the solvent, accurately add 0.2mL of 5% vanillin glacial acetic acid solution (prepared temporarily), shake well, accurately add 0.8mL of perchloric acid, shake well, seal, heat in a 60°C water bath for 15 minutes, take out and cool in an ice water bath for 5 minutes, take out, accurately add 5ml of glacial acetic acid, shake well, use the corresponding reagent as blank, and measure the absorbance at a wavelength of 560nm according to the UV-Vis spectrophotometry, draw a standard curve with the absorbance value as the ordinate and the content as the abscissa.

[0156] 4.5.3 Test sample determination method

[0157] Take about 0.5g of the extract of Qinjifang, weigh it accurately, put it in a stoppered conical bottle, add 10ml of water accurately, ultrasonically treat it for 20 minutes, add 2.8 times of ethanol accurately, let it stand overnight, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of hot water, put it in a separatory funnel, extract it 3 times with water-saturated n-butanol, 20ml each time, combine the extracts, wash it 3 times with n-butanol saturated water, 20ml each time, collect the n-butanol solution, evaporate it to dryness, dissolve the residue in methanol and dissolve it in a 10ml volumetric flask to obtain the test solution. Accurately measure 1.0ml of the test solution, put it in a stoppered test tube, evaporate the reagent, and determine the absorbance according to the method under the standard curve preparation item from "accurately add 0.2ml of 5% vanillin glacial acetic acid solution" in accordance with the law, read the amount of ginsenoside Rb1 in the test solution from the standard curve, calculate, and obtain.

[0158] This product contains 0.55 mg of total saponins per gram.

[0159] Comparative Example 1: Preparation of the water extract of Qinji Fang

[0160] Scutellaria baicalensis, Sophora flavescens, Radix Pseudostellariae, and Crataegus pinnatifida were added with 10 times the amount of water, and the mixture was heated and refluxed for extraction twice, each time for 2 hours, and filtered. The filtrate was concentrated under reduced pressure to a concentrated solution with a relative density of 1.02-1.12 (50-60°C), dried under reduced pressure (-0.07--0.1MPa, ≤60°C), crushed, and sieved through a 60-mesh sieve to obtain dry extract powder 1. Chicken gizzard lining was crushed and sieved through an 80-mesh sieve to obtain chicken gizzard lining fine powder. Take dry extract powder 1 and chicken gizzard lining fine powder and mix them evenly to obtain the Qinji Fang water extract.

[0161] Results - Ingredient Study

[0162] The components of the Qinjifang extract and the Qinjifang water extract were determined, and the results are shown in Tables 4 and 5.

[0163] Table 4: Component transfer rate

[0164]

[0165] Table 5: Ingredient content

[0166]

[0167] According to the data in Table 5, the extract process of Qinji Fang has the following advantages over the traditional water extraction process: through alcohol extraction, water precipitation and elution, the amount of extract is much less than the water extract of the traditional process, and the extract yield is reduced from 42.11% to 20.54%, and some solid particles, proteins and other macromolecules in the water extract are removed to purify the extract; through water precipitation, elution and other refining processes, the content of flavonoids and alkaloids in the extract of Qinji Fang is greatly improved compared with the water extract of Qinji Fang (the highest baicalin content is increased by 15 times, and the lowest oxymatrine is more than 1 times). Therefore, the preparation process of Qinji Fang extract is more suitable than the traditional water extraction process.

[0168] Results - Pharmacological Studies

[0169] 1 Antipyretic effect

[0170] 1.1 Experimental Materials

[0171] 1.1.1 Experimental drugs

[0172] Qinjifang extract, homemade; Shuanghuanglian capsules, produced by Huizhou Traditional Chinese Medicine Factory, Guangdong Province, batch number 151021; medical ethanol, produced by Xinxiang Sanwei Disinfection Preparation Co., Ltd., batch number 20140105; endotoxin, produced by Beijing Dingguo Changsheng Biotechnology Co., Ltd., batch number DH183-1; 2,4-dinitrophenol, produced by China (Zhengzhou) Paini Chemical Reagent Factory, batch number 170323002.

