A method for preparing a medicine for inducing lactation in a lying-in woman

Abstract

The application relates to the technical field of traditional Chinese medicine, and discloses a preparation method of a medicine for lactation promotion of puerpera. The medicine composition for treating dysfunctional uterine bleeding is originally used for treating excessive menstruation and prolonged menstruation of women. The improved preparation method uses a supercritical CO2 extraction method to extract volatile oil, so that the medicine composition for treating dysfunctional uterine bleeding has higher efficacy and can be fully exerted. Through experiments, it is verified that when the improved medicine composition is used for lactation promotion of puerpera, the medicine composition can help to increase the levels of estradiol and progesterone hormones to regulate hormone imbalance, act on developed mammary glands to promote the increase of lactation, and has small toxic and side effects and reduces the burden of the liver.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a method for preparing a drug for promoting lactation in postpartum women. Background Technology

[0002] Breastfeeding helps reduce postpartum bleeding, promotes uterine contraction, accelerates postpartum recovery, and can lower the risk of breast and ovarian cancer. Breast milk contains all the nutrients needed by infants under 6 months of age, is easily digested and absorbed, promotes intestinal development, and increases immune protection.

[0003] During pregnancy, a woman's estrogen and progesterone levels rise continuously to their peak. After childbirth, the mother's prolactin levels rise rapidly, while estrogen and progesterone levels suddenly drop to baseline, easily causing hormonal imbalances. This can lead to postpartum depression, slower physical recovery, and insufficient lactation. Currently, nearly half of postpartum women still face problems such as insufficient milk production, lack of milk, or acute mastitis caused by blocked milk ducts.

[0004] Western medicine typically uses hormone-based drugs directly. Many of these components are excreted through the liver and kidneys, and long-term use can damage liver and kidney function and may lead to dependence. They generally have strong side effects.

[0005] A representative product, Kuning Oral Liquid, can be obtained using the preparation method disclosed in patent application CN1589894A. Kuning Oral Liquid is mainly used to treat menorrhagia and prolonged menstrual periods in women, with minimal toxic side effects. However, the distillation method used in this preparation method for Angelica sinensis, Curcuma longa, Citrus aurantium, and Aucklandia lappa can easily cause the decomposition and denaturation of heat-sensitive active ingredients in these four raw materials, including volatile oils, flavonoids, and terpenes, resulting in a reduced yield of volatile oils and a loss of efficacy. Furthermore, there is currently no research on the efficacy of Kuning Oral Liquid in promoting lactation in postpartum women. Summary of the Invention

[0006] To address the aforementioned problems, this invention provides a method for preparing a drug for promoting lactation in postpartum women that has fewer toxic side effects and more complete efficacy, employing the following technical solution:

[0007] A method for preparing a drug for promoting lactation in postpartum women includes the following steps:

[0008] S1. The volatile oil raw materials are obtained by removing impurities, drying and pulverizing Angelica sinensis, Curcuma longa, Citrus aurantium and Aucklandia lappa;

[0009] S2. The volatile oil raw material is placed in the extraction vessel of a supercritical carbon dioxide extraction device to extract intermediate material. The extraction temperature is 30-40℃, the extraction pressure is 45-60MPa, the carbon dioxide flow rate is 35-55Kg / h, and the extraction time is 120-200min.

[0010] S3. The intermediate material is transferred to a primary separation tank that maintains the supercritical state of carbon dioxide to separate supercritical carbon dioxide containing volatile oil and extract residue separated from carbon dioxide.

[0011] S4. After separation in a two-stage separator, carbon dioxide is separated from the supercritical carbon dioxide containing dissolved volatile oil to obtain volatile oil;

[0012] S5. Soak the extracted residue with motherwort, red peony root, salvia miltiorrhiza, achyranthes bidentata, schizonepeta tenuifolia, dried ginger, and madder root 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 the decoction.

[0013] S6. Filter the decoction, add volatile oil, concentrate to a relative density of 1.10-1.20 at 80℃, cool, slowly add ethanol, stir rapidly to make the alcohol content reach 55-70%, seal, and let stand for 20-30 hours to obtain the standing decoction.

