CN118845959A - A Chinese medicine composition for strengthening spleen and resolving phlegm and preparation method thereof - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition for strengthening spleen and resolving phlegm and a preparation method thereof. The traditional Chinese medicine composition comprises the following components: exocarpium Citri rubrum, parched fructus Perillae, parched Raphani semen, rhizoma Atractylodis, poria, rhizoma Cynanchi Stauntonii, radix Stemonae, radix Asteris and radix Platycodi. The traditional Chinese medicine composition provided by the invention has the effects of ventilating and descending qi, strengthening spleen and reducing phlegm, can be used for treating phlegm turbidity and lung obstruction symptoms, and has good treatment effect on patients with long-term cough, excessive expectoration, white color, easy cough, large morning cough and vomiting, or foam phlegm, chest and gastric fullness, tiredness, anorexia, wiry or slippery pulse, white or greasy tongue fur, chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis and bronchial asthma. The pharmaceutical preparation provided by the invention has the advantages of simple prescription, simple preparation process, small toxic and side effects, convenient administration, easy preparation and low cost.

Description

A Chinese medicine composition for strengthening spleen and resolving phlegm and its preparation method

Technical Field

The present invention relates to the field of medical health technology, and in particular to a Chinese medicine composition for strengthening the spleen and resolving phlegm and a preparation method thereof.

Background Art

Cough refers to a disease characterized by the lung failing to clear and purify due to external factors or internal injuries, the lung qi rising up, impacting the airway, and coughing or expectoration. In traditional Chinese medicine, coughing with sound but no sputum is called cough, coughing with sputum but no sound is called cough, and coughing with sputum and sound is called cough. Clinically, sputum and sound are often seen together, which is difficult to separate, so they are called cough. Cough is one of the most common diseases in internal medicine, with a high incidence rate. According to statistics, the incidence rate of chronic cough is 3%-5%, and the incidence rate in the elderly can reach 10%-15%, and the incidence rate is even higher in cold areas.

Western medicine believes that when the respiratory tract is inflammatory, the composition of the respiratory fluid will change and sputum will be formed. Sputum contains mucus, foreign matter, pathogenic microorganisms, various inflammatory cells, and necrotic and detached mucosal epithelial cells. In various upper respiratory tract diseases such as chronic tracheitis, the glands in the trachea and bronchi are hypertrophic, the goblet cells increase, the amount of secretions increases significantly, and its viscosity also increases greatly. The ciliary movement of the tracheal mucosa is weakened, resulting in obstruction of the sputum clearance function, and mucus is not easy to be discharged. The presence of mucus in the trachea will cause coughing and other symptoms, which is the main cause of acute and chronic cough. Therefore, treating sputum is the main means of treating various upper respiratory tract diseases. The method usually adopted is to make the sputum thinner so that it is easier to cough out, including nebulization inhalation, such as ambroxol or bromhexine nebulization inhalation; or oral bromhexine, intravenous infusion of ambroxol, etc. However, in actual use, there is not only excessive use of antibiotics, but also the expectorant method is not used correctly due to its inconvenience and large side effects, resulting in a slow treatment process.

The main clinical manifestations of COPD are cough, sputum and wheezing; the main clinical symptoms of chronic bronchitis are chronic cough and sputum, and some patients may have wheezing; the main clinical symptoms of bronchiectasis are persistent or recurrent cough and sputum, sometimes accompanied by hemoptysis; the main clinical symptoms of bronchial asthma are cough, sputum, wheezing, dyspnea, etc. Since sputum is the main pathological factor of cough and wheezing, expectoration is one of the most important links in the treatment of COPD, chronic bronchitis, bronchiectasis and bronchial asthma. If it can be accurately grasped and flexibly applied, it can often improve the efficacy.

Traditional Chinese medicine believes that the formation of phlegm is closely related to the various internal organs. "The spleen is the source of phlegm, and the lungs are the container of phlegm." It should be based on the five internal organs and treat both the symptoms and the root causes.

