阅读说明：本技术 一种清热解毒的中药组合物及其制备方法与应用 (Traditional Chinese medicine composition for clearing away heat and toxic materials and preparation method and application thereof ) 是由 陈钦 伍世绩 江洪亮 卢伟宁 陈燕颜 陈宗文 于 2021-07-13 设计创作，主要内容包括：本发明公开了一种清热解毒的中药组合物及其制备方法与应用,所述中药组合物由布渣叶,火炭母,墨旱莲,苏叶,板蓝根,菊花,甘草和柳叶蜡梅制成。本发明中的清热解毒的中药组合物搭配合理,符合君臣佐使的搭配原则,各药材组分具有互补增强的复合效果。本发明中的清热解毒的中药组合物及含有该中药组合物的制剂,能够显著降低小鼠体温,并升高肺炎模型小鼠SOD的水平,显著降低其MPO、肺内积水量、白细胞数、中性粒细胞数和淋巴细胞数水平,具有清热解毒消炎,提高免疫力的作用。(The invention discloses a traditional Chinese medicine composition for clearing away heat and toxic materials, and a preparation method and application thereof. The traditional Chinese medicine composition for clearing heat and removing toxicity is reasonable in collocation, accords with the collocation principle of monarch, minister, assistant and guide, and has complementary and enhanced compound effect of each medicinal material component. The traditional Chinese medicine composition for clearing heat and removing toxicity and the preparation containing the traditional Chinese medicine composition can obviously reduce the body temperature of a mouse, increase the SOD level of a pneumonia model mouse, and obviously reduce the MPO, the lung water accumulation amount, the white blood cell number, the neutrophil count and the lymphocyte count of the mouse, and have the functions of clearing heat, removing toxicity, diminishing inflammation and improving immunity.)

1. The traditional Chinese medicine composition is characterized by being prepared from the following raw materials in parts by weight:

3-50 parts of microcos paniculata, 3-50 parts of Chinese knotweed herb, 1-10 parts of eclipta, 3-25 parts of perilla leaf, 4-60 parts of isatis root, 4-80 parts of chrysanthemum, 2-40 parts of liquorice and 1-25 parts of wintersweet leaf.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:

3-25 parts of microcos paniculata, 3-25 parts of Chinese knotweed herb, 1-5 parts of eclipta, 3-5 parts of perilla leaf, 4-30 parts of isatis root, 4-40 parts of chrysanthemum, 2-20 parts of liquorice and 1-5 parts of wintersweet leaf.

3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight:

2.5-10 parts of microcos paniculata, 2.5-10 parts of Chinese knotweed herb, 1-2 parts of eclipta, 1-5 parts of perilla leaf, 3-12 parts of isatis root, 4-16 parts of chrysanthemum, 2-8 parts of liquorice and 1-5 parts of chimonanthus salicifolius.

4. A food comprising the Chinese medicinal composition according to any one of claims 1 to 3.

5. The food product of claim 4, further comprising a food additive, wherein the food additive comprises potassium sorbate.

6. Food product according to claim 4 or 5, characterized in that the food product is in the form of a beverage and a confectionery, preferably in the form of a beverage.

7. A medicament, which is characterized by comprising the traditional Chinese medicine composition as claimed in any one of claims 1 to 3.

8. The medicament of claim 7, wherein the dosage form of the medicament comprises tablets, powders, capsules, pills, mists and granules.

9. The use of the Chinese medicinal composition of any one of claims 1 to 3 in the preparation of a heat clearing and summer heat relieving agent.

10. The use of claim 9, wherein the heat-clearing agents comprise food and pharmaceutical products.

Technical Field

The invention relates to the field of medicines, and in particular relates to a traditional Chinese medicine composition for clearing heat and removing toxicity, and a preparation method and application thereof.

Background

The south of Lingnan belongs to typical subtropical climate, and has hot summer, rainy and damp property and dry and hot water quality. In addition, people in the Guangdong region like to eat fried and fried dry and hot food, are used to sleep at night, are prone to have the problems of improper diet and insufficient sleep, and are prone to cause 'hot air' or 'excessive internal heat' in the life.