[0014] S7. Filter the settled drug solution, recover the ethanol from the filtrate, and concentrate it to a relative density of 1.15-1.22 at 60°C to obtain a drug composition for promoting lactation in postpartum women.

[0015] S8. Adding excipients to a pharmaceutical composition for promoting lactation in postpartum women; said excipients include one or more of solubilizing excipients, pharmaceutical excipients, or pharmaceutical flavoring agents.

[0016] Preferably, the active ingredients of the pharmaceutical composition for promoting lactation in postpartum women include the following parts by weight: 30 parts of Leonurus japonicus; 30 parts of Angelica sinensis; 30 parts of Paeonia lactiflora; 30 parts of Salvia miltiorrhiza; 20 parts of Curcuma longa; 30 parts of Achyranthes bidentata; 20 parts of Citrus aurantium; 10 parts of Aucklandia lappa; 20 parts of Schizonepeta tenuifolia; 10 parts of Zingiber officinale; and 20 parts of Rubia cordifolia.

[0017] Preferably, the pharmaceutical composition for promoting lactation in postpartum women, by weight, comprises the following raw materials: 30-40 parts by weight of Leonurus japonicus; 30-40 parts by weight of Angelica sinensis; 25-35 parts by weight of Paeonia lactiflora; 30-40 parts by weight of Salvia miltiorrhiza; 15-25 parts by weight of Curcuma longa; 30-40 parts by weight of Achyranthes bidentata; 20-30 parts by weight of Citrus aurantium; 10-20 parts by weight of Aucklandia lappa; 15-25 parts by weight of Schizonepeta tenuifolia; 5-15 parts by weight of Zingiber officinale; and 15-25 parts by weight of Rubia cordifolia.

[0018] Preferably, the excipients added to the drug for promoting lactation in postpartum women are 20-60 parts by weight.

[0019] Preferably, the solubilizing excipient is pharmaceutical-grade povidone or β-cyclodextrin.

[0020] Preferably, the dosage form of the drug for promoting lactation in postpartum women includes decoction, tablets, capsules, pills, injections, sustained-release or controlled-release formulations, and powders.

[0021] In summary, the present invention has the following beneficial technical effects:

[0022] (1) This invention converts the pharmaceutical composition for treating dysfunctional uterine bleeding in the applicant's patent number CN1589894A into a pharmaceutical composition for promoting lactation in postpartum women, and provides a method for preparing the pharmaceutical composition for promoting lactation in postpartum women; during administration, it helps to avoid hormonal imbalance in the postpartum woman's body, helps to promote the normal secretion of prolactin, allows the mammary ducts and mammary alveoli to be fully stimulated and developed, and helps to relieve the postpartum woman's anxiety and depression, so that the postpartum woman is in a good mood and ensures the amount of milk secreted.

[0023] (2) Compared with ordinary medicinal liquids, volatile oils have smaller molecular weights and stronger lipid solubility, making it easier to pass through the body's biological membranes and have high bioavailability. Collecting volatile oils and adding them to the decoction can accelerate drug absorption and efficacy, improve microcirculation, promote blood circulation, help relieve emotional stress, and enhance the body's resistance.

[0024] (3) Supercritical CO2 extraction technology extracts and separates heat-sensitive Chinese medicine components at lower temperatures, which is more conducive to separating volatile oils as effective components. The process is non-toxic, more stable, and has good extraction selectivity. It solves the problem of low volatile oil yield in distillation methods, and the obtained volatile oil has higher purity. The volatile oil and the medicine solution are co-soluble, which promotes the fuller efficacy of the Chinese medicine components. Supercritical fluid has excellent transfer performance and strong penetration, and the extraction and separation speed is faster. There is no reagent pollution, the subsequent purification process is simpler, and the production is more efficient.