National Standard of the People's Republic of China, "Chinese Medicine Clinical Diagnosis and Treatment Terminology, Syndrome Part": "Syndrome of phlegm and turbidity blocking the lungs, its symptoms are phlegm and dampness accumulation, lung qi stagnation, chest tightness, cough and wheezing, spitting out a lot of white sputum, white and greasy tongue coating, and stringy and slippery pulse as common symptoms." "Chinese Medicine Clinical Diagnosis and Treatment Terminology, Treatment Part": "Remove the lungs and resolve phlegm, by removing phlegm and turbidity to promote lung function, it is suitable for the treatment of phlegm and turbidity blocking the lungs."

Traditional Chinese medicine believes that phlegm is mucus discharged from the lungs and airways, and the turbid and thick ones are phlegm, and the clear and thin ones are drink, which are all tangible phlegm. Traditional Chinese medicine has great advantages in treating cough and expectoration, and has accumulated rich treatment experience. Patent CN200510122357.8 discloses a Chinese medicine composition for clearing lungs and resolving phlegm and its preparation method, the components of which include scutellaria, trichosanthes, fritillaria thunbergii, fructus aurantii, mulberry bark, platycodon, cooked rhubarb, anemarrhena, ophiopogon, tangerine peel, bitter apricot, peucedanum, radix stemonae, liquorice, etc., in its preparation method, scutellaria is extracted with water and then acidified and precipitated, the method does not completely extract the effective components of scutellaria, the extract contains more impurities, thereby affecting the therapeutic effect of the medicine, and the standing time is long, which increases the process time and cost, and also increases the possibility of pollution. There are also many prescriptions in the prior art, including Tongxuan Lifei Pills, Jizhi Syrup, Shedan Chuanbei Liquid, Juhong Granules, Fufang Xianzhuli Liquid, Linggui Kechuanning Capsules, etc. However, as the use time increases, many patients gradually find that the treatment effect is no longer obvious and need to replace some drugs for treatment.

Summary of the invention

In order to solve the above technical problems, the present invention provides a Chinese medicine composition for strengthening the spleen and resolving phlegm and a preparation method thereof. The Chinese medicine composition has the effects of promoting lung function and descending qi, strengthening the spleen and resolving phlegm, and has a good therapeutic effect on the phlegm-turbidity obstructing lung syndrome of chronic obstructive diseases, chronic bronchitis, bronchiectasis, and bronchial asthma.

In a first aspect, the present invention provides a traditional Chinese medicine composition, comprising: tangerine peel, stir-fried perilla seeds, stir-fried radish seeds, atractylodes, poria, radix scutellariae, honey stemona, honey aster and platycodon.

As a preferred technical solution of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

40-80 parts of orange peel, 30-70 parts of stir-fried perilla seeds, 20-60 parts of stir-fried radish seeds, 20-60 parts of atractylodes, 20-60 parts of poria, 20-60 parts of white scutellaria, 30-70 parts of honey stemona, 20-60 parts of honey aster and 20-60 parts of platycodon.

Among them, the weight proportion of the tangerine peel can be 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, 70 parts, 72 parts, 75 parts, 78 parts, etc.

The weight portions of the stir-fried perilla seeds can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

The weight portions of the fried radish seeds can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

The weight proportions of the Atractylodes lancea can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

The weight proportions of the Poria cocos can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

The weight portions of the white front can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

The weight proportions of the Stemona officinalis can be 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, 60 parts, 62 parts, 65 parts, 68 parts, etc.

The weight proportions of the honey aster can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

The weight proportions of the Platycodon grandiflorum can be 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 42 parts, 45 parts, 48 parts, 50 parts, 52 parts, 55 parts, 58 parts, etc.

As a preferred technical solution of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

50-70 parts of orange peel, 40-60 parts of stir-fried perilla seeds, 30-50 parts of stir-fried radish seeds, 30-50 parts of atractylodes, 30-50 parts of poria, 30-50 parts of white scutellaria, 40-60 parts of honey stemona, 30-50 parts of honey aster and 30-50 parts of platycodon.