[0173] 1.1.2 Experimental instruments

[0174] JM1000 electronic scale, produced by Yuyao Jiming Weighing and Calibration Equipment Co., Ltd.; AL204 electronic balance, produced by Mettler-Toledo Instruments (Shanghai) Co., Ltd.; HHS-21-8 electric constant temperature water bath, produced by the Medical Equipment Factory of Shanghai Boxun Industrial Co., Ltd.; BCD-248T refrigerator, produced by Xinfei Electric Co., Ltd.; clear glass mercury thermometer, produced by Henan Shengguang Ruida Medical Equipment Co., Ltd.

[0175] 1.1.3 Experimental animals

[0176] Male New Zealand rabbits, 2.0-2.5 kg, ordinary grade, certificate number 37009700000341, provided by Jinan Jinfeng Experimental Animal Co., Ltd., license number SCXK(Lu)20140006; male SD rats, 200-220 g, SPF grade, certificate number 37009200008051, provided by Jinan Pengyue Experimental Animal Breeding Co., Ltd., license number: SCXK(Lu)20140007; Experimental Animal Use License SYXK(Yu)2015-0005.

[0177] 1.1.4 Test solution preparation

[0178] Endotoxin solution: carefully collect 10 mg of bacterial endotoxin, add normal saline to make up to 100 mL, then add 400 times of normal saline to obtain 0.25 μg / mL endotoxin dilution solution, and refrigerate.

[0179] 2,4-Dinitrophenol solution: Weigh 2 g of 2,4-dinitrophenol, add normal saline to make up to 500 mL, protect from light, and refrigerate.

[0180] 1.2 Experimental methods

[0181] 1.2.1 Effects on endotoxin-induced fever model in rabbits

[0182] Male New Zealand rabbits were taken, adapted for 3 days, and body temperature was measured for 3 consecutive days. Rectal temperature was measured twice a day, and rabbits with an average value within the normal body temperature range (38.3-39.7°C) and a body temperature fluctuation of no more than 0.3°C were selected for the experiment. Fasting (water is not forbidden) for 12 hours before the experiment, rectal temperature was measured twice, and the average of the two body temperatures was taken as the basal body temperature. 10 rabbits were randomly selected as the blank control group, and the remaining rabbits were injected with 0.25μg / kg of endotoxin solution (prepared under sterile conditions with sterile 0.9% sodium chloride injection, 1mL / kg) through the ear vein to create a fever model. The body temperature of rabbits in each group was measured 1 hour later, and 50 rabbits with a temperature rise of >1°C were selected and randomly divided into 5 groups according to body temperature (difference). One hour after modeling, the rabbits were gavaged with large, medium and small doses of Qinjifang extract suspension (1000mg / kg, 500mg / kg, 250mg / kg, 100mg / ml, 50mg / ml, 25mg / ml, 10ml / kg, 10, 5 and 2.5 times of the clinical dose), Shuanghuanglian capsule suspension (400mg / kg, 40mg / ml, 10ml / kg, 5 times of the clinical dose), and the same volume of normal saline (blank group and model group). The rectal temperature of the rabbits was measured again at 30min, 1h, 2h, 3h, 4h, 6h and 8h after administration, and the average value was taken as the body temperature. The temperature increase value was calculated, and the temperature increase value = body temperature at different times after medication (body temperature after modeling) minus basal body temperature. Any negative value of body temperature change was counted as 0. The results are shown in Table 6.