[0025] (4) Full extraction of turmeric volatile oil helps with antibacterial activity, improves microcirculation, helps protect the liver and promote bile secretion, promotes body detoxification, and enhances immunity; full extraction of angelica volatile oil can inhibit uterine contractions, produce effects similar to those of progesterone on the uterus, promote the development of mammary alveoli, and promote the excretion of water and sodium; full extraction of bitter orange volatile oil, with active ingredients such as limonene and aromatic alcohols, helps promote digestion, maintain the nutrients needed by the human body, eliminate intestinal gas, and exert antibacterial and antiviral effects; full extraction of costus root volatile oil helps with anti-inflammatory, antitumor, anti-damp-heat, diarrhea-relieving, antispasmodic, antihypertensive, and antibacterial effects.

[0026] (5) Increase the proportion of Leonurus japonicus, Angelica sinensis, Achyranthes bidentata and Salvia miltiorrhiza to achieve the effects of promoting lactation and removing blood stasis. The combination of Schizonepeta tenuifolia and Zingiber officinale is conducive to dispersing qi stagnation and achieving the effect of promoting qi circulation. It is also conducive to timely treatment of abnormal bowel and bladder function caused by postpartum endocrine disorders. Furthermore, the combination of Curcuma longa, Citrus aurantium and Aucklandia lappa plays the role of soothing the liver, regulating qi and strengthening the spleen, so that the postpartum woman is in a good mood and the depression rate is reduced. Attached Figure Description

[0027] Figure 1 Figures showing the changes in body weight of each group of animals during the experiment;

[0028] Figure 2 The effect on milk production in each group of animals;

[0029] Figure 3 Histological changes in rat mammary glands after no treatment with the test substance in the control group;

[0030] Figure 4 Histological changes in rat mammary glands after treatment with the test agent at a low dose;

[0031] Figure 5 Histological changes in rat mammary glands after treatment with the medium-dose test agent;

[0032] Figure 6 Histological changes in rat mammary glands after treatment with a high dose of the test substance. Detailed Implementation

[0033] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0034] The materials, experimental instruments, and reagents used in the embodiments of this invention are as follows:

[0035] 1. Materials

[0036] 1.1 Test sample

[0037] Code name: Improved Kuning Liquid

[0038] Formula: Motherwort 150g, Angelica sinensis 150g, Red peony root 150g, Salvia miltiorrhiza 150g, Curcuma longa 100g, Achyranthes bidentata 150g, Aurantium 100g, Aucklandia lappa 50g, Schizonepeta tenuifolia (charred) 100g, Ginger (charred) 50g, Rubia cordifolia 100g

[0039] Preparation method: Angelica sinensis, Curcuma longa, Citrus aurantium, and Aucklandia lappa were cleaned, dried, and pulverized, and then placed in the extraction vessel of a supercritical carbon dioxide extraction device. The extraction temperature was 35℃, the extraction pressure was 50MPa, the carbon dioxide flow rate was 45Kg / h, and the extraction time was 150min to obtain intermediate material. The intermediate material was transferred to a primary separation tank that maintained the supercritical carbon dioxide state to separate supercritical carbon dioxide containing volatile oil and the extraction residue separated from the carbon dioxide. After secondary separation, the carbon dioxide was separated from the supercritical carbon dioxide containing volatile oil to obtain volatile oil. The extraction residue was soaked in water with Leonurus japonicus, Paeonia lactiflora, Salvia miltiorrhiza, Achyranthes bidentata, Schizonepeta tenuifolia, Zingiber officinale, and Rubia cordifolia for 2.5 hours, and then decocted three times with 8 times the amount of water for 1.5 hours each time to obtain decoction.

[0040] Filter the decoction, add volatile oil, concentrate to a relative density of 1.10-1.20 at 80℃, cool, slowly add ethanol while stirring rapidly to achieve an alcohol content of 55-70%, seal, and let stand for 20-30 hours to obtain a settled medicinal liquid; filter the settled medicinal liquid, recover the ethanol from the filtrate, and concentrate to a relative density of 1.15-1.22 at 60℃ to obtain a pharmaceutical composition for treating dysfunctional uterine bleeding. Add the solubilizing excipient povidone K30 and the flavoring agent monosaccharide syrup to the pharmaceutical composition for treating dysfunctional uterine bleeding to prepare an oral liquid.

