Traditional Chinese medicine preparation for treating postpartum depression and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine preparation for treating postpartum depression and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared from Chinese rose flowers, hypericum perforatum, caulis polygoni multiflori, tortoise shells, radix hedysari, aleppo avens, perilla stems, officinal magnolia flowers, fructus podophylli, loofah sponge, fructus choerospondiatis, entada phaseoloides, rhizoma polygonati and other traditional Chinese medicine raw materials. The traditional Chinese medicine preparation integrates the methods of soothing liver-qi stagnation, nourishing blood for tranquilization, tonifying qi and nourishing yin, promoting blood circulation to remove meridian obstruction and promoting qi circulation to relieve middle energizer, gives consideration to both symptoms and root causes, not only relieves the symptom of postpartum liver depression, but also tonifies the root cause of deficiency of qi and blood, so that liver qi is smooth, qi and blood are full and mind is nourished, and the traditional Chinese medicine preparation has the effect of preventing and treating postpartum depression. The traditional Chinese medicine preparation provided by the invention can improve nervous system functions by influencing expression of hippocampus 5-HT and DA so as to realize the effect of regulating depression-like behaviors; the traditional Chinese medicine composition has a remarkable curative effect on postpartum depression and has a remarkable effect of improving and relieving depressive clinical symptoms of patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical manufacturing, and in particular to a traditional Chinese medicine preparation for treating postpartum depression and a preparation method thereof. Background Art

[0002] Postpartum depression (PPD) is a psychiatric disorder characterized by abnormal mood and emotional development in women after childbirth. It often develops within two weeks after delivery, with symptoms becoming more pronounced between four and six weeks and lasting three to six months. Key clinical symptoms include emotional apathy, depression, self-abandonment, sluggish response, low self-esteem, sleep disturbances, anorexia, impaired neurological thinking, decreased libido, fatigue, and a loss of confidence in life. PPD can also be accompanied by physical impairments, and in severe cases, may lead to suicide attempts. Epidemiological surveys show a domestic incidence rate of 18-30%, with a 50% incidence in subsequent pregnancies, and the incidence continues to increase. While the etiology and pathogenesis of PPD remain unclear, research confirms that PPD is not caused by a single systemic imbalance but rather involves multiple biological factors, including the immune system, neuroendocrine system, and immune system. Comprehensive treatment for PPD primarily involves antidepressants, antianxiety medications, sedatives, hypnotics, and psychotherapy. Western medications can quickly and effectively target the lesions and improve clinical symptoms, but they are prone to adverse reactions such as cardiovascular damage, gastrointestinal reactions, and drug dependence. They also have a high recurrence rate, and their long-term efficacy remains uncertain. Furthermore, because pregnant women are breastfeeding, Western medication interventions have significant limitations.

[0003] Although depression is a Western medical term, symptoms related to depression are documented in most TCM texts, such as "zangzao," "lily disease," "insomnia," "forgetfulness," "insomnia," "running pig," and "madness." From the name of the disease, its etiology and pathogenesis, to treatments and prescriptions, physicians throughout the ages have had profound and unique insights into the condition. In TCM, postpartum depression falls under the category of "depression," an emotional disorder. TCM believes that depression is caused by emotional distress and stagnant Qi, primarily due to internal emotional damage and weak internal Qi. When the liver fails to regulate and the spleen fails to function properly, imbalances in the yin and yang, Qi, and blood of the internal organs occur, leading to malnutrition or disturbance of the mind and impaired Qi flow, resulting in depression. Western medicine has conducted extensive research on postpartum depression, but still lacks effective and safe treatments. Traditional Chinese medicine, with thousands of years of practice, has accumulated extensive experience with this condition and is currently widely used clinically, boasting the advantages of good efficacy, rapid onset, and minimal side effects. Summary of the Invention

[0004] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine preparation for treating postpartum depression, which has the effects of soothing the liver and relieving depression, invigorating qi and nourishing blood, and tranquilizing the mind and the preparation method thereof.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0006] The invention provides a traditional Chinese medicine preparation for treating postpartum depression. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of rose flowers, 10-30 parts of Hypericum perforatum, 10-30 parts of Polygonum multiflorum vines, 10-30 parts of Carapax tortoise shell, 10-30 parts of Astragalus membranaceus, 10-30 parts of Blueberry, 10-30 parts of Perilla stems, 10-30 parts of Magnolia officinalis flowers, 10-30 parts of Lotus microphylla, 10-30 parts of Luffa sponge, 10-30 parts of Choerospondias axillaris, 10-30 parts of Gastrodia elata fruits, and 10-30 parts of Polygonatum sibiricum.

