CN116077586A

CN116077586A - Dendrobium officinale and ginseng immunity enhancing pharmaceutical composition and preparation method and application thereof

Info

Publication number: CN116077586A
Application number: CN202211370461.9A
Authority: CN
Inventors: 张敬杰; 罗玉玲; 刘志伟; 屈相玲; 杨仁惠; 杨元凤; 陈永敏; 周训蓉; 高永跃; 陈竹; 徐献梅; 吴燕
Original assignee: Second Affiliated Hospital Of Guizhou University Of Traditional Chinese Medicine
Current assignee: Second Affiliated Hospital Of Guizhou University Of Traditional Chinese Medicine
Priority date: 2022-11-03
Filing date: 2022-11-03
Publication date: 2023-05-09

Abstract

The invention provides a dendrobium candidum and ginseng immunity-enhancing pharmaceutical composition, and a preparation method and application thereof, wherein the dendrobium candidum and ginseng immunity-enhancing pharmaceutical composition comprises the following raw materials: dendrobium officinale, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, charred hawthorn, radix ophiopogonis and sodium benzoate, and the preparation method comprises the following steps: soaking six Chinese medicinal decoction pieces such as herba Dendrobii in filter bag for 2 hr, decocting for 3 times, adding 8 times of water for the first time, adding 6 times of water for 2 nd and 3 times, decocting for 30min, filtering, mixing decoctions, concentrating the filtrate to relative density of 1.10-1.13 at 50deg.C, adding sodium benzoate, stirring, dissolving, mixing, cooling, and packaging. The obtained pharmaceutical composition has effects of nourishing yin, clearing heat, invigorating qi, promoting salivation, and invigorating stomach. The preparation method is simple and convenient, is convenient for production control, has good stability and high safety, and can be used for standardized and large-scale production; the prepared product has good taste, is free from adding any flavoring agent, and is very suitable for children to take. Not only enriches the clinical medicines for treating children with lung-spleen yin deficiency syndrome, but also has important significance for promoting dendrobium to become the Guizhou big health industry.

Description

Dendrobium officinale and ginseng immunity enhancing pharmaceutical composition and preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a dendrobium nobile ginseng immunity-enhancing pharmaceutical composition, and a preparation method and application thereof.

Background

The invention aims to take the traditional rare traditional Chinese medicine "dendrobium" as a tongs and carry out the research and development of hospital preparations on the empirical prescription "Dendrobium ginseng immunity enhancing mixture (prescription: dendrobium officinale, astragalus, dwarf lilyturf tuber, radix pseudostellariae, dried rehmannia root and scorched hawthorn fruit)" which is the experience inheriter Chen Zhu of the national old traditional Chinese medicine expert academic experience with definite curative effect.

Dendrobium officinale is a dry stem of Dendrobium officinale Dendrobium officinale Kimura et Migo belonging to Orchidaceae. Harvesting for 11 months to 3 months next year, removing impurities, cutting off part of fibrous roots, twisting into spiral or spring shape while heating, and oven drying; or cutting into sections, drying or low-temperature drying, the former is known as "Dendrobium candidum" (Dendrobium otophyllum); the latter is known as "Dendrobium officinale". Sweet and slightly cold. Enter stomach and kidney meridians. Has effects of benefiting stomach, promoting salivation, nourishing yin, and clearing heat. Can be used for treating fever, fluid consumption, dry mouth, polydipsia, stomach yin deficiency, anorexia, retching, deficiency heat after illness, yin deficiency, fire hyperactivity, bone steaming, dim eyesight, and flaccidity of tendons and bones. Modern scientific research proves that the main active ingredients contained in the dendrobium candidum are dendrobium polysaccharide, dendrobine, astragalus, derivatives thereof, trace elements and the like ^[1] The chemical components of the dendrobium candidum are determined at present: polysaccharides, alkaloids, stilbenes, phenols, lignin, and the like, which have a variety of biological activities: regulating immunity, resisting oxidation, resisting tumor, reducing blood sugar, and resisting bacteria. ^[2] The dendrobium polysaccharide has close relation with the pharmacological activity. The polysaccharide content is the main basis for judging the quality of the dendrobium candidum. The dendrobium candidum polysaccharide has an antibacterial effect on staphylococcus aureus, escherichia coli and pneumococcus, and the result shows that the dendrobium candidum polysaccharide has an obvious antibacterial effect. ^[3] The fresh juice of Dendrobium officinale has analgesic and antiinflammatory effects. ^[4]

The radix astragali is dried root of Mongolian radix astragali Astragalus membranaceus (Fisch.) bge.var. Mongholicus (bge.) Hsiao or Astragalus membranaceus Astragalus membranaceus (Fisch.) bge. Collected in spring and autumn, removed fibrous root and root head, and dried in the sun. Sweet and slightly warm. Enter lung and spleen meridians. Tonifying qi and yang, strengthening exterior and arresting sweating, inducing diuresis and relieving edema, promoting fluid production and nourishing blood, promoting the circulation of qi and relieving arthralgia, expelling toxin and pus, healing sore and promoting tissue regeneration. Can be used for treating qi deficiency debilitation, loose stool, sinking of middle-jiao, chronic diarrhea rectocele, hematochezia metrorrhagia, spontaneous perspiration due to exterior deficiency, qi deficiency edema, internal heat diabetes, blood deficiency sallow complexion, hemiplegia, arthralgia, numbness, carbuncle, ulcer, and chronic ulcer Is not converged. Researchers have extracted and separated components such as saponins, polysaccharides, flavones, sterols, amino acids and volatile oils from astragalus. Wherein the components such as saponins, polysaccharides and flavonoids have remarkable chemical activity. The saponin compound is one of important active ingredients in astragalus mongholicus, and most of the saponin compounds are tetracyclic triterpenoid saponin compounds. More than 40 kinds of saponin compounds have been separated from Mongolian radix astragali, membranous milkvetch root and its congeneric plants, mainly including astragalus saponins I-VIII, iso-astragalus saponins I-IV, acetyl astragalus saponins, soybean saponins, etc ^[5] . Astragaloside IV (AS-IV) is a main component of astragalus root with heart strengthening effect, and has wide biological activities of protecting heart, resisting inflammation, resisting oxidation, resisting apoptosis, resisting virus, etc. ^[6] Astragalus Polysaccharides (APS) are the active ingredients with the highest activity in astragalus medicinal materials, and are also the hot content of modern medical research. APS are mainly composed of glucans, including water-soluble and water-insoluble glucans, and heteropolysaccharides, mostly water-soluble acidic heteropolysaccharides. APS participates in regulating organism immunity, and has anti-tumor, anti-infection activity, and cardiovascular protection effects ^[7] . A great deal of experimental researches show that the APS and the astragaloside have obvious immunoregulation effect ^[8] 。

Radix Pseudostellariae is dried root tuber of radix Pseudostellariae Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm of Caryophyllaceae. Most of the stems and leaves in summer withered are picked up, cleaned, removed, put into boiling water and dried in the sun or directly dried in the sun. Sweet and slightly bitter in flavor, neutral in nature. Enter spleen and lung meridians. Replenishing qi to invigorate the spleen, promoting fluid production and moistening the lung. Can be used for treating spleen deficiency, tiredness, inappetence, asthenia after illness, deficiency of qi and yin, spontaneous perspiration, thirst, and dry cough due to lung dryness. The radix pseudostellariae contains a plurality of active ingredients such as amino acid, polysaccharide, glycoside, phospholipid, cyclic peptide, volatile oil and the like, and the radix pseudostellariae has a plurality of biological activities such as enhancing organism, promoting immunity, SOD-like effect, relieving cough, resisting bacteria, resisting viruses and the like when reflecting the active ingredients. ^[9] The volatile oil content in the radix pseudostellariae is high, and researchers detect 78 volatile monomer components from the radix pseudostellariae volatile oil by using a GC-MS technology. The cyclopeptides are characteristic components of radix pseudostellariae, and researchers have separated 16 cyclopeptides from radix pseudostellariaeThe content of saponins in radix Pseudostellariae is low. Researchers separate and obtain various amino acids from radix pseudostellariae, wherein arginine content is highest, and contents of glutamic acid, alanine, aspartic acid and the like are also higher. ^[10]