As a preferred technical solution of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

60 parts of dried orange peel, 50 parts of stir-fried perilla seeds, 40 parts of stir-fried radish seeds, 40 parts of atractylodes, 40 parts of tuckahoe, 40 parts of white scutellaria, 50 parts of honey stemona, 40 parts of honey aster and 40 parts of platycodon.

The compatibility mechanism of the Chinese medicine composition provided by the present invention is as follows:

This prescription has tangerine peel, which is pungent, bitter and warm. It belongs to the lung and spleen meridians and has the effects of regulating qi, relieving fullness, drying dampness and resolving phlegm; stir-fried perilla seeds, which are pungent, warm and belong to the lung meridian, descend qi and resolve phlegm, relieve cough and asthma, and moisten the intestines and relieve constipation. The pungent, warm and dry tangerine peel in the prescription can regulate qi and relieve stagnation, which reflects the idea that treating phlegm first requires treating qi, and phlegm will disappear when qi is smooth. Tangerine peel and stir-fried perilla seeds are both the main medicines. Atractylodes is pungent, bitter and warm, and belongs to the spleen, stomach and liver meridians, dries dampness and strengthens the spleen, dispels wind and cold; Poria is sweet, light and flat, and belongs to the heart, lung, spleen and kidney meridians, promotes diuresis and eliminates dampness, strengthens the spleen and calms the heart; stir-fried radish seeds are pungent, sweet and flat, and belong to the lung, spleen and stomach meridians. It can help digestion and eliminate bloating, descend qi and resolve phlegm. The spleen is the source of phlegm. Poria cocos is sweet and mild in terms of penetrating dampness and strengthening the spleen. It can eliminate dampness and prevent phlegm from forming, thereby treating the source of phlegm. Moreover, Atractylodes lancea, Poria cocos, and Radish Seed are the assistants, playing the role of strengthening the spleen and penetrating dampness, resolving phlegm and relieving cough, and promoting digestion and clearing the bowels, giving the evil a way out. Honey Stemona is sweet, bitter, and slightly warm. It enters the lung meridian, moistens the lungs, lowers qi, and relieves cough. Honey Aster is pungent, bitter, and warm. It enters the lung meridian, moistens the lungs, lowers qi, and relieves phlegm and relieves cough. Whitehead is pungent, bitter, and slightly warm. It enters the lung meridian, lowers qi, eliminates phlegm, and relieves cough. Honey Stemona, Honey Aster, and Whitehead are assistants. Aster and Stemona all enter the lung meridian, warm but not hot, moist but not dry. Whitehead clears the lungs and lowers qi, removes phlegm and relieves cough. The three are used together to moisten the lungs, relieve cough, and resolve phlegm. One moistens and one lowers. The combination of lowering and moistening resolves phlegm and lowers qi, lightly dispels the evil, and helps the monarch and assistant to strengthen the spleen and resolve phlegm. Platycodon grandiflorum, bitter, pungent, neutral, enters the lung meridian. It clears the lungs and relieves throat, removes phlegm and discharges pus, and is the messenger of "carrying medicine upward".

This prescription nourishes the earth and strengthens the middle to stop the source of phlegm and fluid regeneration, eliminates phlegm and eliminates fluid to remove old dirt in the body, warms without being dry, nourishes without being stagnant, eliminates evil without hurting the body, and strengthens the body without hindering the evil. It is a good medicine that can eliminate and nourish, suppress and appease at the same time. All the medicines are used together to play the effect of promoting lung and descending qi, strengthening spleen and eliminating phlegm.

The Chinese medicine composition provided by the invention has the effects of promoting lung function and descending qi, strengthening spleen and resolving phlegm, and can be used for the syndrome of phlegm turbidity blocking lung, with symptoms of long-term cough, large amount of sputum, white color, easy coughing, large amount of coughing in the morning, or foamy sputum, or chest and abdominal fullness, fatigue, poor appetite, stringy or slippery pulse, white or greasy tongue coating, as well as chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, bronchial asthma with the above symptoms.

In a second aspect, the present invention provides use of the Chinese medicine composition described in the first aspect in preparing a medicine for strengthening the spleen and resolving phlegm.