[0183] Table 6 Effect of the extract of Qinji Fang on the temperature change of the endotoxin-induced fever model in rabbits (±s, n=10)

[0184]

[0185]

[0186] Compared with the model group, * P<0.05, ** P<0.01; (the values ​​in brackets are the body temperature increase)

[0187] As can be seen from the table above, there was no significant difference in basal body temperature among the groups before the experiment (P>0.05); 30 minutes after modeling, compared with the blank group, the body temperature of each modeling group increased significantly (P<0.01), and there was no significant difference in body temperature among the modeling groups (P>0.05); compared with the blank group, the body temperature increase values ​​of the model group within 6 hours of modeling were significantly increased (P<0.01), and the body temperature showed an increasing trend at 8 hours (P>0.05), indicating that the fever model was successfully established. Compared with the model group, at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, and 6 hours of drug administration, the large, medium, and small doses of Qinjifang extract groups and Shuanghuanglian capsule groups could significantly reduce the increase in body temperature (P<0.01); 8 hours after drug administration, each drug administration group only had a trend of reducing the increase in body temperature (P>0.05). The results showed that large, medium and small doses of Qinji Fang extract had good antipyretic effect on endotoxin-induced rabbit fever model 30 minutes to 6 hours after administration.

[0188] 1.2.2 Effects on 2,4-dinitrophenol-induced fever model in SD rats

[0189] 75 male SD rats were taken and fed for 3 days. The body temperature was measured for 3 consecutive days. The rectal temperature was measured twice a day. The rats with an average value within the normal body temperature range (37.0-37.7℃) and a body temperature fluctuation of no more than 0.3℃ within a day were selected for antipyretic experiments. Fasting (water is not forbidden) for 12 hours before the experiment, the rectal temperature was measured twice on the day of the experiment, and the average of the two body temperatures was taken as the basal body temperature. 12 rats were randomly selected as the blank control group, and the rest of the rats were subcutaneously injected with 2,4-dinitrophenol 40mg / kg (4mg / mL, 1ml / 100g) on ​​the back to create a fever model. The body temperature of the rats was measured 30 minutes later. 60 rats with a temperature rise of >1℃ were selected and randomly divided into 5 groups according to the body temperature (difference). The rats were gavaged with large, medium and small doses of Qinjifang extract suspension (2000mg / kg, 1000mg / kg, 500mg / kg, 200mg / ml, 100mg / ml, 20mg / ml, 1ml / 100g, 20, 10, 5 times of the clinical dosage), Shuanghuanglian capsule suspension (800mg / kg, 80mg / ml, 1ml / 100g, 10 times of the clinical dosage), and the same volume of 0.2% CMC (blank group and model group, 1ml / 100g). The rectal temperature of the rats was measured again at 10min, 30min, 1h, 2h, 3h, 4h, 5h, 6h, and 7h after administration, 2 times each time, and the average value was taken as the rat body temperature. The temperature increase value was calculated, and the temperature increase value = body temperature at different times after medication (body temperature after modeling) minus basal body temperature. Any negative value of body temperature change was counted as 0. Results Table 7.

[0190] Table 7 Effects of Qinji Fang extract on body temperature changes in 2,4-dinitrophenol-induced fever model in rats ( n=12)

[0191]

[0192] Compared with the model group, *P<0.05, **P<0.01; (the values ​​in brackets are the body temperature increase)

[0193] As can be seen from the table above, there was no significant difference in basal body temperature among the groups before the experiment (P>0.05); 30 minutes after modeling, the body temperature of each group increased significantly compared with the blank group (P<0.01); there was no significant difference in body temperature among the groups (P>0.05); compared with the blank group, the temperature increase values ​​of the model group increased significantly within 7 hours of modeling (P<0.01), indicating that the fever model was successfully established. 10 minutes after drug administration, compared with 30 minutes after modeling, the body temperature of rats in each group increased significantly. Compared with the model group, after drug administration for 10 minutes, the temperature increase values ​​of rats in each drug administration group showed a downward trend; after drug administration for 30 minutes to 6 hours, the large, medium and small doses of Qinjifang extract group and Shuanghuanglian capsule group could significantly reduce the temperature increase values ​​(P<0.01); after drug administration for 7 hours, each drug administration group only had a tendency to reduce body temperature (P>0.05). The results showed that large, medium and small doses of Qinji Fang extract had good antipyretic effect on 2,4-diphenylbenzene-induced fever model in rats 30 minutes to 6 hours after administration.