Radix rehmanniae is fresh or dried root tuber of rehmannia Rehmannia glutinosa Libosch of Scrophulariaceae. Digging in autumn, removing head, fibrous root and silt, and fresh; or baking rehmanniae radix slowly until it is about eight times dry. The former is known as "fresh rehmannia root", and the latter is known as "Sheng Di Huang". The radix rehmanniae is sweet and cold. It enters heart, liver and kidney meridians. Clear heat and cool blood, nourish yin and promote the production of body fluid. Can be used for treating heat entering nutrient blood, toxic heat, speckle, hematemesis, epistaxis, yin injury due to heat disease, dark red tongue, polydipsia, constipation due to body fluid deficiency, yin deficiency, fever, bone steaming, internal heat, and diabetes. The main chemical components in the rehmannia root are saccharides, iridoid glycoside, amino acid and the like, which are also main active components. 8 sugars have been isolated and identified from rehmannia: stachyose, raffinose, glucose, sucrose, fructose, mannyltriase, verbascose and galactose. The rehmannia root has the highest polysaccharide component content and better water solubility, wherein the content of reducing sugar is 140.3-287.3mg.g ^-1 The method comprises the steps of carrying out a first treatment on the surface of the The polysaccharide content is 31.3-50.5 mg.g ^-1 。 ^[11] Rehmannia has the pharmacological activities of resisting oxidation, resisting aging, exciting immunity, reducing blood sugar, resisting cancer, resisting cerebral ischemia, protecting nerve center, promoting hematopoiesis and the like. The rehmannia polysaccharide has many pharmacological effects of resisting tumor, enhancing immunity, promoting hematopoiesis, reducing blood sugar, resisting oxidation, resisting anxiety, inducing BMSCs to differentiate into neuron-like cells, and is one of the main active ingredients of rehmannia. ^[12] The pharmacological experiment of the rehmannia glycoside D, A shows that the rehmannia glycoside D, A has the effects of nourishing yin, enriching blood and reducing blood sugar, and the research shows that the rehmannia glycoside D, A has good water solubility and strong thermal stability. ^[13]

The radix Ophiopogonis is dried root tuber of radix Ophiopogonis Ophiopogon japonicus (L.f) Ker-Gawl of Liliaceae. Collected in summer, washed, repeatedly exposed to the sun, piled up until the roots are dried, removed and dried. Sweet, slightly bitter and slightly cold. It enters heart, lung and stomach meridians. Nourishing yin, promoting salivation, moistening lung, and clearing away heart-fire. Can be used for treating cough due to yin deficiency, cough due to fatigue, sore throat, fluid consumption, thirst, internal heat, diabetes, vexation, insomnia, constipation due to intestinal dryness. Steroid saponin, highIsoflavone and ophiopogon polysaccharide are main active components of ophiopogon ^[14] . Radix Ophiopogonis flavone has physiological effects of resisting myocardial ischemia, resisting thrombosis, resisting oxidation, enhancing immunity, and resisting aging ^[15] Polysaccharide compounds in ophiopogon root have wide and effective functions, and monosaccharide composition mainly comprises fructose and glucose. The ophiopogon polysaccharide has the effects of reducing blood sugar, regulating immunity, relieving asthma, resisting allergy, resisting anoxia, resisting tumor, resisting myocardial ischemia and treating gastrointestinal tract. ^[16]

The fructus crataegi is dried mature fruit of Crataegus pinnatifida Crataegus pinnatifida Bge. Var. Major N.E. Br. or Crataegus pinnatifida Crat aegus pinnatifida Bge. Harvesting in autumn, slicing, and drying. Acid, sweet, slightly warm. It enters spleen, stomach and liver meridians. Promoting digestion, invigorating stomach, promoting qi circulation, removing blood stasis, eliminating turbid pathogen, and reducing blood lipid. Can be used for treating food stagnation, gastric distention, diarrhea, abdominal pain, blood stasis amenorrhea, puerperal blood stasis, especially abdominal pain, chest pain, hernia pain, and hyperlipidemia. The food-digesting and stagnation-removing effects of the charred fructus crataegi are enhanced. It can be used for treating food stagnation, diarrhea, and dysentery. Hawthorn is a medicinal and edible plant and contains various chemical components such as flavonoid, flavane, polymers thereof, triterpenes, organic acids and the like. The fructus crataegi total flavone has blood pressure lowering effect. ^[17] Flavone in fructus crataegi is the main component for reducing blood lipid. ^[18] The fructus crataegi decoction has effect in promoting cellular immunity of mice. Hawthorn flavone is a recognized class of compounds with the highest antioxidant potential. ^[19]

The invention carries out systematic pharmaceutical research on the dendrobium officinale and ginseng immunity enhancing mixture. Herba Dendrobii, sweet and slightly cold in the recipe, is a monarch drug, has the effects of nourishing yin, clearing heat, promoting fluid production and benefiting stomach, and is called as "nourishing yin, tonifying and precious product" in Ben Cao gang mu Mi Yi ". The radix pseudostellariae is sweet and flat and slightly bitter, is ministerial, can tonify qi of lung and spleen, promote fluid production and moisten lung, is a tonic for clearing and tonifying in qi-tonifying herbs, has mild action, and is suitable for the syndrome of deficiency of qi and yin of children. Astragalus root is also a ministerial drug, sweet and slightly warm, and enters lung and spleen meridians, so that the plum is called as "long of tonic" and astragalus root can tonify qi of the whole body, has the effects of invigorating yang, consolidating exterior and arresting sweating, expelling pus and promoting granulation, inducing diuresis and relieving edema, and has remarkable curative effects on infantile anemia, deficiency and hyperhidrosis, deficiency of both qi and blood, deficiency of yin and the like. The adjuvant drug ophiopogon root is sweet, slightly bitter and slightly cold, and the "Ben Cao Xin Zao" is called as "purging the internal heat of the lung, clearing heat evil in the stomach, removing deficiency heat, relieving lung dryness and relieving cough", and can strengthen the effects of nourishing yin, moistening lung, tonifying stomach and promoting fluid production ". The radix rehmanniae is sweet and cold, but has no greasy taste of prepared rehmannia root, can clear heat, nourish yin and promote the production of body fluid, and is suitable for the symptoms of incomplete waste heat and insufficient body fluid of children; the scorched hawthorn fruit is sweet and sour, slightly warm and unhealthy, has the functions of promoting digestion and invigorating stomach, and is good for promoting digestion and stagnation, and because most yin-nourishing medicines are sweet, cold and sticky, the scorched hawthorn fruit can pass qi and blood, so that the whole prescription is supplemented without stagnation and combined with dynamic and static. In conclusion, the whole formula has the effects of nourishing yin, clearing heat, tonifying qi, promoting the production of body fluid and tonifying stomach. After the invention is developed into the mixture, the drug effect substances of the traditional decoction are reserved, the stability of the product is improved by colleagues, the dosage is reduced, and the invention is more convenient for patients to carry. The clinical medicine for treating the children lung-spleen yin deficiency syndrome is enriched.

Disclosure of Invention

The invention aims to provide a dendrobium nobile ginseng immunity-enhancing pharmaceutical composition.

The invention also aims to provide a preparation method of the dendrobium candidum immunity-enhancing pharmaceutical composition.

The invention also aims to provide an application of the dendrobium candidum and ginseng immunity-enhancing pharmaceutical composition in preparing medicines for treating or/and preventing children's spleen-lung yin deficiency.

The invention is realized by the following scheme:

a pharmaceutical composition for enhancing immunity of dendrobium nobile lindl and ginseng comprises the following medicines in parts by weight: 152-168 parts of dendrobium candidum, 255-279 parts of astragalus membranaceus, 125-141 parts of radix pseudostellariae, 125-141 parts of radix rehmanniae, 125-141 parts of scorched hawthorn fruit and 125-141 parts of dwarf lilyturf tuber.