In a third aspect, the present invention provides a pharmaceutical preparation for strengthening the spleen and resolving phlegm, wherein the pharmaceutical preparation comprises the effective ingredients of the traditional Chinese medicine composition described in the first aspect.

The effective ingredients of the traditional Chinese medicine composition of the present invention can be extracted by the preparation method described in the fourth aspect.

As a preferred technical solution of the present invention, the pharmaceutical preparation further includes an excipient.

The excipients may be selected from binders, fillers, disintegrants, lubricants, emulsifiers, flavoring agents, cosolvents, solubilizers, colorants, etc. The present invention does not impose any particular restrictions on the specific types of the excipients, and those skilled in the art may select them according to actual needs.

As a preferred technical solution of the present invention, the dosage form of the pharmaceutical preparation is tablets, capsules, granules or oral liquids, such as syrups.

In a fourth aspect, the present invention provides a method for preparing the pharmaceutical preparation according to the third aspect, the preparation method comprising the following steps:

(1) extracting each raw material with water to obtain a water extract;

(2) preparing the aqueous extract into the dosage form of the pharmaceutical preparation.

As a preferred technical solution of the present invention, the amount of water used in the water extraction in step (1) is 8-12 times the weight of the medicinal material, such as 9 times, 10 times, 11 times, etc.

As a preferred technical solution of the present invention, the water extraction method in step (1) is: decocting at least 2 times, each time for 1.5-3 hours, and filtering.

As a preferred technical solution of the present invention, step (2) preparing the aqueous extract into the dosage form of the pharmaceutical preparation comprises the following steps:

The water extract is concentrated to a relative density of 1.02-1.10 at 50°C, the supernatant is taken, and further concentrated to a relative density of 1.05-1.20 at 60°C, the obtained concentrate is mixed with stevioside and dextrin, and granulated in one step.

The technical solution provided by the embodiment of the present invention has the following advantages compared with the prior art:

1. The Chinese medicine composition provided by the present invention is scientifically compatible with tangerine peel, stir-fried perilla seeds, stir-fried radish seeds, atractylodes, tuckahoe, radix scutellariae, honey stemonae, honey aster and platycodon, which can play the role of promoting lung function and descending qi, strengthening spleen and resolving phlegm. The Chinese medicine composition can be used for phlegm turbidity blocking lung syndrome, with symptoms of long-term cough, large amount of sputum, white color, easy cough, large amount of sputum in the morning, or foamy sputum, or chest and abdominal fullness, fatigue, poor appetite, stringy or slippery pulse, white or greasy tongue coating, as well as chronic obstructive pulmonary disease, chronic bronchitis, bronchiectasis, bronchial asthma with the above symptoms.

2. The pharmaceutical preparation provided by the present invention has a simple prescription, a simple production process, few toxic and side effects, and is convenient to administer. The preparation is easy to manufacture and has low cost.

DETAILED DESCRIPTION

In order to more clearly understand the above-mentioned objectives, features and advantages of the present invention, the scheme of the present invention will be further described below. It should be noted that the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein; it is obvious that the embodiments in the specification are only part of the embodiments of the present invention, rather than all of the embodiments.

Example 1

This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

80 parts of dried orange peel, 30 parts of stir-fried perilla seeds, 60 parts of stir-fried radish seeds, 20 parts of atractylodes, 60 parts of tuckahoe, 20 parts of white scutellaria, 70 parts of honey stemona, 20 parts of honey aster and 60 parts of platycodon.

