Traditional Chinese medicine composition for postpartum lactation promotion as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for postpartum lactation promotion and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition is prepared from astragalus membranaceus, angelica sinensis, ligusticum wallichii, radix rehmanniae recen, tetrapanax papyriferus, cowherb seed, rhizoma cyperi, fructus aurantii, radix paeoniae alba, radix curcumae, loofah sponge, beautiful sweetgum fruit, pericarpium citri reticulatae, uniflower swisscentaury root, rhizoma pinellinae praeparata and poria cocos. The hypogalactia symptom caused by postpartum qi and blood deficiency, liver depression and qi stagnation and phlegm-dampness stagnation can be relieved / treated, and the effect of enhancing immunity is good.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for promoting lactation after childbirth, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. Background Art

[0002] Traditional Chinese medicine believes that the production and secretion of milk are closely related to the internal organs and meridians: milk is transformed from qi and blood. Postpartum qi and blood deficiency is one of the reasons for insufficient milk. Qi can promote the circulation of milk, and qi stagnation may lead to milk stasis and poor excretion; the spleen and stomach are the source of qi and blood biochemical transformation. Weak spleen and stomach will lead to insufficient qi and blood production and a lack of milk source; the liver is responsible for dispersing and regulating qi. Liver qi stagnation will affect the circulation of qi, resulting in milk channel obstruction, milk stasis or poor secretion; the kidneys store essence, and essence and blood have the same origin; insufficient kidney essence may also affect the transformation of milk (especially for older mothers or those with weak constitutions); in addition, milk flows to the breasts through the Chong Mai, Ren Mai and Stomach Meridian of Foot Yangming. Unobstructed meridians are the key to the smooth secretion and excretion of milk.

[0003] Chinese invention patent CN114209786A discloses a lactation-promoting and lactation-promoting decoction and its preparation method. The raw materials of the formula include: 1 liang of angelica sinensis; 4 qian of raw astragalus; 2 qian of jiazhu; 1 liang of fenugreek; 3 qian of cundong; 3 qian of lou lu; 1 qian and 5 fen of tongcao; 1 qian of cirrhosa; 3 qian of pollen; 1 qian and 5 fen of licorice; 5 qian of chuanxiong; 2 qian of angelica dahurica; 2 liang of red ginseng; 5 qian of liquorice; 3 qian of rhizoma smilacis gracile; and 4 qian of coix seed.

[0004] Chinese invention patent CN117379525A discloses a preparation method for a medicine for promoting lactation in parturients, which comprises the following steps: S1, removing impurities from angelica, turmeric, fructus aurantii, and costus root, drying, and crushing to obtain a volatile oil raw material; S2, extracting the volatile oil raw material in an extraction kettle of a supercritical carbon dioxide extraction device to obtain an intermediate material, wherein the extraction temperature is 30-40°C, the extraction pressure is 45-60 MPa, the carbon dioxide flow rate is 35-55 kg / h, and the extraction time is 120-200 min; S3, transferring the intermediate material to a primary separation tank in which carbon dioxide is maintained in a supercritical state, and separating to obtain supercritical carbon dioxide dissolved in volatile oil and extracted medicinal residue separated from the carbon dioxide; S4, separating the carbon dioxide from the supercritical carbon dioxide dissolved in volatile oil through a secondary separation tank. Separate and obtain volatile oil; S5, soak the extracted medicinal residue with Leonurus japonicus, Red Peony Root, Salvia miltiorrhiza, Achyranthes bidentata, Schizonepeta tenuifolia, Dry Ginger and Rubia cordifolia in water for 1.5-3 hours, add 7-9 times the amount of water and boil for 2-3 times, each time for 1-2 hours, to obtain a decoction; S6, filter the decoction, add volatile oil, concentrate to a relative density of 1.10-1.20 at 80°C, let 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 static medicinal solution; S7, filter the static medicinal solution, recover 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 parturients; S8, add excipients to the pharmaceutical composition for promoting lactation in parturients; the excipients include one or more of solubilizing excipients, pharmaceutical excipients or pharmaceutical flavoring agents.

[0005] However, expanding the formula raw material combination, dosage and improving the preparation method based on the existing formula or raw materials to enhance the efficacy of this type of drug is a technical problem that still needs to be solved. Summary of the Invention

[0006] In view of the above technical problems, the present invention provides a traditional Chinese medicine composition for promoting lactation after childbirth, a preparation method and an application thereof, and belongs to the technical field of traditional Chinese medicine preparations.