Further, the composition disclosed by the invention comprises the following medicines in parts by weight: 154-166 parts of dendrobium candidum, 258-276 parts of astragalus membranaceus, 127-139 parts of radix pseudostellariae, 127-139 parts of radix rehmanniae, 127-139 parts of scorched hawthorn fruit and 127-139 parts of dwarf lilyturf tuber.

Further, the composition disclosed by the invention comprises the following medicines in parts by weight: 156-164 parts of dendrobium candidum, 261-273 parts of astragalus membranaceus, 129-137 parts of radix pseudostellariae, 129-137 parts of radix rehmanniae, 129-137 parts of scorched hawthorn fruit and 129-137 parts of dwarf lilyturf tuber.

Further, the composition disclosed by the invention comprises the following medicines in parts by weight: 158-162 parts of dendrobium candidum, 264-270 parts of astragalus membranaceus, 131-135 parts of radix pseudostellariae, 131-135 parts of radix rehmanniae, 131-135 parts of scorched hawthorn fruit and 131-135 parts of dwarf lilyturf tuber.

Further, the composition of the invention comprises the following medicaments in part by weight: 160 parts of dendrobium candidum, 267 parts of astragalus membranaceus, 133 parts of radix pseudostellariae, 133 parts of radix rehmanniae, 133 parts of scorched hawthorn fruit and 133 parts of dwarf lilyturf tuber.

A preparation method of a dendrobium candidum and ginseng immunity-enhancing pharmaceutical composition comprises the following steps: loading six medicines of dendrobium officinale, astragalus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber in a prescription amount into a filter bag, soaking in water for 0.5-6h, decocting for 3 times, adding water which is 6-10 times of the total weight of the medicines in the first decoction, adding water which is 4-8 times of the total weight of the medicines in the second and third times, decocting for 0.5-1.0h each time, filtering, merging the decoctions, concentrating the filtrate to an extract with relative density of 1.05-1.18 at 50 ℃, adding sodium benzoate with the total amount of 0.1-0.3%, stirring, dissolving, cooling and split charging, or adding the collected filtrate into pharmaceutically acceptable auxiliary materials to prepare a pharmaceutically acceptable dosage form.

Further, the preparation method of the invention comprises the following steps: filling six medicines of dendrobium officinale, astragalus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking in water for 2 hours, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5 hour each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, cooling, split charging, or adding the collected filtrate into pharmaceutically acceptable auxiliary materials to prepare a pharmaceutically acceptable dosage form.

The acceptable auxiliary materials are one or more of sodium benzoate, sucrose, maltose, rock sugar, refined honey, dextrin, colloidal silicon dioxide and starch.

The acceptable dosage forms of the invention are mixture, paste, granule, syrup, pill and tablet.

The invention discloses application of a dendrobium candidum and ginseng immunity-enhancing pharmaceutical composition in preparing medicines for treating or/and preventing lung-spleen yin deficiency syndrome of children.

The invention has the following beneficial effects:

1. the invention obtains the water absorption rate test of decoction pieces: the water absorption rate of the decoction pieces is highest, namely about 1.7 times, for convenient operation, the water absorption rate is calculated to be 2 times, namely, the water absorption rate of the decoction pieces is 2 times of the weight of the decoction pieces, and the water absorption rate of the decoction pieces is basically satisfied, so that the water with the weight of 2 times of the weight of the decoction pieces is added in the first extraction, and a foundation is laid for the subsequent water extraction process investigation.

2. According to the invention, through investigation of the soaking time, the yield of total solids and the astragaloside IV content in the extracting solution are taken as investigation indexes, and the proper soaking time is optimized, so that the method is characterized in that the method comprises the following steps of: the paste yield is relatively high in 2h and 6h, and is 28.6 percent and 31.7 percent respectively, and the paste yield is relatively high in 6h, so that the soaking time is 2h from the aspects of time cost and possibility of microorganism breeding due to overlong soaking time; the content of astragaloside IV is measured, and compared with the method of soaking for 6 hours, the content of astragaloside IV in a sample prepared by soaking for 2 hours and then decocting is slightly higher, and the content reaches 1.19mg, so that the soaking time is preferably 2 hours finally.

3. The invention carries out screening experiments on the decocting process conditions, adopts orthogonal experiments and analysis of variance, and obtains: the factors of the times of decoction are obviously different, and the excessive water addition can cause overlong subsequent concentration time, so the decoction is selected to be performed for 3 times, 30 minutes each time, and the water addition multiple is 6 times as the optimal extraction process, A ₃ B ₁ C ₁ The method comprises the steps of carrying out a first treatment on the surface of the By combining the research results of the water absorption and the soaking time, the best finally determined decocting process is adding 8 times of water for soaking for 2 hours, decocting for 30 minutes, adding 6 times of water for the 2 nd time and the 3 rd time, and decocting for 30 minutes.

4. The invention carries out research and experiment on the concentration process to obtain: when the extract is concentrated to about the relative density of 1.10-1.13 (50 ℃), the pH and the product properties meet the relevant regulations of medicines.

5. According to 1121 antibacterial effectiveness inspection method of Chinese pharmacopoeia 2020 edition, the invention carries out investigation on the antibacterial agents with various prescription amounts to obtain the antibacterial agents with the following formula amounts: in the concentration range of 0.15% to 0.30%, both the potassium sorbate and the sodium benzoate can meet the requirements, but the concentration of the sodium benzoate for achieving better antibacterial effect is slightly lower, so that 0.2% of sodium benzoate is selected as the antibacterial agent of the product.

6. The method of the invention carries out comprehensive investigation on production process indexes through pilot scale research, carries out quality assessment on finished products, carries out relevant inspection on the relative density (20 ℃) of the finished products, the pH value, the astragaloside IV content and the loading quantity of the finished products, and obtains the product: the relative density of the product is between 1.12 and 1.14, the pH value is between 4.62 and 4.58, the astragaloside IV content is between 0.13 and 0.155, the loading is more than 150mL, the total number of mold and saccharomycetes is lower than 10cfu/mL, the escherichia coli is not detected, various indexes of the product meet the requirements, and the process conditions are stable and controllable, so that the optimized process can be used for the mass production of the product.

7. After the decoction is developed into the mixture, the medicinal effect substances of the traditional decoction are maintained, the stability of the product is improved, the dosage is reduced, and the decoction is more convenient for patients to carry. The prepared product has good taste, is free from adding any flavoring agent, and is very suitable for children to take.

Detailed Description

Specific technical effects of the present application will be described in detail below by way of examples so that those skilled in the art can better understand the spirit of the present application. It should be noted that the described embodiments are only some embodiments of the present application and not all embodiments. All other embodiments, which can be made by those skilled in the art without the inventive effort, are intended to be within the scope of the present application.

Example 1

The formula comprises the following components: 160g of dendrobium candidum, 267g of astragalus membranaceus, 133g of radix pseudostellariae, 133g of radix rehmanniae, 133g of scorched hawthorn fruit and 133g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5h each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 2

The formula comprises the following components: 168g of dendrobium candidum, 279g of astragalus membranaceus, 141g of radix pseudostellariae, 141g of radix rehmanniae, 141g of scorched hawthorn fruit and 141g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 6 hours, decocting for 3 times, adding 10 times of water for the total weight of the medicines in the first decoction, adding 8 times of water for the second and third times, decocting for 1.0 hour each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.13-1.18 at 50 ℃, adding sodium benzoate accounting for 0.3% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 3

The formula comprises the following components: 152g of dendrobium candidum, 255g of astragalus membranaceus, 125g of radix pseudostellariae, 125g of radix rehmanniae, 125g of scorched hawthorn fruit and 125g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking in water for 0.5h, decocting for 3 times, adding water which is 6 times of the total weight of the medicines in the first decoction, adding water which is 4 times of the total weight of the medicines in the second and third times, decocting for 0.5h each time, filtering, combining the filtrates obtained from the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.05-1.10 at 50 ℃, adding sodium benzoate accounting for 0.1% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 4

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5h, filtering, combining the filtrates obtained in the 3 times of decoction, concentrating the filtrate to an extract with the relative density of 1.27-1.34 (50 ℃), adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the extract.