This embodiment also provides a granule for strengthening the spleen and resolving phlegm, and the preparation method thereof is as follows:

(1) According to the ratio of the Chinese medicine composition provided in this embodiment, take tangerine peel, stir-fried perilla seeds, stir-fried radish seeds, atractylodes, Poria, white scutellaria, honey stemona, honey aster, and platycodon, add 10 times the weight of water, decoct 3 times, each time for 1.5 hours, filter the decoction, and combine the filtrate;

(2) The filtrate is concentrated under reduced pressure (vacuum degree -0.06 to -0.08 MPa, temperature ≤ 85°C) to a relative density of 1.06 at 50°C, cooled to room temperature, centrifuged, and further concentrated to a relative density of 1.15 at 60°C to obtain a concentrated solution, to which stevioside is added for later use. An appropriate amount of auxiliary materials such as dextrin is taken and passed through an 80-mesh sieve, mixed evenly with the above-mentioned concentrated solution, and granulated in one step to obtain the granules for strengthening the spleen and resolving phlegm.

Example 2

This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

40 parts of dried orange peel, 70 parts of stir-fried perilla seeds, 20 parts of stir-fried radish seeds, 60 parts of atractylodes, 20 parts of tuckahoe, 60 parts of white scutellaria, 30 parts of honey stemona, 60 parts of honey aster and 20 parts of platycodon.

This embodiment also provides a granule for strengthening the spleen and resolving phlegm, and the preparation method thereof is as follows:

(1) According to the proportion of the Chinese medicine composition provided in this embodiment, take tangerine peel, stir-fried perilla seeds, stir-fried radish seeds, atractylodes, Poria, white scutellaria, honey stemona, honey aster, and platycodon, add 8 times the weight of water, decoct 3 times, each time for 3 hours, filter the decoction, and combine the filtrate;

(2) The filtrate is concentrated under reduced pressure (vacuum degree -0.06 to -0.08 MPa, temperature ≤ 85°C) to a relative density of 1.02 at 50°C, cooled to room temperature, centrifuged, and further concentrated to a relative density of 1.05 at 60°C to obtain a concentrated solution, and stevioside is added for later use. Another appropriate amount of auxiliary materials such as dextrin is passed through an 80-mesh sieve, mixed evenly with the above-mentioned concentrated solution, and granulated in one step to obtain the granules for strengthening the spleen and resolving phlegm.

Example 3

This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

50 parts of orange peel, 60 parts of stir-fried perilla seeds, 30 parts of stir-fried radish seeds, 50 parts of atractylodes, 30 parts of Poria, 50 parts of white scutellaria, 40 parts of honey stemona, 50 parts of honey aster and 30 parts of platycodon.

This embodiment also provides a granule for strengthening the spleen and resolving phlegm, and the preparation method thereof is as follows:

(1) According to the proportion of the Chinese medicine composition provided in this embodiment, take tangerine peel, stir-fried perilla seeds, stir-fried radish seeds, atractylodes, Poria, white scutellaria, honey stemona, honey aster, and platycodon, add 12 times the weight of water, decoct 3 times, each time for 2 hours, filter the decoction, and combine the filtrate;

(2) The filtrate is concentrated under reduced pressure (vacuum degree -0.06 to -0.08 MPa, temperature ≤85°C) to a relative density of 1.1 at 50°C, cooled to room temperature, centrifuged, and further concentrated to a relative density of 1.2 at 60°C to obtain a concentrated solution, to which stevioside is added for later use. Another appropriate amount of auxiliary materials such as dextrin is passed through an 80-mesh sieve, mixed evenly with the above-mentioned concentrated solution, and granulated in one step to obtain the granules for strengthening the spleen and resolving phlegm.

Example 4

This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

70 parts of dried orange peel, 40 parts of stir-fried perilla seeds, 50 parts of stir-fried radish seeds, 30 parts of atractylodes, 50 parts of tuckahoe, 30 parts of white scutellaria, 60 parts of honey stemona, 30 parts of honey aster and 50 parts of platycodon.

This embodiment also provides a granule for strengthening the spleen and resolving phlegm, and its preparation method is the same as that of Example 1.

Example 5

This embodiment provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

60 parts of dried orange peel, 50 parts of stir-fried perilla seeds, 40 parts of stir-fried radish seeds, 40 parts of atractylodes, 40 parts of tuckahoe, 40 parts of white scutellaria, 50 parts of honey stemona, 40 parts of honey aster and 40 parts of platycodon.

This embodiment also provides a granule for strengthening the spleen and resolving phlegm, and its preparation method is the same as that of Example 1.

