Traditional Chinese medicine composition for treating lung-spleen deficiency syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating lung-spleen deficiency syndrome as well as a preparation method and application thereof. The composition is prepared from the following medicinal materials: astragalus membranaceus, divaricate saposhnikovia root, radix pseudostellariae, pericarpium citri reticulatae, Chinese yam, wine-processed rhizoma polygonati, wine-processed glossy privet fruit, bighead atractylodes rhizome, bran-fried rhizoma atractylodis, clean hawthorn, fried malt, fried rice-grain sprout, fried semen raphani, bran-fried fructus aurantii, radix puerariae and liquorice tablets, and is prepared by the following steps: putting the 16 medicinal materials into a double-layer filter bag, adding water, decocting, and concentrating to obtain clear paste with the relative density of 1.18-1.22 at 60 DEG C; and adding cane sugar into the clear paste for dissolving, concentrating until the relative density is 1.30-1.35 at 60 DEG C, and sub-packaging to obtain the product. The prepared product has the effects of tonifying spleen and appetizing, tonifying lung and nourishing vitality, and tonifying qi and strengthening superficies, is used for nursing various symptoms caused by insufficiency of three internal organs of lung, spleen and kidney in a recovery period and a remission period, and is used for treating lung diseases such as cough, pneumonia, recurrent respiratory tract infection, bronchitis, asthma (in the recovery period), rhinitis and the like. In addition, no adverse reaction is reported in the clinical application process, and the traditional Chinese medicine preparation is an effective and safe traditional Chinese medicine preparation for treating the lung-spleen deficiency syndrome.

Description

Technical Field

[0001] The invention relates to the field of medicine, and in particular to a traditional Chinese medicine composition for treating lung and spleen deficiency syndrome, and a preparation method and application thereof. Background Art

[0002] Pediatric diseases are often related to the spleen and stomach. Ancient doctors attached great importance to "preventive treatment": the focus of disease prevention is often on the spleen and stomach; if the disease has already occurred, the focus of treatment is often on the spleen and stomach; in the diagnosis and treatment of other visceral diseases, the spleen and stomach are often used as the starting point. Although the location of pediatric asthma is in the lungs, it is closely related to the spleen and stomach, which is the relationship between the local and the whole; exogenous infection, phlegm and dampness, and food stagnation are the predisposing factors for the disease; the acute phase is mainly characterized by excess heat syndrome, and the remission phase is mainly characterized by deficiency of the lung and spleen, or a mixture of cold and heat, and both deficiency and excess. [1]

[0003] The spleen and stomach are the foundation of the acquired constitution and the source of qi and blood. They play a very important role in the growth and development of children and the prevention and treatment of diseases, and have been valued by doctors of all dynasties. The spleen and stomach are crucial to the growth and development of children. "Spleen deficiency" is the basic characteristic of the spleen and stomach of children. Symptoms such as loss of appetite, vomiting, diarrhea, and indigestion are all dysfunctions of the spleen and stomach themselves, or due to improper diet, excessive eating of raw and cold food, or eating unclean food, which causes the stomach to lose harmony and descend, the spleen to lose its healthy function, the stomach qi to rise, and the spleen to fail to ascend. The treatment should first be to harmonize the stomach and descend, strengthen the spleen and stop diarrhea, and digest food and remove stagnation. Because children's internal organs are delicate, their lung qi is insufficient, and their defense function is weak, they are easily invaded by exogenous evils, and exogenous diseases occur, such as colds, coughs, phlegm and asthma, which often affect the spleen and stomach functions of children and cause loss of appetite, abdominal distension and diarrhea, etc., which makes the source of qi and blood insufficient, the ability to resist diseases is reduced, and it is difficult to cure the exogenous symptoms. Therefore, in treatment, while relieving and dispersing the qi, we should also pay attention to regulating the spleen and stomach to make the qi and blood biochemically active, which can enhance the body's disease resistance and facilitate recovery from the disease. [2]

[0004] Qian Yi said in "Direct Secrets of Children's Medicine": "Children's five internal organs and six bowels are formed but not complete, complete but not strong", which clearly pointed out that children's internal organs are delicate, and the five internal organs and six bowels are insufficient in form and qi. Among the five internal organs, the deficiency of form and qi of the lungs and spleen is particularly prominent. As Wan Mi Zhai said: children's "spleen is often insufficient" and "lungs are often insufficient", that is, both lungs and spleens are deficient, which is a common physiological characteristic of children. Chronic cough in children is a common symptom in pediatrics of traditional Chinese medicine. Due to the special physiological and pathological characteristics of children, it is quite difficult to cure. Clinically, lung and spleen qi deficiency is a common syndrome type. The spleen should be mainly strengthened and the lungs should be mainly promoted. TCM syndrome differentiation and treatment of chronic cough in children has the advantages of good clinical efficacy and few side effects. Lung and spleen qi deficiency is a common clinical syndrome type. The spleen should be mainly strengthened and promoted. Strengthening the spleen can produce lung metal and can achieve the effect of tonifying both the lungs and spleen; the lungs should be mainly promoted. Promoting the lungs can restore the rise and fall of qi and help strengthen the spleen. [3]

[0005] Recurrent respiratory tract infections in children are common in pediatric clinics. Currently, Western medicine clinics mostly use immunomodulators such as spleen aminopeptide and pidotimod for intervention, but they are expensive, clinical contraindications have not yet been clarified, and the course of treatment is long. In addition to recurrent respiratory tract infections, rhinitis, gastrointestinal dysfunction and other diseases are also frequent in children, which seriously affect children's growth and development, and these diseases are prone to recurrence. Traditional Chinese medicine has achieved good results in the treatment of such diseases. Children's internal organs have the characteristics of "three deficiencies", that is, the lungs are often insufficient, the spleen is often insufficient, and the kidneys are often insufficient, so children are prone to diseases of these three systems. In view of these physiological characteristics, appropriate adjustments and supplements are selected by using methods such as benefiting the lungs, strengthening the spleen, and tonifying the kidneys. Chinese medicine paste prescriptions can have a good effect on the treatment, prognosis consolidation, and strengthening of physical fitness of common chronic and recurrent diseases in clinical practice by benefiting the lungs, strengthening the spleen, and tonifying the kidneys. [4]

[0006] Therefore, the present invention aims to provide a Chinese medicine preparation for treating lung and spleen deficiency syndrome. This prescription is an empirical prescription of Professor Chen Zhu of the Department of Pediatrics of the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine. It began to be used as a hospital agreement prescription in 2016 and has been clinically used for nearly 10 years. The average annual usage in the past three years is close to 1,000 bottles. This prescription has a high acceptance rate in pediatric growth and development clinics, pediatric general clinics and inpatients, and has a high prospect for new drug transformation.

[0007] The traditional process uses water decoction to extract and make the product Zengmian Huyuan Decoction. The present invention intends to conduct a comprehensive pharmaceutical study on the empirical formula Zengmian Huyuan Decoction, focusing on the study of the prescription process of many dosage forms, to provide a scientific basis for the application of hospital preparations. Relying on the research and development of this product can not only improve the quality level of hospital Chinese medicine preparations, but also enrich the product composition of hospital preparations in our province, bringing good news to more children, and has far-reaching social significance. Summary of the invention

[0008] One of the purposes of the present invention is to provide a traditional Chinese medicine composition for treating lung and spleen deficiency syndrome; the second purpose of the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating lung and spleen deficiency syndrome; the third purpose of the present invention is to provide an application of a traditional Chinese medicine composition for treating lung and spleen deficiency syndrome in the preparation of a pharmaceutical preparation for treating lung and spleen deficiency syndrome. The traditional Chinese medicine composition is composed of 16 traditional Chinese medicines including astragalus, siler, pseudoginseng, tangerine peel, yam, polygonatum sibiricum, fructus ligustris, atractylodes macrocephala, stir-fried atractylodes, clean hawthorn, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried fructus aurantii, kudzu root, and liquorice tablets, and is prepared by a whole-prescription water extraction process. In the prescription, astragalus, pseudoginseng, and polygonatum are the main medicines, which can strengthen the spleen and replenish qi, nourish the lungs and strengthen the kidneys; tangerine peel, yam, atractylodes macrocephala, stir-fried atractylodes, fructus ligustris, Pueraria root and Saposhnikovia root are the assistant drugs, while dried orange peel, Chinese yam, Atractylodes macrocephala, and stir-fried Atractylodes macrocephala can strengthen the spleen and promote circulation, and cultivate the acquired foundation. Ligustrum lucidum can nourish yin and tonify the kidney, and nourish both the spleen and kidney, cultivate positive energy, and keep positive energy inside, so that evil cannot interfere. Pueraria root and Saposhnikovia root can release the exterior, raise yang, and dispel wind, which can encourage the body's positive energy to rise, distribute body fluids, and protect the skin surface; Crataegus, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, and Citrus aurantium can help digestion and regulate qi, and harmonize the spleen and stomach qi mechanism; Licorice tablets harmonize all the drugs as the guiding drugs. The whole prescription can strengthen the spleen and appetite, nourish the lungs and nourish the essence, and invigorate qi and consolidate the surface. This prescription has a high acceptance rate in pediatric growth and development clinics, pediatric general clinics, and inpatients, and has a high prospect for new drug transformation. Through clinical observation and follow-up of outpatient children, the results show that this prescription is effective in treating children with lung and spleen deficiency syndrome of lung system diseases, with a high acceptance rate in children, no adverse reactions, and good safety.

