A traditional Chinese medicine composition for postpartum lactation promotion, a preparation method thereof and application thereof

Abstract

The present application relates to a kind of postpartum lactation-promoting traditional Chinese medicine composition and its preparation method and application, belong to traditional Chinese medicine preparation technical field.The present application is prepared from Huangqi, Danggui, Chuanxiong, Shengdihuang, Tonghuo, Wangnoteliu Xing, Xiangfu, Jujie, Yujin, Siluolu, Lulutong, Chenpi, Loulu, Fashi and Fuling to obtain traditional Chinese medicine composition;Can alleviate / treat the lack of milk symptoms caused by postpartum qi and blood deficiency, liver stagnation, phlegm wetness obstruction, also has good immunity enhancing effect.

Description

Technical Field

[0001] This invention relates to a traditional Chinese medicine composition for promoting lactation after childbirth, its preparation method, and its application, belonging to the field of traditional Chinese medicine preparation technology. Background Technology

[0002] Traditional Chinese medicine believes that the production and secretion of breast milk are closely related to the internal organs and meridians: breast milk is transformed from qi and blood, and postpartum qi and blood deficiency is one of the reasons for insufficient breast milk. Qi can promote the flow of breast milk, and qi stagnation may lead to milk stasis and poor drainage; the spleen and stomach are the source of qi and blood production, and spleen and stomach weakness will result in insufficient qi and blood production and a lack of breast milk source; the liver is responsible for regulating qi and blood flow, and liver qi stagnation will affect the flow of qi, leading to blocked milk ducts, milk stasis, or poor secretion; the kidneys store essence, and essence and blood share the same origin; insufficient kidney essence may also affect the production of breast milk (especially for older mothers or those with weak constitutions); in addition, breast milk flows to the breasts through the Chong meridian, Ren meridian, and Stomach meridian of Foot Yangming, and unobstructed meridians are key to the smooth secretion and drainage of breast milk.

[0003] Chinese invention patent CN114209786A discloses a galactagogue decoction and its preparation method. The ingredients of the formula include: Angelica sinensis 1 liang; Astragalus membranaceus 4 qian; Pangolin scales 2 qian; Vaccaria segetalis 1 liang; Ophiopogon japonicus 3 qian; Echinops latifolius 3 qian; Tetrapanax papyriferus 1 qian 5 fen; Fritillaria cirrhosa 1 qian; Pollen 3 qian; Glycyrrhiza uralensis 1 qian 5 fen; Ligusticum chuanxiong 5 qian; Angelica dahurica 2 qian; Panax ginseng 2 liang; Glycyrrhiza uralensis 5 qian; Liquidambar formosana 3 qian; Coix lacryma-jobi 4 qian.

[0004] Chinese invention patent CN117379525A discloses a method for preparing a drug for promoting lactation in postpartum women. The method includes: S1, removing impurities, drying, and pulverizing Angelica sinensis, Curcuma longa, Citrus aurantium, and Aucklandia lappa to obtain volatile oil raw materials; S2, placing the volatile oil raw materials in the extraction vessel of a supercritical carbon dioxide extraction device to extract intermediate materials, with an extraction temperature of 30-40℃, an extraction pressure of 45-60MPa, a carbon dioxide flow rate of 35-55Kg / h, and an extraction time of 120-200min; S3, transferring the intermediate materials to a primary separation tank maintaining a supercritical carbon dioxide state to separate supercritical carbon dioxide containing dissolved volatile oil and extraction residue separated from the carbon dioxide; S4, further processing in a secondary separation tank to separate carbon dioxide from the supercritical carbon dioxide containing dissolved volatile oil. S5. Separate the volatile oil to obtain the extract residue. Soak the extract residue with Leonurus japonicus, Paeonia lactiflora, Salvia miltiorrhiza, Achyranthes bidentata, Schizonepeta tenuifolia, Zingiber officinale, and Rubia cordifolia in water for 1.5-3 hours. Then, add 7-9 times the amount of water and decoct 2-3 times, 1-2 hours each time, to obtain a decoction. S6. Filter the decoction, add the volatile oil, concentrate to a relative density of 1.10-1.20 at 80°C, cool, slowly add ethanol, stir rapidly to make the alcohol content reach 55-70%, seal, and let stand for 20-30 hours to obtain a settled medicinal liquid. S7. Filter the settled medicinal liquid, recover the ethanol from the filtrate, and concentrate to a relative density of 1.15-1.22 at 60°C to obtain a pharmaceutical composition for promoting lactation in postpartum women. S8. Add excipients to the pharmaceutical composition for promoting lactation in postpartum women. The excipients include one or more of the following: solubilizing excipients, pharmaceutical excipients, or pharmaceutical flavoring agents.