[0041] Specifications: 10mL / vial (1.25g / mL)

[0042] Content: Each 1 mL contains 0.81 mg of Leonurus japonicus and 1.73 mg of Paeonia lactiflora (calculated as paeoniflorin) per 1 mL.

[0043] Appearance: A clear, brownish-brown liquid.

[0044] Storage conditions: Store in a tightly closed container in a cool place (not exceeding 20℃).

[0045] 1.2 Reference Standard

[0046] Comparative Example 1: Purified water sterilized by autoclaving at 121℃ for 30 min was used as the feeding agent for mice.

[0047] Comparative Example 2 uses the preparation method of claim 7 disclosed in patent number CN1589894A to obtain Kuning liquid as a feeding agent for mice.

[0048] 1.3 Experimental Subjects

[0049] SPF-grade SD rats that have passed quarantine were selected as experimental subjects, including 80 females and 40 males. They were paired together in a female-to-male ratio of 2:1, and pregnant rats were selected to give birth.

[0050] Body weight during the experiment: 204.3 - 238.1 g, 240.5 - 264.3 g;

[0051] Experimental animal production license number: SCXK(Beijing)2021 - 0011

[0052] Experimental animal use license number: SYXK(Shandong)2022 - 0017

[0053] 1.3.1 Breeding environment of experimental animals

[0054] Use Room 125 in the SPF - level animal house as the breeding room, with the temperature being 20.0 - 26.0 °C, the humidity being 40.0 - 70.0%, the light condition ≥ 200 Lux (12 / 12 light - dark alternation), the fresh air ventilation > 15 times per hour, cleaning daily, and disinfecting regularly.

[0055] Use a rat cage with length × width × height = 485 × 350 × 200 mm, raise 5 rats in each cage, and treat the feces by replacing the rat cage and the bedding with animal feces and urine.

[0056] 1.3.2 Animal feed

[0057] Use the irradiated sterilized experimental mouse maintenance feed provided by Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd., with the production license number of Su Feed License (2019)01008 and batch number 22120124. Feed the mice regularly, and let the mice freely ingest. The preservation of the feed follows the relevant SOP of animal management, and it is placed in an environment with a temperature of 18 - 25 °C and a relative humidity of 20 - 50%.

[0058] 1.3.3 Animal bedding

[0059] Use the irradiated sterilized corn cob bedding (8 - mesh) provided by Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd., with the production license number of Su Feed License (2019)01008 and batch number 1060012. Spread the sterilized bedding at the bottom of the rat cage, covering the entire bottom. The preservation of the bedding follows the relevant SOP of animal management, and it is placed in an environment with a temperature of 18 - 25 °C and a relative humidity of 20 - 50%.

[0060] 1.3.4 Animal drinking water

[0061] Select purified water sterilized by high - pressure steam at 121 °C for 30 min as the animal drinking water, and replace it in time. The mice can freely ingest it.

[0062] 2. Experimental instruments and reagents

[0063] Electronic balance (Kunshan Youkeweite Electronic Technology Co., Ltd., CN-LQC10002 and CN-LQC10001); pipette (Sartorius, single channel); 1 / 100,000 electronic balance (Sartorius, SQP / SECURA125-1CN); Zoltil 50 (Victoire de France, telexamine 125mg, zolpidem 125mg).

[0064] Comparative Example

[0065] A randomized grouping method was used to randomly select 12 rats from the mothers each day. The negative control group was given 10 mL of purified water twice a day. Every two days, the mothers and pups were separated for 5 hours, and then reunited for 1 hour of nursing. The weight changes of each litter of pups were observed, and the milk production was calculated. The observation period lasted for 10 days postpartum.

[0066] Among them, the net weight gain of the litter of pups is calculated as follows: on the second day after birth, the weight of all pups in the litter is taken as the initial weight. The increase in litter weight is obtained by subtracting the initial litter weight from the final litter weight after the 10th day.