[0007] Furthermore, the Chinese medicine preparation is made from the following Chinese medicine raw materials in parts by weight: 15-25 parts of rose, 15-25 parts of Hypericum perforatum, 15-25 parts of Polygonum multiflorum, 15-25 parts of tortoise shell, 15-25 parts of Astragalus membranaceus, 15-25 parts of indigofera, 10-20 parts of Perilla stem, 10-20 parts of Magnolia officinalis flower, 10-20 parts of Lotus microphylla, 10-20 parts of Luffa sponge, 10-20 parts of Ziziphus jujuba, 10-20 parts of Gastrodia elata fruit, and 10-20 parts of Polygonatum sibiricum.

[0008] Furthermore, the Chinese medicine preparation is made from the following Chinese medicine raw materials in parts by weight: 22 parts of rose, 22 parts of Hypericum perforatum, 22 parts of Polygonum multiflorum, 20 parts of tortoise shell, 22 parts of Astragalus membranaceus, 20 parts of indigo plant, 18 parts of Perilla stem, 18 parts of Magnolia officinalis flower, 10 parts of Lotus microphylla, 18 parts of Luffa sponge, 14 parts of Ziziphus jujuba, 10 parts of Gastrodia elata fruit, and 14 parts of Polygonatum sibiricum.

[0009] The present invention also provides a method for preparing a traditional Chinese medicine preparation for treating postpartum depression, wherein the traditional Chinese medicine preparation is prepared according to the following steps:

[0010] (1) Weigh each Chinese herbal medicine raw material according to the above-mentioned parts by weight, wash and dry it, grind it into fine powder, pass it through a 100-150 mesh sieve, and mix it evenly to obtain the Chinese herbal medicine raw powder;

[0011] (2) Take honey at a weight ratio of 1:1.1-1.3 of Chinese herbal medicine powder and honey, heat the honey to boiling, remove foam and impurities, and refine it to a temperature of 110-120°C, with a water content of less than 15%, a light yellow color, and moderate viscosity;

[0012] (3) adding the refined honey from step (2) to the Chinese medicine raw powder while it is still hot, and stirring rapidly to allow the honey and the Chinese medicine raw powder to fully blend and form a medicine mass;

[0013] (4) Divide the medicine mass into small pieces, roll them into strips with a diameter of 4-5 mm, and then cut them into small pieces of 4-5 mm, roll them into balls, and obtain honey pills. Dry them at below 60° C. until the water content is below 10%, which is the Chinese medicine preparation.

[0014] The specification of the traditional Chinese medicine preparation is 3±0.15g / pill.

[0015] The inventors closely followed the core pathogenesis of postpartum symptoms of "excessive deficiency, stasis, and susceptibility to depression and stagnation," adhered to the principles of TCM syndrome differentiation and treatment, summarized extensive clinical treatment experience, and creatively formulated the Chinese medicine preparation of the present invention. The formula uses Chinese rose and Hypericum perforatum as the main ingredients. Chinese rose is sweet and warm, enters the liver meridian, and can soothe liver qi and relieve depression, promote blood circulation and regulate menstruation, specifically targeting postpartum symptoms of liver qi stagnation and qi and blood stasis. Hypericum perforatum is pungent, sweet, and neutral, enters the liver meridian, soothes liver qi and relieves depression, calms the mind, and directly addresses the core of restlessness. The two herbs complement each other, one to soothe the liver qi, relieve depression, and clear the heart, while the other to promote blood circulation, regulate menstruation, and soothe the liver qi, directly addressing the main symptoms of liver qi stagnation and restlessness. It is supplemented with Polygonum multiflorum, tortoise shell, Astragalus membranaceus, and Indigofera chinensis as assistant medicines; Polygonum multiflorum is sweet and mild, enters the heart and liver meridians, nourishes blood and calms the mind, and helps the main medicine to calm the mind; tortoise shell is salty, sweet and slightly cold, enters the liver, kidney and heart meridians, nourishes yin, nourishes blood and replenishes the heart, while taking into account the deficiency of yin and blood after childbirth; Astragalus membranaceus is sweet and warm, replenishes qi and raises yang, consolidates the exterior and stops sweating, makes up for the disadvantages of qi deficiency after childbirth, so that qi is sufficient and blood flows smoothly, and helps relieve depression; Indigofera chinensis is sweet, pungent and mild, replenishes deficiency and relieves pain, dispels wind and dampness, can relieve the whole body discomfort caused by physical weakness after childbirth, and assists in regulating the body's state; the four medicines work together to nourish blood and yin to calm the mind, and replenish qi and raise yang to consolidate the foundation, which not only enhances the tranquilizing effect of the main medicine, but also takes into account the basis of qi and blood deficiency after childbirth, so that the evil is attacked without hurting the good. It is supplemented with perilla stems, Magnolia officinalis flowers, Lotus microphylla, Luffa loofah, Ziziphus jujuba, Glehnia littoralis fruit, and Polygonatum sibiricum as adjuvants; Perilla stems are pungent and warm, regulate qi and relieve fullness, can lead other medicines into the qi, and harmonize the qi; Magnolia officinalis flowers are aromatic and dehumidify, regulate qi and relieve fullness, help Perilla stems to promote qi, and relieve abdominal distension caused by liver depression; Lotus microphylla promotes blood circulation and regulates menstruation, and Luffa loofah promotes menstruation and activates collaterals, and the two help Rose to promote blood circulation and relieve stagnation, so that stagnation can be dispersed; Ziziphus jujuba is sweet and mild, nourishes the heart and calms the mind, promotes qi and blood circulation, enhances the calming power of the whole formula, and promotes qi and blood circulation; Glehnia littoralis fruit is astringent and mild, promotes dampness and swelling, and relieves constipation, prevents liver depression and qi stagnation from causing dampness and turbidity, and is an adjuvant; Polygonatum sibiricum is sweet and mild, replenishes qi and nourishes yin, strengthens the spleen and kidneys, nourishes the essence and blood that is deficient after childbirth, and makes qi and blood biochemically active, which not only helps Astragalus membranaceus to replenish qi, but also assists Tortoise shell to nourish yin.