In ancient times, in order to remove dampness and heat and adapt to the environment, people collected some herbs for clearing heat and removing toxicity, relieving summer heat and removing dampness, and boiled in water for drinking so as to eliminate 'hot air'. The drinking of the herbal medicine liquid actually has certain effect, but because of long use time, incomplete prescription or changed condition, how to compound a complete and significant-effect Chinese herbal medicine formula often has certain difficulty.

In the south of the five Ridges, people in the Guangdong area are easily disturbed by excessive internal heat and heavy moisture due to the particularity of regional weather and life habits, so that the people have the daily habit of drinking herbal tea and Chinese medicaments. The herbal tea is a beverage which is prepared by taking Chinese herbal medicines as raw materials, eating and summarizing according to local climate, water and soil characteristics, in the process of preventing diseases and health care for a long time by people in Guangdong, hong Kong and Australia areas, taking the traditional Chinese medicine health preserving theory as guidance, and having the effects of clearing heat and detoxicating, promoting the production of body fluid to quench thirst, removing fire and removing dampness and the like, and is accompanied with daily life of people. With the development of science and technology, medical research and food medical research have been quite successful, and a great deal of research work put into traditional Chinese medicines leads people to have a quite high level of cognition on herbal tea, thus providing theoretical and technical support for developing novel herbal tea health care products. Based on the demand of the heat-clearing and detoxifying compound beverage in the current market, the traditional Chinese medicine herbal tea beverage capable of effectively solving the problems of excessive internal heat, heavy moisture and the like is developed, has extremely high market value and improves the richness of the traditional Chinese medicine beverage in the market.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art described above. Therefore, the invention provides a traditional Chinese medicine composition for clearing heat and removing toxicity, which can obviously reduce the body temperature of a mouse, increase the level of SOD (superoxide dismutase) of a pneumonia model mouse, and obviously reduce the levels of MPO, lung water accumulation, white blood cell number, neutrophil count and lymphocyte count of the mouse, and has the functions of clearing heat, removing toxicity, diminishing inflammation and improving immunity.

The invention provides a traditional Chinese medicine composition, which is prepared from the following raw materials in parts by weight:

3-50 parts of microcos paniculata, 3-50 parts of Chinese knotweed herb, 1-10 parts of eclipta, 3-25 parts of perilla leaf, 4-60 parts of isatis root, 4-80 parts of chrysanthemum, 2-40 parts of liquorice and 1-25 parts of wintersweet leaf.

Distributing dregs and leaves: sour in taste and cool in nature. It enters spleen and stomach meridians. The efficacy is as follows: to remove food retention, clear heat and remove dampness in other seasons. The main treatment is as follows: can be used for treating food stagnation, common cold, fever, damp-heat jaundice, etc.

Charcoal mother: slightly sour and astringent taste and cool nature. The efficacy is as follows: clearing away heat and toxic material, removing dampness by diuresis, removing food stagnation, cooling blood, relieving itching, improving vision, and removing nebula. The main treatment is as follows: can be used for treating dysentery, dyspepsia, hepatitis, common cold, tonsillitis, pharyngolaryngitis, diphtheria, pertussis, corneal nebula, mastitis, mycotic vaginitis, leucorrhea, furuncle, infantile pustule, eczema, and venomous snake bite.

And (3) eclipta: also called as black kohlrabi, nature, flavor, channel tropism, sweet acid and cool. The efficacy is as follows: cool blood, stop bleeding, tonify kidney and nourish yin. The main treatment is as follows: it can be used for treating hematemesis, hemoptysis, epistaxis, hematuria, hematochezia, dysentery, hemorrhage due to knife wound, premature gray hair, diphtheria, stranguria with turbid urine, leukorrhagia, pudendal pruritus, and mouse nevus.

Purple perilla: the part used as the medicine mainly comprises stem leaves and fruit seeds, the leaves are sweating, cough-relieving, aromatic stomach-invigorating and diuretic, and the medicine has the functions of easing pain, calming and detoxifying, and has high effect on treating cold, and has high curative effect on abdominal pain and vomiting caused by fish and crab poisoning; the stem has the function of calming the air and preventing miscarriage; zi can relieve cough, dispel phlegm, relieve asthma and disperse mental depression.