[0009] In order to achieve the above object, the present invention is implemented by the following technical solutions:

[0010] The Chinese medicine composition for treating lung and spleen deficiency syndrome of the present invention is composed of the following raw material components in parts by weight: 15-25 parts of astragalus, 5-15 parts of siler, 5-15 parts of Pseudostellariae Radix, 5-15 parts of dried orange peel, 5-15 parts of yam, 5-15 parts of polygonatum sibiricum, 5-15 parts of fructus ligustris, 5-15 parts of atractylodes macrocephala, 4-8 parts of stir-fried atractylodes lancea with bran, 4-8 parts of pure hawthorn, 4-8 parts of stir-fried malt, 4-8 parts of stir-fried rice sprouts, 4-8 parts of stir-fried radish seeds, 4-8 parts of stir-fried fructus aurantii, 4-8 parts of kudzu root, and 4-8 parts of liquorice tablets.

[0011] Preferably, the Chinese medicine composition for treating lung and spleen deficiency syndrome described in the present invention is composed of the following raw material ingredients in parts by weight: 18-22 parts of astragalus, 8-12 parts of siler, 8-12 parts of Pseudostellariae Radix, 8-12 parts of dried tangerine peel, 8-12 parts of yam, 8-12 parts of polygonatum sibiricum, 8-12 parts of Ligustrum lucidum, 8-12 parts of atractylodes, 5-7 parts of stir-fried atractylodes, 5-7 parts of pure hawthorn, 5-7 parts of stir-fried malt, 5-7 parts of stir-fried rice sprouts, 5-7 parts of stir-fried radish seeds, 5-7 parts of stir-fried fructus aurantii, 5-7 parts of kudzu root, and 5-7 parts of liquorice tablets.

[0012] Further preferably, the Chinese medicine composition for treating lung and spleen deficiency syndrome described in the present invention is composed of the following raw material ingredients in parts by weight: 20 parts of astragalus, 10 parts of siler, 10 parts of pseudoginseng, 10 parts of tangerine peel, 10 parts of yam, 10 parts of polygonatum sibiricum, 10 parts of fructus ligustri lucidi, 10 parts of atractylodes, 6 parts of stir-fried atractylodes, 6 parts of clean hawthorn, 6 parts of stir-fried malt, 6 parts of stir-fried rice sprouts, 6 parts of stir-fried radish seeds, 6 parts of stir-fried fructus aurantii, 6 parts of kudzu root, and 6 parts of liquorice tablets.

[0013] The method for preparing a traditional Chinese medicine composition for treating lung and spleen deficiency syndrome of the present invention comprises the following steps:

[0014] (1) Weighing the medicinal materials: weighing astragalus, saposhnikovia divaricata, Pseudostellaria pseudoginseng, dried orange peel, Chinese yam, Polygonatum sibiricum, Ligustrum lucidum, Atractylodes macrocephala, stir-fried Atractylodes lancea, clean hawthorn, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium, Pueraria root, and liquorice tablets according to the proportion of the formula;

[0015] (2) Decoction: put all the herbs into a double-layer filter bag, add water and decoct for 1-3 times, add 7.5-11.5 times the amount of water for the first time, and add 6-10 times the amount of water for the second and third times, decoct for 0.5-1 h each time, and combine the decoctions;

[0016] (3) Concentration: Combine the decoctions and concentrate to a clear paste with a relative density of 1.18-1.22 at 60°C;

[0017] (4) Prepare the finished product by mixing the ingredients: add sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.30-1.35 at 60°C, and package it.

[0018] Preferably, the preparation method of the present invention is decocted three times, with 7.5 times the amount of water added for the first time, and 6 times the amount of water added for the second and third times, and each decoction is for 1 hour.

[0019] The dosage of sucrose in the preparation method of the present invention is 20-40 parts.

[0020] Preferably, the amount of sucrose used in the preparation method of the present invention is: 30 parts.

[0021] The Chinese medicine composition of the present invention or the clear paste prepared by the preparation method is used in preparing a pharmaceutical preparation for treating lung and spleen deficiency syndrome.

[0022] The above-mentioned pharmaceutical preparation comprises the Chinese medicine composition described in the present invention or the clear paste prepared by the preparation method and pharmaceutically acceptable excipients.

[0023] The pharmaceutical preparation of the present invention is a decoction, a soup, a mixture, a syrup, a granule, a capsule, a tablet or a pill.

[0024] The weight parts mentioned in the present invention can be g, kg and other weight units known in the medical field.

[0025] Compared with the prior art, the present invention has the following beneficial effects:

[0026] 1. The product prepared by the present invention is used to treat children with lung disease and lung and spleen deficiency syndrome, and its therapeutic effect is significant. The composition has the effects of strengthening the spleen and appetizing, nourishing the lungs and nourishing the essence, and replenishing qi and strengthening the exterior. After long-term clinical application verification, the results show that for children with lung and spleen deficiency syndrome, the total effective rate of the product of the present invention reaches 97.1%, and the therapeutic effect is significant; in terms of the clinical symptom and sign scores before and after treatment, the clinical symptom and sign scores after treatment are significantly higher than those before treatment, the children have a high degree of acceptance, and no adverse reactions occur, the safety is good, and it is worthy of promotion and application in clinical practice.

[0027] 2. The preparation method of the present invention is reasonable and feasible, and the quality of the obtained product is stable.

[0028] (1) The decoction paste was prepared by water decoction extraction process, and the extraction process, orthogonal test and optimal extraction process were verified. The results showed that: 1) When the decoction was decocted 3 times, each time for 60 minutes, and the water addition ratio was 6 times as the optimal extraction process, the paste yield, puerarin transfer rate and comprehensive score were all high. Since the results of the previous study showed that the decoction pieces would absorb 1.5 times of their own weight of water, the optimal extraction process finally determined was to add 7.5 times of water for the first decoction, 6 times of water for the second and third decoctions, and 60 minutes each time; 2) The optimal process extraction conditions were verified, and the average paste yield was 43.5%, RSD was 0.9%, the average puerarin transfer rate was 83.6%, RSD was 2.4%; the average comprehensive score was 63.6, RSD was 1.71%, indicating that the extraction process had good repeatability and the process was reasonable and feasible.

[0029] (2) The clear paste was prepared by vacuum concentration, with the content, relative density and properties of puerarin as the evaluation indicators. The results showed that when the extract was concentrated to a clear paste with a relative density of 1.18-1.25 (60°C), the puerarin content and properties were relatively good, and the solution was viscous and easy to collect. However, considering that when the relative density is too high in production, the concentrated liquid may be difficult to pour and transfer, and a certain amount of space needs to be reserved for the subsequent addition of auxiliary materials, the optimal relative density of the concentrated clear paste was finally determined to be 1.18-1.22 (60°C).

[0030] (3) The present invention investigates the effect of sucrose dosage on the quality of the finished product. The results show that as the amount of sucrose increases, the sweetness increases. However, too much sucrose has an impact on the appearance of the preparation. At the same time, the addition of too much sucrose will make the paste too viscous and the fluidity will deteriorate, which is not conducive to the smooth progress of the subsequent filling process. Therefore, it is finally selected to add 75g of sucrose to the clear paste prepared from every 2.5 clinical prescriptions of the decoction pieces.

[0031] (4) The present invention investigates the effect of the relative density of sucrose added to the clear paste and then continued to heat and concentrate on the product properties and taste. The results show that when the relative density of the concentrate is 1.30-1.35, its viscosity, appearance, properties, hardness, taste and comprehensive score are relatively good, and it is convenient to use.

[0032] (5) The final preparation process was verified by small and medium tests, and the results were as follows: 1) The small test sample was flagged, with moderate viscosity and easy to use, semi-fluid, moderate hardness, smooth mouthfeel, no foreign matter, no charred debris, and an average puerarin content of 1.85 mg / g, with an RSD of 2.32%. 2) The pilot finished product was a brownish-brown thick semi-fluid; bitter and slightly sweet; its identification, inspection, content determination, and microbial limit all met the requirements.

[0033] 3. The present invention improves the traditional decoction into different dosage forms such as decoction paste, mixture, granule, syrup, gel, etc., which not only increases the stability of the drug, but also makes it convenient for patients to take, reduces the dosage, and is more convenient for patients to carry and store. At the same time, it can also enrich the product composition of hospital preparations in our province, bring good news to more children, and has far-reaching social significance.

[0034] 4. The present invention adopts the method of whole-formula water extraction to extract Chinese herbal medicine slices, thereby maintaining the effective substances of traditional decoctions and ensuring the consistency of the developed dosage form and the clinical efficacy of the decoction. DETAILED DESCRIPTION

[0035] The technical solution of the present invention is further described in detail below through specific embodiments.

[0036] Example 1 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0037] Ingredients: 20g of Astragalus, 10g of Saposhnikovia, 10g of Pseudostellaria, 10g of Tangerine Peel, 10g of Dioscorea, 10g of Polygonatum sibiricum with wine, 10g of Ligustrum lucidum with wine, 10g of Atractylodes macrocephala, 6g of Atractylodes lancea fried with bran, 6g of Hawthorn, 6g of fried malt, 6g of fried rice sprouts, 6g of fried radish seeds, 6g of fried Citrus aurantium, 6g of Pueraria root, and 6g of liquorice tablets.