[0194] 1.2.3 Statistical processing methods

[0195] Data analysis was performed using SPSS 19.0 for Windows statistical package, and the quantitative data were expressed as mean ± standard deviation. The groups were compared by one-way analysis of variance, and the least significant difference (LSD) method was used for equal variance test, and the Games-Howel1 method was used for unequal variance test.

[0196] 1.3 Conclusion

[0197] Endotoxin can significantly increase the body temperature of rabbits within 6 hours, and the early fever model is successful. The rabbits were given a single oral administration of the Qinjifang extract suspension at a dose of 300mg / kg, 150mg / kg, and 75mg / kg. Within 30min to 6h of administration, large, medium, and small doses of Qinjifang extract can significantly reduce the body temperature of the rabbits. This suggests that large, medium, and small doses of Qinjifang extract have a good antipyretic effect on the endotoxin-induced rabbit fever model within 30min to 6h after administration.

[0198] 2,4-Dinitrophenol can significantly increase the body temperature of SD rats within 6 hours, and the fever model was successfully established. Rats were given a single oral administration of the Qinjifang extract suspension at a dose of 600mg / kg, 300mg / kg, and 150mg / kg. Within 30min to 6h of administration, large, medium, and small doses of Qinjifang extract can significantly reduce the body temperature of rats. This suggests that large, medium, and small doses of Qinjifang extract have a good antipyretic effect on the 2,4-dinitrophenol-induced fever model in rats 30min-6h after administration.

[0199] 2. Digestion and elimination of food accumulation

[0200] 2.1 Experimental Materials

[0201] 2.1.1 Experimental drugs

[0202] Qinjifang extract, homemade; Jianweixiaoshi tablets, Jiangzhong Pharmaceutical Co., Ltd., batch number 20200707; milk powder, Anyinqiao Biotechnology Co., Ltd., 0808132X; soy powder, Guangxi Nanfang Black Sesame Food Co., Ltd., 81770; mouse gastrin (GAS) enzyme-linked immunosorbent assay kit, Nanjing Jiancheng Bioengineering Institute, 20200301; nitric oxide (NO) test kit, Nanjing Jiancheng Bioengineering Institute, 20200317; cholinesterase (CHE) test kit, Nanjing Jiancheng Bioengineering Institute, 20200328; ink, Beijing Ink Factory, 1022-1144.

[0203] 2.1.2 Experimental instruments

[0204] YP3002 1 / 10,000 electronic balance, Shanghai Yueping Scientific Instrument Co., Ltd.; UV-6100 ultraviolet-visible spectrophotometer, Wenzhou Aoli Biomedical Instrument Factory; HHS-21-8 electric constant temperature water bath, produced by Shanghai Boxun Industrial Co., Ltd. Medical Equipment Factory; BCD-248T refrigerator, produced by Xinfei Electric Co., Ltd.; EMax Plus microplate reader, Meigu Molecular Instrument Shanghai Co., Ltd.; RJ-TGL-16C high-speed centrifuge, Wuxi Ruijiang Analytical Instrument Co., Ltd.; BL-420E+ biological signal acquisition and processing system, Chengdu Taimeng Technology Co., Ltd.

[0205] 2.1.3 Experimental animals

[0206] Healthy SPF KM mice, weighing 18-22 g, half male and half female, were purchased from Chengdu Dashuo Experimental Animal Co., Ltd., license number: SCXK (Sichuan) 2015-30. Laboratory Animal Use License SYXK (Henan) 2015-0005.