Radix isatidis: has the effects of clearing away heat and toxic materials, cooling blood, and relieving sore throat. Mainly treats exogenous fever, early warm disease, swollen and sore throat, warm poison and macula, mumps, erysipelas, carbuncle and sore toxin.

Chrysanthemum: bitter and sweet in taste, slightly cold in nature. It enters lung and liver meridians. Dispel wind and clear heat, pacify liver and improve vision, clear heat and remove toxicity. Wind-heat type common cold, headache, vertigo, red and swollen eyes, dim eyes, sores, carbuncles and pyogenic infections.

Licorice root: sweet in flavor and neutral in nature. Detoxicating, antiinflammatory, antiallergic, expectorant, antitussive, and adrenocortical hormone-like effects.

Wintersweet leaf: has the effects of dispelling wind, relieving exterior syndrome, clearing away heat and toxic materials, regulating qi, invigorating spleen, promoting digestion, and relieving diarrhea, and has good therapeutic effects on spleen deficiency, dyspepsia, diarrhea, epigastric pain, gastric upset, and acid regurgitation.

The traditional Chinese medicine composition consists of eight components, namely microcos paniculata, herb Polygoni chinensis, eclipta, folium perillae, radix isatidis, chrysanthemum, liquorice and chimonanthus salicifolius. Wherein, the radix isatidis is used as a monarch drug for clearing heat, detoxifying and cooling blood; the chrysanthemum disperses wind and clears heat, the microcos paniculata leaves digest and resolve stagnation, the herb of Chinese knotweed promotes diuresis and resolves stagnation, the blood is cooled and relieves itching, the nebula is removed, the three medicines together assist the radix isatidis to clear away heat and toxic materials and cool blood, and the three medicines are ministerial medicines together; the liquorice root can eliminate phlegm and relieve cough, the perilla leaf can invigorate the stomach and promote diuresis, and detoxicate, and the chimonanthus salicifolius can dispel wind and release exterior, so that the effects of eliminating phlegm, relieving cough and promoting diuresis are exerted together, and the liquorice root and the chimonanthus salicifolius are adjuvant drugs; the yerbadetajo herb regulates all the medicines to be used together, and the medicines play the roles of clearing heat and removing toxicity, cooling blood and removing toxicity, eliminating phlegm and promoting urination together.

According to the first aspect of the present invention, in some embodiments of the present invention, the Chinese medicinal composition is prepared from the following raw materials in parts by weight:

3-25 parts of microcos paniculata, 3-25 parts of Chinese knotweed herb, 1-5 parts of eclipta, 3-5 parts of perilla leaf, 4-30 parts of isatis root, 4-40 parts of chrysanthemum, 2-20 parts of liquorice and 1-5 parts of wintersweet leaf.

According to the first aspect of the present invention, in some embodiments of the present invention, the Chinese medicinal composition is prepared from the following raw materials in parts by weight:

2.5-10 parts of microcos paniculata, 2.5-10 parts of Chinese knotweed herb, 1-2 parts of eclipta, 1-5 parts of perilla leaf, 3-12 parts of isatis root, 4-16 parts of chrysanthemum, 2-8 parts of liquorice and 1-5 parts of chimonanthus salicifolius.

In a second aspect of the present invention, there is provided a food product comprising the Chinese medicinal composition according to the first aspect of the present invention.

According to a second aspect of the invention, in some embodiments of the invention, the food product further comprises a food additive.

In some preferred embodiments of the invention, the food additive comprises a preservative, a flavoring agent, a food color, or a sweetener. Of course, those skilled in the art can reasonably add a proper amount of food additives according to actual use requirements to achieve the technical effects of enhancing the taste of the food or improving the characteristics of the food, and the like.

In some preferred embodiments of the invention, the food additive is a preservative.

In some preferred embodiments of the invention, the preservative is potassium sorbate.