Example 5

The preparation method comprises the following steps: putting six drugs of dendrobium officinale, astragalus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water for the total weight of the drugs in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 600g of sucrose, stirring, continuously concentrating to the relative density of 1.30-1.35 (80 ℃), preparing 1000g, and sub-packaging to obtain the soft extract.

Example 6

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, adding water for 2.5h, decocting for 3 times, adding water 10 times of the total weight of the medicines in the first decoction, adding water 8 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 500g of maltose, stirring, continuously concentrating to the relative density of 1.30-1.35 (80 ℃), preparing 1000g, and subpackaging to obtain the decocted paste.

Example 7

The formula comprises the following components: 168g of dendrobium candidum, 276g of astragalus mongholicus, 131g of radix pseudostellariae, 131g of radix rehmanniae, 131g of scorched hawthorn fruit and 131g of radix ophiopogonis.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, adding water for 2.5h, decocting for 3 times, adding water 10 times of the total weight of the medicines in the first decoction, adding water 8 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 600g of maltose, stirring and continuing concentrating to the relative density of 1.30-1.35 (80 ℃), preparing 1000g, and subpackaging to obtain the decocted paste.

Example 8

The formula comprises the following components: 152g of dendrobium candidum, 255g of astragalus, 129g of radix pseudostellariae, 129g of radix rehmanniae, 129g of scorched hawthorn fruit and 129g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, adding water for 2.5h, decocting for 3 times, adding water 10 times of the total weight of the medicines in the first decoction, adding water 8 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrates obtained in the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 700g of rock sugar, stirring, continuously concentrating to the relative density of 1.30-1.35 (80 ℃), preparing 1000g, and subpackaging to obtain the soft extract.

Example 9

The formula comprises the following components: 164g of dendrobium candidum, 270g of astragalus, 127g of radix pseudostellariae, 127g of radix rehmanniae, 127g of charred hawthorn and 127g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, adding water for 2.5h, decocting for 3 times, adding water 10 times of the total weight of the medicines in the first decoction, adding water 8 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrates obtained in the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 500g of refined honey, stirring, continuously concentrating to the relative density of 1.30-1.35 (80 ℃), preparing 1000g, and subpackaging to obtain the decocted paste.

Example 10

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water of the total weight of the medicines in the first decoction, adding 6 times of water in the 2 nd and 3 rd times, decocting for 0.5h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 100g of dextrin and 5g of colloidal silicon dioxide into each 100g of paste, preparing a soft material, sieving with a 14-mesh sieve, granulating, drying at 60 ℃ until the water content is below 6%, finishing granules, and subpackaging to obtain granules.

Example 11

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2 hours, decocting for 3 times, adding 8 times of water of the total weight of the medicines in the first decoction, adding 6 times of water in the 2 nd and 3 rd times, decocting for 0.5 hour, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to clear paste with the relative density of 1.00-1.10 (50 ℃), adding 450g of sucrose, boiling, adding 0.2% of sodium benzoate of the total amount of a prescription, stirring, dissolving, mixing uniformly, filtering, fixing the volume to 1000mL, cooling and packaging to obtain syrup.

Example 12

The formula comprises the following components: 154g of dendrobium candidum, 258g of astragalus membranaceus, 127g of radix pseudostellariae, 127g of radix rehmanniae, 127g of scorched hawthorn fruit and 127g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 6 times of water for the total weight of the medicines in the first decoction, adding 4 times of water for the second and third times, decocting for 0.5h each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 13

The formula comprises the following components: 156g of dendrobium candidum, 261g of astragalus, 129g of radix pseudostellariae, 129g of radix rehmanniae, 129g of scorched hawthorn fruit and 129g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking in water for 1.5h, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5h each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.15% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 14

The formula comprises the following components: 158g of dendrobium candidum, 264g of astragalus, 131g of radix pseudostellariae, 131g of radix rehmanniae, 131g of scorched hawthorn fruit and 131g of dwarf lilyturf tuber.

Example 15

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 3 hours, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5 hour each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 16

The formula comprises the following components: 162g of dendrobium candidum, 270g of astragalus membranaceus, 135g of radix pseudostellariae, 135g of radix rehmanniae, 135g of scorched hawthorn fruit and 135g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 3 hours, decocting for 3 times, adding 10 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 1 hour each time, filtering, combining the filtrates obtained in the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.25% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 17

The formula comprises the following components: 164g of dendrobium candidum, 273g of astragalus membranaceus, 137g of radix pseudostellariae, 137g of radix rehmanniae, 137g of scorched hawthorn fruit and 137g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 3 hours, decocting for 3 times, adding 10 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 1 hour each time, filtering, combining the filtrate obtained by the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.25% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and packaging to obtain the mixture.

Example 18

The formula comprises the following components: 166g of dendrobium candidum, 276g of astragalus mongholicus, 139g of radix pseudostellariae, 139g of radix rehmanniae, 139g of scorched hawthorn fruit and 139g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 4 times of water for the second and third times, decocting for 0.5h each time, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.15% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the mixture.

Example 19

The formula comprises the following components: 168g of dendrobium candidum, 279g of astragalus membranaceus, 130g of radix pseudostellariae, 130g of radix rehmanniae, 130g of scorched hawthorn fruit and 130g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, adding water for 1h, decocting for 3 times, adding water which is 8 times of the total weight of the medicines in the first decoction, adding water which is 6 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrate obtained by 3 times of decoction, concentrating the filtrate to an extract with the relative density of 1.27-1.34 (50 ℃), adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and subpackaging to obtain the extract.

Example 20

The formula comprises the following components: 168g of dendrobium candidum, 279g of astragalus membranaceus, 127g of radix pseudostellariae, 127g of radix rehmanniae, 127g of scorched hawthorn fruit and 127g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus membranaceus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, adding water for 2.5h, decocting for 3 times, adding water 10 times of the total weight of the medicines in the first decoction, adding water 8 times of the total weight of the medicines in the second and third times, decocting for 1h, filtering, combining the filtrates obtained in the 3 times of decoction, concentrating the filtrate to an extract with the relative density of 1.27-1.34 (50 ℃), adding sodium benzoate accounting for 0.15% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling and packaging to obtain the extract.

Example 21

The formula comprises the following components: 164g of dendrobium candidum, 270g of astragalus membranaceus, 130g of radix pseudostellariae, 130g of radix rehmanniae, 130g of scorched hawthorn fruit and 130g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 6 times of water for the total weight of the medicines in the first decoction, adding 4 times of water for the second and third times, decocting for 0.5h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 100g of dextrin and 5g of colloidal silica into each 100g of paste, preparing a soft material, sieving with a 14-mesh sieve, granulating, drying at 60 ℃ until the water content is below 6%, granulating, and subpackaging to obtain granules.

Example 22

The formula comprises the following components: 160g of dendrobium candidum, 265g of astragalus membranaceus, 135g of radix pseudostellariae, 135g of radix rehmanniae, 135g of scorched hawthorn fruit and 135g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 3h, decocting for 3 times, adding 10 times of water of the total weight of the medicines in the first decoction, adding 8 times of water in the second and third times, decocting for 1h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 100g of dextrin and 5g of colloidal silicon dioxide into each 100g of paste, preparing a soft material, sieving with a 14-mesh sieve, granulating, drying at 60 ℃ until the water content is below 6%, finishing granules, and subpackaging to obtain granules.

Example 23

The formula comprises the following components: 165g of dendrobium candidum, 275g of astragalus membranaceus, 129g of radix pseudostellariae, 129g of radix rehmanniae, 129g of scorched hawthorn fruit and 129g of dwarf lilyturf tuber.