[0005] Expanding the formulation and dosage of raw materials, as well as improving the preparation method, to enhance the efficacy of this type of drug based on existing formulations or raw materials are still technical problems that need to be solved. Summary of the Invention

[0006] This invention addresses the aforementioned technical problems by proposing a traditional Chinese medicine composition for promoting lactation after childbirth, its preparation method, and its application, belonging to the field of traditional Chinese medicine preparation technology.

[0007] The traditional Chinese medicine composition for promoting lactation after childbirth provided by this invention comprises the following ingredients: Astragalus membranaceus, Angelica sinensis, Ligusticum chuanxiong, Rehmannia glutinosa, Tetrapanax papyriferus, Vaccaria segetalis, Cyperus rotundus, Citrus aurantium, Paeonia lactiflora, Curcuma longa, Luffa cylindrica, Liquidambar formosana, Citrus reticulata, Echinops latifolius, Pinellia ternata, and Poria cocos; it relieves the symptoms of insufficient lactation caused by postpartum qi and blood deficiency, liver qi stagnation, and phlegm-dampness obstruction.

[0008] The traditional Chinese medicine composition for promoting lactation after childbirth provided by this invention comprises, by weight, the following ingredients: 25-35 parts Astragalus membranaceus, 10-20 parts Angelica sinensis, 10-20 parts Ligusticum chuanxiong, 10-20 parts Rehmannia glutinosa, 5-15 parts Tetrapanax papyriferus, 25-35 parts Vaccaria segetalis, 15-25 parts Cyperus rotundus, 15-25 parts Citrus aurantium, 15-25 parts Paeonia lactiflora, 15-25 parts Curcuma longa, 5-15 parts Luffa cylindrica, 25-35 parts Liquidambar formosana, 5-15 parts Citrus reticulata, 15-25 parts Echinops latifolius, 10-20 parts Pinellia ternata, and 15-25 parts Poria cocos.

[0009] The traditional Chinese medicine composition for promoting lactation after childbirth provided by this invention comprises, by weight, the following ingredients: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata, and 20 parts Poria cocos.

[0010] In the postpartum lactation-promoting traditional Chinese medicine composition provided by the present invention, the weight ratio of Astragalus membranaceus and Liquidambar formosana is (0.8-1.5):(0.75-1.2).

[0011] The present invention also provides a method for preparing a traditional Chinese medicine composition for promoting postpartum lactation, comprising the following steps: preparing materials according to the stated dosage; crushing the raw materials, adding water and decocting, cooling to obtain cooled material, adding fermentation bacteria and adjuvants to obtain pre-fermented material, and then fermenting, sterilizing, filtering, and concentrating to obtain a traditional Chinese medicine composition for promoting postpartum lactation.

[0012] In the preparation method, the weight ratio of the pulverized raw material to water is 1:5-60.

[0013] In the preparation method, the process of adding water for boiling and cooling includes adding water for boiling and then cooling.

[0014] In the preparation method, the temperature is cooled to 15-30℃.

[0015] In the preparation method, the additives include a carbon source and a nitrogen source.

[0016] In the preparation method, the carbon source includes glucose, sucrose, and fructose.

[0017] In the preparation method, the nitrogen source includes potassium dihydrogen phosphate or dipotassium hydrogen phosphate.

[0018] In the preparation method, the weights of the carbon source and nitrogen source are 0.5-3% and 0.008-0.1% of the pre-fermented product, respectively.

[0019] In the preparation method, the fermentation bacteria include Candida cruzie and Lactobacillus sacchariformis.

[0020] In the preparation method, the ratio of Candida crocea and Lactobacillus sacchari in the fermentation bacteria is 1:0.5-1.5.

[0021] In the preparation method, the concentration of the fermenting bacteria in the pre-fermented product is 10. 9 -10 12 per g.

[0022] In the preparation method, the fermentation is anaerobic fermentation.

[0023] In the preparation method, the fermentation temperature and time are 25-40℃ and 3-6 days.

[0024] In the preparation method, the concentration is increased to 8-20% of the weight of the filtered filtrate.

[0025] The preparation method further includes a drying step after concentration.