[0016] The Chinese medicine preparation of the present invention has distinct levels of monarch, minister, adjuvant and envoy ingredients, and integrates the methods of soothing the liver and relieving depression, nourishing blood and calming the mind, invigorating qi and nourishing yin, activating blood circulation and unblocking meridians, and promoting qi and relieving fullness, taking into account both the symptoms and the root causes, and relieving the symptoms of postpartum liver depression and replenishing the root causes of qi and blood deficiency, so that the liver qi is smooth, the qi and blood are replenished, and the mind is nourished, thereby achieving the effect of preventing and treating postpartum depression.

[0017] The results of animal experiments show that the Chinese medicine preparation provided by the present invention can significantly improve the depressive-like behavior of rats with postpartum depression model, significantly increase the expression levels of 5-HT and DA in the hippocampus of rats with PDD model, and improve CNS function, indicating that the Chinese medicine preparation of the present invention can improve the function of the nervous system by affecting the expression of 5-HT and DA in the hippocampus, thereby achieving the effect of regulating depressive-like behavior.

[0018] The results of clinical efficacy observation show that the Chinese medicine preparation of the present invention has significant therapeutic effects on postpartum depression, with a total therapeutic efficacy of up to 94.12%. It can significantly improve the patient's HAMD score results, and has a significant improvement and relief effect on the patient's clinical symptoms such as depression, irritability and crying, insomnia, chest tightness, poor appetite, and fullness in the ribs. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 Results of the depressive-like behavior test of rats in each group; (A) Sugar water preference rate; (B) Swimming immobility time; (C) Horizontal score of open field test; (D) Vertical score of open field test; Note: **P<0.01 compared with the blank group; **P<0.01 compared with the sham operation group △△ P<0.01; compared with the model group, # P<0.05, ## P<0.01, ### P<0.001.

[0020] Figure 2 are the 5-HT (A) and DA (B) contents in the hippocampus of rats in each group; Note: Compared with the blank group, **P<0.01; Compared with the sham operation group, △△ P<0.01; compared with the model group, # P<0.05, ## P<0.01, ### P<0.001.

[0021] Figure 3 HAMD scores of the two groups of patients; Note: ns P>0.05; ****P<0.0001.

[0022] Figure 4 Traditional Chinese Medicine symptom scores for the two groups of patients; Note: ns P>0.05; ****P<0.0001. DETAILED DESCRIPTION

[0023] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0024] Example 1

[0025] A traditional Chinese medicine preparation for treating postpartum depression is prepared according to the following steps:

[0026] (1) Weigh the following Chinese medicinal raw materials according to the following weight ratios: 22 parts of rose flowers, 22 parts of Hypericum perforatum, 22 parts of Polygonum multiflorum, 20 parts of Carapax tortoise shell, 22 parts of Astragalus root, 20 parts of Blueberry root, 18 parts of Perilla stem, 18 parts of Magnolia officinalis flower, 10 parts of Lotus microphylla, 18 parts of Luffa, 14 parts of Choerospondias australis, 10 parts of Gastrodia elata fruit, and 14 parts of Polygonatum sibiricum, wash and dry, grind into fine powder, pass through a 100-150 mesh sieve, and mix well to obtain Chinese medicinal raw powder;

[0027] (2) Take honey at a weight ratio of 1:1.1-1.3 of Chinese herbal medicine powder and honey, heat the honey to boiling, remove foam and impurities, and refine it to a temperature of 110-120°C, with a water content of less than 15%, a light yellow color, and moderate viscosity;

[0028] (3) adding the refined honey from step (2) to the Chinese medicine raw powder while it is still hot, and stirring rapidly to allow the honey and the Chinese medicine raw powder to fully blend and form a medicine mass;

[0029] (4) Divide the medicine mass into small pieces, roll them into strips with a diameter of 4-5 mm, and then cut them into small pieces of 4-5 mm, roll them into balls, and obtain honey pills. Dry them at below 60° C. until the water content is below 10%, which is the Chinese medicine preparation.