[0207] 2.2 Experimental methods

[0208] SPF KM mice weighing 19-22g, half male and half female, were taken and adaptively fed for 3 days. They were randomly divided into 6 groups according to their weight and gender, with 10 mice in each group, namely food accumulation model group, Jianwei Xiaoshi tablets group, high-dose group of Qinjifang extract, medium-dose group of Qinjifang extract, low-dose group of Qinjifang extract, and normal control group. The normal control group was fed normally, and the other groups were fed with homemade high-protein, high-calorie feed (made of soybean powder, flour, and milk powder in a ratio of 2:1:1, mixed well, added with water to make biscuits, and dried) every day, and 50% milk 2mL·(kg·mouse) -1, free food and water intake, for 7 consecutive days, the weight, abdominal circumference of mice, and the average food intake and feces volume of each mouse on the 2nd, 5th and 8th days were tested and recorded. The food intake and feces volume were significantly reduced, the abdomen was bloated, and the abdominal circumference increased, indicating successful modeling. Large, medium and small doses of Qinjifang extract suspension (3000mg / kg, 1500mg / kg, 1000mg / kg, 300mg / ml, 150mg / ml, 100mg / ml, 1ml / 100g, 30, 15, 7.5 times the clinical dosage), Jianweixiaoshi tablet suspension (750mg / kg, 75mg / ml, 1ml / 100g, 10 times the clinical dosage), and the same volume of normal saline (blank group and model group, 1ml / 100g) were respectively administered.

[0209] Before the experiment, the mice were fasted but not watered for 10 hours. 0.5 hours after the last administration, each group was given 0.05% carbon powder 0.3 mL / mouse. After 20 minutes, the mice were killed by cervical dislocation. The gastrointestinal tract from the cardia to the end of the rectum was immediately taken. The stomach was taken from the pyloric sphincter, put into 8 mL of physiological saline solution, chopped and stirred, and left to stand at room temperature for 1 hour. Centrifuged at 3000 r / min for 15 minutes, the absorbance of the supernatant at 546 nm (A value) was measured as the residual amount of carbon powder in the stomach. Another 4 mice were taken and given carbon powder suspension and immediately killed. The stomach was taken and its absorbance was measured as the reference absorbance of carbon powder. Gastric emptying rate % = (1-A gastric carbon powder / A reference carbon powder) × 100%. The small intestine was taken out and the mesentery was separated. The intestinal tube from the pylorus to the ileocecum was cut and placed on a tray. The small intestine was gently pulled into a straight line to measure the distance of the carbon powder and the total length of the small intestine. Small intestine propulsion rate % = carbon powder advance distance / total length of small intestine × 100%. At the same time, blood was collected from the eyeballs of mice before they were killed, at 3000 r / min -1 Centrifuge for 15 minutes, and store the serum in a -80℃ refrigerator for later use. Follow the instructions of the three kits to determine the levels of gastrin, cholinesterase, and nitric oxide in the serum.

[0210] 2.4 Statistical analysis

[0211] The experimental data are uniformly expressed as: mean ± standard deviation The data were analyzed using SPSS 21.0 software. The results were compared using the t-test. The results were considered statistically significant when P < 0.05.

[0212] 2.5 Measurement results

[0213] Compared with the normal control group, the model group had a very significant difference, indicating that modeling significantly inhibited the intestinal propulsion rate and gastric emptying rate. Compared with the model group, the Jianweixiaoshi tablet control group and the high dose and medium dose of Qinjifang extracts could increase the intestinal propulsion and gastric emptying rate of mice, and there was a significant effect P<0.05, indicating that the normal dose of Qinjifang extract had a significant therapeutic effect on mice with food accumulation. The results are shown in Table 8.

[0214] Table 8 Intestinal propulsion rate and gastric emptying rate results ( n=10)

[0215]

[0216] Compared with the model group, *P<0.05, **P<0.01

[0217] Compared with the normal control group, the three indicators of the model group were significantly affected, which shows that under the food accumulation model, the contents of the three indicators in the serum have changed significantly, and the detection is meaningful. Compared with the model group, the Jianwei Xiaoshi Tablets group and the high-dose and medium-dose extracts of Qinji Fang can promote the secretion of gastrin and cholinesterase in the human body and reduce the content of NO in the blood, and the effect is significant P<0.05. The Qinji Fang extract has a significant therapeutic effect on mice with spleen deficiency and food accumulation. The results are shown in Table 9.