[0026] The present invention also provides the use of a traditional Chinese medicine composition for promoting postpartum lactation in the preparation of a finished drug, wherein the composition accounts for 0.1-80% by weight in the finished drug.

[0027] Beneficial technical effects of the present invention:

[0028] This invention uses Astragalus membranaceus, Angelica sinensis, Ligusticum chuanxiong, Rehmannia glutinosa, Tetrapanax papyriferus, Vaccaria segetalis, Cyperus rotundus, Citrus aurantium, Paeonia lactiflora, Curcuma longa, Luffa cylindrica, Liquidambar formosana, Citrus reticulata, Echinops latifolius, Pinellia ternata, and Poria cocos to prepare a traditional Chinese medicine composition; it can relieve / treat symptoms of insufficient lactation caused by postpartum qi and blood deficiency, liver qi stagnation, and phlegm-dampness obstruction.

[0029] The drug prepared by this invention can effectively promote lactation, and the drug group of this invention can alleviate / treat cases of insufficient lactation.

[0030] This invention utilizes Astragalus membranaceus, Liquidambar formosana, and Vaccaria segetalis in a formula to significantly enhance the galactagogue effect. Furthermore, the combination of Astragalus membranaceus and Liquidambar formosana synergistically enhances the galactagogue effect.

[0031] This invention utilizes fermentation to significantly enhance the galactagogue effect, and the drug fermented using the specific fermenting bacteria *Candida krusei* CICC 31807 and *Lactobacillus sacchariformis* GDMCC NO.: 1.1769 exhibits a good galactagogue effect. The combined fermentation of *Candida krusei* CICC 31807 and *Lactobacillus sacchariformis* GDMCC NO.: 1.1769 in this invention synergistically enhances the galactagogue effect; the galactagogue effect is even better when the ratio of the two bacteria is maintained at 1:0.5-1.5 while keeping the total amount of fermenting bacteria constant.

[0032] The drug of this invention can effectively enhance the phagocytic capacity of RAW264.7 macrophages, thereby improving immunity and enhancing postpartum immunity. This invention uses Astragalus membranaceus, Liquidambar formosana, and Vaccaria segetalis to enhance the drug's immunomodulatory effects to a certain extent; it also uses Candida krusei CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 for co-fermentation to synergistically enhance the drug's effect on the phagocytic capacity of RAW264.7 macrophages, and the ratio of these two strains also influences the drug's immunomodulatory effect to some extent. Detailed Implementation

[0033] The present invention further elaborates on the solution and effects of the present invention in conjunction with specific embodiments.

[0034] I. Experimental Preparation

[0035] 1. Drug 1

[0036] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0037] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0038] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0039] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0040] 2. Drug 2

[0041] (1) Prepare the ingredients according to the weight proportions mentioned above: 34 parts Astragalus membranaceus, 13 parts Angelica sinensis, 17 parts Ligusticum chuanxiong, 17 parts Rehmannia glutinosa, 8 parts Tetrapanax papyriferus, 32 parts Vaccaria segetalis, 18 parts Cyperus rotundus, 17 parts Citrus aurantium, 23 parts Paeonia lactiflora, 21 parts Curcuma longa, 9 parts Luffa cylindrica, 26 parts Liquidambar formosana, 8 parts Citrus reticulata, 22 parts Echinops latifolius, 10 parts Pinellia ternata and 21 parts Poria cocos.

[0042] (2) Mix and crush the raw materials, add 25 times the total mass of water to boil, and then cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:1.5), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 32℃ for 4.5 days), sterilizes, and obtains fermented material.

[0043] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.92% and 0.051%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0044] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 17.2% of the filtrate weight. Then it was vacuum dried to a water content of 1.59wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0045] 3. Drug 3

[0046] (1) Prepare the ingredients according to the weight proportions mentioned above: 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0047] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0048] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0049] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0050] 4. Drug 4

[0051] (1) Prepare the ingredients according to the weight proportions mentioned above: 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 60 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0052] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0053] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0054] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0055] 5. Drug 5

[0056] (1) Prepare the ingredients according to the weight proportions mentioned above: 60 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0057] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0058] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0059] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0060] 6. Drug 6

[0061] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0062] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil, and then cool to room temperature to obtain the cooled material. Heat at 60°C and stir at 100 rpm for 5 hours to obtain the extract.

[0063] (3) The extract was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0064] 7. Drug 7

[0065] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0066] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time are 35℃, 4 days), sterilizes, and obtains fermented material.