[0030] The specification of the traditional Chinese medicine preparation is 3±0.15g / pill.

[0031] Example 2

[0032] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 16 parts of rose, 14 parts of Hypericum perforatum, 14 parts of Polygonum multiflorum, 14 parts of Carapax tortoise shell, 14 parts of Astragalus membranaceus, 12 parts of Indigofera chinensis, 12 parts of Perilla stem, 10 parts of Magnolia officinalis flower, 10 parts of Lotus microphylla, 12 parts of Luffa sponge, 12 parts of Choerospondias australis, 10 parts of Gastrodia elata fruit, and 12 parts of Polygonatum sibiricum.

[0033] Example 3

[0034] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 28 parts of rose, 26 parts of Hypericum perforatum, 28 parts of Polygonum multiflorum, 24 parts of Carapax tortoise shell, 26 parts of Astragalus membranaceus, 22 parts of Indigofera chinensis, 24 parts of Perilla stem, 24 parts of Magnolia officinalis flower, 12 parts of Lotus microphylla, 20 parts of Luffa sponge, 26 parts of Ziziphus jujuba, 12 parts of Gastrodia elata fruit, and 22 parts of Polygonatum sibiricum.

[0035] Example 4

[0036] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 15 parts of rose flowers, 15 parts of Hypericum perforatum, 15 parts of Polygonum multiflorum vine, 15 parts of tortoise shell, 15 parts of red astragalus, 15 parts of blue cloth, 10 parts of perilla stem, 10 parts of Magnolia officinalis flower, 10 parts of small-leaved lotus, 10 parts of luffa, 10 parts of jujube, 10 parts of jujube, 10 parts of vine fruit, and 10 parts of polygonatum.

[0037] Example 5

[0038] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 25 parts of rose, 25 parts of Hypericum perforatum, 15-25 parts of Polygonum multiflorum, 25 parts of tortoise shell, 25 parts of red astragalus, 25 parts of blue cloth, 20 parts of perilla stem, 20 parts of Magnolia officinalis flower, 10 parts of small-leaved lotus, 20 parts of luffa, 20 parts of jujube, 10 parts of jujube, and 20 parts of polygonatum.

[0039] Example 6

[0040] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 18 parts of rose flowers, 20 parts of Hypericum perforatum, 20 parts of Polygonum multiflorum vine, 16 parts of tortoise shell, 18 parts of red astragalus, 16 parts of blue cloth, 14 parts of perilla stem, 16 parts of Magnolia officinalis flower, 10 parts of small-leaved lotus, 16 parts of luffa, 16 parts of jujube, 10 parts of jujube, and 16 parts of polygonatum.

[0041] Example 7

[0042] The difference between this embodiment and embodiment 1 is that the Chinese medicinal raw materials are weighed according to the following parts by weight: 20 parts of rose flowers, 20 parts of Hypericum perforatum, 16 parts of Polygonum multiflorum vine, 16 parts of tortoise shell, 20 parts of red astragalus, 20 parts of blue cloth, 15 parts of perilla stem, 15 parts of Magnolia officinalis flower, 10 parts of small-leaved lotus, 15 parts of luffa, 15 parts of jujube, 10 parts of jujube, and 15 parts of polygonatum.

[0043] Example 8

[0044] Effects of the Chinese medicine preparation of the present invention on behavior, hippocampal 5-HT, DA and BDNF in rats with postpartum depression

[0045] 1 Experimental Materials

[0046] 1.1 Experimental animals

[0047] Sixty SPF female SD rats, aged 9-10 weeks and weighing (220±20) g, were fed adaptively for 7 days before the open field test and modeling was started.

[0048] 1.2 Experimental drugs

[0049] The traditional Chinese medicine preparation of the present invention comprises the following ingredients: 22 parts of rose flowers, 22 parts of Hypericum perforatum, 22 parts of Polygonum multiflorum vine, 20 parts of tortoise shell, 22 parts of Astragalus membranaceus, 20 parts of blue clover, 18 parts of perilla stem, 18 parts of magnolia officinalis flower, 10 parts of lotus microphylla, 18 parts of luffa sponge, 14 parts of jujube, 10 parts of radix scutellariae, and 14 parts of polygonatum; the ingredients are weighed and washed according to the above parts by weight, decocted with 3-4 times the amount of water for 30 minutes, filtered, the decoction liquid collected, the decoction liquid repeated twice, the decoction liquids combined, concentrated to a traditional Chinese medicine stock solution with a crude drug content of 1 g / mL, and refrigerated for later use.

