A traditional Chinese medicine preparation for treating postpartum depression and a preparation method thereof

Abstract

The application 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 traditional Chinese medicine raw materials such as Chinese weigela, St. John's wort, radix polygoni multiflori, turtle shell, red sage root, blue cloth, perilla stem, magnolia flower, small leaf lotus, loofah, Chinese olive, rattan, and rhizoma polygonati. The traditional Chinese medicine preparation integrates the methods of soothing liver and relieving depression, nourishing blood and tranquilizing the mind, tonifying qi and nourishing yin, promoting blood circulation to remove meridian obstruction, and promoting qi circulation to relieve food retention, and takes both the symptoms and the root cause into account. The traditional Chinese medicine preparation can not only relieve the symptoms of postpartum liver depression, but also tonify qi and blood deficiency, so that liver qi is unobstructed, qi and blood are sufficient, and the heart spirit is nourished, thereby achieving the effect of preventing and treating postpartum depression. The traditional Chinese medicine preparation can affect the expression of hippocampus 5-HT and DA, improve the function of the nervous system, and further realize the effect of regulating depressive behavior. The traditional Chinese medicine preparation has a significant curative effect on postpartum depression, and can significantly improve and relieve the depressive clinical symptoms of patients.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine preparation for treating postpartum depression and a preparation method thereof. BACKGROUND

[0002] Postpartum depression (PPD) is a mental disorder disease, which is a mood abnormality disease occurring in women after childbirth, often occurs within 2 weeks after childbirth, and the symptoms are particularly obvious within 4-6 weeks, and the disease course can last for 3-6 months. The main clinical symptoms include apathy, depression, self-abasement, slow reaction, low self-evaluation, sleep disorder, anorexia, impaired neural thinking, decreased libido, fatigue, and loss of confidence in life, and also accompanied by limb disorders, etc. Severe cases may have suicidal tendencies. Epidemiological surveys show that the incidence rate in China is 18-30%, the incidence rate of re-pregnancy is 50%, and it shows a continuous growth trend. The etiology and pathogenesis of PPD have not been clearly defined, and research has confirmed that the occurrence of PPD is not caused by a single system disorder, and is related to biological factors including one bed, neuroendocrine, immune and other systems. The comprehensive treatment of PPD mainly includes antidepressants, anxiolytics, sedative hypnotics and psychological treatment. Western medicine treatment can quickly and effectively act on the target of the disease and improve the clinical symptoms, but it is easy to cause adverse reactions such as damage to the cardiovascular system, gastrointestinal reactions, drug dependence, and has a high recurrence rate, and the long-term efficacy needs to be discussed. And because the puerpera is in the lactation period, the intervention of western medicine has great limitations.

[0003] Although depression is a western medicine name, many medical books in traditional Chinese medicine record diseases related to depression, such as "zang depression", "lily disease", "insomnia", "forgetfulness", "insomnia", "bendun", "craziness", etc. From the disease name, etiology and pathogenesis to treatment methods and medicines, ancient physicians have deep and unique insights into the disease. Postpartum depression belongs to "depression" in the category of emotional diseases in traditional Chinese medicine. Traditional Chinese medicine believes that depression is caused by emotional discomfort and stagnation of qi movement, mainly related to emotional damage and weak visceral qi. When the liver fails to drain, the spleen fails to transport, and the yin and yang qi and blood of the viscera are out of balance, the heart spirit is malnourished or disturbed, and the qi movement is unsmooth, resulting in depression. Western medicine has more research on postpartum depression, but still lacks effective and safe treatment methods. Traditional Chinese medicine has accumulated rich experience in the treatment of such diseases in thousands of years of medical practice, and is widely used in clinical practice, with the advantages of good curative effect, fast effect and small side effects. SUMMARY

[0004] In view of the deficiencies of the prior art, the present application provides a traditional Chinese medicine preparation for treating postpartum depression and a preparation method thereof, which has the effects of soothing the liver, resolving depression, tonifying qi and nourishing blood, and calming the mind and soothing the heart.

[0005] To achieve the above object, the technical scheme is as follows:

[0006] The application provides a traditional Chinese medicine preparation for treating postpartum depression, which is made of the following traditional Chinese medicine raw materials in parts by weight: Rosa rugosa 10-30 parts, Hypericum perforatum 10-30 parts, Polygonum multiflorum 10-30 parts, Plastrum Testudinis 10-30 parts, Hedysarum polybotrys 10-30 parts, Isodonis 10-30 parts, Perilla frutescens L. stem 10-30 parts, Magnolia officinalis flower 10-30 parts, Disporopsis pernyi 10-30 parts, Lagenaria siceraria 10-30 parts, Ziziphus mauritiana 10-30 parts, Entada phaseoloides 10-30 parts and Polygonatum sibiricum 10-30 parts.