The preparation method comprises the following steps: loading six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water of the total weight of the medicines in the first decoction, adding 6 times of water in the 2 nd and 3 rd times, decocting for 0.5h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.20-1.25 (80 ℃), adding 100g of dextrin and 5g of colloidal silica into each 100g of paste, preparing a soft material, sieving with a 14-mesh sieve, granulating, drying at 60 ℃ until the water content is below 6%, grading, and subpackaging to obtain granules.

Example 24

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 10 times of water for the total weight of the medicines in the first decoction, adding 8 times of water for the second and third times, decocting for 1h, filtering, combining the filtrates obtained by the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.00-1.10 (50 ℃), adding 430g of sucrose, boiling, adding 0.3% of sodium benzoate in the total amount of the prescription, stirring, dissolving, mixing uniformly, filtering, fixing the volume to 1000mL, cooling and packaging to obtain syrup.

Example 25

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 10 times of water for the total weight of the medicines in the first decoction, adding 8 times of water for the second and third times, decocting for 1h, filtering, combining the filtrates obtained by the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.00-1.10 (50 ℃), adding 440g of sucrose, boiling, adding 0.2% of sodium benzoate in the total amount of the prescription, stirring, dissolving, mixing uniformly, filtering, fixing the volume to 1000mL, cooling and packaging to obtain syrup.

Example 26

The formula comprises the following components: 158g of dendrobium candidum, 270g of astragalus, 131g of radix pseudostellariae, 131g of radix rehmanniae, 131g of scorched hawthorn fruit and 130g of dwarf lilyturf tuber.

The preparation method comprises the following steps: putting six medicines of dendrobium candidum, astragalus root, radix pseudostellariae, radix rehmanniae, charred hawthorn and dwarf lilyturf tuber into a filter bag, soaking for 2h, decocting for 3 times, adding 8 times of water of the total weight of the medicines in the first decoction, adding 6 times of water in the 2 nd and 3 rd times, decocting for 0.5h, filtering, combining the filtrates of the 3 times of decoction, concentrating the filtrate to a clear paste with the relative density of 1.00-1.10 (50 ℃), adding 460g of sucrose, boiling, adding 0.2% of sodium benzoate of the total amount of the prescription, stirring, dissolving, mixing uniformly, filtering, fixing the volume to 1000mL, cooling and packaging to obtain syrup.

To further verify the feasibility of the invention, the inventors performed a series of experiments, comprising the following steps:

1. investigation of preparation technique

1. Literature data on the main chemical composition and physicochemical properties of each drug in prescription

1.1 prescription composition

The dendrobium, ginseng and immunity-enhancing mixture prescription consists of six traditional Chinese medicines of dendrobium officinale, astragalus, radix pseudostellariae, scorched hawthorn fruit, dwarf lilyturf tuber and dried rehamnnia root, and the medicinal materials are all a part of the carrier of the 2020 edition of Chinese pharmacopoeia, do not contain toxic medicinal materials, and do not have eighteen antagonisms and nineteen incompatibilities.

1.2 analysis of the Main chemical Components of the herbs in the recipe

Dendrobium officinale: the main active ingredients of the dendrobium polysaccharide, dendrobine, stilbenes and derivatives thereof, trace elements and the like are contained, and the chemical ingredients of the dendrobium candidum are determined at present: polysaccharides, alkaloids, stilbenes, phenols, lignin, and the like, which have a variety of biological activities: regulating immunity, resisting oxidation, resisting tumor, reducing blood sugar, and resisting bacteria. The dendrobium polysaccharide has close relation with the pharmacological activity. The polysaccharide content is the main basis for judging the quality of the dendrobium candidum.

Radix astragali: contains main active ingredients such as saponins, polysaccharides, flavonoids, etc. The saponin compound is one of important active ingredients in astragalus mongholicus, and most of the saponin compounds are tetracyclic triterpenoid saponin compounds. Astragaloside IV (AS-IV) is a main component of astragalus root with heart strengthening effect, and has wide biological activities of protecting heart, resisting inflammation, resisting oxidation, resisting apoptosis, resisting virus, etc. Astragalus Polysaccharides (APS) are the active ingredients with the highest activity in astragalus medicinal materials, and are also the hot content of modern medical research. APS are mainly composed of glucans, including water-soluble and water-insoluble glucans, and heteropolysaccharides, mostly water-soluble acidic heteropolysaccharides. APS participates in regulating organism immunity, and has anti-tumor, anti-infection activity, and cardiovascular protection effects. A great deal of experimental researches show that the APS and the astragaloside have remarkable immunoregulation effect.

Radix pseudostellariae: contains various effective components such as amino acids, polysaccharides, glycosides, phospholipids, cyclic peptides, volatile oil, etc., and the radix Pseudostellariae has various biological activities such as enhancing organism, promoting immunity, SOD-like effect, relieving cough, resisting bacteria, and resisting virus.

Radix rehmanniae: the main chemical components are saccharides, iridoid glycoside, amino acid and the like, which are also main active components. 8 sugars have been isolated and identified from rehmannia: stachyose, raffinose, glucose, sucrose, fructose, mannyltriase, verbascose and galactose. The rehmannia root has the highest polysaccharide component content and better water solubility, wherein the content of reducing sugar is 140.3-287.3mg.g < -1 >; the polysaccharide content is 31.3-50.5 mg g < -1 >. Rehmannia has the pharmacological activities of resisting oxidation, resisting aging, exciting immunity, reducing blood sugar, resisting cancer, resisting cerebral ischemia, protecting nerve center, promoting hematopoiesis and the like. The rehmannia polysaccharide has many pharmacological effects of resisting tumor, enhancing immunity, promoting hematopoiesis, reducing blood sugar, resisting oxidation, resisting anxiety, inducing BMSCs to differentiate into neuron-like cells, and is one of the main active ingredients of rehmannia. The pharmacological experiment of the rehmannia glycoside D, A shows that the rehmannia glycoside D, A has the effects of nourishing yin, enriching blood and reducing blood sugar, and the research shows that the rehmannia glycoside D, A has good water solubility and strong thermal stability.

Radix Ophiopogonis: steroid saponins, homoisoflavonoids and ophiopogonpolysaccharide are the main active ingredients of ophiopogon root. The ophiopogon root flavone has wide and effective functions of resisting myocardial ischemia, resisting thrombosis, resisting oxidation, enhancing immunity, resisting aging and other physiological functions, and the monosaccharide composition of the ophiopogon root polysaccharide compound mainly comprises fructose and glucose. The ophiopogon polysaccharide has the effects of reducing blood sugar, regulating immunity, relieving asthma, resisting allergy, resisting anoxia, resisting tumor, resisting myocardial ischemia and treating gastrointestinal tract.

And (3) burnt hawthorn: hawthorn is a medicinal and edible plant and contains various chemical components such as flavonoid, flavane, polymers thereof, triterpenes, organic acids and the like. The fructus crataegi total flavone has blood pressure lowering effect. Flavone in fructus crataegi is the main component for reducing blood lipid. The fructus crataegi decoction has effect in promoting cellular immunity of mice. Hawthorn flavone is a recognized class of compounds with the highest antioxidant potential.

2. Dosage form selection

The Hushen immunopotentiator is derived from an empirical formula derived from the teaching of the national academic inheritance Chen Zhu of the traditional Chinese medicine specialist. Dendrobium officinale and ginseng mixture has the effects of nourishing yin, clearing heat, tonifying qi, promoting fluid production and tonifying stomach. The decoction is used as a medicine clinically, and has better curative effect. In order to facilitate the administration of patients, the subject group systematically researches the preparation process of the dendrobium ginseng immunity enhancing mixture by combining the clinical traditional usage and the physicochemical properties of chemical components in prescription decoction pieces according to the related requirements of the medical institution for implementing record management of Chinese medicinal preparation by applying the traditional process issued by the drug administration of Guizhou province, and performs pilot-scale production, simultaneously performs qualitative and quantitative researches and control on main effective components, establishes quality standards, and provides data support for the subsequent production of products with stable and controllable quality and curative effect. Referring to the clinical practice, the final formulation is selected as a mixture.