[0050] Fluoxetine hydrochloride, 20mg / tablet.

[0051] 2 Experimental methods

[0052] 2.1 Experimental Animal Grouping

[0053] Each rat underwent an open field test, and the total open field score of the rat within 3 minutes was calculated (total open field score = vertical score + horizontal score). Rats with a total open field score >120 or <30 were considered to have depressive tendencies and needed to be eliminated. Qualified rats were randomly divided into a blank group (n=10), a sham operation group (n=10), and a PPD model group (n=40).

[0054] 2.2 Preparation of postpartum depression (PDD) rat model

[0055] A rat model of postpartum depression (PPD) was established using the classic hormone withdrawal method after hormonal stimulation of pregnancy. In addition to the blank group, the sham-operated group and the PDD model group underwent surgery. The specific procedures were as follows:

[0056] Rats were anesthetized with 40 mg / kg of 2% sodium pentobarbital injected intraperitoneally. Rats in the PPD model group underwent bilateral ovariectomy. They were immobilized in the right lateral position on the operating table. A 2 cm incision was made lateral to the spine and 2 cm posterior to the costal margin. After local disinfection and skin preparation, surgical scissors and a scalpel were used to sequentially separate the skin, fascia, and muscle, exposing the internal organs. The left uterine horn was located, and the surrounding adipose tissue was clamped and pulled out of the body. The fallopian tubes and ovaries were located and ligated before removal. The uterine bodies were returned to the abdominal cavity, and the wounds were sutured sequentially. Local disinfection with iodine was performed. A vaginal smear was performed the day after surgery. Five consecutive methylene blue-stained vaginal images indicated estrous cycles, indicating successful castration and confirming complete ovariectomy. The same procedures were used in the sham-operated group. Ovaries were not removed in rats; only a small amount of adipose tissue surrounding the ovaries was removed. Rats in the PPD model group that underwent successful castration underwent hormone withdrawal to simulate hormone secretion levels during pregnancy. They received subcutaneous injections of 0.2 ml / day (4 mg) of progesterone and 0.1 ml / day (2.5 μg) of estradiol benzoate for 16 consecutive days. Starting on day 17, they received 0.1 ml / day (50 μg) of estradiol benzoate for 7 consecutive days, with the injections discontinued on day 24. The sham-operated and normal control groups received subcutaneous injections of 0.3 ml of sesame oil for 16 consecutive days, and starting on day 17, they received 0.1 ml of sesame oil for 7 consecutive days, with the injections discontinued on day 24. Subsequently, behavioral open field testing was performed, and a significant decrease in scores indicated successful model establishment.

[0057] 2.3 Drug administration

[0058] The rats with successful modeling were randomly divided into four groups: model group (Model group), positive control group (PC group), low-dose group (Low group), and high-dose group (High group), with 10 rats in each group. In the positive control group, the modeled rats were gavaged with a fluoxetine hydrochloride aqueous solution at a dose of 0.2 mg / 100 g; in the low-dose group, the modeled rats were gavaged with a traditional Chinese medicine solution of the present invention at a dose of 0.75 g / 100 g; in the high-dose group, the modeled rats were gavaged with a traditional Chinese medicine solution of the present invention at a dose of 1.5 g / 100 g; in the blank group (BC group) and sham-operated group (Sham group), the rats were gavaged with an equal amount of distilled water. Each group was administered once daily for 4 consecutive weeks. After the administration, the animals were behaviorally tested.

[0059] 2.4 Behavioral Observation

[0060] After the administration, the rats in each group were subjected to sucrose preference test (SPT), forced swimming test (FST) and open field test (OFT).

[0061] Sugar Preference Test (SPT): After the final drug administration, rats were deprived of food and water for 24 hours. Pre-weighed 1% sugar solution and tap water were then administered. Six hours later, the water bottles were swapped. Twelve hours later, the water bottles were retrieved and weighed, and sugar and tap water intake was calculated. Sugar preference rate = sugar solution consumption / (sugar solution consumption + tap water consumption).

[0062] Forced swim test (FST): Rats were acclimated to the test environment for 2 hours beforehand. The rats were placed in a transparent glass container (25 cm in diameter, 60 cm in height), with a water depth of approximately 35 cm and a temperature of 25°C. The forced swim test consisted of two parts: a 15-minute pre-swimming period on the first day and a 5-minute test period 24 hours later. The test was recorded with a camera. The room remained quiet during the test, and rats were unable to see each other. After the test, the video was reviewed and analyzed. The immobility time was calculated.