[0038] Example 2 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0039] Ingredients: 25g of Astragalus, 15g of Saposhnikovia, 10g of Pseudostellaria, 10g of Tangerine Peel, 10g of Dioscorea Opposita, 10g of Polygonatum sibiricum with wine, 10g of Ligustrum lucidum with wine, 10g of Atractylodes macrocephala, 5g of stir-fried Atractylodes lancea with bran, 5g of clean Hawthorn, 5g of stir-fried malt, 5g of stir-fried rice sprouts, 5g of stir-fried radish seeds, 5g of stir-fried Citrus aurantium, 5g of Pueraria root, and 5g of liquorice tablets.

[0040] Example 3 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0041] Ingredients: 15g of Astragalus, 5g of Saposhnikovia divaricata, 5g of Pseudostellaria pseudoginseng, 5g of dried tangerine peel, 5g of Chinese yam, 10g of Polygonatum sibiricum with wine, 10g of Ligustrum lucidum with wine, 10g of Atractylodes macrocephala, 7g of stir-fried Atractylodes lancea with bran, 7g of clean Hawthorn, 7g of stir-fried malt, 7g of stir-fried rice sprouts, 7g of stir-fried radish seeds, 7g of stir-fried Citrus aurantium, 7g of Pueraria root, and 7g of liquorice tablets.

[0042] Example 4 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0043] Ingredients: 20g of Astragalus, 15g of Saposhnikovia, 10g of Pseudostellaria, 10g of Tangerine Peel, 10g of Dioscorea Opposita, 10g of Polygonatum sibiricum with wine, 10g of Ligustrum lucidum with wine, 10g of Atractylodes macrocephala, 5g of stir-fried Atractylodes lancea with bran, 5g of clean Hawthorn, 5g of stir-fried malt, 5g of stir-fried rice sprouts, 5g of stir-fried radish seeds, 6g of stir-fried Citrus aurantium, 6g of Pueraria root, and 6g of liquorice tablets.

[0044] Example 5 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0045] Ingredients: 20g of Astragalus, 10g of Saposhnikovia, 15g of Pseudostellaria, 15g of Tangerine Peel, 15g of Dioscorea Opposita, 10g of Polygonatum sibiricum, 10g of Ligustrum lucidum, 10g of Atractylodes macrocephala, 5g of stir-fried Atractylodes lancea with bran, 5g of clean Hawthorn, 5g of stir-fried malt, 5g of stir-fried rice sprouts, 5g of stir-fried radish seeds, 5g of stir-fried Citrus aurantium, 5g of Pueraria root, and 5g of liquorice tablets.

[0046] Example 6 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0047] Ingredients: 22g of Astragalus, 12g of Saposhnikovia, 12g of Pseudostellaria, 12g of Tangerine Peel, 12g of Dioscorea, 12g of Polygonatum sibiricum with wine, 12g of Ligustrum lucidum with wine, 12g of Atractylodes macrocephala, 5g of stir-fried Atractylodes lancea with bran, 5g of clean Hawthorn, 5g of stir-fried malt, 5g of stir-fried rice sprouts, 5g of stir-fried radish seeds, 5g of stir-fried Citrus aurantium, 5g of Pueraria root, and 5g of liquorice tablets.

[0048] Example 7 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0049] Ingredients: 22g of Astragalus, 12g of Saposhnikovia, 8g of Pseudostellaria, 8g of Tangerine Peel, 8g of Dioscorea, 8g of Polygonatum sibiricum with wine, 8g of Ligustrum lucidum with wine, 8g of Atractylodes macrocephala, 7g of Atractylodes lancea with bran, 7g of Hawthorn, 7g of stir-fried malt, 7g of stir-fried rice sprouts, 7g of stir-fried radish seeds, 7g of stir-fried Citrus aurantium, 7g of Pueraria root, and 7g of liquorice tablets.

[0050] Example 8 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0051] Ingredients: 18g of Astragalus, 8g of Saposhnikovia divaricata, 8g of Pseudostellaria pseudoginseng, 8g of dried tangerine peel, 8g of Chinese yam, 8g of Polygonatum sibiricum with wine, 8g of Ligustrum lucidum with wine, 8g of Atractylodes macrocephala, 7g of stir-fried Atractylodes lancea with bran, 7g of clean Hawthorn, 7g of stir-fried malt, 7g of stir-fried rice sprouts, 7g of stir-fried radish seeds, 7g of stir-fried Citrus aurantium, 7g of Pueraria root, and 7g of liquorice tablets.

[0052] Example 9 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0053] Ingredients: 18g Astragalus, 12g Saposhnikovia, 12g Pseudostellaria, 12g Tangerine Peel, 12g Dioscorea, 12g Polygonatum, 12g Ligustrum lucidum, 12g Atractylodes, 6g stir-fried Atractylodes with bran, 6g Hawthorn, 6g stir-fried malt, 6g stir-fried rice sprouts, 6g stir-fried radish seeds, 6g stir-fried Citrus aurantium, 6g Pueraria, and 6g liquorice tablets.

[0054] Example 10 A Chinese medicine composition for treating lung and spleen deficiency syndrome

[0055] Ingredients: 20g of Astragalus, 15g of Saposhnikovia divaricata, 15g of Pseudostellaria pseudoginseng, 10g of dried tangerine peel, 10g of Chinese yam, 5g of Polygonatum sibiricum, 5g of Ligustrum lucidum, 5g of Atractylodes macrocephala, 6g of stir-fried Atractylodes lancea with bran, 6g of clean Hawthorn, 6g of stir-fried malt, 6g of stir-fried rice sprouts, 6g of stir-fried radish seeds, 6g of stir-fried Citrus aurantium, 6g of Pueraria root, and 6g of liquorice slices.

[0056] The compositions of the Chinese medicine compositions of Examples 1-10 are used in the following preparation methods

[0057] Example 11 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0058] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0059] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and 6 times the amount of water for the second and third times. Decoction for 1 hour each time, and combine the decoctions.

[0060] (3) Concentration: The decoction is concentrated to a clear paste with a relative density of 1.18-1.22 at 60°C;

[0061] (4) Prepare the finished product by mixing the ingredients: add 30 g of sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.30-1.35 at 60°C, and divide it into portions to obtain the paste (Zengmian Huyuan Paste).

[0062] Example 12 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0063] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0064] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 9.5 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Decoction for 45 min each time, and combine the decoctions.

[0065] (3) Concentration: The decoction is concentrated to a clear paste with a relative density of 1.18-1.22 at 60°C;

[0066] (4) Prepare the finished product by mixing the ingredients: add 25 g of sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.30-1.35 at 60°C, and divide it into portions to obtain the paste (Zengmian Huyuan Paste).

[0067] Example 13 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0068] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0069] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 11.5 times the amount of water for the first time, and 10 times the amount of water for the second and third times. Decoction for 0.5 h each time, and combine the decoctions.

[0070] (3) Concentration: The decoction is concentrated to a clear paste with a relative density of 1.18-1.22 at 60°C;

[0071] (4) Prepare the finished product by mixing the ingredients: add 30 g of sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.30-1.35 at 60°C, and divide it into portions to obtain the paste (Zengmian Huyuan Paste).

[0072] Example 14 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0073] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0074] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and 6 times the amount of water for the second and third times. Decoction for 0.5 h each time, and combine the decoctions.

[0075] (3) Concentration: Concentrate the decoction to a clear paste with a relative density of 1.15-1.18 at 60°C;

[0076] (4) Prepare the finished product by mixing the ingredients: add 25 g of sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.28-1.30 at 60°C, and divide it into portions to obtain the paste (Zengmian Huyuan Paste).

[0077] Example 15 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0078] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0079] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0080] (3) Concentration: The decoction is concentrated to an extract with a relative density of 1.25-1.30 at 60°C;

[0081] (4) Preparing ingredients to prepare finished products: Add 0.2% sodium benzoate to the extract and package it to obtain the extract.

[0082] Example 16 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0083] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0084] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0085] (3) Concentration: Concentrate the decoction to a clear paste with a relative density of 1.05-1.09 at 60°C;

[0086] (4) Prepare the finished product by adding 0.2% sodium benzoate to the clear paste and packaging to obtain a mixture or oral solution.

[0087] Example 17 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0088] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0089] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0090] (3) Concentration: Combine the decoctions and concentrate to an extract with a relative density of 1.25-1.30 at 60°C;

[0091] (4) Preparing ingredients to prepare finished products: adding dextrin, soluble starch, corn starch, sucrose, microcrystalline cellulose and silicon dioxide to the extract, granulating, drying, granulating, sieving and packaging to obtain granules.

[0092] Example 18 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0093] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0094] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0095] (3) Concentration: Combine the decoctions and concentrate to an extract with a relative density of 1.25-1.30 at 60°C;

[0096] (4) Preparing ingredients to make finished products: Prepare extract powder by using hot air circulation drying oven, vacuum drying, spray drying, belt drying or the like, add dextrin, soluble starch, corn starch, sucrose, microcrystalline cellulose, silicon dioxide to the extract powder, granulate, dry, granulate, sieve and package to obtain granules.

[0097] Example 19 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0098] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0099] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0100] (3) Concentration: Combine the decoctions and concentrate to an extract with a relative density of 1.15-1.25 at 60°C;

[0101] (4) Preparing ingredients to prepare finished products: adding dextrin, soluble starch, corn starch, sucrose, microcrystalline cellulose and silicon dioxide to the extract, granulating, drying, granulating, sieving and packaging to obtain granules.