Comparative Example 1

This comparative example provides a traditional Chinese medicine composition, comprising the following components in parts by weight:

60 parts of Dried Tangerine Peel, 80 parts of Scutellaria Baicalensis, 80 parts of Fagopyrum scabra, 40 parts of Perilla Seed, 50 parts of Stemona, 40 parts of Hippophae Rhamnoides, 40 parts of Aster Tataricum and 40 parts of Platycodon grandiflorum.

This comparative example also provides an expectorant granule, and its preparation method is the same as that of Example 1.

Performance Testing

1. To explore the expectorant effect of the Chinese medicine composition of the present invention.

(1) Experimental materials: 50 healthy mice, CD-1 (ICR), SPF grade, weighing 18-20 g; the spleen-strengthening and phlegm-resolving granules prepared in Example 5 and the spleen-strengthening and phlegm-resolving granules prepared in Comparative Example 1.

(2) Experimental method: Mice were randomly divided into 5 groups according to body weight, with 10 mice in each group, half of which were male and half were female, including a blank control group, a high-dose group of Example 5, a medium-dose group of Example 5, a low-dose group of Example 5, and a high-dose group of Comparative Example 1.

Each group was gavaged and the dosage per kg of mouse was the amount of the active ingredient (excluding excipients) in the granules. The specific dosage is shown in Table 1. The blank control group was given purified water (0.2 mL/10 g) in the same way, once a day for 7 consecutive days. The mice were fasted but not allowed to drink water for 16 hours before the experiment. One hour after the last dose of the drug, 0.5 mL of 0.5% phenol red solution was injected intraperitoneally. 30 minutes after the injection, the mice were killed and fixed in the supine position. The skin in the middle of the neck was cut, the trachea was separated, and a No. 7 needle (with a flat head) was inserted into the trachea for about 0.3 cm. After ligation with silk thread, 0.5 mL of 5% _NaHCO3 solution was drawn into the trachea with a syringe, and the respiratory tract was irrigated back and forth through the needle for 3 times. The irrigating fluid was collected and injected into a test tube, and 0.5 mL of 5% _NaHCO3 solution was drawn again. The respiratory tract was irrigated 3 more times as above. The irrigating fluids were combined, and the colorimetry was performed at a wavelength of 546 nm to determine the absorbance value. The phenol red excretion was calculated based on the standard curve, and the differences between the groups were compared by t-test.

The test results are shown in Table 1:

Table 1

Compared with the blank control group, *P<0.05, **P<0.01.

It can be found from Table 1 that the high, medium and low doses of the Chinese medicine composition provided by the present invention can significantly increase the concentration of phenol red in bronchial lavage fluid, especially the medium dose group and the high dose group can effectively promote the excretion of phenol red, which is significantly different from the blank control group, and the high dose group of Example 5 is better than the high dose group of Comparative Example 1, indicating that the Chinese medicine composition provided by the present invention has an excellent expectorant effect.

2. Explore the clinical effects of the Chinese medicine composition of the present invention

A retrospective analysis was conducted by collecting clinical data of patients admitted to the respiratory department of a certain hospital:

A total of 60 patients with chronic cough and expectoration (chronic obstructive pulmonary disease patients with phlegm) caused by high secretion of airway mucus and TCM syndrome of phlegm obstructing the lung were selected and randomly divided into 2 groups, 30 cases in each group. There were 18 males and 12 females in the experimental group; there were 19 males and 11 females in the control group, aged 46-68 years old. There was no significant difference in age, gender, and initial symptom score between the two groups (P＞0.05), and they were comparable.

Control group: Linggui Kechuanning Capsule, a Chinese patent medicine recommended by the 2011 edition of the TCM Diagnosis and Treatment Guidelines for COPD for the treatment of phlegm and turbidity blocking the lungs, was taken orally, 5 capsules each time, 3 times a day.

