Traditional chinese medicine composition for replenishing qi and enhancing immunity in children, preparation method therefor, and use thereof

Abstract

A traditional Chinese medicine composition for replenishing qi and enhancing immunity in children, a preparation method therefor, and use thereof. The traditional Chinese medicine composition comprises the following raw materials: 5-10 parts by weight of Codonopsis radix, 10-20 parts by weight of Ficus hirta, 10-20 parts by weight of Poria, 10-20 parts by weight of Hordei germinatus fructus, and 10-20 parts by weight of Mume fructus. Codonopsis radix, as a monarch drug, and Ficus hirta, as a minister drug, cooperate to invigorate the spleen, replenish qi, and regulate the immune function of the body. Moreover, Poria, Hordei germinatus fructus, and Mume fructus are used to invigorate the spleen, promote digestion, and nourish yin. The traditional Chinese medicine composition can ameliorate clinical symptoms in pediatric patients with recurrent respiratory tract infection.

Description

A traditional Chinese medicine composition for replenishing qi and boosting immunity in children, its preparation method and application Technical Field This invention belongs to the field of food and medicine homology health food technology, specifically relating to a traditional Chinese medicine composition for children to replenish qi and enhance immunity, its preparation method and application. Background Technology Recurrent respiratory tract infection (RRTI) in children refers to a clinical condition characterized by an increased frequency of upper or lower respiratory tract infections exceeding normal limits within one year. In my country, approximately 80% of pediatric outpatient visits are for respiratory illnesses, with RRTI accounting for over 50% of these cases. Children have weak immune systems and their bodily functions are not yet fully developed. RRTI is characterized by its prolonged duration and recurring episodes. If not treated thoroughly, it can easily lead to multi-systemic diseases such as asthma, nephritis, myocarditis, and meningitis, severely impacting the child's health and growth, and even increasing the risk of chronic heart and lung diseases in adulthood. Immunomodulators are the basic clinical medications for RRTI, with commonly used drugs including spleen peptide, pidotimod, and panfuscated levofloxacin. However, these drugs are not only expensive, but symptoms are also prone to recurrence after discontinuation. In recent years, with the accumulation of clinical evidence, the treatment of recurrent respiratory tract infections (RRTI) using traditional Chinese medicine (TCM) has gradually gained attention. Although some TCM herbs are already used to treat RRTI in clinical practice, their clinical efficacy is not very satisfactory. Therefore, it is necessary to develop a combination of medicinal and edible herbs that can effectively prevent and treat RRTI to meet the body's daily defense needs. Summary of the Invention The first objective of this invention is to provide a traditional Chinese medicine composition for replenishing qi and boosting immunity in children. The second objective of this invention is to provide a method for preparing the traditional Chinese medicine composition. The third objective of this invention is to provide the application of the traditional Chinese medicine composition. According to a first aspect of the present invention, a traditional Chinese medicine composition for children to replenish qi and enhance immunity is provided, wherein the raw materials comprising, by weight, are: 5-10 parts of Codonopsis pilosula, 10-20 parts of Ficus hirta, 10-20 parts of Poria cocos, 10-20 parts of malt, and 10-20 parts of Prunus mume. This invention posits that children with recurrent respiratory infections are mostly in a state of immune imbalance, primarily manifesting as recurrent colds, pharyngitis, tracheitis, and pneumonia. Therefore, based on their pathogenesis and clinical manifestations, this invention proposes a formula using the principles of traditional Chinese medicine differentiation and treatment. Codonopsis pilosula is the chief herb in this formula, specifically tonifying the Qi of the lungs and spleen. Ficus hirta also strengthens the spleen and lungs, serving as an assistant herb. Together, they greatly tonify the Qi of the lungs and spleen, and jointly regulate the body's immune function. Poria cocos strengthens the spleen, tonifies Qi, and eliminates dampness; malt strengthens the spleen and aids digestion; and dried plum nourishes Yin, stimulates appetite, eliminates phlegm, quenches thirst, regulates the middle Jiao, and astringes lung Qi. The combined effects of these herbs, while tonifying the spleen and lungs, also aid digestion and harmonize the middle Jiao, preventing excessive tonification that could stagnate the Qi of the lungs and spleen. Dried plum also nourishes Yin and moistens dryness, mitigating the excessive warming and drying properties of Codonopsis pilosula. The entire formula works synergistically to tonify Qi and enhance immunity, effectively improving the clinical symptoms of children with recurrent respiratory infections. The raw materials for this formula come from the following sources: Codonopsis pilosula: The root of Codonopsis pilosula (Franch.) Nannf., Codonopsis pilosula Nannf. var. (Nannf.) L.Shen, or Codonopsis tangshen Oliv., all belonging to the genus Codonopsis of the family Campanulaceae. Five-finger fig: The root of Ficus simplicissima Lour., a plant in the Moraceae family. Poria: The dried sclerotium of the fungus Poriacocos (Schw.) Wolf, belonging to the genus Poria in the family Polyporaceae. Malt: The mature fruit of barley (Hordeum vulgare L.), a plant belonging to the genus Hordeum in the family Poaceae, is germinated and dried. Ume: The nearly mature fruit of Prunus mume (Sieb.) Sieb. et Zuce., a plant belonging to the genus Prunus in the family Rosaceae. The raw materials Codonopsis pilosula, Poria cocos, malt, and dried plum in the herbal composition of this invention belong to substances that are "both food and traditional Chinese medicine" (as stated in the "Notice of the Ministry of Health on Further Regulating the Management of Raw Materials for Health Foods").