[0007] The present invention provides a traditional Chinese medicine composition for promoting lactation after childbirth. The raw materials of the composition are astragalus, angelica, ligusticum chuanxiong, raw rehmannia root, tongcao, vaccaria segetalis, cyperus rotundus, fructus aurantii, white peony root, curcuma, luffa, fennel, tangerine peel, scutellaria baicalensis, pinellia ternata and poria. The composition can relieve the symptoms of lack of lactation caused by postpartum qi and blood deficiency, liver depression and qi stagnation, and phlegm-dampness obstruction.

[0008] The traditional Chinese medicine composition for promoting lactation after childbirth provided by the present invention comprises the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of angelica, 10-20 parts of ligusticum, 10-20 parts of raw rehmannia, 5-15 parts of tongcao, 25-35 parts of vaccaria, 15-25 parts of cyperus, 15-25 parts of fructus aurantii, 15-25 parts of white peony root, 15-25 parts of curcuma, 5-15 parts of luffa, 25-35 parts of rhizoma liquidambar, 5-15 parts of tangerine peel, 15-25 parts of smilax china, 10-20 parts of pinellia and 15-25 parts of poria.

[0009] The present invention provides a traditional Chinese medicine composition for promoting lactation after childbirth. The raw materials are, in parts by weight, 30 parts of astragalus, 15 parts of angelica, 15 parts of ligusticum, 15 parts of raw rehmannia, 10 parts of tongcao, 30 parts of vaccaria, 20 parts of cyperus, 20 parts of fructus aurantii, 20 parts of white peony root, 20 parts of curcuma, 10 parts of luffa, 30 parts of rhizoma liquidambar, 10 parts of dried tangerine peel, 20 parts of smilax china, 12 parts of pinellia and 20 parts of poria.

[0010] In the traditional Chinese medicine composition for promoting lactation after childbirth provided by the present invention, the weight ratio of astragalus root to rhizoma liquidambarelliae 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 lactation after childbirth, comprising the following steps: preparing materials according to the dosage; crushing the raw materials, decocting with water, cooling to obtain cooled materials, adding fermentation bacteria and auxiliary agents to obtain pre-fermented materials, and then fermenting, sterilizing, filtering, and concentrating to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

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

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

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

[0015] In the preparation method, the auxiliary agent includes 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 weight of the carbon source and the nitrogen source are 0.5-3% and 0.008-0.1% of the pre-fermented material.

[0019] In the preparation method, the fermentation bacteria include Candida krusei and Lactobacillus cerevisiae.

[0020] In the preparation method, the ratio of Candida krusei to Lactobacillus cerevisiae in the fermentation bacteria is 1:0.5-1.5.

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

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

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

[0024] In the preparation method, the filtrate is concentrated to 8-20% by weight of the filtrate.

[0025] In the preparation method, a drying step is further included after concentration.

[0026] The present invention also provides the use of the traditional Chinese medicine composition for promoting lactation after childbirth in the preparation of finished medicines, wherein the weight of the composition in the finished medicines is 0.1-80%.

[0027] Beneficial technical effects of the present invention:

[0028] The invention adopts astragalus, angelica, chuanxiong, raw rehmannia, tongcao, vaccaria, cyperus, fructus aurantii, white peony root, curcuma, luffa, rhizoma liquidambar, tangerine peel, smilax china, pinellia and poria to prepare a traditional Chinese medicine composition; the traditional Chinese medicine composition can relieve / treat the symptoms of lack of milk caused by postpartum qi and blood deficiency, liver depression and qi stagnation, and phlegm-dampness obstruction.

[0029] The medicine prepared by the present invention can effectively promote lactation, and the medicine group of the present invention can alleviate / treat the situation of milk regurgitation and lack of milk.

[0030] The present invention uses astragalus, liquidambar and vaccaria in the prescription to significantly improve the lactation effect. The combination of astragalus and liquidambar can synergistically improve the lactation effect.

[0031] The present invention significantly enhances lactation-inducing effects through fermentation. The combination of the specific fermentative bacteria Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC No. 1.1769 exhibits a strong lactation-inducing effect. The combined fermentation of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC No. 1.1769 enhances the lactation-inducing effect of the drug. The lactation-inducing effect of the fermented drug is even better when the ratio of the two bacteria is within the range of 1:0.5-1.5, while maintaining the total amount of fermentative bacteria unchanged.

[0032] The drug of the present invention can effectively enhance the phagocytic ability of macrophages RAW264.7, thereby improving immunity and enhancing postpartum immunity. The drug utilizes astragalus, Fructus Lulufen, and Vaccariae to enhance the drug's immune function to a certain extent. Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 are used for combined fermentation to synergistically enhance the drug's effect on the phagocytic ability of macrophages RAW264.7. The ratio of the two also influences the drug's immune-enhancing effect to a certain extent. DETAILED DESCRIPTION

[0033] The present invention further illustrates the solutions and effects of the present invention in conjunction with the contents of the specific implementation methods.