According to a second aspect of the invention, in some embodiments of the invention, the food product is in the form of a beverage or a candy.

In some preferred embodiments of the present invention, the beverage comprises herbal tea, and the preparation method comprises:

weighing the raw traditional Chinese medicinal materials, soaking in boiling water for 8-10 seconds, fishing out, adding water with the mass 8 times of the total mass of the raw traditional Chinese medicinal materials, decocting repeatedly for two times, mixing decoctions, concentrating to a liquid medicine with the mass 10 times of the total mass of the raw traditional Chinese medicinal materials, adding 0.1% (w/w) potassium sorbate, filtering (fine filtering) at normal temperature, sterilizing, adjusting the pH value to 4.2-5.2, and subpackaging in packaging bottles to obtain the traditional Chinese medicine preparation.

In some preferred embodiments of the present invention, the confectionery comprises a tabletted confectionery prepared by a process comprising:

weighing raw traditional Chinese medicinal materials, adding the raw traditional Chinese medicinal materials into 12 times of water, soaking for 0.5h, decocting for three times, each time for 45min, filtering, combining filtrates, concentrating until 1mL of water solution at least contains 2g of active ingredients of the medicinal materials, adding ethanol until the volume percentage of the ethanol is 80%, standing overnight, filtering, recovering ethanol, drying at low temperature, crushing, adding 1 time of starch, mixing uniformly, granulating, drying, tabletting and subpackaging to obtain the traditional Chinese medicinal preparation.

In a third aspect of the present invention, a medicament is provided, which comprises the Chinese medicinal composition according to the first aspect of the present invention.

According to a third aspect of the present invention, in some embodiments of the present invention, the dosage form of the medicament includes tablets, powders, capsules, pills, mists, and granules.

In some preferred embodiments of the present invention, the tablet is prepared by the following method:

weighing the raw materials, crushing into coarse powder, extracting twice with 10 times (mass ratio) of 70% ethanol, combining the extracting solutions, concentrating under reduced pressure, recovering ethanol, mixing the extract with 3 times of starch, granulating, drying, adding magnesium stearate accounting for 5% of the total weight, uniformly mixing, tabletting and subpackaging.

In some preferred embodiments of the present invention, the capsule is prepared by the following steps:

weighing raw materials, drying, pulverizing into fine powder, sieving with 300 mesh sieve, adding magnesium stearate 2% of the total weight, and making into capsule; or

Weighing raw materials, adding into 14 times of 70% ethanol, reflux extracting for 2 times, each for 3 hr, filtering, mixing filtrates, and recovering ethanol. Concentrating the extract under reduced pressure to dry, pulverizing, adding 1 time of starch, mixing, granulating, oven drying, and packaging.

In some preferred embodiments of the present invention, the method for preparing the pill is:

weighing raw material traditional Chinese medicinal materials, adding water for extraction, concentrating the extracting solution until 1mL of extracting solution at least contains 2g of medicinal material active ingredients, adding ethanol until the alcohol is 70%, precipitating overnight, filtering, concentrating the filtrate under reduced pressure to obtain a thick extract, drying, preparing water into pills, and coating to obtain the traditional Chinese medicine composition.

In some preferred embodiments of the present invention, the aqueous solution is an oral liquid, and the preparation method of the oral liquid comprises:

weighing raw traditional Chinese medicinal materials, adding water for extraction, concentrating the extract until 1mL of the extract at least contains 2g of active ingredients of the medicinal materials, adding ethanol until the ethanol content is 70%, precipitating overnight, filtering, concentrating the filtrate under reduced pressure, removing the ethanol, filtering, adding tween-80 accounting for 2% of the total weight, 3% of benzoic acid and 5% of sodium benzoate into the filtrate, mixing uniformly, subpackaging, and sterilizing by wet-hot steam to obtain the traditional Chinese medicine.

In some preferred embodiments of the present invention, the powder is prepared by:

weighing the raw materials, drying, pulverizing into fine powder, and packaging.