[0007] Further, the traditional Chinese medicine preparation is made of the following traditional Chinese medicine raw materials in parts by weight: Rosa rugosa 15-25 parts, Hypericum perforatum 15-25 parts, Polygonum multiflorum 15-25 parts, Plastrum Testudinis 15-25 parts, Hedysarum polybotrys 15-25 parts, Isodonis 15-25 parts, Perilla frutescens L. stem 10-20 parts, Magnolia officinalis flower 10-20 parts, Disporopsis pernyi 10-20 parts, Lagenaria siceraria 10-20 parts, Ziziphus mauritiana 10-20 parts, Entada phaseoloides 10-20 parts and Polygonatum sibiricum 10-20 parts.

[0008] Further, the traditional Chinese medicine preparation is made of the following traditional Chinese medicine raw materials in parts by weight: Rosa rugosa 15-25 parts, Hypericum perforatum 15-25 parts, Polygonum multiflorum 15-25 parts, Plastrum Testudinis 15-25 parts, Hedysarum polybotrys 15-25 parts, Isodonis 15-25 parts, Perilla frutescens L. stem 10-20 parts, Magnolia officinalis flower 10-20 parts, Disporopsis pernyi 10-20 parts, Lagenaria siceraria 10-20 parts, Ziziphus mauritiana 10-20 parts, Entada phaseoloides 10-20 parts and Polygonatum sibiricum 10-20 parts.

[0009] The application further provides a preparation method of the traditional Chinese medicine preparation for treating postpartum depression.

[0010] (1) the traditional Chinese medicine raw materials are weighed according to the above weight proportions, washed, dried, ground into fine powder, sieved through a 100-150 mesh sieve and uniformly mixed to obtain traditional Chinese medicine raw powder;

[0011] (2) honey is taken according to a weight ratio of traditional Chinese medicine raw powder:honey of 1:1.1-1.3, the honey is heated to boiling, foam and impurities are removed, and the honey is refined to a temperature of 110-120 ℃, a water content of less than 15% and a light yellow color with moderate viscosity;

[0012] (3) the refined honey in step (2) is added into the traditional Chinese medicine raw powder while hot, and quickly stirred to make the honey and the traditional Chinese medicine raw powder fully mix to form a medicine mass;

[0013] (4) the medicine mass is divided into small pieces, rolled into long strips with a diameter of 4-5 mm, then cut into small sections with a length of 4-5 mm, rolled into balls to obtain honey pills, and dried at a temperature of less than 60 ℃ until the water content is less than 10% to obtain the traditional Chinese medicine preparation.

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

[0015] The inventors adhere to the core pathogenesis of postpartum "multiple deficiency and blood stasis, easy to depression and stagnation", follow the principle of TCM syndrome differentiation and treatment, and creatively combine to obtain the traditional Chinese medicine preparation of the present application. In the prescription, Chinese weigela and St. John's wort are used as the monarch drugs; Chinese weigela is Gan-wen and belongs to liver meridian, and can soothe liver and relieve depression, activate blood and regulate menstruation, and is aimed at postpartum liver depression and blood stasis; St. John's wort is Xing-gan Ping, and belongs to liver meridian, and can soothe liver and relieve depression, and calm the mind, and directly reaches the core of mental unrest; the two are used together, one to soothe liver and relieve depression and calm the mind, and one to activate blood and regulate menstruation and soothe liver, and directly point to the main symptoms of liver depression and stagnation and mental unrest. The first wu-teng, turtle shell, red sage, and blue cloth are used as the minister drugs; the first wu-teng is Gan-ping, and belongs to heart and liver meridians, and can nourish blood and calm the mind, and assist the monarch drugs to calm the mind; turtle shell is Xian-gan Xie-han, and belongs to liver, kidney and heart meridians, and can nourish yin and blood and tonify heart, and take into account postpartum yin blood deficiency; red sage is Gan-wen, and can tonify qi and ascend yang, and can make up for the postpartum qi deficiency, so that the qi is sufficient and the blood flows unobstructed, and assist the function of relieving depression; blue cloth is Gan-xin Ping, and can tonify deficiency and relieve pain, and can relieve wind and dampness, and can relieve the whole body discomfort caused by postpartum deficiency, and assist the regulation of the body state; the four drugs work together to nourish blood and yin to calm the mind, and tonify qi and ascend yang to consolidate the base, which not only enhances the effect of the monarch drugs to calm the mind, but also takes into account the postpartum deficiency of qi and blood, so that the pathogenic factors do not harm the healthy qi. In addition, perilla stem, magnolia flower, small leaf lotus, silk gourd, sumac, rattan, and turmeric are used as the auxiliary drugs; perilla stem is Xing-wen, and can regulate qi and expand the middle, and can lead the drugs into the qi aspect and regulate qi movement; magnolia flower is aromatic and can dissipate dampness and regulate qi and expand the middle, and can assist perilla stem to unblock qi movement and relieve abdominal distension caused by liver depression; small leaf lotus can activate blood and regulate menstruation, and silk gourd can unblock channels and activate collaterals, and the two can assist Chinese weigela to activate blood and unblock stagnation, so that the stagnation is dispersed; sumac is Gan-ping, and can nourish heart and calm the mind, and activate blood and unblock qi, and can enhance the calming effect of the whole prescription, and also unblock qi and blood; rattan is astringent and flat, and can relieve dampness and swelling and unblock the bowels, and prevent liver depression and qi stagnation from causing dampness and turbidity, and is used as an auxiliary drug; turmeric is Gan-ping, and can tonify qi and nourish yin, and can tonify the spleen and kidney, and nourish the postpartum deficiency of essence and blood, so that the production of qi and blood is abundant, and it not only assists red sage in tonifying qi, but also assists turtle shell in nourishing yin.