[0034] 1. Experimental Preparation

[0035] 1. Drug 1

[0036] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0037] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0039] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0040] 2. Drug 2

[0041] (1) Prepare the following ingredients in proportion by weight: 34 parts of Astragalus, 13 parts of Chinese Angelica, 17 parts of Chuanxiong, 17 parts of Rehmannia root, 8 parts of Smilax glabra, 32 parts of Vaccaria segetalis, 18 parts of Cyperus rotundus, 17 parts of Citrus aurantium, 23 parts of White Peony, 21 parts of Curcuma aromatica, 9 parts of Luffa, 26 parts of Fructus Smilacis Glabrae, 8 parts of Citrus reticulatae, 22 parts of Rhizoma Cyperi, 10 parts of Pinellia ternata, and 21 parts of Poria.

[0042] (2) The raw materials were mixed and crushed, 25 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:1.5), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 32°C and 4.5 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0044] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 17.2% of the filtrate weight, and then vacuum dried to a water content of 1.59 wt% to obtain a traditional Chinese medicine composition for postpartum lactation.

[0045] 3. Drugs

[0046] (1) Prepare the following ingredients according to the weight ratios: 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Radix Rehmanniae, 10 parts of Scutellariae, 20 parts of Cyperus rotundus, 20 parts of Fructus Aurantii Immaturus, 20 parts of Paeonia lactiflora, 20 parts of Curcuma aromatica, 10 parts of Luffa, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0047] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0049] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0050] 4. Drugs

[0051] (1) Prepare the following ingredients in parts by weight: 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Radix Rehmanniae, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Fructus Aurantii Immaturus, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa Spina, 60 parts of Fructus Smilacis Glabrae, 10 parts of Pericarpium Citri Reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Rhizoma Pinelliae and 20 parts of Poria.

[0052] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0054] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0055] 5. Drugs

[0056] (1) Prepare the following ingredients in proportions by weight: 60 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 10 parts of Tangerine peel, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0057] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:0.8), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0059] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0060] 6. Drugs

[0061] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0062] (2) The raw materials were mixed and crushed, 30 times the total mass of the mixture was added with water, boiled, and cooled to room temperature to obtain a cooled material, which was heated at 60°C and stirred at 100 rpm for 5 hours to obtain an extract;

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

[0064] 7. Drugs

[0065] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0066] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and cooled to room temperature to obtain a cooled material. Fermentation bacteria (the fermentation bacteria was Candida krusei CICC 31807), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented material, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a 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 11 pcs / g;

[0068] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0069] 8. Drugs

[0070] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0071] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, and fermentation bacteria (the fermentation bacteria was Lactobacillus cerevisiae GDMCC NO.: 1.1769), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented material, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a 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 11 pcs / g;

[0073] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0074] 9. Drugs

[0075] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0076] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, and fermentation bacteria (the fermentation bacteria was Lactobacillus plantarum VIP (N) 16421), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented material, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days), sterilized, and a fermented material was obtained.

[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 11 pcs / g;

[0078] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0079] 10. Drugs

[0080] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0081] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:0.2), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0083] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0084] 11. Drugs

[0085] (1) Prepare the following ingredients in proportions by weight: 30 parts of Astragalus, 15 parts of Chinese Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia root, 10 parts of Smilax glabra, 30 parts of Vaccaria segetalis, 20 parts of Cyperus rotundus, 20 parts of Citrus aurantium, 20 parts of White Peony Root, 20 parts of Curcuma aromatica, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia ternata, and 20 parts of Poria.

[0086] (2) The raw materials were mixed and crushed, 30 times the total mass of water was added to the mixture, and the mixture was boiled and then cooled to room temperature to obtain a cooled material, fermentation bacteria (composed of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in a quantity ratio of 1:3.5), sucrose and dipotassium hydrogen phosphate were added to obtain a pre-fermented product, which was then subjected to anaerobic fermentation (fermentation temperature and time were 35°C and 4 days) and sterilized to obtain a fermented product.

[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 11 pcs / g;

[0088] (3) The fermented product is filtered using a 1 μm filter membrane, the filtrate is concentrated under reduced pressure to 14.7% of the filtrate weight, and then vacuum dried to a water content of 1.65 wt%, to obtain a traditional Chinese medicine composition for postpartum lactation.