[0063] Open field test (OFT): The open field box is an empty cube with a length and width of 80 cm and a height of 40 cm. The walls of the box are black, and the bottom is evenly divided into 25 squares of equal area with yellow lines. It is carried out in a quiet, light-shielded environment. The rat is placed in the center grid on the bottom of the box for 5 minutes. The number of times the animal passes through the grid is used as the horizontal score (all four limbs must enter the grid), and the number of times the animal stands upright is used as the vertical score (the two forelimbs are off the ground as one scoring standard). The room is soundproofed. After each rat is tested, the inner wall and bottom of the open field box are cleaned with 70% ethanol to prevent the residual information of the rat from the previous test (feces, urine, and odor, etc.) from affecting the results of the next test. Each animal is measured once, and the horizontal and vertical scores are counted.

[0064] 2.5 5-HT and DA contents in rat hippocampus

[0065] After the behavioral test, the rats in each group were killed, serum was collected, and the hippocampal tissue was isolated on ice. The 5-HT and DA levels were determined by enzyme-linked immunosorbent assay.

[0066] 2.6 Statistical analysis

[0067] Statistical analysis was performed using Prism 8.0.2, and one-way analysis of variance was used for comparison between groups. The results were expressed as mean ± standard deviation ( ) format, and the t test was used. P < 0.05 was considered statistically significant.

[0068] 3 Results

[0069] 3.1 Effects on depressive-like behavior in PDD rats

[0070] like Figure 1 As shown in A, compared with the blank group, the sucrose preference rate of rats in the model group was significantly decreased (P<0.01); compared with the sham operation group, the sucrose preference rate of rats in the model group was significantly decreased (P<0.01); there was no significant change in the sucrose preference rate of rats in the blank group compared with the sham operation group (P>0.05); compared with the model group, the sucrose preference rate of rats in the positive control group, low-dose group and high-dose group were significantly increased, with significant differences (P<0.05, P<0.01).

[0071] like Figure 1 As shown in B, compared with the blank group, the swimming immobility time of the rats in the model group was significantly increased (P<0.01); compared with the sham operation group, the swimming immobility time of the rats in the model group was significantly increased (P<0.01); there was no significant change in the swimming immobility time of the rats in the blank group compared with the sham operation group (P>0.05); compared with the model group, the swimming immobility time of the rats in the positive control group, low-dose group and high-dose group were significantly reduced, with significant differences (P<0.01).

[0072] like Figure 1 As shown in CD, in the open field test, compared with the blank group, the horizontal scores and vertical scores of the rats in the model group were significantly reduced (P<0.01); compared with the sham operation group, the horizontal scores and vertical scores of the rats in the model group were significantly reduced (P<0.01); the horizontal scores and vertical scores of the rats in the blank group did not change significantly compared with the sham operation group (P>0.05); compared with the model group, the horizontal scores and vertical scores of the rats in the positive control group, low-dose group and high-dose group were significantly increased, with significant differences (P<0.05, P<0.01, P<0.001).

[0073] 3.2 Effects on 5-HT and DA Contents in Rat Hippocampus

[0074] like Figure 2As shown, compared with the blank group, the 5-HT and DA contents in the hippocampus of the rats in the model group were significantly decreased (P<0.01); compared with the sham operation group, the 5-HT and DA contents in the hippocampus of the rats in the model group were significantly decreased (P<0.01); there was no significant change in the 5-HT and DA contents in the hippocampus of the rats in the blank group compared with the sham operation group (P>0.05); compared with the model group, the 5-HT and DA contents in the hippocampus of the rats in the positive control group, low-dose group and high-dose group were significantly increased, with significant differences (P<0.05, P<0.01, P<0.001).

[0075] 4 Conclusion

[0076] The above results show that the traditional Chinese medicine preparation provided by the present invention can significantly improve the depressive-like behavior of rats with postpartum depression model. In the above experiment, the levels of 5-HT and DA in the hippocampus of rats in the model group decreased, indicating that there is a state of central nervous system (CNS) dysfunction in the pathogenesis of PPD, and the traditional Chinese medicine preparation of the present invention significantly increased the expression levels of 5-HT and DA in the hippocampus of PDD model rats and improved CNS function, suggesting that the possible mechanism of action of the traditional Chinese medicine preparation of the present invention is to improve the function of the nervous system by affecting the expression of 5-HT and DA in the hippocampus, thereby achieving the effect of regulating depressive-like behavior.

[0077] Example 9

[0078] Clinical observation of the Chinese medicine preparation of the present invention on patients with postpartum depression

[0079] 1 Objects and Methods

[0080] 1.1 Research subjects

[0081] Sixty-eight patients with postpartum depression admitted between January and December 2024 were enrolled in the study and randomly divided into an observation group and a control group, with 34 patients in each group. The observation group included patients aged 23-33 years (mean, 25.06±4.22) years; the duration of illness ranged from 1-4 months (mean, 1.94±0.58) months; 20 were primiparas and 14 were multiparas; 22 had vaginal births and 12 had cesarean sections. The observation group included patients aged 23-34 years (mean, 25.74±5.03) years; the duration of illness ranged from 1-4 months (mean, 1.78±0.69) months; 19 were primiparas and 15 were multiparas; 21 had vaginal births and 13 had cesarean sections. No significant differences in general information were found between the two groups (P>0.05), indicating comparability.