[0016] The traditional Chinese medicine preparation of the present application has clear levels of monarch, minister and auxiliary drugs, and integrates the methods of soothing liver and relieving depression, nourishing blood and calming the mind, tonifying qi and nourishing yin, activating blood and unblocking collaterals, and regulating qi and expanding the middle, and takes into account the symptoms and root causes, so that the liver depression after delivery is relieved, the qi and blood deficiency is tonified, the liver qi is unblocked, the blood is sufficient, and the mind is nourished, and the effect of preventing and treating postpartum depression is achieved.

[0017] The animal experiment results show that the traditional Chinese medicine preparation provided by the present application can significantly improve the depression-like behavior of postpartum depression model rats, significantly improve the expression level of 5-HT and DA in the hippocampus of PDD model rats, and improve the function of CNS, which shows that the traditional Chinese medicine preparation of the present application can improve the function of nervous system by affecting the expression of 5-HT and DA in the hippocampus, and then realize the function of regulating depression-like behavior.

[0018] The clinical observation results show that the traditional Chinese medicine preparation has significant curative effect on postpartum depression, the total effective rate of treatment can reach 94.12%, can significantly improve the HAMD score results of the patients, has obvious improvement and remission effect on the clinical symptoms such as emotional depression, irritable, insomnia, chest stuffiness, stuffiness and other clinical symptoms of the patients. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 Depression-like behavior determination results of rats in each group; (A) sugar water preference rate; (B) swimming immobility time (C) level score of open field experiment; (D) vertical score of open field experiment; 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.

[0020] Figure 2 5-HT (A) and DA (B) contents in hippocampal tissues 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 two groups of patients; Note: ns P>0.05; ****P<0.0001.

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

[0023] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below in combination with the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0024] Embodiment 1

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

[0026] (1) Each Chinese medicine raw material is weighed according to the following weight fraction: 22 parts of Rosa rugosa, 22 parts of Hypericum perforatum, 22 parts of Polygonum multiflorum, 20 parts of Plastrum Testudinis, 22 parts of Hedysarum polybotrys, 20 parts of Perilla frutescens, 18 parts of Perilla frutescens stem, 18 parts of Magnolia officinalis flower, 10 parts of Disporopsis pernyi, 18 parts of Luffa cylindrica, 14 parts of Phyllanthus emblica, 10 parts of Entada phaseoloides, and 14 parts of Polygonatum sibiricum, washed, dried, ground into fine powder, sieved through a 100-150 mesh sieve, and mixed uniformly to obtain Chinese medicine raw powder;

[0027] (2) Honey is taken according to a weight ratio of Chinese medicine raw powder: honey of 1:1.1-1.3, the honey is heated to boiling, foam and impurities are removed, and the honey is refined to a temperature of 110-120℃, with a water content of less than 15% and a light yellow color with moderate viscosity;

[0028] (3) The refined honey of step (2) is added to the Chinese medicine raw powder while hot, and stirred quickly to allow the honey and Chinese medicine raw powder to fully mix and form a medicine mass;

[0029] (4) The medicine mass is divided into small pieces, rolled into long strips with a diameter of 4-5 mm, and then cut into small sections of 4-5 mm, rolled into balls to obtain honey pills, which are dried at a temperature of 60℃ or lower until the water content is less than 10%, thereby obtaining the Chinese medicine preparation.