[0102] Example 20 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0103] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0104] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0105] (3) Concentration: Combine the decoctions and concentrate to a clear paste with a relative density of 1.05-1.09 at 60°C;

[0106] (4) Prepare the finished product by adding syrup to the clear paste, mixing, and packaging to obtain the syrup.

[0107] Example 21 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0108] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0109] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0110] (3) Concentration: Combine the decoctions and concentrate to a clear paste with a relative density of 1.05-1.09 at 60°C;

[0111] (4) preparing finished products by preparing the finished products by adding agar and konjac gum as a matrix to the clear paste to prepare a gel, and adding 0.2% sodium benzoate as an antibacterial agent to mix and package to obtain a gel.

[0112] Example 22 Preparation method of a Chinese medicine composition for treating lung and spleen deficiency syndrome

[0113] (1) Weighing the medicinal materials: weighing astragalus, Pseudostellariae Radix, Polygonatum sibiricum with wine, dried orange peel, Chinese yam, Atractylodes macrocephala, stir-fried Atractylodes lancea with bran, Ligustrum lucidum with wine, Pueraria root, Saposhnikovia divaricata, Crataegus pinnatifida, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium with bran, and liquorice tablets according to the proportion of the formula;

[0114] (2) Decoction: Put all the herbs into a double-layer filter bag, add water and decoct for 3 times. Add 7.5 times the amount of water for the first time, and add 6 times the amount of water for the second and third times. Decoction for 1 hour each time. Pass the extract through a 100-mesh sieve and combine the decoctions.

[0115] (3) Concentration: Combine the decoctions and concentrate to a clear paste with a relative density of 1.05-1.09 at 60°C;

[0116] (4) Preparing ingredients to prepare finished products: Sodium alginate and xanthan gum are added to the clear paste as a matrix to prepare a gel, and 0.2% sodium benzoate is added as an antibacterial agent to mix and package to obtain a gel.

[0117] In order to further verify the feasibility of the present invention, the inventor conducted a series of experiments, as follows:

[0118] 1. Process inspection and test

[0119] Dosage form 1: Decoction

[0120] 1. Prescription composition

[0121] The prescription of the Chinese medicine composition of the present invention consists of 16 Chinese medicinal materials, including astragalus, saposhnikovia, pseudostellaria, tangerine peel, yam, polygonatum sibiricum, fructus Ligustri Lucidi, atractylodes macrocephala, stir-fried atractylodes with bran, clean hawthorn, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried fructus aurantii, pueraria root, and licorice tablets. All the medicinal materials are included in the first volume of the 2020 edition of the "Chinese Pharmacopoeia", do not contain toxic medicinal materials, and have no 18 anti-compatibility and 19 fear incompatibility contraindications.

[0122] 2. Choice of dosage form

[0123] The original form of administration of this prescription was decoction, but it tasted bad for children and had poor compliance. We processed the prescription into a paste, which significantly improved the taste and reduced the dosage, and the acceptance of parents and children increased day by day. At the same time, the decoction paste has the advantages of high concentration, small volume, significant effect, stable dosage form, convenient administration, and good taste; combined with large-scale production conditions and the needs of clinical medication, the decoction paste was initially selected for research and development.

[0124] 3. Prescription process research

[0125] This prescription is a Chinese medicine compound, which is used in clinical practice in the form of decoction. According to traditional medication habits, the decoction is prepared by water extraction and concentration. The auxiliary materials used in the decoction are sugar or invert sugar, and commonly used ones are honey, sucrose, and maltose. Considering that children are not suitable for taking honey, and there are few suppliers of medicinal grade maltose and it is expensive, this product uses sucrose as the final molding auxiliary material. The basic process route is: the above sixteen pieces of medicinal materials are boiled and extracted → the water extract is concentrated to a relative density → sucrose is added → concentrated to a thick paste with a specified relative density → packaging → finished product (Zengmian Huyuan Paste).

[0126] 3.1 Extraction process research

[0127] 3.1.1 Determination of water absorption rate of decoction pieces

[0128] Weigh 1 / 2 of the clinical prescription amount of decoction pieces, add 10 times the amount of water to soak, soak for different time periods, filter, weigh the wet medicine (until the weight of the decoction pieces no longer increases), and determine the water absorption rate of the decoction pieces. The formula is as follows (the results are shown in Table 1).

[0129]

[0130] mb—mass of the slice in the water-saturated state (g)

[0131] mg—mass of the slice in dry state (g)

[0132] Table 1 Investigation on water absorption rate of decoction pieces

[0133]

[0134] It can be seen from Table 1 that the water absorption rate of the slices after soaking for 8 hours is about 1.5 times. Therefore, when adding water for the first time for decoction, the water absorption of the dry slices should be supplemented. To facilitate production calculations, when adding water for the first time for decoction, all the water should be used to extract the slices, and 1.5 times the amount of water should be added to the slices.

[0135] 3.1.2 Determination of soaking time

[0136] Under the condition of satisfying the water absorption rate of the medicinal slices, the influence of the soaking time on the paste yield of the prescription was examined. The total solid yield was used as the investigation index, and the soaking time with the greatest influence on the paste yield of the prescription was selected.

[0137] 3.1.2.1 Extraction solution preparation

[0138] Weigh 1 / 2 of the clinical prescription amount of the slices, add 9.5 times the amount of water for the first time, and 8 times the amount of water for the second and third times. Considering that the decoction is easy to breed bacteria and deteriorate if soaked for too long, and combined with the feasibility of large-scale production, we designed several samples of no soaking, soaking for 1 hour, 2 hours, and 4 hours, decoct 3 times, 30 minutes each time, filter, combine the filtrate, concentrate the filtrate to less than 100mL, cool, and add water to make up to 100mL. Set aside.

[0139] 3.1.2.2 Determination of total solid yield

[0140] Referring to the extract determination method in Appendix 2201 of the 2020 edition of the Chinese Pharmacopoeia, accurately transfer 10 mL of the extract into an evaporating dish that has been dried to a constant weight, evaporate to dryness in a water bath, dry at 105°C for 3 hours, cool in a desiccator for 30 minutes, quickly and accurately weigh the weight, and calculate the paste rate by weighing. The formula is as follows.

[0141]

[0142] W is the weight of total solid matter in 10 mL of extract, and Wt is the total weight of the raw materials.

[0143] The effect of immersion time on the paste yield is shown in Tables 2 and 3.

[0144] Table 2 Effect of soaking time on paste yield

[0145]

[0146] Table 3 The results of variance analysis on the effect of soaking time on the paste yield

[0147]

[0148] Conclusion: As shown in Table 3, P = 0.093, P > 0.05. The results show that the soaking time has no significant effect on the paste yield. Therefore, we chose not to soak before decoction and directly extract.

[0149] 3.1.3 Decoction process screening

[0150] 3.1.3.1 Determination of orthogonal factor levels

[0151] The main factors affecting water decoction are: decoction times, water addition, and decoction time. This experiment takes these three factors as the investigation factors, takes 3 levels for each, and conducts a 3-factor 3-level orthogonal test to screen the water extraction process conditions. The factor level table is shown in Table 4.

[0152] Table 4 Water extraction orthogonal factor level table

[0153]

[0154] Note: Add 1.5 times more water for the first extraction.

[0155] 3.1.3.2 Selection of evaluation indicators

[0156] We used the comprehensive scoring method to optimize the extraction process and calculated the comprehensive scores of the transfer rate and the yield rate of puerarin in Pueraria root, where the weights of the transfer rate and the yield rate were 0.5 respectively, and the calculation formula was as follows:

[0157]

[0158] 3.1.3.3 Sample preparation

[0159] Weigh 9 portions of decoction pieces according to the prescription ratio, and press L9(3 4 ) was decocted and extracted under orthogonal experimental conditions, filtered, the extracts were combined, and concentrated to less than 100 mL, cooled, and water was added to make up to 100 mL.

[0160] 3.1.3.4 Determination of puerarin content in water extraction orthogonal test samples

[0161] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel as filler, methanol-0.2% acetic acid solution (25:75) as mobile phase; detection wavelength: 250nm; column temperature: 30°C. The theoretical plate number calculated based on the puerarin peak is not less than 4000.

[0162] Preparation of reference solution: Accurately weigh an appropriate amount of puerarin reference substance, add water to dissolve it and prepare a solution containing 20ug of puerarin per 1ml.

[0163] Preparation of test solution: Concentrate the extract to 100mL, take 5mL, place in a 25mL volumetric flask, add 30% ethanol to the mark, shake well, filter with a 0.45um microporous filter membrane, discard 1mL of the initial filtrate, and take the subsequent filtrate as the test solution.

[0164] Assay: Accurately pipette 10uL of the test solution and reference solution respectively, inject into the chromatograph, record the peak area, and calculate the content. The results are shown in Tables 5 and 6.

[0165] Calculation of puerarin transfer rate

[0166]

[0167] C1 is the puerarin content in the extract (ug.mL -1 );

[0168] C2 is the puerarin content in Pueraria root (%, g / g);

[0169] Wt is the weight of the kudzu root slices (g).

[0170] 3.1.3.5 Determination of the paste yield: Accurately transfer 10 mL of the extract to a constant-weight evaporating dish, evaporate to dryness in a water bath, dry at 105°C for 3 hours, cool in a desiccator for 30 minutes, quickly and accurately weigh, and calculate the paste yield using the following formula.