[2002] According to Announcement No. 51 and Announcement No. 9 of 2023, which states that Codonopsis pilosula and 9 other substances are traditionally both food and Chinese medicinal materials, Five-finger Peach is classified as a common food (Reply from the General Office of the National Health and Family Planning Commission on Issues Related to Five-finger Peach (National Health and Family Planning Commission Office Food Letter

[2014] No. 205)). All the ingredients in the formula are Chinese medicinal materials that can be used in health food, and their sources are safe and reliable. In some embodiments, the dosage form of the traditional Chinese medicine composition is an oral solution, powder, or granule. In some implementations, food- or pharmaceutically acceptable excipients may also be added. In some embodiments, the excipient is at least one selected from the following: sustained-release agent, excipient, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant. According to a second aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition for replenishing qi and enhancing immunity in children is provided. When the dosage form of the traditional Chinese medicine composition is an oral solution, the preparation method includes the following steps: Soak the raw materials in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and maintain a gentle boil for 1-2 hours. Filter, and repeat the decoction process on the residue 1-2 times. Combine the filtrates to obtain the final product. After cooling, the oral solution is dispensed for easy carrying and distribution. According to a third aspect of the present invention, a method for preparing the above-mentioned traditional Chinese medicine composition for replenishing qi and enhancing immunity in children is provided. When the dosage form of the traditional Chinese medicine composition is a powder, the preparation method includes the following steps: Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it. According to a fourth aspect of the present invention, the above-described traditional Chinese medicine composition for replenishing qi and boosting immunity in children is provided for use in the preparation of a food-medicine homology composition for improving or preventing recurrent respiratory infections in children. According to a fifth aspect of the present invention, the above-described traditional Chinese medicine composition for replenishing qi and enhancing immunity in children is provided for use in the preparation of food-medicine homologous health products that improve the body's immune function and / or prevent and treat colds, pharyngitis, bronchitis or pneumonia. The beneficial effects of this invention include: (1) The traditional Chinese medicine composition for children to replenish qi and enhance immunity of the present invention can effectively improve the immune imbalance of children with recurrent respiratory infections, enhance the body's immune function, and reduce the number of colds, pharyngitis, bronchitis, pneumonia and the number of recurrent respiratory infections. (2) This invention uses a clever combination of ingredients, with Codonopsis pilosula as the principal ingredient and Prunus cerasifera as the assistant ingredient, to strengthen the spleen and replenish qi, and regulate the body's immune function. At the same time, it is combined with Poria cocos, malt, and Prunus mume to strengthen the spleen, promote digestion, and nourish yin. The whole formula is a combination of moistening and drying, which can strengthen the spleen and lungs, and nourish without harming the spleen and stomach, and warm without drying, so as to achieve the effect of replenishing qi and enhancing immunity. Clinical studies have found that the traditional Chinese medicine composition for children to replenish qi and enhance immunity of this invention can significantly improve the clinical symptoms of children with recurrent respiratory infections. Detailed Implementation The present invention will be further described in detail below with reference to specific embodiments. It is worth noting that the following embodiments are only for better explaining the content of the present invention and do not limit the scope of protection of the present invention. Process steps not disclosed in the embodiments are prior art. Unless otherwise specified, all raw materials are commercially available. Example 1 The oral solution for children to replenish qi and boost immunity in this embodiment consists of the following ingredients: Codonopsis pilosula 5g, Ficus hirta 10g, Poria cocos 10g, Hordeum vulgare 10g, and Prunus mume 10g. Its preparation method includes the following steps: (1) Soak the raw materials in 10 times their weight of water for 30 minutes, then heat to boiling and keep simmering for 1 hour. After separation, the first decoction and the dregs are obtained. Take the dregs obtained after the first decoction, add water equivalent to 8 times the total weight of the raw materials, heat to boiling and keep simmering for 1 hour. After separation, the second decoction and the dregs are obtained. Combine the first decoction and the second decoction to obtain an oral solution. (2) Cool the obtained oral solution and dispense it. This ratio is for one dose, and one dose is approximately 150 mL. Example 2 The powder for children to replenish qi and boost immunity in this embodiment consists of the following ingredients: Codonopsis pilosula 5g, Ficus hirta 10g, Poria cocos 10g, Hordeum vulgare 10g, and Prunus mume 10g. Its preparation method includes the following steps: (1) Take Codonopsis pilosula, crush it, and pass it through a 10-mesh and a 50-mesh sieve at the same time. Continue to crush the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. (2) Grind the five-finger peach, poria cocos, malt and dried plum into powder according to the method in step (1); (3) Mix all the raw material powders evenly, pack them into a sealed bag, and seal it. When taking it, dissolve it in about 150mL of warm water. Example 3 The oral solution for replenishing qi and boosting immunity in children in this embodiment consists of the following ingredients: Codonopsis pilosula 7g, Ficus hirta 15g, Poria cocos 15g, Hordeum vulgare 15g, and Prunus mume 15g. Its preparation method is the same as in Example 1. Example 4 The powder for replenishing qi and boosting immunity in children in this embodiment consists of the following ingredients: 10g of Codonopsis pilosula, 20g of Ficus hirta, 20g of Poria cocos, 20g of malt, and 20g of Prunus mume. Its preparation method is the same as in Example 2. The oral solution for boosting qi and immunity in children prepared in Example 1 was used in children with recurrent respiratory infections. Information on gender, age, symptoms, and follow-up symptoms of 30 children with recurrent respiratory infections was collected from August 5, 2024 to August 30, 2024, and their main symptoms were scored. The 30 children with recurrent respiratory infections ranged in age from 2 to 14 years, with a mean age of 7.35 years; there were 19 males and 11 females. The main symptoms before medication included nasal congestion, cough, sneezing, sweating, fatigue, and poor appetite. A comparative study was conducted on the symptoms of 30 children with recurrent respiratory infections before and after taking the Children's Qi-Boosting and Immunity-Enhancing Oral Solution. The results showed that the average scores of symptom evaluation for nasal congestion, cough, sneezing, excessive sweating, fatigue, and poor appetite were all lower after taking the oral solution than before (Table 1). This indicates that the Children's Qi-Boosting and Immunity-Enhancing Oral Solution is significantly effective in relieving or improving symptoms such as nasal congestion, cough, sneezing, excessive sweating, fatigue, and poor appetite caused by recurrent respiratory infections in children (P<0.05). The research results suggest that the traditional Chinese medicine composition of the present invention has a good effect on improving symptoms such as nasal congestion, cough, sneezing, excessive sweating, fatigue, and poor appetite in children caused by recurrent respiratory infections. This indicates that the traditional Chinese medicine composition of the present invention has a good effect on improving recurrent respiratory infections in children. Table 1. Statistical analysis of the effects of children's qi-boosting and immunity-enhancing oral solutions on symptoms of recurrent respiratory infections. The above descriptions are merely some specific embodiments of the present invention. For those skilled in the art, various modifications and improvements can be made without departing from the inventive concept of the present invention, and all such modifications and improvements fall within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for replenishing qi and boosting immunity in children, characterized in that, The raw material composition by weight includes: 5-10 parts of Codonopsis pilosula, 10-20 parts of Ficus hirta, 10-20 parts of Poria cocos, 10-20 parts of malt, and 10-20 parts of dried plum.