Experimental group: the Chinese medicine composition of the present invention: 6g of Citrus aurantium, 5g of stir-fried Perilla seeds, 4g of stir-fried Radish seeds, 4g of Atractylodes macrocephala, 4g of Poria cocos, 4g of Radix Phellodendri, 5g of Stemona candied, 4g of Aster candied and 4g of Platycodon grandiflorum; it is a decoction (400mL) provided by the hospital, 1 dose per day, 1 bag each time, 200mL per bag, 1 time in the morning and 1 time in the evening, taken warm, and the efficacy is observed for 14 consecutive days.

The observation indicators are as follows:

a. Sputum volume VAS score

The Visual Analogue Scale (VAS) was used, with a 10-cm straight line marked with 10 scales, with the two ends representing "no sputum" (0) and "the most sputum imagined" (10) respectively. Patients marked the corresponding parts of the straight line according to their degree of feeling, and the distance from the 0 end was the score. The same method was used before and after clinical treatment to make a more objective score and to evaluate the treatment effect more objectively.

The clinical results are shown in Table 2:

Table 2

Group Pre-treatment score Post-treatment score Experimental Group 4.87±1.04 2.13±1.04**△△ Control group 4.93±1.22 3.27±1.14**

Note: Compared with before treatment, **p＜0.01; compared with the control group, △△p＜0.01.

It can be found from Table 2 that there is no statistically significant difference in VAS scores between the experimental group and the control group before treatment (P>0.05), which is comparable. The VAS scores of sputum volume in the experimental group and the control group before and after treatment are compared, and the difference is statistically significant (P<0.01). The data in Table 2 show that both the experimental group and the control group have therapeutic effects on improving sputum volume, and the effect of the Chinese medicine composition of the present invention in the experimental group is more obvious.

b. TCM symptom efficacy

According to the Guidelines for Clinical Research of New Chinese Medicines (Trial Implementation), the main symptoms of wheezing, coughing, and expectoration were graded and scored as none (0 points), mild (3 points), moderate (6 points), and severe (9 points), and the secondary symptoms of epigastric distension, sticky mouth, poor appetite or anorexia, and tongue coating were graded and scored as none (0 points), mild (1 point), moderate (2 points), and severe (3 points). The sum of the scores of each symptom was the score of chronic obstructive pulmonary disease (phlegm obstructing the lungs). The evaluation was conducted once before and after treatment.

Clinical control: clinical symptoms disappear, efficacy index ≥ 90%;

Markedly effective: clinical symptoms are significantly alleviated, 70%≤efficacy index＜90%;

Effective: Clinical symptoms are significantly alleviated, 30%≤efficacy index<70%;

Ineffective: clinical symptoms did not improve or worsened, efficacy index <30%;

Efficacy index = (TCM syndrome score before treatment - TCM syndrome score after treatment) / TCM syndrome score before treatment × 100%.

The results are shown in Table 3:

Table 3

It can be found from Table 3 that the effective rate of the Chinese medicine composition provided by the present invention is 90%, while the effective rate of the control group is 70%, indicating that the Chinese medicine composition provided by the present invention is more effective for patients with chronic obstructive pulmonary disease (phlegm turbidity blocking the lungs syndrome).

c. TCM symptom scoring

According to the Guidelines for Clinical Research of New Chinese Medicines (Trial Implementation), the main symptoms of wheezing, coughing, and expectoration were graded and scored as none (0 points), mild (3 points), moderate (6 points), and severe (9 points), and the secondary symptoms of epigastric distension, sticky mouth, poor appetite or anorexia, and tongue coating were graded and scored as none (0 points), mild (1 point), moderate (2 points), and severe (3 points). The sum of the scores of each symptom was the score of chronic obstructive pulmonary disease (phlegm obstructing the lungs). The evaluation was conducted once before and after treatment.

The TCM syndrome scores are shown in Table 4:

Table 4

Group Average score before treatment Average score after treatment Experimental Group 24.0±3.4 6.1±5.3**△△ Control group 23.5±3.6 11.7±6.4**

Note: Compared with before treatment, **p＜0.01; compared with the control group, △△p＜0.01.