[0067] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0068] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0069] 8. Drugs

[0070] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0071] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (the fermentation bacteria is Lactobacillus saccharigenes GDMCC NO.: 1.1769), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time are 35℃, 4 days) and sterilization to obtain fermented material.

[0072] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0073] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0074] 9. Drug 9

[0075] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0076] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (the fermentation bacteria is Lactobacillus plantarum VIP(N)16421), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time are 35℃, 4 days), sterilizes, and obtains fermented material.

[0077] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0078] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0079] 10. Drugs 10

[0080] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0081] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil, and then cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:0.2), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0082] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0083] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0084] 11. Drugs

[0085] (1) Prepare the ingredients according to the weight proportions mentioned above: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

[0086] (2) Mix and crush the raw materials, add 30 times the total mass of water to boil and cool to room temperature to obtain cooled material. Add fermentation bacteria (Candida cruzi CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in a ratio of 1:3.5), sucrose and dipotassium hydrogen phosphate to obtain pre-fermented material. Then, it undergoes anaerobic fermentation (fermentation temperature and time of 35℃ for 4 days), sterilizes, and obtains fermented material.

[0087] In the pre-fermented product, the weight concentrations of sucrose and dipotassium hydrogen phosphate were 2.7% and 0.055%, respectively, and the concentration of fermentation bacteria was 3.60 × 10⁻⁶. 11 pcs / g;

[0088] (3) The fermentation product was filtered using a 1μm filter membrane, and the filtrate was concentrated under reduced pressure to 14.7% of the filtrate weight. Then it was vacuum dried to a water content of 1.65wt% to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

[0089] Among the above, *Candida cruzi* CICC 31807, *Lactobacillus sacchariformis* GDMCC NO.: 1.1769, and *Lactobacillus plantarum* VIP(N)16421 were purchased from the China Industrial Microbial Culture Collection Center, the Guangdong Provincial Microbial Culture Collection Center, and CNCI-Laiyao Biotechnology, respectively.

[0090] II. Experimental Testing

[0091] 1. Lactation test

[0092] Consumables and animals: the above drugs 1-11, mice (SPF grade KM mice, male 42±3g, female 37±3g), feed (AIN93G purified type, catalog number Jiangsu Xietong Pharmaceutical Bioengineering Co., Ltd.), lactation-promoting pills (Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Darentang Pharmaceutical Factory, National Drug Approval Number Z12020069).

[0093] Pre-experimental treatment: Mice were acclimatized and allowed to mate freely. After giving birth, mice with a birth time difference of less than 20 hours were selected as subjects for later experiments.

[0094] Grouping: Based on the weight of the mice, the experimental subjects were randomly divided into four groups: blank group, model group, positive group, and drug group, with 8 mice in each group.

[0095] The treatment details for each group are as follows: Control group: 15 mL / kg of normal saline was administered by gavage at 9:00 AM and 9:00 PM. Model group: 8.5 mg / kg of bromocriptine mesylate solution was administered by gavage at 9:00 AM, and 15 mL / kg of normal saline was administered by gavage at 2:00 PM. Positive drug group: 8.5 mg / kg of bromocriptine mesylate solution was administered by gavage at 9:00 AM, and 3.5 g / kg of lactation-promoting pills (diluted with normal saline, 15 mL / kg) was administered by gavage at 2:00 PM. Drug group: 8.5 mg / kg of bromocriptine mesylate solution was administered by gavage at 9:00 AM, and the above drugs 1-11 (2 g / kg, diluted with normal saline, 15 mL / kg) were administered by gavage at 2:00 PM. All groups were administered the drugs for a total of 12 days. The average milk yield (K) between 10:00 AM and 12:00 PM on days 3 and 12 was recorded. 3天 and K 12天 The data was then used. Based on the K value, the increase in K value for each group compared to the model group was calculated as ΔK. The results are shown in Table 1.