[0218] Table 9 Three hormone levels in serum ( n=10)

[0219]

[0220]

[0221] Compared with the model group, *P<0.05, **P<0.01

[0222] 2.6 Conclusion

[0223] Functional dyspepsia has many clinical manifestations, and the corresponding mechanisms of each manifestation are also different. The most common one is gastrointestinal motility disorder. Intestinal propulsion rate, gastric emptying rate and gastrointestinal secretion hormones can all be used as test indicators to measure gastrointestinal motility. The extract of Qinji Fang can promote the secretion of gastrin and cholinesterase in mice with food accumulation, reduce the content of nitric oxide in serum, thereby regulating gastrointestinal activity and playing a role in digestion and regulation.

[0224] discuss

[0225] This Chinese medicine compound is mainly composed of five herbs, including scutellaria baicalensis, sophora flavescens, pseudoginseng, hawthorn, and chicken's gizzard lining. It is referred to as the Scutellaria baicalensis and chicken's gizzard lining. This prescription takes the heat-clearing and fire-purging effects of scutellaria baicalensis and sophora flavescens, the Qi-invigorating and spleen-strengthening effects of pseudoginseng, and the digestion and accumulation-removing effects of hawthorn and chicken's gizzard lining. The five herbs work together to clear heat and eliminate accumulation. It has a significant therapeutic effect on fever caused by food accumulation. This prescription is formulated in combination with clinical and modern drug use practices and is used to treat fever caused by food accumulation in children.

[0226] The main chemical components of each single herb in the Qinji prescription are: scutellaria baicalensis (flavonoids), sophora flavescens (alkaloids), pseudoginseng (saponins, polysaccharides), hawthorn (organic acids, polysaccharides), chicken gizzard lining (polysaccharides, proteins). At present, there is no report on purifying and preparing a part for treating fever caused by indigestion in children from the Qinji prescription. The present invention extracts scutellaria baicalensis, sophora flavescens, pseudoginseng and hawthorn in the Qinji prescription through alcohol, separates and purifies alkaloids, saponins and flavonoids with macroporous resin, and grinds and mixes with chicken gizzard lining to obtain the active part of the Qinji prescription for treating fever caused by indigestion in children. The part has the effects of clearing heat and digesting food, and has the value of innovative drug research and development.

[0227] All documents mentioned in the present invention are cited as references in this application, just as each document is cited as reference individually. In addition, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the claims attached to this application.

Claims

1. A Chinese medicine composition, characterized in that: The Chinese medicine composition comprises: (1) an extract of the first Chinese medicine composition, wherein the first Chinese medicine composition comprises the following components: 5-20 parts by weight of Scutellaria baicalensis; Sophora flavescens 5-20 parts by weight; 2-15 parts by weight of Pseudostellaria heterophylla; Hawthorn 2-15 parts by weight; and (2) a second Chinese medicinal component, wherein the second Chinese medicinal component comprises: 3-12 parts by weight of chicken gizzard lining.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises: 10-15 parts by weight of Scutellaria baicalensis, 10-15 parts by weight of Sophora flavescens, 5-12 parts by weight of Pseudostellaria heterophylla and 5-12 parts by weight of Crataegus pinnatifida; and the second Chinese medicine component comprises 6-9 parts by weight of Gallus gallus domesticus.