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

[0031] Example 2

[0032] The difference between this example and Example 1 is that each Chinese medicine raw material is weighed according to the following weight fraction: 16 parts of Rosa rugosa, 14 parts of Hypericum perforatum, 14 parts of Polygonum multiflorum, 14 parts of Plastrum Testudinis, 14 parts of Hedysarum polybotrys, 12 parts of Perilla frutescens, 12 parts of Perilla frutescens stem, 10 parts of Magnolia officinalis flower, 10 parts of Disporopsis pernyi, 12 parts of Luffa cylindrica, 12 parts of Phyllanthus emblica, 10 parts of Entada phaseoloides, and 12 parts of Polygonatum sibiricum.

[0033] Example 3

[0034] The difference between this example and Example 1 is that each Chinese medicine raw material is weighed according to the following weight fraction: 28 parts of Rosa rugosa, 26 parts of Hypericum perforatum, 28 parts of Polygonum multiflorum, 24 parts of Plastrum Testudinis, 26 parts of Hedysarum polybotrys, 22 parts of Perilla frutescens, 24 parts of Perilla frutescens stem, 24 parts of Magnolia officinalis flower, 12 parts of Disporopsis pernyi, 20 parts of Luffa cylindrica, 26 parts of Phyllanthus emblica, 12 parts of Entada phaseoloides, and 22 parts of Polygonatum sibiricum.

[0035] Example 4

[0036] The difference between this example and Example 1 is that each Chinese medicine raw material is weighed according to the following weight fraction: 15 parts of Rosa rugosa, 15 parts of Hypericum perforatum, 15 parts of Polygonum multiflorum, 15 parts of Plastrum Testudinis, 15 parts of Hedysarum polybotrys, 15 parts of Perilla frutescens, 10 parts of Perilla frutescens stem, 10 parts of Magnolia officinalis flower, 10 parts of Disporopsis pernyi, 10 parts of Luffa cylindrica, 10 parts of Phyllanthus emblica, 10 parts of Entada phaseoloides, and 10 parts of Polygonatum sibiricum.

[0037] Example 5

[0038] The difference between this embodiment and Example 1 is that each Chinese medicinal material is taken by weight parts as follows: Rosa rugosa 25 parts, Hypericum perforatum 25 parts, Polygonum multiflorum 15-25 parts, Plastrum Testudinis 25 parts, Hedysarum polybotrys 25 parts, Lysimachia clethroides 25 parts, Perilla frutescens L. var. crispa 20 parts, Magnolia officinalis 20 parts, Disporum smilacinum 10 parts, Luffa cylindrica 20 parts, Choerospondia axillaris 20 parts, Entada phaseoloides 10 parts, Polygonatum sibiricum 20 parts.

[0039] Example 6

[0040] The difference between this embodiment and Example 1 is that each Chinese medicinal material is taken by weight parts as follows: Rosa rugosa 18 parts, Hypericum perforatum 20 parts, Polygonum multiflorum 20 parts, Plastrum Testudinis 16 parts, Hedysarum polybotrys 18 parts, Lysimachia clethroides 16 parts, Perilla frutescens L. var. crispa 14 parts, Magnolia officinalis 16 parts, Disporum smilacinum 10 parts, Luffa cylindrica 16 parts, Choerospondia axillaris 16 parts, Entada phaseoloides 10 parts, Polygonatum sibiricum 16 parts.

[0041] Example 7

[0042] The difference between this embodiment and Example 1 is that each Chinese medicinal material is taken by weight parts as follows: Rosa rugosa 20 parts, Hypericum perforatum 20 parts, Polygonum multiflorum 16 parts, Plastrum Testudinis 16 parts, Hedysarum polybotrys 20 parts, Lysimachia clethroides 20 parts, Perilla frutescens L. var. crispa 15 parts, Magnolia officinalis 15 parts, Disporum smilacinum 10 parts, Luffa cylindrica 15 parts, Choerospondia axillaris 15 parts, Entada phaseoloides 10 parts, Polygonatum sibiricum 15 parts.

[0043] Example 8

[0044] Effects of the Chinese medicinal preparation of the present application on behavior, hippocampal 5-HT, DA and BDNF of postpartum depression rats

[0045] 1 Experimental materials

[0046] 1.1 Experimental animals

[0047] 60 SPF level SD female rats, 9-10 weeks old, weighing (220±20) g, were adaptively fed for 7 days before the open field experiment, and then modeling was started.