[0067] The weight change of the mother mouse was determined by the first weight taken on the second day after giving birth. The weight change of the mother mouse was obtained by subtracting the first weight from the last weight taken after the 10th day.

[0068] Starting from the date of administration, the entire litter of pups was weighed every morning at 9:00, and recorded as W1;

[0069] After isolating the pups from their mothers for 5 hours, gently press the pups' abdomens to expel urine, weigh them again, and record the weight as W2.

[0070] After the pups were placed in the same cage with their mother for 1 hour of nursing, the pups were weighed for the third time and recorded as W3. The hourly milk production of the mother was calculated by the weight difference of all the pups in the litter before and after nursing for 1 hour (W3-W2), plus the average basal metabolic rate of the entire litter of pups in 1 hour ((W1-W2) / 5).

[0071] Milk production per hour of a female mouse = W3 - W2 + (W1 - W2) / 5

[0072] Table 1 shows the rat numbers, body weight during the quarantine period, and body weight during the drug administration period for the control group. Table 2 shows the indicators of rat milk production as reflected by the increase in mouse body weight.

[0073] Table 1. Rat numbers, rat weights during quarantine, and rat weights during drug administration in the control group.

[0074]

[0075]

[0076] Table 2. Milk production in rats as reflected by the increase in body weight in the control group.

[0077]

[0078]

[0079]

[0080] Comparative Example 2

[0081] The conditions and procedures were the same as in Comparative Example 1. The difference was that the drug used to feed the rats in this comparative example was Kuning solution prepared by the method disclosed in claim 7 of patent number CN1589894A. 20 mL of Kuning solution stock solution with a concentration of 1.25 g / mL was taken and 80 mL of purified water was added. After shaking evenly, a drug solution with a concentration of 0.25 g / mL was prepared, hereinafter referred to as CN Kuning solution. The volume of liquid each time was still 10 mL.

[0082] Table 3 shows the rat numbers, quarantine period weight, and drug administration period weight of the rats in the CN Kuning liquid group in this comparative example. Table 4 shows the lactation volume index of the rats in the CN Kuning liquid group as reflected by the increase in mouse weight.

[0083] Table 3. Rats in the CN Kuning Liquid group: rat numbers, rat weight during quarantine, and rat weight during drug administration.

[0084]

[0085]

[0086] Table 4. Milk production in rats as reflected by the increase in body weight in the CN Kuning liquid group.

[0087]

[0088]

[0089]

[0090] Example 1

[0091] The conditions and procedures were the same as in Comparative Example 1. The difference was that the drug used to feed the rats in this example was replaced with a modified kuning solution prepared by supercritical extraction. 20 mL of the modified kuning solution stock solution with a concentration of 1.25 g / mL was taken, 80 mL of purified water was added, and the solution was shaken evenly to prepare a low-dose group solution with a drug concentration of 0.25 g / mL. The volume of the liquid each time was still 10 mL.

[0092] Table 5 shows the rat numbers, quarantine period weight, and drug administration period weight of the low-dose group in this embodiment. Table 6 shows the lactation volume of the rats in the low-dose group as reflected by the increase in mouse weight.

[0093] Table 5. Rat numbers, rat weights during quarantine, and rat weights during the administration period in the low-dose group.

[0094]

[0095] Table 6. Milk production in rats in the low-dose group, as reflected by the increase in body weight in mice.

[0096]

[0097]

[0098]

[0099]

[0100] Example 2

[0101] The conditions and procedures were the same as in Comparative Example 1. The difference was that the drug used to feed the rats in this example was replaced with a modified kuning solution prepared by supercritical extraction. 40 mL of the modified kuning solution stock solution with a concentration of 1.25 g / mL was taken, 60 mL of purified water was added, and the solution was shaken evenly to prepare a medium-dose solution with a drug concentration of 0.5 g / mL. The volume of the liquid each time was still 10 mL.

[0102] Table 7 shows the rat numbers, quarantine period weight, and administration period weight of the rats in the medium-dose group in this embodiment. Table 8 shows the lactation volume of the rats in the medium-dose group as reflected by the weight gain of the mice.