[0171]

[0172] W is the weight of total solid matter in 10 mL of extract, and Wt is the total weight of the raw materials.

[0173] Table 5L9(3 4 )Orthogonal experimental design experimental variance analysis results (n=2)

[0174]

[0175] Table 6 Analysis of variance table for comprehensive scores of water extraction orthogonal test

[0176]

[0177] Note: F0.05(2,2)=19.00, F0.01(2,2)=99.0

[0178] Result analysis: From the intuitive analysis results, we know that the influence of the three factors on the results is A>C>B, and we get the best condition as A3B3C3; we take the blank column where the D factor is located as the error source, and perform variance analysis on the orthogonal design results. From the variance analysis results, it can be seen that there is no significant difference among the three factors. Considering that adding too much water will lead to a longer final concentration and paste collection time, and extend the production cycle, combined with the comprehensive score and the actual situation of large-scale production, we choose the best combination as A3B3C1, that is, choose to decoct 3 times, each time for 60 minutes, and add 6 times of water as the best extraction process. According to the results of previous studies, the decoction pieces will absorb 1.5 times their own weight of water, so the extraction process we finally determined is to add 7.5 times of water for the first decoction, 6 times of water for the second and third times, and decoct for 60 minutes each time, and filter the extract for later use.

[0179] 3.1.3.6 Extraction process verification experiment of three batches of samples

[0180] According to the results of the orthogonal design experiment, three batches of samples were extracted, and the extract was concentrated to 100 mL. The extract yield and puerarin transfer rate in the samples were determined, and the comprehensive score was calculated. The verification test results are shown in Table 7.

[0181] Table 7 Extraction process validation test

[0182]

[0183] From the results in the above table, we can see that the comprehensive score of the verification test is consistent with the orthogonal design optimization result, indicating that the water extraction process conditions are basically stable.

[0184] 3.2 Concentration process research

[0185] Combined with the actual situation of large-scale production, and in order to reduce the degradation of active ingredients at high temperature, the clear paste was prepared by vacuum concentration. The concentration of the clear paste was determined based on the content, relative density and properties of puerarin to determine the appropriate concentration process conditions.

[0186] Investigation of the concentration degree of the clear paste: A batch of liquid medicine was extracted according to the preliminary determined extraction process, and 200 ml of the extract was measured respectively, a total of 6 portions, each portion was concentrated to different degrees, and the collection state of each portion of liquid medicine was observed. After cooling, the volume of the concentrated liquid medicine was measured, and the relative density was measured to determine the concentration degree of the clear paste. See Table 8 for details.

[0187] Table 8 Inspection table of the concentrated state of clear paste

[0188]

[0189] Summary: After a certain degree of concentration, the content of puerarin in the sample did not decrease significantly; as the degree of concentration increased, the relative density of the solution increased. Considering that when the relative density is too large during production, the concentrated solution may be difficult to pour and transfer, and a certain amount of space needs to be reserved for the subsequent addition of auxiliary materials, it is necessary to control the appropriate degree of concentration. Therefore, we initially concentrated the extract to a clear paste with a relative density of 1.18-1.22 (60°C).

[0190] 3.3 Determination of the paste collection process

[0191] 3.3.1 Determination of excipient types

[0192] Decoctions require a certain amount of sugar or invert sugar to be added to the clear paste, which not only increases the viscosity of the paste, but also has an antibacterial effect. Commonly used sugars include honey, sucrose, maltose, and crystal sugar. However, with the implementation of the national policy on filing management of auxiliary materials, we have fewer compliant auxiliary materials to choose from. Honey, sucrose, and maltose have all been filed, but the price of maltose is too high. If used, it will greatly increase the finished product, thereby increasing the patient's medical expenses. Honey is not recommended for children, so we choose sucrose.

[0193] 3.3.2 Selection of sucrose dosage

[0194] Take 300 mL of the extract (equivalent to 2.5 clinical prescriptions of decoction pieces), concentrate to about 120 mL, add different prescriptions of sucrose, and continue to concentrate to 150 mL. Determine the relative density, observe the properties, and ease of use. The results are shown in Table 9.

[0195] Table 9 Effect of sucrose dosage on finished product quality

[0196]

[0197] From the above results, it can be seen that as the amount of sucrose increases, the sweetness increases. However, too much sucrose has an impact on the appearance of the preparation. At the same time, the addition of too much sucrose will make the paste too viscous and the fluidity will deteriorate, which is not conducive to the smooth progress of the subsequent filling process. Therefore, we chose to add 25g of sucrose to the clear paste prepared from every 2.5 clinical prescriptions of the decoction pieces.

[0198] 3.3.3 Determination of concentration endpoint

[0199] After adding sucrose to the clear paste, continue to heat it to melt it, and continue to stir and concentrate it until it is in a flag-hanging state. During the process of collecting the decoction, as the water content decreases, the viscosity gradually increases and the fluidity gradually deteriorates; on the other hand, the decoction with a high degree of concentration gradually increases in hardness after cooling, and the taste becomes less and less lubricated, and more burnt debris will be produced. Therefore, we scored the samples obtained from each prescription during the research process and determined the concentration end point based on the comprehensive scoring results.

[0200] 3.3.3.1 Liquidity score

[0201] Use a glass rod to pick it up, observe the state of the fluid, and score it. The score table is as follows Table 10:

[0202] Table 10 Liquidity score table

[0203]

[0204] 3.3.3.2 Viscosity, appearance, and properties

[0205] According to traditional experience, the viscosity, appearance and properties of the paste are compared, and the full score (10 points) is calculated based on the requirements for high-quality paste under traditional experience; the scores for appearance properties under other conditions decrease in sequence.

[0206] 3.3.3.3 Hardness and taste

[0207] Decoction pastes need to be in a semi-fluid state, but as the time of paste collection increases, the decoction paste will gradually become harder and harder to use after cooling or when stored in the refrigerator. The taste will also become less and less smooth, and more burnt debris will be produced. Therefore, moderate hardness, smooth taste, and no burnt debris will be given full marks (10 points); other scores will decrease in turn.

[0208] 3.3.3.4 Determination of the concentration end point of thick paste

[0209] Take 5 portions of extract, concentrate them to a clear paste with a relative density of about 1.2, add the prescribed amount of sucrose, and continue stirring to prevent the generation of burnt debris. Each sample is concentrated to a different degree, and the flowability, viscosity, appearance, properties, hardness, and taste are examined, and the comprehensive score is calculated to determine the detailed research results. See Tables 11 and 12.

[0210] Table 11 Scoring of thick paste concentration

[0211]

[0212]

[0213] Table 12 Relative density measurement results (20°C)

[0214]

[0215] Summary: From the above results, it can be seen that samples 3 and 4 are more ideal.

[0216] Based on the above research results, we have preliminarily determined the prescription process for the small test confirmation batch: add 7.5 times the weight of the slices of water for the first decoction, add 6 times the weight of water for the second and third decoctions, decoct for 60 minutes each time, and combine the three extracts for use. The extract is concentrated to a clear paste with a density of 1.18-1.22 (g / mL) (60℃ thermal measurement), and the density of the clear paste is determined by the gravimetric method (the calculation formula is as follows), sampled, cooled to about 60℃, filled with a 250mL measuring cylinder, and the weight of the paste is weighed.

[0217]

[0218] Add the prescribed amount of sucrose to the clear paste, heat to melt, continue to concentrate on low heat until it reaches the mark, measure the density (thermal measurement at 60℃), stop heating, collect, and package when the temperature drops below 80℃.

[0219]

[0220] 3.4 Small-scale test preparation process confirmation

[0221] According to the above confirmation process, three samples were prepared as small test confirmation batch samples. According to the general rules of the Chinese Pharmacopoeia, the relative density, puerarin content and insoluble matter were determined by the relative density determination method under the decoction and paste item. The detailed research results are shown in Tables 13 to 16:

[0222] Table 13 Results of inspection on the appearance of small test batch samples

[0223]

[0224] Table 14 Results of determination of insoluble matter in small test batch samples

[0225]

[0226]

[0227] Table 15 Puerarin content determination results of small test batch samples

[0228]

[0229] Table 16 Results of relative density content determination of small test batch samples

[0230]

[0231] 3.5 Pilot study

[0232] 3.5.1 Bottle packaging:

[0233] Based on the above research results and combined with the production equipment of our institute, we have preliminarily formulated the prescription process for pilot production. This large-scale production was scaled up 10 times according to the proposed preparation process conditions. In order to conduct a comprehensive investigation of the production process indicators, we evaluated the quality of the finished product. The relative density (20℃), pH value, puerarin content and filling volume of the finished product were checked. The results are shown in Table 17.

[0234] Table 17 Statistics of pilot production results

[0235]

[0236]

[0237] 3.5.2 Bag packaging:

[0238] Combined with the production equipment of the preparation center of our hospital, this large-scale production was carried out in batches of 5,000 bags according to the planned preparation process conditions. The relative density (20°C), pH value, puerarin content and filling volume of the finished product were checked, and the results are shown in Table 18.