[0048] 1.2 Experimental drugs

[0049] The Chinese medicinal preparation of the present application has the following prescription composition: Rosa rugosa 22 parts, Hypericum perforatum 22 parts, Polygonum multiflorum 22 parts, Plastrum Testudinis 20 parts, Hedysarum polybotrys 22 parts, Lysimachia clethroides 20 parts, Perilla frutescens L. var. crispa 18 parts, Magnolia officinalis 18 parts, Disporum smilacinum 10 parts, Luffa cylindrica 18 parts, Choerospondia axillaris 14 parts, Entada phaseoloides 10 parts, Polygonatum sibiricum 14 parts; the washed ones are taken by weight parts, decocted with 3-4 times water for 30 min, filtered, the decocted liquid is collected, decocted twice repeatedly, the decocted liquids are combined, concentrated to a Chinese medicinal stock solution with a crude drug content of 1 g / mL, and stored in cold storage for standby.

[0050] Fluoxetine hydrochloride, 20mg / tablet.

[0051] 2 Experimental Methods

[0052] 2.1 Grouping of experimental animals

[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 an open field score >120 or <30 were considered to have a depressive tendency and were excluded. The qualified rats were randomly divided into a blank group (n=10), a sham-operated group (n=10), and a PPD model group (n=40).

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

[0055] A rat model of postpartum depression was established using the classic hormone withdrawal method following simulated pregnancy. Except for the control group, the sham-operated group and the PDD model group underwent surgery. The specific procedures are as follows:

[0056] Rats were anesthetized by intraperitoneal injection of 2% sodium pentobarbital at a dose of 40 mg / kg. Rats in the PPD model group underwent bilateral ovariectomy. They were fixed on the right side of the operating table, and a skin 2 cm lateral to the spine and 2 cm posterior to the costal margin was selected. After local disinfection and preparation, the skin, fascia, and muscles were dissected sequentially using surgical scissors and a scalpel to expose the internal organs. The left uterine horn was located, and the surrounding adipose tissue was clamped and pulled out. The fallopian tubes and ovaries were located upwards along the uterine horn, and both ovaries were found, ligated, and removed. The uterine body was returned to the abdominal cavity, and the wound was sutured sequentially. The area was then disinfected with povidone-iodine. Vaginal smears were examined on the second day post-surgery. Five consecutive days of methylene blue-stained vaginal images indicating a positive estrous cycle confirmed successful ovariectomy and complete ovarian removal. The same method was used in the sham-operated group. In the sham-operated group, only a small amount of adipose tissue surrounding the ovaries was removed, without ovarian removal. In the PPD model group of rats with successful castration, the hormone withdrawal method was used to simulate the hormone secretion levels during rat pregnancy. Rats were subcutaneously injected with progesterone injection 0.2 ml / day (4 mg) and estradiol benzoate injection 0.1 ml / day (2.5 μg) for 16 consecutive days. From day 17, estradiol benzoate injection 0.1 ml / day (50 μg) was injected subcutaneously for 7 consecutive days, and injections were stopped on day 24. In the sham-operated group and the normal group, sesame oil 0.3 ml was injected subcutaneously for 16 consecutive days. From day 17, sesame oil 0.1 ml was injected subcutaneously for 7 consecutive days, and injections were stopped on day 24. Subsequently, the open field test was performed. A significant decrease in the score indicated successful model establishment.

[0057] 2.3 Drug administration

[0058] Rats that successfully developed the model were randomly divided into four groups: the model group (Model group), the positive control group (PC group), the low-dose group (Low group), and the high-dose group (High group), with 10 rats in each group. The positive control group was administered fluoxetine hydrochloride aqueous solution by gavage at a dose of 0.2 mg / 100 g; the low-dose group was administered the original Chinese medicine solution of this invention by gavage at a dose of 0.75 g / 100 g; the high-dose group was administered the original Chinese medicine solution of this invention by gavage at a dose of 1.5 g / 100 g; and the blank group (BC group) and the sham-operated group (Sham group) were administered an equal volume of distilled water by gavage. All groups were administered the medication once daily for four consecutive weeks. Behavioral tests were performed on the animals after the treatment period.

[0059] 2.4 Behavioral Observation

[0060] After the administration was completed, rats in each group underwent the sugar water preference test (SPT), forced swimming test (FST), and open field test (OFT).