3. The Chinese medicine composition according to claim 1, characterized in that: The extract of the first Chinese medicine composition is prepared by the following method: (S1) alcohol extraction: using an ethanol solution to heat reflux extract the first traditional Chinese medicine composition to obtain a filtrate; (S2) water precipitation: the filtrate obtained in (S1) is concentrated under reduced pressure and then water is added to form a first dispersion, and the dispersion is allowed to stand to form a supernatant and a precipitate; (S3) elution: mixing the precipitate obtained in step (S2) with ethanol to form a second dispersion, and eluting and purifying the supernatant of the dispersion to obtain an eluate; and (S4) Drying: The eluate in step (S3) is concentrated and dried under reduced pressure to obtain an extract of the first traditional Chinese medicine composition.

4. The Chinese medicine composition according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition contains ingredients selected from the following group: baicalin, wogonin, baicalein, wogonin, melaleucatin A-7-O-β-D-glucuronide, matrine, sophoridine, oxymatrine, D-anhydrous glucose, and ginsenoside Rb1.

5. The Chinese medicine composition according to claim 4, characterized in that: The Chinese medicine composition contains ingredients selected from the following group: The content of baicalin is 17.76-19.76%, based on the total weight of the traditional Chinese medicine composition; The content of wogonin is 0.86-1.06%, based on the total weight of the traditional Chinese medicine composition; The content of baicalein is 1.2-1.5%, based on the total weight of the traditional Chinese medicine composition; The content of wogonin is 3-3.5%, based on the total weight of the traditional Chinese medicine composition; The content of the melaleuca alternifolia A-7-O-β-D-glucuronide is 1.3-1.5%, based on the total weight of the traditional Chinese medicine composition; The content of matrine is 0.1-0.3%, based on the total weight of the traditional Chinese medicine composition; The content of sophoridine is 0.1-0.4%, based on the total weight of the traditional Chinese medicine composition; The content of oxymatrine is 1.59-1.9%, based on the total weight of the traditional Chinese medicine composition; The content of D-anhydrous glucose is 0.3-0.6%, based on the total weight of the traditional Chinese medicine composition; The content of ginsenoside Rb1 is 0.08-0.21%, based on the total weight of the traditional Chinese medicine composition.

6. A method for preparing the Chinese medicine composition according to claim 1, characterized in that: Includes steps: (S1) alcohol extraction: using an ethanol solution to heat reflux extract the first Chinese medicine composition to obtain a filtrate; (S2) water precipitation: the filtrate obtained in (S1) is concentrated under reduced pressure and then water is added to form a first dispersion, and the dispersion is allowed to stand to form a supernatant and a precipitate; (S3) elution: mixing the precipitate obtained in step (S2) with ethanol to form a second dispersion, and eluting and purifying the supernatant of the second dispersion to obtain an eluate; (S4) drying: concentrating and drying the eluate in step (S3) under reduced pressure to obtain an extract of the first Chinese medicine composition; and (s5) mixing the extract and chicken gizzard lining powder to obtain the Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that: In the step (s3), the elution is to elute and purify the supernatant of the second dispersion through a macroporous adsorption resin column; Preferably, the macroporous adsorption resin is a styrene-type weakly polar macroporous adsorption resin column.

8. The preparation method according to claim 7, characterized in that: The elution process of the macroporous adsorption resin comprises: firstly eluting and removing impurities with 0.2-1.2 times BV purified water, discarding the water elution and removing impurities liquid, then eluting with 2-6 times BV 55-65% ethanol aqueous solution in turn, collecting the eluate, eluting again with 6-8 times BV 90-98% ethanol, continuing to collect the eluate until the elution is completed, combining the eluate, and concentrating to obtain extract A.

9. A use of the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: Used for preparing a pharmaceutical composition or preparation, wherein the pharmaceutical composition or preparation is used for: (i) preventing and / or treating food stagnation; (ii) preventing and / or treating fever caused by food stagnation.

10. A pharmaceutical composition, characterized in that The pharmaceutical composition comprises the Chinese herbal extract as described in any one of claims 1-5; and a pharmaceutically acceptable carrier; preferably, the pharmaceutical composition is selected from the following group: granules, capsules, and tablets.

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