[0239] Table 18 Statistics of pilot production results

[0240]

[0241] Dosage form 2: extract

[0242] The whole formula adopts water extraction technology. The astragalus and other medicinal pieces in the prescription are added to the extraction equipment. 7.5 times of water is added for the first decoction, and 6 times of water is added for the second and third times. Each decoction is for 60 minutes. The extract is passed through a 100-mesh sieve for later use, and concentrated to an extract with a relative density of 1.25-1.30. 0.2% sodium benzoate is added as an antibacterial agent and the product is packaged.

[0243] Dosage form three: mixture or oral solution

[0244] The whole formula adopts water extraction technology. The astragalus and other medicinal pieces in the prescription are added to the extraction equipment. 7.5 times of water are added for the first decoction, and 6 times of water are added for the second and third times. Each decoction is for 60 minutes. The extract is passed through a 100-mesh sieve for later use, concentrated to a relative density of 1.05-1.09, and 0.2% sodium benzoate is added as an antibacterial agent before packaging.

[0245] Dosage form 4: Granules

[0246] The whole formula adopts water extraction technology. The astragalus and other medicinal pieces in the prescription are added to the extraction equipment. 7.5 times of water are added for the first decoction, and 6 times of water are added for the second and third times. Each decoction is for 60 minutes. The extract is passed through a 100-mesh sieve for later use, and concentrated to a relative density of 1.25-1.35. Dextrin, soluble starch, corn starch, sucrose, microcrystalline cellulose, silicon dioxide, etc. are added to granulate, dry, sort the particles, sieve, and package.

[0247] Dosage form 5: Syrup

[0248] The whole formula adopts water extraction technology. The astragalus and other medicinal pieces in the prescription are added to the extraction equipment. Add 7.5 times of water for the first decoction, and 6 times of water for the second and third times. Each decoction is for 60 minutes. The extract is passed through a 100-mesh sieve for later use, concentrated to a relative density of 1.05-1.09, added to the syrup and mixed, and then packaged.

[0249] Dosage form six: gel

[0250] The whole formula adopts water extraction technology. The astragalus and other medicinal pieces in the prescription are added into the extraction equipment. 7.5 times of water are added for the first decoction, and 6 times of water are added for the second and third times. Each decoction is for 60 minutes. The extract is passed through a 100-mesh sieve for later use, and concentrated to a relative density of 1.05-1.09. Agar, sodium alginate, konjac gum, xanthan gum and the like are used as the matrix to prepare a gel, and 0.2% sodium benzoate is added as an antibacterial agent to mix and package the mixture.

[0251] 4. Effect Experiment Data

[0252] The results of pilot production show that the indicators of the pilot samples prepared using the proposed parameters meet the requirements and the process conditions are stable and controllable, indicating that the optimized process can be used for large-scale production of this product.

[0253] By adopting the method of whole-formula water extraction to extract Chinese herbal medicine slices, the effective substances of traditional decoctions are maintained, ensuring the consistency of the developed dosage form and the clinical efficacy of the decoction. At the same time, we prepare the extracts into different preparation forms for the applicability of prescriptions. Doctors and patients can choose according to the situation. Preparing decoctions into different dosage forms such as decoctions, mixtures, granules, syrups, gels, etc. not only increases the stability of the drug, but also makes it easier for patients to take, reduces the dosage, and is more convenient for patients to carry.

[0254] 5. Clinical efficacy verification trial

[0255] 3. Experimental Design

[0256] 3.1 Source of cases

[0257] All cases were from outpatients and inpatients diagnosed with lung diseases and lung and spleen deficiency in the Department of Pediatrics of the Second Affiliated Hospital of Guizhou University of Chinese Medicine, and they were also voluntary clinical researchers in this project.

[0258] 3.2 Collection time

[0259] From January 2020 to October 2024.

[0260] 3.3 Diagnostic criteria

[0261] 3.3.1 Western medicine diagnostic criteria

[0262] Western medicine diagnostic criteria: According to the diagnosis of pneumonia in Zhu Futang's "Practical Pediatrics" 7th edition [4] .

[0263] (1) Symptoms: fever, cough, phlegm in the throat, expectoration, shortness of breath, rapid breathing, and difficulty breathing.

[0264] (2) Pulmonary signs: moderate or coarse moist rales or fine moist rales may be heard.

[0265] (3) Chest AP radiograph: flaky or patchy infiltration shadows or interstitial changes.

[0266] 3.3.2 TCM diagnostic criteria

[0267] The diagnostic criteria were formulated based on the Guidelines for Diagnosis and Treatment of Common Pediatric Diseases in Traditional Chinese Medicine (1st edition, July 2012). [2] . Lung and spleen deficiency syndrome, main symptoms: cough, expectoration, rough breathing, no rales; a few scattered wet rales and / or a few sputum sounds; more wet rales and / or sputum sounds. Secondary symptoms: fatigue, complexion, sweating, loose stools, poor appetite. Tongue and pulse: red tongue, thin white fur, weak pulse. See Table 19.

[0268] Table 19 Quantitative table for grading symptoms of lung and spleen deficiency syndrome in lung diseases

[0269]

[0270]

[0271] 3.4 Inclusion criteria

[0272] (1) Conform to the diagnostic criteria of Western medicine.

[0273] (2) Meet the diagnostic criteria of TCM syndromes.

[0274] (3) Determine the age range of subjects based on the purpose of each clinical trial and the characteristics of the disease.

[0275] (4) Sign the informed consent form for entering the study.

[0276] 3.5 Exclusion criteria

[0277] (1) People with food or drug allergies.

[0278] (2) Patients whose condition is critical and it is difficult to make an accurate evaluation of the effectiveness and safety of new drugs.

[0279] (3) Poor compliance and children with mental illness.

[0280] 4 Observation indicators

[0281] 4.1 Safety Observation

[0282] (1) General physical examination items

[0283] If adverse reactions occur, the clinical manifestations, time of occurrence, severity, symptomatic treatment methods and results should be recorded to objectively evaluate their safety.

[0284] 4.2 Efficacy observation (evaluated once before and after treatment)

[0285] (1) Relevant symptoms and tongue and pulse required by this test, and pay attention to the onset time and recovery time.

[0286] (2) Related symptoms: cough, sputum, fatigue, pale complexion, sweating, loose stools, and poor appetite.

[0287] (3) Related signs: Lung auscultation: Clear breath sounds in both lungs; Coarse breath sounds in both lungs; Occasionally, a small amount of coarse and moderate moist rales are heard; Coarse breath sounds in both lungs, with audible coarse and moderate moist rales.

[0288] (4) Follow-up: Follow-up will be conducted once 15 days after the end of treatment.

[0289] 5. Efficacy evaluation

[0290] 5.1 The efficacy evaluation criteria are formulated according to the "Efficacy Criteria for Diagnosis and Efficacy of TCM Diseases and Syndromes":

[0291] (1) Cure: After treatment, the main symptoms and secondary symptoms basically disappear, and the efficacy index n>90%;

[0292] (2) Markedly effective: After treatment, the main symptoms are significantly improved, the secondary symptoms basically disappear, and the efficacy index is 90% ≤ n < 70%;

[0293] (3) Effective: After treatment, the main symptoms improved and the secondary symptoms improved, with an efficacy index of 70% ≤ n < 30%;

[0294] (4) Ineffective: There is no significant difference in the improvement of symptoms and signs after treatment compared with before treatment, and the efficacy index is ≤30%.

[0295] Therapeutic index n = (score before treatment - score after treatment) / score before treatment × 100%.

[0296] 6 Statistical analysis

[0297] All data were analyzed using SPSS 22.0 statistical software. The independent sample t test was used for comparison between groups before and after treatment when the normal distribution was met; the rank sum test was used when the normal distribution was not met.

[0298] 7 Results

[0299] 7.1 Results of demographic baseline balance analysis: demographic baseline for the use of Huyuan ointment. See Table 20.

[0300] Table 20 Demographic baseline of the use of Zengmian Huyuan ointment

[0301]

[0302] 7.2 Comprehensive efficacy

[0303] The total effective rate of treatment among children in the two groups was 97.1%. See Table 21.

[0304] Table 21 Statistics of total effective rate after treatment

[0305]

[0306] 7.3 Comparison of clinical symptom and sign scores before and after treatment

[0307] Compared with before treatment, the clinical symptom and sign scores after treatment were significantly higher than those before treatment, and the difference was extremely statistically significant (P < 0.001). See Table 22.

[0308] Table 22 Comparison of clinical symptom and sign scores between groups before and after treatment

[0309]

[0310] Note: Intra-group comparison: compared with before treatment, # P<0.001.

[0311] 7.4 Comparison of symptom scores before and after treatment

[0312] Compared with before treatment, the scores of clinical symptoms and signs in the two groups after treatment were significantly higher than those before treatment, and the difference was extremely statistically significant (P < 0.001). See Table 23.

[0313] Table 23 Comparison of symptoms and signs between groups before and after treatment

[0314]

[0315]

[0316] Note: Comparison of symptoms and signs within the same group: Compared with before treatment, cough, sputum, lung auscultation, fatigue, complexion, sweating, loose stools, and appetite were significantly improved (P < 0.001)

[0317] 7.5 Follow-up results after treatment

[0318] 7.5.1 Post-treatment follow-up in terms of gender, clinical symptoms and signs

[0319] (1) Gender distribution: According to the data table, male participants accounted for 76.81% and female participants accounted for 23.19%. This shows that in this survey, male participation was significantly higher than female participation. See Table 24.