[0061] Sugar water preference test (SPT): After the last oral administration of medication, rats were deprived of food and water for 24 hours. Then, they were given pre-weighed 1% sugar water and tap water. After 6 hours, the water bottles were exchanged. After 12 hours, the water bottles were collected, weighed, and the intake of sugar water and tap water was calculated. Sugar water preference rate = Sugar water consumption / (Sugar water consumption + Tap water consumption).

[0062] Forced swimming test (FST): Rats are acclimatized to the test environment for 2 hours beforehand. They are placed in a transparent glass container, 25 cm in diameter and 60 cm high, with a water depth of approximately 35 cm and a water temperature of 25°C. The forced swimming test consists of two parts: a 15-minute pre-swimming session on the first day, followed by a 5-minute formal test 24 hours later. Video recordings are used to capture the event. The room is kept quiet during the test, and different rats cannot see other rats being tested. The video recordings are then analyzed after the test. The immobility time of the rats during swimming is calculated.

[0063] Open Field Test (OFT): The open field box is an internal cube, 80cm long, 80cm wide, and 40cm high. The walls are black, and the bottom is divided into 25 equal-area squares by yellow lines. The test is conducted in a quiet, dark environment. Rats are placed in the center square of the bottom of the box for 5 minutes. The number of times the animal passes through a square (all four limbs must be inside) is the horizontal score, and the number of times the animal stands upright is the vertical score (both forelimbs leaving the ground is considered one score). The room is soundproofed. After each test, the inner walls and bottom of the open field box are cleaned with 70% ethanol to avoid residual information from previous tests (feces, urine, odor, etc.) affecting the results of subsequent tests. Each animal is tested once, and the horizontal and vertical scores are counted.

[0064] 2.5 Content of 5-HT and DA in the hippocampus of rats

[0065] After the end of each group of rats behavior test, the rats were sacrificed, the serum was collected, the hippocampus tissue was separated on ice, and the 5-HT, DA content was determined by enzyme-linked immunosorbent assay.

[0066] 2.6 Statistical analysis

[0067] Statistical processing was performed using Prism 8.0.2, one-way ANOVA was used for comparison between groups, the results were expressed in the form of mean ± standard deviation (x±s), and t test was used. P<0.05 was statistically significant.

[0068] 3 Results

[0069] 3.1 Effect on depressive-like behavior of PDD rats

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

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

[0072] As shown in Figure 1 C-D, in the open field test, compared with the blank group, the model group rats had significantly reduced horizontal score and vertical score (P<0.01); compared with the sham operation group, the model group rats had significantly reduced horizontal score and vertical score (P<0.01); there was no significant change in the horizontal score and vertical score of rats between the blank group and the sham operation group (P>0.05); compared with the model group, the horizontal score and vertical score of rats in the positive control group, the low-dose group and the high-dose group were significantly increased, and the difference was significant (P<0.05, P<0.01, P<0.001).

[0073] 3.2 Effect on 5-HT, DA content in hippocampus tissue of rats

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

[0075] 4CONCLUSION

[0076] The above results show that the traditional Chinese medicine preparation provided by the present application can significantly improve the depressive behavior of the postpartum depression model rats. In the above experiment, the 5-HT and DA levels in the hippocampal tissues of the model group rats decreased, indicating that PPD exists in a central nervous system (CNS) functional disorder state during the pathogenesis, and the traditional Chinese medicine preparation of the present application significantly increased the 5-HT and DA expression levels in the hippocampal tissues of the PDD model rats, improved the CNS function, suggesting that the possible mechanism of the traditional Chinese medicine preparation of the present application is to affect the expression of hippocampal 5-HT and DA, improve the nervous system function, and then realize the role of regulating depressive behavior.

[0077] Example 9

[0078] Clinical observation of the traditional Chinese medicine preparation of the present application on postpartum depression patients

[0079] 1Subject and method

[0080] 1.1Research object

[0081] 68 cases of postpartum depression patients treated from January 2024 to December 2024 were selected as the research object, and the patients were randomly divided into observation group and control group by random number table method, 34 cases in each group. The age of the patients in the observation group was 23-33 years old, and the average age was (25.06±4.22) years old; the disease duration was 1-4 months, and the average was (1.94±0.58) months; 20 cases were primipara, and 14 cases were multipara; 22 cases were eutocia, and 12 cases were cesarean section. The age of the patients in the observation group was 23-34 years old, and the average age was (25.74±5.03) years old; the disease duration was 1-4 months, and the average was (1.78±0.69) months; 19 cases were primipara, and 15 cases were multipara; 21 cases were eutocia, and 13 cases were cesarean section. There was no significant difference in general data between the two groups (P>0.05) and they were comparable.