[0082] 1.2 Diagnostic criteria

[0083] The diagnostic criteria of Western medicine refer to the "CCMD-3 Chinese Classification and Diagnostic Criteria for Mental Disorders (Third Edition)": (1) Depressed mood; (2) Lack of interest or pleasure in participating in all or most activities; (3) Significant weight loss or gain in a short period of time; (4) Insomnia or frequent lack of sleep; (5) Frequent fatigue or weakness; (6) Feeling that doing things is meaningless or guilty; (7) Inattention or decreased thinking ability; (8) Severe suicidal tendencies; (9) The occurrence of 5 or more of the above clinical manifestations within 1 month after delivery, and (1) and (2) must be present.

[0084] The TCM diagnostic standard refers to the "TCM Disease Diagnosis and Efficacy Standards" for "Postpartum Depression": the main symptoms are depression, irritability, crying, insomnia and nightmares, and secondary symptoms are chest tightness, poor appetite, fullness in the ribs, thin and greasy tongue coating, and a stringy pulse.

[0085] 1.3 Inclusion criteria

[0086] Meet the diagnostic criteria; age 21-45 years; Hamilton Depression Rating Scale (HAMD) score ≥ 20 points; voluntarily participate and obtain informed consent.

[0087] 1.4 Exclusion criteria

[0088] (1) Severe dysfunction of the heart, liver, and kidneys and other organic diseases; (2) Allergy to the medication; (3) Confirmed secondary depression caused by other reasons; (4) Diagnosed with anxiety, depression, and other mental disorders during pregnancy; (5) History of other mental illnesses; (6) Treatment with oral antidepressants or other intervention methods in the past 3 months.

[0089] 1.5 Methods

[0090] 1.5.1 Treatment methods

[0091] Control group: Supportive psychotherapy (a psychological auxiliary treatment based on common sense of human life and understanding and care for postpartum women, including comfort, listening, understanding, encouragement, discussion, etc.), psychological counseling was conducted once a week, each time for about 30 minutes, 4 weeks as a course of treatment, and 3 courses of treatment were continuous.

[0092] Observation group: On the basis of supportive psychological therapy, the Chinese medicine preparation prepared in Example 1 was given, 8 pills / time, 3 times a day, 4 weeks as a course of treatment, and 3 courses of treatment were given continuously.

[0093] 1.5.2 Observation indicators

[0094] 1.5.2.1 Depressive mental state

[0095] The 24-item HAMD scale was used to assess patients' depressive status. A HAMD score >35 indicated severe depression; a HAMD score 20 ≤ ≤ 35 indicated moderate depression; a HAMD score 8 ≤ <19 indicated mild depression; and a HAMD score <8 indicated no depression. This scale was administered before and after treatment.

[0096] 1.5.2.2 Traditional Chinese Medicine Symptom Score

[0097] The TCM symptom score was established based on the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases (2012 Edition)" and statistically evaluated three primary symptoms: depression, irritability, crying, and insomnia and dreaminess; and two secondary symptoms: chest tightness, poor appetite, and flank distension. The absence of these primary symptoms was scored as 0, mild as 2, moderate as 4, and severe as 6. The absence of these secondary symptoms was scored as 0, mild as 1, moderate as 2, and severe as 3. The more severe the condition, the higher the score. This scale was used to assess patients before and after treatment.

[0098] 1.5.2.3 Clinical treatment effects

[0099] Based on the Guiding Principles for Clinical Research of New Chinese Medicines:

[0100] Recovery: HAMD score reduction ≥ 80%, TCM symptom score reduction ≥ 90%;

[0101] Markedly effective: HAMD score decreased by 51%-79%, and TCM symptom score decreased by 70%-89%;

[0102] Effective: HAMD score decreased by 25%-50%, and TCM symptom score decreased by 40-69%;

[0103] Ineffective: There was no significant change in HAMD score and TCM symptom score, or the score even increased.

[0104] 1.6 Statistical analysis

[0105] Statistical analysis was performed using Prism 8.0.2. The mean ± standard deviation was used to express the measurement data. The independent sample t test was used between groups, and the paired sample t test was used within the group. The enumeration data were expressed as %, and the intergroup comparison was performed using the χ 2 Test, P < 0.05 indicates that the difference is statistically significant.

[0106] 2 Results

[0107] 2.1 Comparison of HAMD scores between the two groups before and after treatment

[0108] Before treatment, there was no significant difference in HAMD scores between the two groups (P>0.05). After treatment, the HAMD scores of both groups were significantly reduced (P<0.0001); among them, the HAMD score of the observation group was significantly lower than that of the control group (P<0.0001). Figure 3 shown.