[0103] Table 7 shows the rat numbers, quarantine period weight, and administration period weight of the rats in the medium-dose group.

[0104]

[0105] Table 8 shows the amount of milk produced in rats in the mid-dose groups, as reflected by the increase in body weight in mice.

[0106]

[0107]

[0108]

[0109] Example 3

[0110] The conditions and procedures were the same as in Comparative Example 1. The difference was that the drug used to feed the rats in this example was replaced with a modified kuning solution prepared by supercritical extraction. 80 mL of the modified kuning solution stock solution with a concentration of 1.25 g / mL was taken, 20 mL of purified water was added, and the solution was shaken evenly to prepare a high-dose group solution with a drug concentration of 1.0 g / mL. The volume of the liquid each time was still 10 mL.

[0111] Table 9 shows the rat numbers, quarantine period weight, and drug administration period weight of the high-dose group in this embodiment. Table 10 shows the lactation volume of the rats in the high-dose group as reflected by the weight gain of the mice.

[0112] Table 9. Rat numbers, quarantine period weight, and drug administration period weight of the high-dose group.

[0113]

[0114] Table 10. Milk production in rats as a reflection of weight gain in mice in the high-dose group.

[0115]

[0116]

[0117]

[0118] in conclusion

[0119] Depend on Figure 1 It can be seen that during the experiment, the weight growth trends of the blank control group, the low, medium and high dose groups of the modified Kuning liquid were consistent, and there was no statistical difference.

[0120] Depend on Figure 2 It can be seen that the milk secretion of the female mice in the high, medium and low dose groups of Kuning oral liquid was not significantly different from that in the early stage of the experiment. However, in the later stage of the experiment, the milk secretion of the female mice in the high, medium and low dose groups of Kuning oral liquid was significantly higher than that in the blank dose group.

[0121] After the experiment, nipples and mammary gland tissues of female rats were collected, fixed with paraformaldehyde, and the mammary glands of each group of animals were subjected to routine sampling, dehydration, paraffin embedding, sectioning, HE staining, and microscopic examination for histopathological examination.

[0122] Figure 3 The breast tissue in the blank control group was in a lactating state, with abundant and clearly segmented lobules, and acini at different secretory stages visible within the lobules; the acinar epithelial cells were tall columnar, low columnar, or cuboidal, consisting of a single layer of cells, and the acinar cavities were enlarged and regularly shaped. Some tissue specimens showed eosinophilic secretions in the acinar cavities, and numerous round vacuoles formed by lipid droplets were visible within the cavities; a few breast specimens contained small amounts of adipose tissue and stromal components.

[0123] The growth and development of the breast, as well as the performance of its various physiological functions, depend on the combined action of various related endocrine hormones. For example, estrogen promotes the epithelial proliferation of mammary ducts, the development of connective tissue surrounding the ducts and lobules, causing the ducts to elongate and branch, and stimulates the anterior pituitary gland to synthesize and release prolactin. Similarly, progesterone promotes the development of mammary lobules and alveoli. Among estrogens, estradiol is the most active, and among progesterone, progesterone is the most physiologically active. Figures 4-6 As shown (bar = 100 μm), when the concentration of the modified Kuning solution used increased, the number of mammary lobules increased, the lobule lobulation became more obvious, the number of acini within the lobules increased, the acinar cavities were smaller than those in the normal group, and the acini were more numerous and denser, especially in the medium-dose group; the acinar cavities of tall columnar acinar epithelium increased, and double and multilayer acinar epithelium could be seen in some tissue areas, which was more common in the high- and medium-dose groups than in the low-dose group; the acinar cavities in the high-dose group were larger than those in the medium-dose group, and the cavities were filled with eosinophilic secretions, with a greater number of ducts.

[0124] This shows that the modified Kuning solution has an improving effect on the amount of milk produced in postpartum rats.

[0125] The above are all preferred embodiments of the present invention, which further describe the purpose, technical solution and advantages of the present invention in detail. However, they are not intended to limit the scope of protection of the present invention. All equivalent changes made within the spirit and principles of the present invention, based on the structure, shape and principle of the present invention, should be included within the scope of protection of the present invention.