It can be found from Table 4 that there is no statistically significant difference in symptom scores between the experimental group and the control group before treatment (P>0.05), which is comparable. There is a statistically significant difference in symptom scores between the experimental group and the control group before and after treatment (P<0.01); the difference in total symptom scores between the experimental group and the control group after treatment is statistically significant (P<0.01). The data in Table 4 show that both the experimental group and the control group have therapeutic effects on patients with chronic obstructive pulmonary disease (phlegm and turbidity blocking the lung syndrome), but the Chinese medicine composition provided by the present invention in the experimental group is better in alleviating symptoms.

In summary, the Chinese medicine composition provided by the present invention has significant therapeutic effects on chronic obstructive pulmonary disease (phlegm blocking the lungs syndrome), with symptoms of prolonged coughing, large amount of sputum, white sputum, easy coughing, large amount of coughing up in the morning, or foamy sputum, or chest and abdominal fullness, fatigue, poor appetite, stringy or slippery pulse, and white or greasy tongue coating.

It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

The above description is only a specific embodiment of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments described herein, but should conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. A traditional Chinese medicine composition, characterized in that the traditional Chinese medicine composition comprises: exocarpium Citri rubrum, parched fructus Perillae, parched Raphani semen, rhizoma Atractylodis, poria, rhizoma Cynanchi Stauntonii, radix Stemonae, radix Asteris and radix Platycodi.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

40-80 parts of exocarpium citri rubrum, 30-70 parts of fried perilla fruit, 20-60 parts of fried radish seed, 20-60 parts of rhizoma atractylodis, 20-60 parts of poria cocos, 20-60 parts of rhizoma cynanchi, 30-70 parts of radix stemonae, 20-60 parts of aster melitensis and 20-60 parts of platycodon grandiflorum.

3. The traditional Chinese medicine composition according to claim 1 or 2, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

50-70 parts of exocarpium citri rubrum, 40-60 parts of fried perilla fruit, 30-50 parts of fried radish seed, 30-50 parts of rhizoma atractylodis, 30-50 parts of poria cocos, 30-50 parts of rhizoma cynanchi, 40-60 parts of radix stemonae, 30-50 parts of aster melitensis and 30-50 parts of platycodon grandiflorum.

4. The traditional Chinese medicine composition according to any one of claims 1-3, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

60 parts of exocarpium citri rubrum, 50 parts of fried perilla, 40 parts of fried radish seed, 40 parts of rhizoma atractylodis, 40 parts of poria cocos, 40 parts of rhizoma cynanchi, 50 parts of radix stemonae, 40 parts of radix asteris and 40 parts of platycodon grandiflorum.

5. Use of a Chinese medicinal composition according to any one of claims 1-4 for the preparation of a medicament for invigorating spleen and reducing phlegm.

6. A pharmaceutical preparation for invigorating spleen and resolving phlegm, characterized in that the pharmaceutical preparation comprises the active ingredients of the traditional Chinese medicine composition according to any one of claims 1-4.

7. The pharmaceutical formulation of claim 6, further comprising an excipient.

8. The pharmaceutical formulation according to claim 6 or 7, wherein the pharmaceutical formulation is in the form of a tablet, capsule, granule or oral liquid.

9. A method of preparing a pharmaceutical formulation according to any one of claims 6 to 8, comprising the steps of:

(1) Carrying out water extraction on the raw materials to obtain water extract;

(2) Preparing the aqueous extract into a dosage form of the pharmaceutical preparation.

10. The method according to claim 9, wherein the amount of water used in the water extraction in the step (1) is 8 to 12 times the mass of the medicinal material;

And/or, the water extraction method in the step (1) comprises the following steps: decocting for at least 2 times for 1.5-3 hr each time, and filtering;

and/or, the step (2) of preparing the aqueous extract into a dosage form of the pharmaceutical preparation comprises the following steps:

Concentrating the water extract to a relative density of 1.02-1.10 at 50deg.C, collecting supernatant, concentrating to a relative density of 1.05-1.20 at 60deg.C, mixing the concentrated solution with stevioside and dextrin, and granulating in one step.