[0109] 2.2 Comparison of TCM symptom scores between the two groups of patients before and after treatment

[0110] Before treatment, there was no significant difference in the TCM symptom scores between the two groups (P>0.05). After treatment, the TCM symptom scores of both groups were significantly reduced (P<0.0001); among them, after treatment, the TCM symptom scores of the observation group were significantly lower than those of the control group (P<0.0001). Figure 4 shown.

[0111] 2.3 Comparison of clinical efficacy between the two groups

[0112] The total effective rate of the control group was 64.71%, and the total effective rate of the observation group was 94.16%, with significant difference between the two groups (P<0.05).

[0113] Table 1 Comparison of clinical efficacy between the two groups [cases (%)]

[0114]

[0115] 3 Conclusion

[0116] The Chinese medicine preparation of the present invention has a significant therapeutic effect on postpartum depression, with a total effective rate of up to 94.12%. It can significantly improve the HAMD score results of patients and has a significant improvement and relief effect on clinical symptoms such as depression, irritability and crying, insomnia and dreaminess, chest tightness and poor appetite, and rib fullness. The Chinese medicine preparation of the present invention has a clear hierarchy of monarch, minister, assistant and guiding ingredients, integrating the methods of soothing the liver and relieving depression, nourishing blood and calming the mind, replenishing qi and nourishing yin, activating blood circulation and unblocking meridians, and promoting qi and relieving fullness. The various ingredients complement each other and take both the symptoms and the root cause into consideration. It not only relieves the symptoms of postpartum liver depression, but also replenishes the root cause of qi and blood deficiency, so that the liver qi is smooth, the qi and blood are replenished, and the mind is nourished, thereby achieving the effect of preventing and treating postpartum depression.

[0117] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine preparation for treating postpartum depression, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of rose flowers, 10-30 parts of Hypericum perforatum, 10-30 parts of Polygonum multiflorum vines, 10-30 parts of tortoise shells, 10-30 parts of Astragalus membranaceus, 10-30 parts of blueberry, 10-30 parts of perilla stems, 10-30 parts of Magnolia officinalis flowers, 10-30 parts of lotus microphylla, 10-30 parts of loofah, 10-30 parts of jujube trees, 10-30 parts of euphorbia pulex, and 10-30 parts of polygonatum.

2. A Chinese medicine preparation for treating postpartum depression according to claim 1, characterized in that The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of rose flowers, 15-25 parts of Hypericum perforatum, 15-25 parts of Polygonum multiflorum vines, 15-25 parts of tortoise shells, 15-25 parts of red astragalus, 15-25 parts of blue clover, 10-20 parts of perilla stems, 10-20 parts of magnolia officinalis flowers, 10-20 parts of lotus microphylla, 10-20 parts of loofah, 10-20 parts of jujube trees, 10-20 parts of euphorbia pulex, and 10-20 parts of polygonatum.

3. A Chinese medicine preparation for treating postpartum depression according to claim 1, characterized in that The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 22 parts of rose flowers, 22 parts of Hypericum perforatum, 22 parts of Polygonum multiflorum vine, 20 parts of tortoise shell, 22 parts of red astragalus, 20 parts of blue clover, 18 parts of perilla stems, 18 parts of magnolia officinalis flowers, 10 parts of lotus microphylla, 18 parts of luffa, 14 parts of jujube, 10 parts of euphorbia pulex, and 14 parts of polygonatum.

4. The method for preparing a traditional Chinese medicine preparation for treating postpartum depression according to any one of claims 1 to 3, wherein: The Chinese medicine preparation is prepared according to the following steps: (1) Weigh each Chinese herbal medicine raw material according to the above-mentioned parts by weight, wash and dry it, grind it into fine powder, pass it through a 100-150 mesh sieve, and mix it evenly to obtain the Chinese herbal medicine raw powder; (2) Take honey at a weight ratio of 1:1.1-1.3 of Chinese herbal medicine powder and honey, heat the honey to boiling, remove foam and impurities, and refine it to a temperature of 110-120°C, with a water content of less than 15%, a light yellow color, and moderate viscosity; (3) adding the refined honey from step (2) to the Chinese medicine raw powder while it is still hot, and stirring rapidly to allow the honey and the Chinese medicine raw powder to fully blend and form a medicine mass; (4) Divide the medicine mass into small pieces, roll them into strips with a diameter of 4-5 mm, and then cut them into small pieces of 4-5 mm, roll them into balls, and obtain honey pills. Dry them at below 60° C. until the water content is below 10%, which is the Chinese medicine preparation.

5. The method for preparing a Chinese medicine preparation for treating postpartum depression according to claim 4, wherein: The specification of the traditional Chinese medicine preparation is 3±0.15g / pill.

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