In some preferred embodiments of the present invention, the preparation method of the granule is:

weighing raw materials, adding 10 times of 60% ethanol, extracting for 3 times, each time for 1.5 hr, filtering, mixing filtrates, concentrating the filtrate to Baume degree of 1.25, adding 2 times of soluble starch and 3 times of glucose powder, granulating, oven drying, and packaging.

In a fourth aspect of the present invention, an application of the Chinese medicinal composition of the first aspect of the present invention in preparing a heat clearing and summer heat relieving agent is provided.

According to a fourth aspect of the invention, in some embodiments of the invention, the indications of the heat-clearing and summer-heat-relieving preparation include reduction of body temperature rise caused by dryness heat, improvement of decrease of SOD caused by pneumonia, and reduction of MPO, lung water accumulation, white blood cell count, neutrophil count and lymphocyte count levels in vivo, and improvement of immunity.

According to a fourth aspect of the invention, in some embodiments of the invention, the heat-clearing agents comprise food and pharmaceutical products.

The invention has the beneficial effects that:

1. the traditional Chinese medicine composition for clearing heat and removing toxicity is reasonable in collocation and accords with the collocation principle of monarch, minister, assistant and guide, wherein the radix isatidis is used for clearing heat, removing toxicity and cooling blood as a monarch; the chrysanthemum disperses wind and clears heat, the microcos paniculata leaves digest and resolve stagnation, the herb of Chinese knotweed promotes diuresis and resolves stagnation, the blood is cooled and relieves itching, the nebula is removed, the three medicines together assist the radix isatidis to clear away heat and toxic materials and cool blood, and the three medicines are ministerial medicines together; the liquorice root has the effects of expelling phlegm and stopping coughing, invigorating the stomach and promoting diuresis, and detoxifying, and the chimonanthus salicifolius has the effects of dispelling wind and relieving exterior syndrome, and jointly plays the roles of expelling phlegm, stopping coughing and promoting diuresis, and is used as an adjuvant drug; the yerbadetajo herb regulates all the medicines to be used together, exerts the effects of clearing heat and removing toxicity, cooling blood and removing toxicity, eliminating phlegm and promoting urination together, and has complementary and enhanced compound effects.

2. The traditional Chinese medicine composition for clearing heat and removing toxicity and the preparation containing the traditional Chinese medicine composition can obviously reduce the body temperature of a mouse, increase the SOD level of a pneumonia model mouse, and obviously reduce the MPO, the lung water accumulation amount, the white blood cell number, the neutrophil count and the lymphocyte count of the mouse, and have the functions of clearing heat, removing toxicity, diminishing inflammation and improving immunity.

Detailed Description

In order to make the objects, technical solutions and technical effects of the present invention more clear, the present invention will be described in further detail with reference to specific embodiments. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.

The experimental materials and reagents used are, unless otherwise specified, all consumables and reagents which are conventionally available from commercial sources.

EXAMPLE 1A Chinese medicinal composition for clearing away Heat and toxic materials (tablet 1)

Weighing the Chinese medicinal materials according to the following weight ratio

10kg of microcos paniculata, 10kg of Chinese knotweed herb, 2kg of eclipta, 5kg of perilla leaf, 12kg of isatis root, 16kg of chrysanthemum, 8kg of liquorice and 5kg of chimonanthus salicifolius.

Pulverizing the traditional Chinese medicine raw materials into coarse powder, extracting twice with 10 times (mass ratio) of 70% ethanol, combining the extracting solutions, concentrating under reduced pressure, recovering ethanol, adding 3 times of starch into the extract, mixing, granulating, drying, adding magnesium stearate accounting for 5% of the total weight, uniformly mixing, tabletting and subpackaging.

Example 2A Chinese medicinal composition for clearing away Heat and toxic materials (Capsule 1)

Weighing the Chinese medicinal materials according to the following weight ratio

2kg of microcos paniculata, 2kg of Chinese knotweed herb, 1kg of eclipta, 1kg of perilla leaf, 3kg of isatis root, 4kg of chrysanthemum, 2kg of liquorice and 1kg of salix leaf and wintersweet.