[0096] Table 1: Lactation Induction Test

[0097] Serial number / g <![CDATA[K 3天 ]]> <![CDATA[K 12天 ]]> <![CDATA[△K 3天 ]]> <![CDATA[△K 12天 <!-- 6 -->]]> Blank group 2.92 5.93 0.78 4.57 Model group 2.14 1.36 / / Positive drugs 3.48 5.24 1.34 3.88 Drug 1 3.27 5.11 1.13 3.75 Drug 2 3.21 5.00 1.07 3.64 Drug 3 2.63 4.02 0.49 2.66 Drug 4 3.13 4.88 0.99 3.52 Drug 5 3.05 4.74 0.91 3.38 Drug 6 2.71 4.15 0.57 2.79 Drug 7 2.95 4.57 0.81 3.21 Drug 8 2.98 4.62 0.84 3.26 Drug 9 2.89 4.47 0.75 3.11 Drug 10 3.10 4.82 0.96 3.46 Drug 11 3.14 4.89 1.00 3.53

[0098] Based on the test data in Table 1, it can be seen that the drug prepared in this invention can effectively promote lactation. Based on the test results of the model group on days 3 and 12, it can be seen that the use of bromocriptine mesylate solution to construct a lactation suppression and hypogalactia model, and by comparing the drug with the model group and the blank group, shows that the drug group can alleviate or treat lactation suppression and hypogalactia.

[0099] Comparison of drugs 1 and 3 shows that omitting Astragalus membranaceus, Liquidambar formosana, and Vaccaria segetalis significantly reduces the galactagogue effect. The use of Astragalus membranaceus, Liquidambar formosana, and Vaccaria segetalis in the formula of this invention significantly enhances the galactagogue effect. Tests on drugs 1, 4-5 show that the combination of Astragalus membranaceus and Liquidambar formosana synergistically enhances the galactagogue effect. Comparison of drugs 1, 4, and 9 shows that the fermentation method used in this invention significantly enhances the galactagogue effect, and the drug fermented using the specific fermentation bacteria *Candida krusei* CICC31807 and *Lactobacillus sacchariformis* GDMCC NO.: 1.1769 exhibits good galactagogue activity. According to tests of drugs 1 and 7-8, the co-fermentation of Candida cruzii CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 in this invention can mutually promote and enhance the galactagogue effect of the drugs; while tests of drugs 1 and 10-11 show that the galactagogue effect of the fermented drugs is reduced when the ratio of the two bacteria is not in the range of 1:0.5-1.5 while keeping the total amount of fermentation bacteria constant.

[0100] II. Immunity Boosting Test

[0101] Consumables and Animals: Drugs 1-11, lipopolysaccharide LPS (Catalog No. ST1470, Beyotime Biotechnology), DMEM high-glucose complete culture medium (containing 10% FBS) (Catalog No. PM150210B, Dingxiangtong, Supplier: Wuhan Pronosai Life Science Technology Co., Ltd.).

[0102] Grouping and Samples: The drugs were diluted in DMEM high-glucose complete medium. The blank group was: medium; the positive drug group was: 1.05 μg / mL lipopolysaccharide (LPS); and the drug groups 1-11 were: 15 μg / mL.

[0103] Experimental procedure: Logarithmic growth phase RAW264.7 macrophages were taken and diluted with culture medium to obtain a suspension (cell concentration 1×10⁻⁶). 5The sample was inoculated at 100 μL / mL, and then 100 μL of suspension was seeded into each well of a 96-well plate. The plates were incubated at 37°C and 5% CO2 for 12 hours. Then, 100 μL of each sample was added to the wells (designed for 4 parallel test wells). The plates were incubated for another 48 hours, the supernatant was discarded, and the sample was stained with 0.05% neutral red solution. After staining for 1 hour, the supernatant was discarded, and the plates were washed four times with PBS. Then, 150 μL of lysis buffer (ethanol and acetic acid in a 1:1 mass ratio) was added to each well. The plates were incubated at 37°C with shaking for 20 minutes. The absorbance (OD) was then measured at 550 nm, and the phagocytic index (α) was calculated, where α = OD0. 样品组 / OD 空白组 ×100; OD 空白组 The absorbance OD value of the blank group. 样品组 The absorbance (OD) values ​​are for the non-blank group. Based on the obtained α values, the increase in α value (Δα) compared to the positive drug group was calculated for each group. The results are shown in Table 2.