[0089] Among the above, Candida krusei CICC 31807, Lactobacillus cerevisiae GDMCC NO.: 1.1769 and Lactobacillus plantarum VIP (N) 16421 were purchased from China Industrial Microorganism Culture Collection Center, Guangdong Provincial Microorganism Culture Collection Center and China Inspection and Metrology-Laiyao Biological, respectively.

[0090] 2. Experimental Test

[0091] 1. Lactation test

[0092] Consumables and animals: the above-mentioned drugs 1-11, mice (SPF-grade KM mice, male 42±3g, female 37±3g), feed (AIN93G purified type, product number Jiangsu Collaborative Pharmaceutical Bioengineering Co., Ltd.), and lactation pills (Darentang Pharmaceutical Factory, Tianjin Zhongxin Pharmaceutical Group Co., Ltd., national medicine standard Z12020069).

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

[0094] Grouping: The mice were randomly divided into blank group, model group, positive group and drug group according to their weight according to the above experimental subjects, with 8 mice in each group.

[0095] The treatment conditions of each group are as follows: Blank group: gavage with normal saline, 15 mL / kg each time, once at 9:00 am and 9:00 pm. Model group: gavage with 8.5 mg / kg bromocriptine mesylate solution at 9:00 am and 15 mL / kg normal saline at 2:00 pm. Positive drug group: gavage with 8.5 mg / kg bromocriptine mesylate solution at 9:00 am and 3.5 g / kg of prolactin pills (diluted with normal saline, gavage volume 15 mL / kg) at 2:00 pm. Drug group: gavage with 8.5 mg / kg bromocriptine mesylate solution at 9:00 am and the above drugs 1-11 (gavage volume 2 g / kg, diluted with normal saline, gavage volume 15 mL / kg) at 2:00 pm. Each group was treated for a total of 12 days, and the average lactation K between 10:00 am and 12:00 pm on the 3rd and 12th days was calculated. 3天 and K 12天 Then, based on the K value, the ΔK value of the increase in K value of each group compared with the model group was calculated. The results are shown in Table 1.

[0096] Table 1: Lactation 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] Combined with the test data in Table 1, it can be seen that the drug prepared by the present invention can effectively promote lactation. Combined with the test results of the model group on days 3 and 12, it can be seen that the bromocriptine mesylate solution was used to construct a milk-reduction and angalactia model, and combined with the comparison of the drug group with the model group and the blank group, it can be seen that the drug group can alleviate or treat the condition of milk-reduction and angalactia.

[0099] Comparison of drugs 1 and 3 shows that the galactagogue effect of the drug significantly decreases when Astragalus, Scutellaria baicalensis, and Vaccaria segetalis are omitted from the prescription. The present invention significantly improves the galactagogue effect by using Astragalus, Scutellaria baicalensis, and Vaccaria segetalis in the prescription. Testing of drugs 1, 4-5 shows that the combination of Astragalus and Scutellaria baicalensis can synergistically enhance the galactagogue effect. Comparison of drugs 1, 4, and 9 shows that the present invention significantly enhances the galactagogue effect by fermentation, and the drug fermented using the combination of the specific fermentation bacteria Candida krusei CICC31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 has a better galactagogue effect. The tests on drugs 1, 7, and 8 showed that the combined fermentation of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 in the present invention can synergistically enhance the lactogenic effect of the drug. However, the tests on drugs 1, 10, and 11 showed that the lactogenic effect of the fermentation drug was reduced when the ratio of the two bacteria was not within the range of 1:0.5-1.5 while maintaining the total amount of fermentation bacteria.

[0100] 2. Immunity Enhancement Test

[0101] Consumables and animals: the above-mentioned drugs 1-11, lipopolysaccharide LPS (catalog number ST1470, Beyotime Biotechnology), DMEM high-glucose complete medium (containing 10% FBS) (catalog number PM150210B, Dingxiangtong, supplier: Wuhan Punosai Life Science Co., Ltd.).

[0102] Grouping and samples: DMEM high-glucose complete medium was used to dilute the drugs, including: blank group: medium; positive drug group: 1.05 μg / mL lipopolysaccharide LPS; drug 1-11 group: 15 μg / mL.