The traditional Chinese medicine raw materials in the embodiment are dried and crushed into fine powder, the fine powder is sieved by a 300-mesh sieve, magnesium stearate with the total weight of 2 percent is added, and the mixture is prepared into capsules.

Example 3A Chinese medicinal composition (pill) for clearing away heat and toxic materials

Weighing the Chinese medicinal materials according to the following weight ratio

20kg of microcos paniculata, 20kg of Chinese knotweed herb, 5kg of eclipta, 10kg of perilla leaf, 25kg of isatis root, 30kg of chrysanthemum, 20kg of liquorice and 10kg of chimonanthus salicifolius.

Extracting the traditional Chinese medicine raw materials in the embodiment by adding water, concentrating the extracting solution until 1mL of extracting solution contains at least 2g of medicinal material active ingredients, adding ethanol until the alcohol content is 70%, precipitating overnight, filtering, concentrating the filtrate under reduced pressure to obtain a thick extract, drying, preparing pills by water, and coating to obtain the traditional Chinese medicine composition.

Example 4A Chinese medicinal composition (oral liquid) for clearing away heat and toxic materials

Weighing the Chinese medicinal materials according to the following weight ratio

10kg of microcos paniculata, 10kg of Chinese knotweed herb, 5kg of eclipta, 10kg of perilla leaf, 15kg of isatis root, 20kg of chrysanthemum, 10kg of liquorice and 3kg of chimonanthus salicifolius.

Extracting the traditional Chinese medicine raw materials in the embodiment by adding water, concentrating the extracting solution until 1mL of the extracting solution contains at least 2g of medicinal material active ingredients, adding ethanol until the ethanol content is 70%, precipitating overnight, filtering, concentrating the filtrate under reduced pressure, removing the ethanol, filtering, adding tween-80 accounting for 2% of the total weight, 3% of benzoic acid and 5% of sodium benzoate into the filtrate, mixing uniformly, subpackaging, and sterilizing by wet-heat steam to obtain the traditional Chinese medicine composition.

Example 5A Chinese medicinal composition for clearing away Heat and toxic materials (herbal tea potion)

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 7kg of perilla leaf, 18kg of isatis root, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

Soaking the traditional Chinese medicine raw materials in the embodiment in boiling water for 8-10 seconds, fishing out, adding 8 times of water by the total mass of the medicinal materials, decocting repeatedly for two times, combining the decoctions, concentrating to a liquid medicine of which the mass is 10 times of that of the original medicinal materials, adding 0.1% (w/w) of potassium sorbate, filtering (fine filtering) at normal temperature, sterilizing, adjusting the pH value to 4.2-5.2, and subpackaging in packaging bottles to obtain the traditional Chinese medicine composition.

Example 6A Chinese medicinal composition (powder) for clearing away heat and toxic materials

Weighing the Chinese medicinal materials according to the following weight ratio

10kg of microcos paniculata, 10kg of Chinese knotweed herb, 5kg of eclipta, 6kg of perilla leaf, 10kg of isatis root, 20kg of chrysanthemum, 5kg of liquorice and 15kg of chimonanthus salicifolius.

The traditional Chinese medicine raw materials in the embodiment are dried, crushed into fine powder and subpackaged to obtain the traditional Chinese medicine composition.

Example 7A Chinese medicinal composition (granule) for clearing away heat and toxic materials

Weighing the Chinese medicinal materials according to the following weight ratio

10kg of microcos paniculata, 10kg of Chinese knotweed herb, 5kg of eclipta, 6kg of perilla leaf, 10kg of isatis root, 20kg of chrysanthemum, 5kg of liquorice and 15kg of chimonanthus salicifolius.

Adding the traditional Chinese medicine raw materials in the embodiment into 10 times of 60% ethanol for extraction for 3 times, each time for 1.5h, filtering, combining the filtrates, concentrating the filtrate until the Baume degree is 1.25, adding 2 times of soluble starch and 3 times of glucose powder, granulating, drying, and subpackaging to obtain the traditional Chinese medicine composition.