[0104] Table 2: Immunity Enhancement Test

[0105] Serial Number / % α △α Blank group / / Positive drugs 112.13 / Drug 1 127.64 15.51 Drug 2 126.03 13.90 Drug 3 120.14 8.01 Drug 4 124.78 12.65 Drug 5 123.06 10.93 Drug 6 114.79 2.66 Drug 7 120.82 8.69 Drug 8 121.57 9.44 Drug 9 118.05 5.92 Drug 10 123.83 11.70 Drug 11 125.16 13.03

[0106] According to the test results in Table 2, the drug of this invention can effectively enhance the phagocytic capacity of RAW264.7 macrophages, thereby improving immunity and enhancing postpartum immunity. Comparing drugs 1 and 3-11, it can be seen that the use of Astragalus membranaceus, Liquidambar formosana, and Vaccaria segetalis in this invention enhances the drug's immunomodulatory effect to a certain extent; the co-fermentation of Candida albicans CICC 31807 and Lactobacillus sacchariformis GDMCC NO.: 1.1769 enhances the drug's effect on improving the phagocytic capacity of RAW264.7 macrophages, and the ratio of these two strains also affects the drug's immunomodulatory effect to some extent.

Claims

1. A traditional Chinese medicine composition for promoting lactation after childbirth, characterized in that, According to the weight parts, the raw materials are: 25-35 parts Astragalus membranaceus, 10-20 parts Angelica sinensis, 10-20 parts Ligusticum chuanxiong, 10-20 parts Rehmannia glutinosa, 5-15 parts Tetrapanax papyriferus, 25-35 parts Vaccaria segetalis, 15-25 parts Cyperus rotundus, 15-25 parts Citrus aurantium, 15-25 parts Paeonia lactiflora, 15-25 parts Curcuma longa, 5-15 parts Luffa cylindrica, 25-35 parts Liquidambar formosana, 5-15 parts Citrus reticulata, 15-25 parts Echinops latifolius, 10-20 parts Pinellia ternata, and 15-25 parts Poria cocos. The preparation method of a traditional Chinese medicine composition for promoting lactation after childbirth includes the following steps: preparing materials according to the stated weight proportions; crushing the raw materials, adding water and decocting, cooling to obtain cooled materials, adding fermentation bacteria and adjuvants to obtain pre-fermented materials, and then fermenting, sterilizing, filtering, and concentrating to obtain a traditional Chinese medicine composition for promoting lactation after childbirth. The fermentation bacteria consist of Candida crocea and Lactobacillus sacchari in a ratio of 1:0.5-1.

5.

2. The traditional Chinese medicine composition for promoting lactation after childbirth according to claim 1, characterized in that, According to the weight proportions, the ingredients are: 30 parts Astragalus membranaceus, 15 parts Angelica sinensis, 15 parts Ligusticum chuanxiong, 15 parts Rehmannia glutinosa, 10 parts Tetrapanax papyriferus, 30 parts Vaccaria segetalis, 20 parts Cyperus rotundus, 20 parts Citrus aurantium, 20 parts Paeonia lactiflora, 20 parts Curcuma longa, 10 parts Luffa cylindrica, 30 parts Liquidambar formosana, 10 parts Citrus reticulata peel, 20 parts Echinops latifolius, 12 parts Pinellia ternata and 20 parts Poria cocos.

3. The traditional Chinese medicine composition for promoting lactation after childbirth according to claim 1, characterized in that, The weight ratio of Astragalus membranaceus to Liquidambar formosana is (0.8-1.5):(0.75-1.2).

4. A method for preparing a traditional Chinese medicine composition for promoting postpartum lactation according to any one of claims 1-3, characterized in that, Includes the following steps: Prepare the materials according to the stated weight proportions; crush the raw materials, add water and decoct, cool to obtain cooled material, add fermentation bacteria and adjuvants to obtain pre-fermented material, and then ferment, sterilize, filter, concentrate to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

5. The method for preparing a traditional Chinese medicine composition for promoting postpartum lactation according to claim 4, characterized in that, The process of concentration also includes a drying step.

6. The method for preparing a traditional Chinese medicine composition for promoting postpartum lactation according to claim 4, characterized in that, Additives include carbon sources and nitrogen sources.

7. The method for preparing a traditional Chinese medicine composition for promoting postpartum lactation according to claim 4, characterized in that, Fermentation is anaerobic fermentation; or, the fermentation temperature and time are 25-40℃ for 3-6 days; or, the carbon source includes glucose, sucrose or fructose; or, the nitrogen source includes potassium dihydrogen phosphate or dipotassium hydrogen phosphate; or, the ratio of Candida croceae to Lactobacillus sacchari in the fermentation bacteria is 1:0.5-1.

5.

8. The use of a traditional Chinese medicine composition for promoting postpartum lactation according to any one of claims 1-3 or a traditional Chinese medicine composition for promoting postpartum lactation prepared by the preparation method according to any one of claims 4-7 in the preparation of a drug for promoting postpartum lactation.