[0103] Experimental procedure: RAW264.7 macrophages in logarithmic growth phase were diluted with culture medium to obtain suspension (cell concentration 1×10 5 / mL), then 100 μL of the suspension was inoculated into a 96-well plate per well, and cultured at 37°C and 5% CO2 for 12 hours. 100 μL of samples from each group were added to the well plate (4 parallel test wells were designed), and cultured for 48 hours. The supernatant was discarded, and 0.05% neutral red solution was added for staining. After staining for 1 hour, the supernatant was discarded, and PBS was washed 4 times. Then 150 μL of lysis solution composed of ethanol and acetic acid in a mass ratio of 1:1 was added to each well, and the plates were shaken in a 37°C water bath for 20 minutes. Then, the absorbance OD value was measured at 550 nm to calculate the phagocytic index α value, where α = OD 样品组 / OD 空白组 ×100;OD 空白组 is the absorbance OD value of the blank group, OD 样品组 is the absorbance OD value of the non-blank group. Based on the obtained α value, the Δα value of the increase in α value of each group compared to the positive drug group was calculated. 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 the present invention can effectively enhance the phagocytic ability of macrophages RAW264.7, improve immunity, and enhance postpartum immunity. A comparison of drugs 1 and 3-11 shows that the present invention uses Astragalus, Fructus Lulufen, and Vaccariae to enhance the drug's immunity to a certain extent; the combined fermentation of Candida krusei CICC 31807 and Lactobacillus cerevisiae GDMCC NO.: 1.1769 synergistically enhances the drug's effect on the phagocytic ability of macrophages RAW264.7, and the ratio of the two also affects the drug's immune-enhancing effect to a certain extent.

Claims

1. A Chinese medicine composition for postpartum lactation, characterized in that: The raw materials are: Astragalus, Angelica, Chuanxiong, Rehmannia root, Smilax glabra, Vaccaria segetalis, Cyperus rotundus, Citrus aurantium, White peony root, Curcuma aromatica, Luffa loofah, Rhizoma Smilacis Glabrae, Tangerine peel, Rhizoma Cyperi, Pinellia ternata and Poria cocos.

2. A Chinese medicine composition for postpartum lactation according to claim 1, characterized in that, The raw materials are as follows: 25-35 parts of astragalus, 10-20 parts of angelica, 10-20 parts of chuanxiong, 10-20 parts of raw rehmannia, 5-15 parts of tongcao, 25-35 parts of fenugreek, 15-25 parts of cyperus, 15-25 parts of aurantium, 15-25 parts of white peony, 15-25 parts of turmeric, 5-15 parts of luffa, 25-35 parts of rhizoma smilacis gracile, 5-15 parts of tangerine peel, 15-25 parts of smilax china, 10-20 parts of pinellia and 15-25 parts of poria.

3. A Chinese medicine composition for promoting lactation after childbirth according to claim 1, characterized in that In terms of weight, the raw materials are: 30 parts of Astragalus, 15 parts of Angelica, 15 parts of Chuanxiong, 15 parts of Rehmannia, 10 parts of Smilax, 30 parts of Vaccaria, 20 parts of Cyperus, 20 parts of Citrus aurantium, 20 parts of White Peony, 20 parts of Curcuma, 10 parts of Luffa, 30 parts of Rhizoma Smilacis Glabrae, 10 parts of Citrus reticulatae, 20 parts of Rhizoma Cyperi, 12 parts of Pinellia and 20 parts of Poria.

4. A Chinese medicine composition for promoting lactation after childbirth according to claim 1, characterized in that The weight ratio of Astragalus membranaceus and Rhizoma Lulufen is (0.8-1.5):(0.75-1.2).

5. A method for preparing a traditional Chinese medicine composition for promoting lactation after childbirth according to any one of claims 1 to 4, characterized in that: The following steps are involved: The raw materials are prepared according to the dosage; the raw materials are crushed, boiled with water, cooled to obtain cooled materials, fermentation bacteria and auxiliary agents are added to obtain pre-fermented materials, and then fermented, sterilized, filtered, and concentrated to obtain a traditional Chinese medicine composition for promoting lactation after childbirth.

6. The method for preparing a Chinese medicine composition for postpartum lactation according to claim 5, wherein: After concentration, a drying step is also included.

7. The method for preparing a Chinese medicine composition for promoting lactation after childbirth according to claim 5, wherein: Additives include carbon sources and nitrogen sources.

8. The method for preparing a Chinese medicine composition for postpartum lactation according to claim 5, wherein: Fermentative bacteria include Candida krusei and Lactobacillus cerevisiae.

9. The method for preparing a Chinese medicine composition for postpartum lactation according to claim 5, wherein: The fermentation is anaerobic fermentation; or, the fermentation temperature and time are 25-40° C. and 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 krusei to Lactobacillus cerevisiae in the fermentation bacteria is 1:0.5-1.

5.

10. Use of the traditional Chinese medicine composition for promoting lactation after childbirth according to any one of claims 1 to 4 or the traditional Chinese medicine composition for promoting lactation after childbirth prepared by the preparation method according to any one of claims 5 to 9 in preparing finished drugs.