Example 8A Chinese medicinal composition for clearing away Heat and toxic materials (tablet 2)

Weighing the Chinese medicinal materials according to the following weight ratio

3kg of microcos paniculata, 3kg of Chinese knotweed herb, 10kg of eclipta, 6kg of perilla leaf, 10kg of isatis root, 20kg of chrysanthemum, 5kg of liquorice and 10kg of chimonanthus salicifolius.

Adding the traditional Chinese medicine raw materials in the embodiment into 12 times of water, soaking for 0.5h, decocting for three times, each time for 45min, filtering, combining filtrates, concentrating until 1mL of water solution at least contains 2g of medicinal material active ingredients, adding ethanol to make the volume percentage of the ethanol be 80%, standing overnight, filtering, recovering ethanol, drying at low temperature, crushing, adding 1 time of starch, mixing uniformly, granulating, drying, tabletting, and subpackaging to obtain the traditional Chinese medicine composition.

Example 9A Chinese medicinal composition for clearing away Heat and toxic materials (Capsule 2)

Weighing the Chinese medicinal materials according to the following weight ratio

3kg of microcos paniculata, 3kg of Chinese knotweed herb, 10kg of eclipta, 6kg of perilla leaf, 15kg of isatis root, 15kg of chrysanthemum, 5kg of liquorice and 10kg of salix leaf and wintersweet.

The traditional Chinese medicine raw materials in the embodiment are added into 70% ethanol with the amount of 14 times of the amount of the raw materials in the embodiment for reflux extraction for 2 times, each time lasts for 3 hours, the filtration is carried out, the filtrates are combined, and the ethanol is recovered. Concentrating the extract under reduced pressure to dry, pulverizing, adding 1 time of starch, mixing, granulating, oven drying, packaging, and filling into hollow capsule.

Comparative example 1 prescription of non-cloth residue leaf

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of Chinese knotweed herb, 3kg of yerbadetajo herb, 7kg of perilla leaf, 18kg of isatis root, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 2 non-charcoal parent drug formulation

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 3kg of eclipta, 7kg of perilla leaves, 18kg of isatis roots, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 3 eclipta-free prescription

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 7kg of perilla leaf, 18kg of isatis root, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 4 folium Perillae-free formulation

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 18kg of isatis root, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 5 Isatis root-free prescription

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 7kg of perilla leaf, 12kg of chrysanthemum, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 6 prescription without chrysanthemum

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 7kg of perilla leaf, 18kg of isatis root, 4kg of liquorice and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 7 prescription without licorice

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 7kg of perilla leaf, 18kg of isatis root, 12kg of chrysanthemum and 7kg of chimonanthus salicifolius.

The preparation method is the same as example 5.

Comparative example 8 Chimonanthus salicifolius-free prescription

Weighing the Chinese medicinal materials according to the following weight ratio

15kg of microcos paniculata, 15kg of Chinese knotweed herb, 3kg of eclipta, 7kg of perilla leaf, 18kg of isatis root, 12kg of chrysanthemum and 4kg of liquorice.

The preparation method is the same as example 5.

Effect testing experiment

(1) The influence of the heat-clearing and detoxifying traditional Chinese medicine composition on a mouse pneumonia model is as follows:

preparing a mouse model of chronic bronchopneumonia:

taking 140 BALB/c mice (purchased in the centers of medical experimental animals in Guangdong province and raised in the centers of SPF (specific pathogen free) animals in the traditional Chinese medicine institute in Guangdong province) with the age of 6-8 weeks and the weight of 18-22 g, randomly dividing the mice into 14 groups, wherein each group comprises 10 mice (half of each mouse), and grouping the mice into: a blank control group, a model group, a clarithromycin group, a low dose group of the drug of the present invention (example 5), a medium dose group of the drug of the present invention (example 5), a high dose group of the drug of the present invention (example 5), and a comparative group of 1 to 8. The model group, the clarithromycin group, the low dose group of the drug of the present invention (example 5), the medium dose group of the drug of the present invention (example 5), the high dose group of the drug of the present invention (example 5), and the comparative groups 1 to 8 were prepared by spraying 15% (v/v) ammonia water to the pharynx of mice with a throat sprayer at 3 puffs each for 3 consecutive days, each spray being 1 time in the morning and afternoon. The placebo group was swallowed with saline in the same manner.