[0082] 1.2Diagnosis standard

[0083] The western medicine diagnostic criteria refer to CCMD-3 Chinese Classification and Diagnostic Criteria of Mental Disorders (third edition): (1) having depressive mood; (2) lacking interest or joy in participating in all or most activities; (3) significantly decreasing or increasing body mass in a short time; (4) insomnia or often feeling sleep deficiency; (5) often feeling fatigue or lack of strength; (6) feeling meaningless or guilty in doing things; (7) inattention or reduced thinking ability; (8) severe suicidal tendency; (9) appearing the above-mentioned 5 or more clinical manifestations within 1 month after delivery, and must have the (1) and (2).

[0084] The TCM diagnostic criteria refer to Postpartum Depression of TCM Disease Diagnosis and Efficacy Criteria: the main symptoms are depressive mood, irritability and crying, insomnia and dreaminess, the secondary symptoms are chest stuffiness, dull appetite, distention and fullness of lateral ribs, thin and greasy fur, and wiry pulse, etc.

[0085] 1.3 Inclusion criteria

[0086] Meeting the diagnostic criteria; age 21-45 years old; Hamilton Depression Scale score (HAMD) ≥20 points; voluntarily participating and obtaining informed consent.

[0087] 1.4 Exclusion criteria

[0088] (1) severe dysfunction of heart, liver and kidney and other organic diseases; (2) allergic to the drug; (3) confirming secondary depression caused by other reasons; (4) diagnosing anxiety, depression and other mental disorders during pregnancy; (5) having a history of other mental diseases; (6) taking oral antidepressants or other intervention methods within the last 3 months.

[0089] 1.5 Methods

[0090] 1.5.1 Treatment method

[0091] Control group: supportive psychotherapy (a kind of psychological auxiliary treatment by human general life common sense and understanding and care for postpartum women, including comforting, listening, understanding, encouraging, discussing and other ways), conducting psychological counseling once a week, each time for about 30 minutes, treating for 4 weeks as a course, and continuously treating for 3 courses.

[0092] Observation group: on the basis of supportive psychotherapy, giving the traditional Chinese medicine preparation prepared in Example 1, 8 pills / time, 3 times a day, treating for 4 weeks as a course, and continuously treating for 3 courses.

[0093] 1.5.2 Observation index

[0094] 1.5.2.1 Depressed psychological state

[0095] The patient's depressive state was evaluated using the HAMD scale, which has 24 items. A HAMD score > 35 indicates severe depression; 20 ≤ HAMD score ≤ 35 is moderate depression; 8 ≤ HAMD score < 19 is mild depression; and HAMD score < 8 is no depression. The scale was evaluated before and after treatment.

[0096] 1.5.2.2 TCM symptom score

[0097] The TCM symptom score was set according to the "TCM Diagnosis and Treatment Criteria (2012 Edition)", and three main symptoms: emotional depression, irritability and crying, insomnia and dreaminess, and two secondary symptoms: chest stuffiness and dullness, and distension and fullness of the lateral chest were evaluated. No main symptoms were scored 0, mild 2, moderate 4, and severe 6. No secondary symptoms were scored 0, mild 1, moderate 2, and severe 3. The more severe the disease, the higher the score. The scale was evaluated before and after treatment.

[0098] 1.5.2.3 Clinical treatment effect

[0099] According to the "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine":

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

[0101] Marked effect: HAMD score reduction 51%-79%, TCM symptom score reduction 70-89%;

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

[0103] No effect: No significant change in HAMD score and TCM symptom score, or even an increase in score.

[0104] 1.6 Statistical analysis

[0105] Prism 8.0.2 was used for statistical processing. The mean ± standard deviation was used to represent the measurement data, the non-independent sample t-test was used for inter-group comparison, the paired sample t-test was used for intra-group comparison, the % was used to represent the count data, the χ 2 test was used for inter-group comparison, and P < 0.05 was considered statistically significant. 2 Results

[0106] 2.1 Comparison of HAMD scores before and after treatment in the two groups of patients

[0107] 2.2 Comparison of TCM symptom scores before and after treatment in the two groups of patients

[0108] Before treatment, the HAMD scores of the patients in the two groups had no significant difference (P>0.05). After treatment, the HAMD scores of the patients in the two groups were significantly reduced (P<0.0001); among them, after treatment, the HAMD score of the patients in the observation group was significantly lower than that in the control group (P<0.0001). The results are shown in Table 1. Figure 3

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

[0110] Before treatment, the TCM symptom scores of the patients in the two groups had no significant difference (P>0.05). After treatment, the TCM symptom scores of the patients in the two groups were significantly reduced (P<0.0001); among them, after treatment, the TCM symptom score of the patients in the observation group was significantly lower than that in the control group (P<0.0001). The results are shown in Table 1. Figure 4

[0111] 2.3 Comparison of clinical efficacy of 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%, and there was a significant difference between the two groups (P<0.05).