[0320] Table 24 Gender survey statistics

[0321] Options Subtotal Proportion male 53 76.81％ female 16 23.19％ Number of valid responses to this question 69

[0322] (2) Cough and sputum: According to the data table, 62.32% of the participants said "no cough", while 36.23% of the participants said "occasionally cough". This shows that most people do not have cough symptoms, and the proportion of occasional cough is relatively high, but still in a relatively small range. The proportion of intermittent cough is extremely low, accounting for only 1.45%. See Table 25.

[0323] Table 25 Cough and sputum situation

[0324] Options Subtotal Proportion none 43 62.32％ Occasional cough 25 36.23％ Intermittent cough that does not affect rest and sleep 1 1.45％ Frequent coughing during the day and night, affecting rest and sleep 0 0％ Number of valid responses to this question 69

[0325] The vast majority of respondents (82.61%) said they did not cough up phlegm, a few (15.94%) had little phlegm, and only 1.45% said they had a little more phlegm in their throats, while no one chose "phlegm in the throat, like roaring, and a lot of phlegm". This shows that most people are in a good condition in terms of coughing up phlegm, and only a very small number of people have mild phlegm symptoms. See Table 26.

[0326] Table 26 Respondents' cough and sputum

[0327] Options Subtotal Proportion none 57 82.61％ Less sputum 11 15.94％ More phlegm in throat 1 1.45％ Phlegm in the throat, like roaring, large amount of phlegm 0 0％

[0328] (3) Fatigue and complexion: From the data, it can be seen that all participants selected the option of “normal”, indicating that they did not feel tired or weak. See Table 27.

[0329] Table 27 Fatigue statistics

[0330] Options Subtotal Proportion normal 69 100％ Fatigue, lack of energy after activity, and less activity than usual 0 0％ Number of valid responses to this question 69

[0331] According to the data table, the vast majority of respondents (98.55%) have normal complexion, and only 1.45% have pale yellow complexion. This shows that the overall health of the respondents is good, and the proportion of normal complexion is much higher than the proportion of pale yellow complexion. See Table 28.

[0332] Table 28 Complexion Statistics

[0333] Options Subtotal Proportion normal 69 98.55％ Pale yellow complexion 1 1.45％ Number of valid responses to this question 69

[0334] (4) Sweating and loose stools: Through the analysis of the data, it can be seen that among the participants, 68.12% of them believed that their sweating was normal, while 31.88% said that they still sweated a lot when they were at rest. This shows that the sweating of most participants is within the normal range, but a considerable number of people still have abnormal sweating. See Table 29.

[0335] Table 29 Sweating Statistics

[0336] Options Subtotal Proportion normal 47 68.12％ Sweating even at rest 22 31.88％ Number of valid responses to this question 69

[0337] According to the data table, the vast majority of respondents (98.55%) said they did not have loose stools, and only 1.45% of respondents said they had loose stools. This shows that the incidence of loose stools in this sample is extremely low, which may be related to the good health of the respondents. See Table 30.

[0338] Table 30 Statistics of loose stools

[0339] Options Subtotal Proportion none 68 98.55％ have 1 1.45％ Number of valid responses to this question 69

[0340] (5) Appetite: According to the data table, 79.71% of the participants chose "normal", while 20.29% chose "reduced". This shows that the eating status of most participants is considered normal, but there is still a relatively high proportion (20.29%) who think that their diet has decreased. See Table 31.

[0341] Table 31 Appetite Statistics

[0342] Options Subtotal Proportion normal 55 79.71％ reduce 14 20.29％ Number of valid responses to this question 69

[0343] (6) Overall feeling after using the paste prescription:

[0344] According to data analysis, 37.68% of users gave feedback of "very good" and 60.87% of users said "average", indicating that most users were neutral about the effect of the paste, and only a few users (1.45%) felt "not very good", and no user chose "very bad". See Table 32.

[0345] Table 32 Overall feeling

[0346] Options Subtotal Proportion A Very good 26 37.68％ BGeneral 42 60.87％ C is not good 1 1.45％ D Very bad 0 0％ Number of valid responses to this question 69

[0347] (7) Adverse reactions:

[0348] According to the data table, all participants did not experience adverse reactions during the use of the paste prescription, and option B "none" accounted for 100%. See Table 33.

[0349] Table 33 Adverse reaction status

[0350] Options Subtotal Proportion Yes 0 0％ BNo 69 100％ C Uncertain 0 0％ Number of valid responses to this question 69

[0351] 7.5.2 General follow-up after treatment

[0352] This questionnaire survey collected a total of 69 valid samples, mainly analyzing the recognition and related experiences of children and parents after using the paste prescription. The results are as follows:

[0353] (1) Gender distribution: Male participants accounted for 76.81% and female participants accounted for 23.19%. The proportion of males in the sample was significantly higher than that of females.

[0354] (2) Cough and sputum: Most participants (62.32%) said they did not have a cough, and 82.61% of the participants did not have sputum, indicating that the overall respiratory symptoms of the group using the paste prescription were milder.

[0355] (3) Fatigue and complexion: All participants reported a normal mental state and 98.55% had a normal complexion, indicating that the paste formula has a positive effect on improving physical fitness.

[0356] (4) Sweating and loose stools: 68.12% of the participants thought that their sweating was normal and that they had almost no loose stools (98.55% said that they had no loose stools), reflecting that they were in good physical condition after using the paste prescription.

[0357] (5) Appetite: 79.71% of the participants reported a normal appetite, and 20.29% reported a decreased appetite.

[0358] (6) Overall feeling after using the paste prescription: 37.68% of the participants thought the overall feeling was very good, and 60.87% thought it was just average, indicating that most people were satisfied with the experience of using the paste prescription.

[0359] (7) Degree of health improvement: 37.68% of respondents believed that their health status had improved significantly, 57.97% believed that it had improved to a certain extent, and only 4.35% said that there had been no change. No one reported that their condition had worsened.

[0360] (8) Compliance with doctor's orders: 40.58% of the participants always followed the doctor's orders, and the majority (55.07%) followed them most of the time, indicating that the participants attached great importance to the doctor's orders.

[0361] (9) Convenience of taking the medicine: 53.62% of the respondents thought that the process of taking the paste prescription was very convenient, and 42.03% thought it was relatively convenient, which reflects that the experience of taking the paste prescription was good.

[0362] (10) Taste satisfaction: 47.83% of the respondents were very satisfied with the taste of the paste, and 49.28% were somewhat satisfied. The overall taste evaluation was high.

[0363] (11) Adverse reactions: All participants reported that they did not experience any adverse reactions during the use of the paste prescription, indicating that the paste prescription is relatively safe.

[0364] In summary, participants who used the paste prescriptions were generally satisfied with their effects and experiences, and performed well in terms of health improvement, compliance with doctor's orders, and ease of use.

[0365] 8 Comprehensive efficacy analysis

[0366] The results of this study showed that Zengmian Huyuan Paste can improve the symptoms and signs of children with lung disease and lung and spleen deficiency syndrome, with a total effective rate of 97.1%. This shows that Zengmian Huyuan Paste can significantly improve the clinical symptoms and signs of children with lung disease and lung and spleen deficiency syndrome, and is an effective and safe Chinese medicine preparation for treating children with lung disease and lung and spleen deficiency syndrome, and is worthy of promotion and application in clinical practice.

[0367] Typical case scenario:

[0368] Case 1

[0369] The patient, Shen xx, male, 7 years old, visited the pediatric outpatient clinic of our hospital on May 5, 2024.

[0370] Symptoms: susceptible, obese, occasional cough, little sputum, coarse breath sounds in both lungs, poor spirit, excessive sweating, normal bowel movements, pale tongue with greasy white coating, and weak pulse.

[0371] TCM diagnosis and syndrome differentiation: cough due to deficiency of lung and spleen

[0372] Western medicine diagnosis: cough recovery period

[0373] Syndrome analysis: This patient has a sign of both lung and spleen deficiency. The lung controls qi and respiration, and is connected to the skin and fur. Lung deficiency means that the defense against external pathogens is not solid, and the patient is easily invaded by external pathogens. Therefore, the patient has repeated respiratory tract infections. After the onset of the disease, the patient's body is weak and unable to resist pathogens, resulting in a prolonged course of illness, a difficult cough, a low voice and a weak breath. The lung qi is weak, the release and descent are abnormal, and the distribution of body fluids is disordered, which condenses into phlegm, so the sputum is clear and thin. The spleen is the foundation of the acquired constitution, the source of qi and blood production, and is responsible for transporting and transforming water, grain and moisture. If the spleen is weak, it will lose qi when it moves. If the lung and spleen qi are weak, the body will lose its function of consolidation and control, and the body fluid will leak out and cause sweating. The pale tongue coating is white and greasy, and the pulse is thin and weak, which are all evidences of both lung and spleen deficiency and internal accumulation of phlegm and dampness.

[0374] Treatment process: At the first visit, 2 doses of Zengmi Huyuan ointment were given, 2 times a day, 3 spoons each time, warm. Montelukast was taken orally once before bedtime. The child was advised to avoid wind and keep warm, and eat a light and easy-to-digest diet. At the second visit, the child's cough was relieved, sputum was smoother than before, and the appetite was slightly increased. He still sweated a lot when moving, so he continued to take the medicine. At the third visit, the cough basically disappeared, the complexion turned slightly ruddy, the mental state improved, and he sweated a lot when sleeping. All the symptoms of the child were eliminated. After 3 months of follow-up, the number of respiratory tract infections decreased sharply and the physical condition was significantly improved.