2. The traditional Chinese medicine composition for replenishing qi and boosting immunity in children according to claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is an oral solution, powder, or granule.

3. The traditional Chinese medicine composition for replenishing qi and enhancing immunity in children according to claim 1 or 2, characterized in that, Pharmaceutically acceptable excipients can also be added.

4. The traditional Chinese medicine composition for replenishing qi and boosting immunity in children according to claim 3, characterized in that, The excipients are at least one of the following: sustained-release agent, excipient, filler, binder, wetting agent, disintegrant, absorption promoter, adsorbent carrier, surfactant, and lubricant.

5. A method for preparing the traditional Chinese medicine composition for replenishing qi and boosting immunity in children according to any one of claims 1-4, characterized in that, When the dosage form of the traditional Chinese medicine composition is an oral solution, its preparation method includes the following steps: Soak the raw materials in 8-12 times their weight of water for 20-40 minutes, then heat to boiling and maintain a gentle boil for 1-2 hours. Filter the mixture and boil the residue 1-2 times. Combine the filtrates to obtain the final product.

6. A method for preparing the traditional Chinese medicine composition for replenishing qi and boosting immunity in children according to any one of claims 1-4, characterized in that, When the dosage form of the traditional Chinese medicine composition is a powder, its preparation method includes the following steps: Crush or chop each raw material separately, then pass the crushed or chopped raw materials through 10-mesh and 50-mesh sieves respectively. Continue to crush or chop the coarse particles that cannot pass through the 10-mesh sieve, and take the powder that is between the 10-mesh and 50-mesh sieves. Then mix the powders of each raw material according to the formula, put them into a packaging bag, and seal it.

7. The use of the traditional Chinese medicine composition for replenishing qi and boosting immunity in children according to any one of claims 1-4 in the preparation of a health product that is both food and medicine, for improving or preventing recurrent respiratory infections in children.

8. The use of the traditional Chinese medicine composition for replenishing qi and enhancing immunity in children according to any one of claims 1-4 in the preparation of a health product that is both food and medicine, which improves the body's immune function and / or prevents and treats colds, pharyngitis, bronchitis or pneumonia.

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