After the molding was successful, the mice were gavaged starting on day 4, and the gavage dose of each group is shown in table 1. Both the blank control group and the model group were subjected to intragastric administration with distilled water. The administration is carried out 2 times per day for 5 days. After treatment, serum is taken, and the content of CD3+, CD4+ and CD8+ in the serum is detected by flow cytometry.

TABLE 1 intragastric administration dose for each group

After 24h of last administration, taking off cervical vertebra, killing the mouse, weighing the left lung of the mouse as wet mass, drying, weighing dry mass, and calculating the water accumulation in the lung; taking the right lung of a mouse, washing the right lung with a washing liquid through bronchoalveolar cells, and collecting the washing liquid after washing for detecting the activities of SOD (superoxide dismutase) and MPO (myeloperoxidase); inflammatory cell accumulation in the wash was determined using a hematology analyzer.

The results of the measurements are shown in tables 2 and 3.

TABLE 2 measurement results of MPO, SOD and lung water accumulation in each mouse pneumonia model (x. + -.s, n 10)

The model group was compared to the blank control group,^▲P＜0.05，^▲▲p is less than 0.01; each drug group was compared to the model group,^*the content of P is less than 0.05,^**P＜0.01。

TABLE 3 measurement results of white blood cell count, neutral cell count and lymphocyte count in each group of mouse pneumonia models (x. + -.s, n 10)

The model group was compared to the blank control group,^▲P＜0.05，^▲▲p is less than 0.01; each drug group was compared to the model group,^*the content of P is less than 0.05,^**P＜0.01。

the results show that the low-dose group, the medium-dose group and the high-dose group all have influence on various detection indexes of the mouse pneumonia model, the SOD level can be obviously increased, the MPO level, the lung water accumulation amount, the white blood cell level, the neutrophil count and the lymphocyte count level can be obviously reduced, and the influence of the traditional Chinese medicine composition with different doses (example 5) on various detection indexes of the mouse pneumonia model has statistical significance compared with the model group. In addition, the results show that the effect of the prescription of the traditional Chinese medicine composition in the embodiment of the present invention on the above examination indexes has no statistical difference (p > 0.05) when any single prescription is removed, which indicates that the effect of the traditional Chinese medicine composition in the embodiment of the present invention is generated based on the complementary and synergistic effect of each medicinal material, and the effect of the traditional Chinese medicine composition in the embodiment of the present invention cannot be achieved when any single prescription is removed.

(2) And (3) toxicology detection:

taking 40 BALB/c mice (purchased in the centers of medical experimental animals in Guangdong province and raised in the centers of SPF (specific pathogen free) animals in the traditional Chinese medicine institute in Guangdong province) with the age of 6-8 weeks and the weight of 18-22 g, randomly dividing the mice into 2 groups, wherein each group comprises 20 mice (half each female and half), and grouping the mice as follows: blank control group and drug group. Mice were fasted for 16h before the experiment.

The blank control group was continuously perfused with normal saline, and the drug group was perfused with the formulation of example 5. The prescription in the example 5 is administered according to the maximum tolerance (maximum gavage dose, 200mL/kg/d), converted into human clinical dose, and is gavage for 1 day 2 times a day. The status of the mice after each gavage was observed and the number of dead mice was counted, 48h of non-dead mice, and the status was continuously observed for 2 weeks.

The results are shown in Table 4.

TABLE 4 toxicity of the groups of mice

In this example, the maximum dose of the drug group was 182 times the clinical dose. The administration dosage of the first intragastric administration is the maximum administration dosage (182 times), and after intragastric administration, the mice have symptoms of shrugging, reduced activity, wheezing, lassitude and the like, but do not have death. After the second gavage, the mice exhibited essentially the same behavior as after the first dose, with no discomfort except for reduced activity. The prescription in the above embodiment has no obvious toxicity problem, and can be safely used as food or medicine.

The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.