[0375] Case 2

[0376] The patient, Chen XX, male, 3 years old, had lung disease [lung and spleen deficiency syndrome] and was admitted to the pediatric outpatient clinic of our hospital on July 7, 2024.

[0377] Chief complaint: cough recovery period

[0378] Current medical history: The child is susceptible to bronchitis or bronchopneumonia about 2-3 times a month. The main clinical manifestations are persistent cough, clear and thin sputum, loss of appetite, abdominal distension and loose stools, and excessive sweating during sleep. He has visited the local hospital many times, and the above symptoms still recur after symptomatic treatment. He is in good spirits, but has poor appetite and sleep, loose stools, 1-2 times / day, and normal urination.

[0379] Current symptoms: Occasionally, there is a single cough, which is worse in the morning and at night. The cough is aggravated by cold air stimulation, and white thin sputum is coughed up. The abdomen is slightly swollen, but there is no fever, nasal congestion, runny nose, wheezing, shortness of breath, or breathing difficulties. There is no barking cough or chicken-like tail sound, no vomiting, abdominal pain, etc. The patient is clear-minded, in good spirits, the throat is not red, the heart rhythm is regular, and no murmurs are heard in the valve areas. The breath sounds of both lungs are clear, and no dry or wet rales are heard. The abdomen is slightly swollen, and no masses are palpable in the whole abdomen.

[0380] Tongue appearance: Pale tongue, white and slightly greasy coating

[0381] Pulse: Weak pulse

[0382] Past medical history: Denied history of hypertension. Denied history of diabetes. Denied history of heart disease. Denied history of surgical trauma. Denied history of smoking.

[0383] TCM diagnosis and syndrome differentiation: lung diseases, lung and spleen deficiency

[0384] Western medicine diagnosis: bronchial pneumonia

[0385] Syndrome differentiation and analysis: This syndrome is characterized by cough, asthma, poor appetite, and loose stools caused by deficiency of both the lung and spleen. The spleen and stomach are the source of diseases, and the lung and stomach are the organs for storing diseases. When the spleen is deficient and its function is impaired, there will be loss of appetite, abdominal distension, and loose stools; when the spleen is deficient, dampness will be generated, and dampness will accumulate to generate phlegm, which will be mostly thin and white. The phlegm will be stored in the lungs, and the lung qi will be unfavorable, resulting in persistent cough and asthma.

[0386] Auxiliary examination: None.

[0387] Treatment principle: Strengthen the spleen and benefit the lungs

[0388] Theory, method and prescription: Zengmian Huyuan Paste

[0389] Syndrome differentiation and treatment: Eat a light diet and avoid eating raw, cold, sweet and greasy foods

[0390] The TCM diagnosis was: lung disease and lung and spleen deficiency, and the patient was treated with Zengmian Huyuan Paste. After 15 days of treatment, the patient was reexamined and the symptoms were gradually alleviated, with no nasal congestion or cough, and the symptoms and signs were basically relieved.

[0391] Case 3

[0392] The patient, Wu XX, male, 3 years old, visited the pediatric outpatient clinic of our hospital on October 12, 2024.

[0393] Current medical history: susceptible to infection, sweating, bad breath, loss of appetite, abdominal distension, loose stools, poor sleep, easy to turn over. History of high fever convulsions. Cough for 2 weeks, cough after catching a cold 3 weeks ago. Cefuroxime, chlorhexidine, etc. were given. The symptoms were slightly relieved by drug treatment, but the patient still coughs and expectorates, and the remaining sputum is not completely gone. The sputum is mostly thin and white, the nasal mucosa is slightly red, the throat is slightly red, and the tonsils are enlarged I°. Tongue: The tongue is pale white, with a white and slightly greasy coating.

[0394] Past medical history: Denied history of hypertension. Denied history of diabetes. Denied history of heart disease. Denied history of surgical trauma.

[0395] TCM diagnosis and syndrome differentiation: lung disease, lung and spleen deficiency, Western medicine diagnosis: recurrent respiratory tract infection

[0396] Syndrome differentiation and analysis: The spleen and stomach are the source of diseases, while the lungs and stomach are the organs for storing diseases. When the spleen is weak and its function is impaired, there will be loss of appetite, abdominal distension and loose stools; when the spleen is weak, dampness will be generated, and dampness will accumulate and generate phlegm, which will be mostly thin and white, and will be stored in the lungs. If the lung qi is not smooth, there will be constant coughing and asthma.

[0397] Syndrome differentiation and treatment: Eat a light diet and avoid eating raw, cold, sweet and greasy foods

[0398] Auxiliary examination: None.

[0399] Treatment principle: Strengthen the spleen and benefit the lungs

[0400] Theory, method and prescription: Zengmian Huyuan Paste

[0401] Syndrome differentiation and treatment: Eat a light diet and avoid eating raw, cold, sweet and greasy foods

[0402] The diagnosis of TCM is: lung disease and lung and spleen deficiency, and the treatment is treated with Zengmian Huyuan paste. Follow-up after 30 days of treatment showed that the symptoms were significantly alleviated, the number of respiratory tract infections decreased sharply, and the physical condition was significantly improved.

[0403] Although the present invention has been described in detail above by means of general description, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine composition for treating lung and spleen deficiency syndrome, characterized in that: The invention is composed of the following raw material ingredients in parts by weight: 15-25 parts of astragalus, 5-15 parts of siler, 5-15 parts of pseudoginseng, 5-15 parts of tangerine peel, 5-15 parts of yam, 5-15 parts of polygonatum sibiricum, 5-15 parts of fructus ligustris, 5-15 parts of atractylodes, 4-8 parts of stir-fried atractylodes with bran, 4-8 parts of pure hawthorn, 4-8 parts of stir-fried malt, 4-8 parts of stir-fried rice sprouts, 4-8 parts of stir-fried radish seeds, 4-8 parts of stir-fried fructus aurantii, 4-8 parts of kudzu root, and 4-8 parts of liquorice tablets.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is composed of the following raw material ingredients in parts by weight: 18-22 parts of astragalus, 8-12 parts of siler, 8-12 parts of pseudoginseng, 8-12 parts of tangerine peel, 8-12 parts of yam, 8-12 parts of polygonatum sibiricum, 8-12 parts of fructus ligustris, 8-12 parts of atractylodes, 5-7 parts of stir-fried atractylodes with bran, 5-7 parts of pure hawthorn, 5-7 parts of stir-fried malt, 5-7 parts of stir-fried rice sprouts, 5-7 parts of stir-fried radish seeds, 5-7 parts of stir-fried fructus aurantii, 5-7 parts of kudzu root, and 5-7 parts of liquorice tablets.

3. The Chinese medicine composition according to claim 2, characterized in that: The composition is composed of the following raw materials in parts by weight: 20 parts of astragalus, 10 parts of siler, 10 parts of pseudoginseng, 10 parts of tangerine peel, 10 parts of yam, 10 parts of polygonatum sibiricum, 10 parts of Ligustrum lucidum, 10 parts of atractylodes, 6 parts of stir-fried atractylodes, 6 parts of clean hawthorn, 6 parts of stir-fried malt, 6 parts of stir-fried rice sprouts, 6 parts of stir-fried radish seeds, 6 parts of stir-fried fructus aurantii, 6 parts of kudzu root, and 6 parts of liquorice tablets.

4. A method for preparing a Chinese medicine composition for treating lung and spleen deficiency syndrome as claimed in any one of claims 1 to 3, characterized in that: The steps include: (1) Weighing the medicinal materials: weighing astragalus, saposhnikovia divaricata, Pseudostellaria pseudoginseng, dried orange peel, Chinese yam, Polygonatum sibiricum, Ligustrum lucidum, Atractylodes macrocephala, stir-fried Atractylodes lancea, clean hawthorn, stir-fried malt, stir-fried rice sprouts, stir-fried radish seeds, stir-fried Citrus aurantium, Pueraria root, and liquorice tablets according to the proportion of the formula; (2) Decoction: put all the herbs into a double-layer filter bag, add water and decoct for 1-3 times, add 7.5-11.5 times the amount of water for the first time, and add 6-10 times the amount of water for the second and third times, decoct for 0.5-1 h each time, and combine the decoctions; (3) Concentration: Combine the decoctions and concentrate to a clear paste with a relative density of 1.18-1.22 at 60°C; (4) Prepare the finished product by mixing the ingredients: add sucrose to the clear paste and dissolve it, concentrate it to a relative density of 1.30-1.35 at 60°C, and package it.

5. The preparation method according to claim 4, characterized in that: The decoction was performed three times, with 7.5 times the amount of water added for the first time and 6 times the amount of water added for the second and third times, and each decoction was performed for 1 hour.

6. The preparation method according to claim 4, characterized in that: The amount of sucrose used is 20-40 parts.

7. The preparation method according to claim 4, characterized in that: The amount of sucrose used is 30 parts.

8. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the thick paste prepared by the preparation method according to any one of claims 4 to 7 in preparing a pharmaceutical preparation for treating lung and spleen deficiency syndrome.

9. The use according to claim 8, characterized in that: The pharmaceutical preparation comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 or the clear paste prepared by the preparation method according to any one of claims 4 to 7 and pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that The pharmaceutical preparation is ointment, decoction, mixture, syrup, granule, capsule, tablet, pill or gel.

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