3. Prescription Process study

According to the physicochemical properties of the medicines in the formula, most of the effective components are water-soluble components, the water extraction mode is proper for retaining most of the effective components, and meanwhile, the water extraction technology is adopted in the whole formula combined with the requirements of the traditional preparation record, so that microorganisms are easy to breed in the storage process of the liquid preparation, and therefore, the bacteria inhibitor is also required to be screened to ensure the stability of the product. Through researches, the process route of the product is determined as follows: decocting six decoction pieces of Dendrobium officinale and Astragalus membranaceus in water, concentrating the water extract to obtain a liquid medicine, adding sodium benzoate in a prescription amount, stirring and dissolving to obtain a bacteriostatic agent, filtering, filling and obtaining a finished product.

Next, we elaborate the process of the prescription of the dendrobium nobile ginseng immune enhancing mixture from the extraction process, the concentration process and the screening of bacteriostat.

3.1 research on extraction Process

The extraction process of the traditional Chinese medicine decoction pieces is a key ring in the preparation process of the traditional Chinese medicine preparation, and the water absorption rate, the soaking process and the decocting process parameters of the decoction pieces are required to be examined in detail so as to screen out the proper extraction process. Through research, we finally determine that decoction pieces are soaked in 8 times of water for 2 hours, decocted for 30 minutes, added with 6 times of water for the second time and the third time, decocted for 30 minutes, combined with the three times of extracting solution, and screened by a 100-mesh sieve for standby.

3.1.1 determination of Water absorption of decoction pieces

Weighing 36g of decoction pieces with 1/2 clinical prescription, soaking in 10 times of water for different times, filtering, weighing wet medicine (until decoction pieces weight is not increased), and measuring water absorption of decoction pieces with the following formula (the result is shown in Table 1).

mb-quality of decoction pieces in saturated state of water absorption (g)

mg-quality of decoction pieces in dry state (g)

Table 1 investigation of water absorption of decoction pieces

As can be seen from Table 1, the water absorption of the decoction pieces after soaking for 24 hours was about 1.7 times, and the water absorption was calculated as 2 times for convenience of operation, i.e., the water absorption of the decoction pieces was 2 times the weight of the decoction pieces. Therefore, the water which is 2 times of the weight of the decoction pieces should be added for the first extraction.

3.1.2 determination of soaking time

Under the condition of meeting the water absorption of decoction pieces, the influence of soaking time on the prescription paste yield and the extraction of active ingredients is examined, and the total solid yield and the astragaloside IV content in the extracting solution are taken as examination indexes, so that the proper soaking time is optimized.

3.1.2.1 preparation of the extract

Weighing 36g of decoction pieces with the clinical prescription dosage of 1/2, adding 12 times of water for the first time and 10 times of water for the second time, considering that bacteria are easy to breed and deteriorate due to overlong soaking time of water decoction, and combining the feasibility of mass production, we design to soak 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours and not soak several samples, decoct for 2 times for 30 minutes each time, filter, combine the filtrates, and fix the solution to 250mL for later use.

3.1.2.2 Total solids yield determination

25mL of the liquid medicine prepared in the step 3.1.2.1 is precisely removed, two parts of the liquid medicine are added into an evaporation dish with constant weight, the liquid medicine is evaporated to dryness in a water bath, the liquid medicine is dried at 105 ℃, the total solid matter weight is measured according to a method of the general constant weight of the part of the 2020 edition of Chinese pharmacopoeia, and the total solid matter yield is calculated, and the formula is as follows (the result is shown in Table 2, and the analysis of variance is shown in Table 3).

W is the weight of solids in 25mL of filtrate, V is the constant volume, and Wt is the sample feeding weight.

TABLE 2 influence of soaking time on paste yield

TABLE 3 one-factor analysis of variance table of soaking time versus paste yield

The small knot: analysis of variance of one factor shows that: p is less than 0.05, which indicates that different soaking times have significant differences;

the soaking time has a certain influence on the paste yield. Although the paste yield of the sample prepared by soaking for 6 hours and then decocting is slightly high, the selection of 2 hours is suitable from the viewpoints of time cost and possibility of microorganism growth due to too long soaking time.

3.1.2.3 Astragaloside IV content determination

(1) Preparation of control solution

Taking 5mg of astragaloside IV reference substance, precisely weighing, placing into a 10mL volumetric flask, dissolving with methanol to constant volume, filtering with 0.45um filter membrane, and collecting the subsequent filtrate to obtain reference substance solution.

(2) Preparation of test solutions

And (3) precisely removing 20mL of the liquid medicine prepared in the step 2.1.1, extracting with 50mL, 25mL and 25mL water saturated n-butanol respectively, mixing the four extracts, adding ammonia test solution (400 mL of ammonia water is diluted to 1000 mL) for 3 times, removing 20mL of the washing solution each time, adding the n-butanol layer into an evaporating dish, volatilizing in water bath, dissolving residues with methanol to 5mL, filtering with a 0.45um filter membrane, and obtaining a subsequent filtrate to obtain a sample solution.

(3) Sample measurement

Adopting high performance liquid chromatography and an evaporative light detector to measure the astragaloside IV content, wherein the liquid phase condition is as follows: chromatographic column: irite BDS-C18 (4.6 mm×250mm,5 um), mobile phase: acetonitrile-water (38:62), volumetric flow: 1mL.min-1, column temperature: 40 ℃. Sample injection volume: the reference solutions are 20uL and 5uL respectively, the sample solution is 20uL, the content is calculated by adopting an external standard two-point logarithmic equation, and the results are shown in tables 4 and 5.

Table 4 investigation of astragaloside IV content by soaking time

TABLE 5T test results for single sample

The small knot: from the single sample T test results, it can be seen that: p is less than 0.05, which shows that different soaking time has a certain influence on the content of astragaloside, and the content of astragaloside in a sample prepared by soaking for 2 hours and then decocting is slightly higher.

Conclusion: by combining the results of the ointment yield and the astragaloside IV and combining the actual situation of mass production, we choose to soak for 2 hours and then decoct.

3.1.3 screening of decoction Process

The whole prescription adopts a water extraction process, 6 Chinese medicinal decoction pieces such as dendrobium officinale and the like in the prescription are filled into a double-layer filter bag, soaked for 2 hours by adding water, tested according to an orthogonal test design table, the decoctions are combined, three main factors influencing the decocting effect are filtered, the decocting times, the decocting time and the water adding amount are inspected, and according to the level of 3 of each factor, L is used ₉ (3 ⁴ ) Orthogonal table arrangement test (table 6). The process is evaluated by taking the ointment yield and the astragaloside IV content as indexes, the water extraction condition is optimized, and the results are shown in tables 7-10.

3.1.3.1 determination of the paste yield: concentrating to 150mL according to the volume of the decoction, precisely taking 20mL to an evaporation dish with constant weight, evaporating in water bath, drying at 105 ℃ to constant weight, and weighing to calculate the paste rate with the following formula.

W is the weight of solids in the extracted liquid, and Wt is the weight of the sample.

3.1.3.2 determination of Astragaloside IV transfer Rate:

(1) Preparation of control solution

(2) Preparation of test solutions

(3) Sample treatment for determining astragaloside IV content in astragalus decoction pieces

Taking about lg of the product powder (sieving with a fourth sieve), precisely weighing, placing into a conical flask with a plug, precisely adding 50ml of 80% methanol solution containing 4% of concentrated ammonia test solution (taking 4ml of concentrated ammonia test solution, adding 80% of methanol to 100ml, shaking uniformly), weighing by a seal plug, heating and refluxing for 1 hour, cooling, weighing by a certain weight, supplementing the lost weight with 80% methanol solution containing 4% of concentrated ammonia test solution, shaking uniformly, filtering, precisely measuring 25ml of continuous filtrate, evaporating to dryness, dissolving the residue with 80% methanol, transferring to a 5ml measuring flask, adding 80% of methanol to scale, shaking uniformly, filtering, and taking the continuous filtrate to obtain the product.