Claims

1. A method for preparing a drug for promoting lactation in postpartum women, characterized in that, Includes the following steps: S1. The volatile oil raw materials are obtained by removing impurities, drying and pulverizing Angelica sinensis, Curcuma longa, Citrus aurantium and Aucklandia lappa; S2. The volatile oil raw material is placed in the extraction vessel of a supercritical carbon dioxide extraction device to extract intermediate material. The extraction temperature is 30-40℃, the extraction pressure is 45-60MPa, the carbon dioxide flow rate is 35-55Kg / h, and the extraction time is 120-200min. S3. The intermediate material is transferred to a primary separation tank that maintains the supercritical state of carbon dioxide to separate supercritical carbon dioxide containing volatile oil and extract residue separated from carbon dioxide. S4. After separation in a two-stage separator, carbon dioxide is separated from the supercritical carbon dioxide containing volatile oil to obtain volatile oil; S5. Soak the extracted residue with motherwort, red peony root, salvia miltiorrhiza, achyranthes bidentata, schizonepeta tenuifolia, dried ginger, and madder root 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 the decoction. S6. Filter the decoction, add volatile oil, concentrate to a relative density of 1.10-1.20 at 80℃, cool, slowly add ethanol, stir rapidly to make the alcohol content reach 55-70%, seal, and let stand for 20-30 hours to obtain the standing decoction. S7. Filter the settled liquid, recover the ethanol from the filtrate, and concentrate it to a relative density of 1.15-1.22 at 60°C to obtain a pharmaceutical composition for promoting lactation in postpartum women. S8. Adding excipients to a pharmaceutical composition for promoting lactation in postpartum women; said excipients include one or more of solubilizing excipients, pharmaceutical excipients, or pharmaceutical flavoring agents; The herbal raw materials of the pharmaceutical composition for promoting lactation in postpartum women are: 30-40 parts by weight of Leonurus japonicus, 30-40 parts by weight of Angelica sinensis, 25-35 parts by weight of Paeonia lactiflora, 30-40 parts by weight of Salvia miltiorrhiza, 15-25 parts by weight of Curcuma longa, 30-40 parts by weight of Achyranthes bidentata, 20-30 parts by weight of Citrus aurantium, 10-20 parts by weight of Aucklandia lappa, 15-25 parts by weight of Schizonepeta tenuifolia, 5-15 parts by weight of Zingiber officinale, and 15-25 parts by weight of Rubia cordifolia.

2. The method for preparing a galactagogue for postpartum women according to claim 1, characterized in that, The medicinal materials used in the pharmaceutical composition for promoting lactation in postpartum women are: 30 parts by weight of Leonurus japonicus, 30 parts by weight of Angelica sinensis, 30 parts by weight of Paeonia lactiflora, 30 parts by weight of Salvia miltiorrhiza, 20 parts by weight of Curcuma longa, 30 parts by weight of Achyranthes bidentata, 20 parts by weight of Citrus aurantium, 10 parts by weight of Aucklandia lappa, 20 parts by weight of Schizonepeta tenuifolia, 10 parts by weight of Zingiber officinale, and 20 parts by weight of Rubia cordifolia.

3. The method for preparing a galactagogue for postpartum women according to claim 1, characterized in that, The excipients added to the drug for promoting lactation in postpartum women are 20-60 parts by weight.

4. The method for preparing a galactagogue for postpartum women according to claim 1, characterized in that, The solubilizing excipient is pharmaceutical grade povidone or β-cyclodextrin.

5. The method for preparing the galactagogue for postpartum women according to any one of claims 1-4, characterized in that, The dosage form of the drug used to promote lactation in postpartum women is decoction, tablet, capsule, pill or powder.

6. The method for preparing the galactagogue for postpartum women according to any one of claims 1-4, characterized in that, The dosage form of the drug used to promote lactation in postpartum women is a sustained-release or controlled-release formulation.

Images