(4) Sample measurement

Adopting high performance liquid chromatography and an evaporative light detector to measure the astragaloside IV content, wherein the liquid phase condition is as follows: chromatographic column: irite BDS-C18 (4.6 mm×250mm,5 um), mobile phase: acetonitrile-water (38:62), volumetric flow: 1mL.min ^-1 Column temperature: 40 ℃. Evaporative light scattering detector conditions: drift tube temperature (80 ℃), atomizing temperature (40 ℃) nitrogen flow rate (1.6 SLM). Sample injection volume: the reference substance solutions are 20uL and 5uL respectively, the sample solution is 20uL, and the content is calculated by adopting an external standard two-point logarithmic equation.

(5) Astragaloside IV transfer rate calculation

C1 is astragaloside IV content (mg.mL) in the extractive solution ^-1 ) C2 is the astragaloside IV content (%), g/g) in the astragalus decoction pieces, and Wt is the feeding weight (g) of the astragalus decoction pieces.

TABLE 6 factor level Table

TABLE 7 analysis of variance of% of paste yield in decoction process conditions L9 (34) orthogonal test

TABLE 8 decoction process conditions L9 (34) orthogonal test Astragaloside IV transfer% variance analysis table

TABLE 9 decoction process conditions L9 (34) orthogonal test comprehensive analysis of variance table

Visual analysis of Table 10

Analysis of results: from visual analysis, the influence of each factor on the ointment yield and the astragaloside IV comprehensive component is A>C>B, the best scheme is A ₁ B ₃ C ₃ The method comprises the steps of carrying out a first treatment on the surface of the However, the analysis of variance results show that the factor A has significant difference, and the follow-up concentration time is overlong due to excessive water addition, so that the decoction is selected to be 3 times, 30 minutes each time, and the water addition multiple is 6 times as the optimal extraction process, A ₃ B ₁ C ₁ . Combining the research results of the water absorption and the soaking time, the final extraction process is that 8 times of water is added for soaking for 2 hours, the water is added for 30 minutes for 2 times and 3 times, the water is added for 6 times, the water is decocted for 30 minutes, the three extraction solutions are combined, and the three extraction solutions are screened by a 100-mesh sieve for standby.

3.1.3.3 three-batch sample extraction process verification experiment

Taking clinical prescription decoction pieces according to the optimal extraction process condition A ₃ B ₁ C ₁ Extraction, determination of paste rate and astragaloside IV transfer rate, and the results show (see Table 11): the average value of the paste yield is 34.9%, and the RSD% is 0.2%; astragaloside IV transfer rate 45.3%, rsd=1.4%, comprehensive score 99, rsd=1.2%, consistent with expectations, demonstrating that the extraction process is stable and feasible.

Table 11 extraction process validation test

The small knot: according to the research results, the water extraction process is preliminarily determined, the water absorption and soaking time research results are combined, the finally determined extraction process is that 8 times of water is added for 2 hours, the water is decocted for 30 minutes, 6 times of water is added for the second time and the third time, the water is decocted for 30 minutes, and the three times of extraction solutions are combined for standby.

3.2 research on concentration Process

Because the preparation is a mixture of the traditional process, the traditional habit and the actual production condition are considered, and normal pressure concentration is adopted.

Weighing 1 clinical prescription decoction pieces, extracting according to the optimal process of 3.1, concentrating the decoction at normal pressure to about 150mL, 120mL, 100mL and 75mL, observing the properties of the solution, and determining the content and relative density of astragaloside IV (20 ℃ C., according to the relative density check method of 0601 of the edition 2020 of Chinese pharmacopoeia), and the results are shown in tables 12 and 13.

TABLE 12 Properties and relative Density (20 ℃ C.) of the extracts at different levels of concentration

TABLE 13 extraction yield of Astragaloside IV for different levels of concentration of the extracts

The small knot: as can be seen from the results of the samples with different concentrated volumes of 3 batches of samples, 1 clinical prescription dose decoction piece is concentrated to 150mL, 120mL, 100mL and 75mL according to the formulated process, the amounts of astragaloside IV in each sample are not significantly different, the relative density is increased along with the reduction of the final volume of concentration, and the concentration is sticky when the final volume of 75mL is reached, the concentration is easy to cause gelatinization and difficult to control, so that the concentration to a greater degree is not carried out any more. To determine the concentration endpoint, we again examined, taking 150mL of the extract, concentrating to about 75mL, and taking the relative density at 50 ℃ as the concentration endpoint judgment basis. And meanwhile, the concentrated solution is cooled to room temperature to measure the pH value, so that a basis is provided for the selection of the subsequent bacteriostat. The results of the investigation are shown in Table 14:

TABLE 14 concentrated liquid phase Density (50 ℃) and pH determination

The small knot: according to the research results, 1 clinical prescription decoction piece is initially decocted according to a determined decoction process, and then the decoction liquid is combined, filtered and the extract liquid is concentrated to about the relative density of 1.1 (50 ℃) for standby.

3.3 selection of bacteriostat

Because the product is prepared by a water extraction process, the product is easy to deteriorate and mould in the storage process. In order to increase the stability of the mixture and ensure the quality of the preparation, an effective bacteriostatic agent must be selected. According to the first edition of Chinese pharmacopoeia 2020, the most commonly used bacteriostats for medicine are benzoic acid and its sodium salt, sorbic acid and its potassium salt, and hydroxyphenyl ethyl esters, respectively. Benzoic acid and sodium salt thereof are acid preservative, and have stronger antibacterial effect when the pH is 2.5-4; when the pH is more than 5.5, the antibacterial effect is obviously weakened. Sorbic acid and potassium salts thereof are also acidic preservatives, have a good inhibitory effect on fungi and yeasts and are suitable for a pH range of <6. Although the ethylparaben has wide antibacterial effect on mould, yeast and bacteria, the ethylparaben is poor in water solubility and almost insoluble in water, and the clarity of the ethylparaben is affected by adding the ethylparaben to a mixture. Meanwhile, most of bacteriostats selected by referring to a plurality of mixture products in pharmacopoeia are potassium sorbate and sodium benzoate. Therefore, we initially select potassium sorbate and sodium benzoate for investigation, and according to the bacteriostasis efficacy inspection method of 1121 in the Chinese pharmacopoeia 2020 edition, examine each prescription amount of bacteriostat to screen out the best bacteriostat suitable for the product, we determine the pH value of the solution obtained by each bacteriostat prescription, and the results of each concentration of bacteriostat are shown in Table 15; meanwhile, we count the reduced lg values of 14 days and 28 days relative to the previous time point, and according to the antibacterial effectiveness test result, the two antibacterial agents can meet the requirements within the concentration range of 0.20-0.30%. However, the bacteriostatic efficacy of sodium benzoate is stronger, and in order to ensure the stability of the storage process and also consider the principle of minimum bacteriostatic concentration, 0.2% of sodium benzoate is selected as the bacteriostatic agent of the product, and the detailed study data are shown in Table 16.

TABLE 15 effect of bacteriostat on pH of solution results

Table 16 reduced lg values for 14 and 28 days of incubation of samples from each of the bacteriostat formulas

Remarks: the difference value of the reduced lg value is the difference value between the lg value of the bacterial count measured at each interval and the lg value at the previous time point.

According to the research results, the water extraction process is preliminarily determined, and the water absorption and soaking time research results are combined, wherein the finally determined extraction process is that 8 times of water is added for soaking for 2 hours, the water is decocted for 30 minutes, the second time and the third time are added with 6 times of water, the water is decocted for 30 minutes, the three times of extraction solutions are combined, filtered and concentrated to have the relative density of about 1.1 (50 ℃), and 0.2% of sodium benzoate is added for stirring and dissolving, so that the water-soluble compound medicine is obtained.

3.4 confirmation of the preparation Process by small trial

According to the research results, the whole prescription is preliminarily determined by adopting a water extraction process and combining the research results of water absorption and soaking time, the finally determined extraction process is that 8 times of water is added for 2 hours, the water is decocted for 30 minutes, 6 times of water is added for the second time and the third time, the water is decocted for 30 minutes, the three times of extraction solutions are combined, the concentration is carried out to 150mL, the relative density (50 ℃) is measured, and the prescription sodium benzoate is added for stirring and dissolution, thus obtaining the water-soluble sodium benzoate. The preparation process is used for preparing 3 batches of small test samples, the relative density (20 ℃) of finished products, the pH value, the astragaloside IV content of the finished products and the related examination of appearance properties, and the results are shown in tables 17 to 21.

Table 17 Small test confirmation batch intermediate relative Density test results (50 ℃ C.)

Table 18 Small test confirmation batch of the results of the relative Density test (20 ℃ C.)

The small knot: the results show that the relative densities of the three batches of samples are between 1.14 and 1.15, and the relative densities of the three batches of samples are relatively close.

Table 19 results of the pilot-test confirmation batch pH test

The small knot: the results show that the pH values of the three batches of samples are between 4.51 and 4.62, and the pH values of the three batches of samples are relatively close.

Table 20 test results of the test for confirming the properties of the batch

Table 21 test results of determination of Astragaloside IV content of the finished product

3.5 pilot study

Based on the above results, combined with the production facility of this hospital, we initially developed a pilot production prescription process. The mass production is amplified by 10 times according to the planned preparation process conditions. The quality of the finished product is evaluated by comprehensively examining the production process indexes. The relative density (20deg.C), pH, astragaloside IV content and loading of the final product were examined and the results are shown in tables 22-28.

Table 22 intermediate relative Density measurement (50 ℃ C.)

Table 23 shows the results of the relative density measurement of the sample products (20 ℃ C.)

The small knot: the results show that the relative densities of the three batches of samples are between 1.12 and 1.14, and the relative densities of the three batches of samples are relatively close. The relative density of the product is controlled between 1.12 and 1.14 by preliminary determination.

Table 24, sample finished product pH detection results (20 ℃ C.)

The small knot: the results showed that the pH values of the three batches were between 4.62 and 4.58.

Table 25 shows the results of the test sample finished product loading test (n=3)

The small knot: taking 3 bottles of the product according to four general rules 0942 (minimum filling quantity inspection method) of the Chinese pharmacopoeia 2020 edition, and measuring the filling quantity (standard: average filling quantity is not less than labeled quantity, and each container filling quantity is not less than 97% of labeled filling quantity), wherein the result shows that the filling quantity of three batches of samples is greater than 150mL, and the three batches of samples meet the regulations.

Table 26 results of finished product property test

Table 27 determination of Astragaloside IV

Table 28 statistical Table of pilot plant results

The pilot-scale production results show that various indexes of pilot-scale samples prepared by adopting the set parameters meet the requirements, and the process conditions are stable and controllable, thus the process is feasible.

2. Experimental effects and summary

The pilot-scale production results show that various indexes of pilot-scale samples prepared by adopting the set parameters meet the requirements, and the process conditions are stable and controllable, so that the optimized process can be used for mass production of the product.

After the decoction is developed into the mixture, the medicinal effect substances of the traditional decoction are maintained, the stability of the product is improved, the dosage is reduced, and the decoction is more convenient for patients to carry.

The successful development of the project can bring good news to a plurality of patients, improve the life quality of the patients and lighten the economic burden, and has positive significance for families of the patients and even the whole society. The variety of the hospital preparation is expanded and enriched, and the people are benefited. Meanwhile, the multi-scale development of the large health industry in our province is promoted, so that the dendrobium industry becomes a new development bright point of the large health industry in Guizhou.

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Claims

1. The dendrobium candidum and ginseng immunity enhancing pharmaceutical composition is characterized by comprising the following medicines in parts by weight: 152-168 parts of dendrobium candidum, 255-279 parts of astragalus membranaceus, 125-141 parts of radix pseudostellariae, 125-141 parts of radix rehmanniae, 125-141 parts of scorched hawthorn fruit and 125-141 parts of dwarf lilyturf tuber.

2. The pharmaceutical composition of dendrobium nobile lindl ginseng immunity enhancing as claimed in claim 1, wherein the composition is composed of the following medicines in parts by weight: 154-166 parts of dendrobium candidum, 258-276 parts of astragalus membranaceus, 127-139 parts of radix pseudostellariae, 127-139 parts of radix rehmanniae, 127-139 parts of scorched hawthorn fruit and 127-139 parts of dwarf lilyturf tuber.

3. The pharmaceutical composition of dendrobium nobile lindl ginseng immunity enhancing as claimed in claim 1, wherein the composition is composed of the following medicines in parts by weight: 156-164 parts of dendrobium candidum, 261-273 parts of astragalus membranaceus, 129-137 parts of radix pseudostellariae, 129-137 parts of radix rehmanniae, 129-137 parts of scorched hawthorn fruit and 129-137 parts of dwarf lilyturf tuber.

4. The pharmaceutical composition of dendrobium nobile lindl ginseng immunity enhancing according to claim 1, wherein the composition is composed of the following medicines in parts by weight: 158-162 parts of dendrobium candidum, 264-270 parts of astragalus membranaceus, 131-135 parts of radix pseudostellariae, 131-135 parts of radix rehmanniae, 131-135 parts of scorched hawthorn fruit and 131-135 parts of dwarf lilyturf tuber.

5. The pharmaceutical composition of dendrobium nobile lindl ginseng immunity enhancing according to claim 1, wherein the composition is composed of the following medicines in parts by weight: 160 parts of dendrobium candidum, 267 parts of astragalus membranaceus, 133 parts of radix pseudostellariae, 133 parts of radix rehmanniae, 133 parts of scorched hawthorn fruit and 133 parts of dwarf lilyturf tuber.

6. A process for preparing a pharmaceutical composition according to any one of claims 1 to 5, comprising the steps of: loading six medicines of dendrobium officinale, astragalus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber in a prescription amount into a filter bag, soaking in water for 0.5-6h, decocting for 3 times, adding water which is 6-10 times of the total weight of the medicines in the first decoction, adding water which is 4-8 times of the total weight of the medicines in the second and third times, decocting for 0.5-1.0h each time, filtering, merging the decoctions, concentrating the filtrate to an extract with relative density of 1.05-1.18 at 50 ℃, adding sodium benzoate with the total amount of 0.1-0.3%, stirring, dissolving, mixing, cooling, and split charging the collected filtrate into pharmaceutically acceptable auxiliary materials to prepare a pharmaceutically acceptable dosage form.

7. The method of preparing a pharmaceutical composition according to claim 6, comprising the steps of: filling six medicines of dendrobium officinale, astragalus, radix pseudostellariae, radix rehmanniae, scorched hawthorn fruit and dwarf lilyturf tuber into a filter bag, soaking in water for 2 hours, decocting for 3 times, adding 8 times of water for the total weight of the medicines in the first decoction, adding 6 times of water for the second and third times, decocting for 0.5 hour each time, filtering, combining the filtrates of 3 times of decoction, concentrating the filtrate to an extract with relative density of 1.10-1.13 at 50 ℃, adding sodium benzoate accounting for 0.2% of the total amount of the prescription, stirring, dissolving, mixing uniformly, cooling, subpackaging, and preparing the obtained filtrate or adding pharmaceutically acceptable auxiliary materials into the collected filtrate to prepare a pharmaceutically acceptable dosage form.

8. The method of preparing a pharmaceutical composition according to any one of claims 6 or 7, wherein the acceptable excipients are one or more of sodium benzoate, potassium sorbate, sucrose, maltose, crystal sugar, refined honey, dextrin, colloidal silica, starch.

9. The method of preparing a pharmaceutical composition according to any one of claims 6 or 7, wherein the acceptable dosage form is a mixture, a paste, a granule, a syrup, a pill, a tablet.

10. The dendrobium nobile lindl ginseng immunity-enhancing pharmaceutical composition is characterized by being applied to the preparation of medicines for treating or/and preventing children's lung-spleen yin deficiency.