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

[0114]

[0115] 3. Conclusion

[0116] The traditional Chinese medicine preparation has a significant effect on postpartum depression, and the total effective rate can reach 94.12%, which can significantly improve the HAMD score of the patients, and has obvious improvement and relief effect on the clinical symptoms such as emotional depression, irritability, insomnia, dreaminess, chest stuffiness, and so on. The traditional Chinese medicine preparation has a clear hierarchy of whole, assistant and auxiliary, and integrates the methods of soothing liver and relieving depression, nourishing blood and tranquilizing the mind, tonifying qi and nourishing yin, promoting blood circulation to remove meridian obstruction, and regulating qi to relieve food retention. The components complement each other, and the superficial and essential are considered together, so that the liver qi is unobstructed, the qi and blood are sufficient, and the heart spirit is nourished, which can prevent and treat postpartum depression.

[0117] The above examples are only used to illustrate the technical solutions of the present application, but not limit it; although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that they can modify the technical solutions recorded in the foregoing examples, or make equivalent replacement to part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.​​

Claims

1. A traditional Chinese medicine preparation for treating postpartum depression, characterized in that, The traditional Chinese medicine preparation is made from the following weight parts of traditional Chinese medicine raw materials: Rosa rugosa 10-30 parts, Hypericum perforatum 10-30 parts, Polygonum multiflorum 10-30 parts, Plastrum Testudinis 10-30 parts, Hedysarum polybotrys 10-30 parts, Rubia akane 10-30 parts, Perilla frutescens stem 10-30 parts, Magnolia officinalis flower 10-30 parts, Disporum smilaceifolium 10-30 parts, Luffa cylindrical 10-30 parts, Ziziphus mauritiana 10-30 parts, Entada phaseoloides 10-30 parts, Polygonatum sibiricum 10-30 parts.

2. The traditional Chinese medicine preparation for treating postpartum depression according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following weight parts of traditional Chinese medicine raw materials: Rosa rugosa 15-25 parts, Hypericum perforatum 15-25 parts, Polygonum multiflorum 15-25 parts, Plastrum Testudinis 15-25 parts, Hedysarum polybotrys 15-25 parts, Rubia akane 15-25 parts, Perilla frutescens stem 10-20 parts, Magnolia officinalis flower 10-20 parts, Disporum smilaceifolium 10-20 parts, Luffa cylindrical 10-20 parts, Ziziphus mauritiana 10-20 parts, Entada phaseoloides 10-20 parts, Polygonatum sibiricum 10-20 parts.

3. The traditional Chinese medicine preparation for treating postpartum depression according to claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following weight parts of traditional Chinese medicine raw materials: Rosa rugosa 22 parts, Hypericum perforatum 22 parts, Polygonum multiflorum 22 parts, Plastrum Testudinis 20 parts, Hedysarum polybotrys 22 parts, Rubia akane 20 parts, Perilla frutescens stem 18 parts, Magnolia officinalis flower 18 parts, Disporum smilaceifolium 10 parts, Luffa cylindrical 18 parts, Ziziphus mauritiana 14 parts, Entada phaseoloides 10 parts, Polygonatum sibiricum 14 parts.

4. The preparation method of the traditional Chinese medicine preparation for treating postpartum depression according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine preparation is prepared according to the following steps: (1) The traditional Chinese medicine raw materials are weighed according to the above weight parts, washed, dried, ground into fine powder, sieved through a 100-150 mesh sieve, and uniformly mixed to obtain traditional Chinese medicine raw powder; (2) Honey is taken at a weight ratio of traditional Chinese medicine raw powder: honey of 1:1.1-1.3, the honey is heated to boiling, foam and impurities are removed, and the honey is refined to a temperature of 110-120℃, with a water content of less than 15% and a light yellow color with moderate stickiness; (3) The refined honey of step (2) is added to the traditional Chinese medicine raw powder while hot, and rapidly stirred to fully mix the honey and the traditional Chinese medicine raw powder to form a medicine mass; (4) The medicine mass is divided into small pieces, rolled into long strips with a diameter of 4-5 mm, then cut into small sections of 4-5 mm, and rolled into balls to obtain honey pills, which are dried at 60℃ or below until the water content is less than 10%, thereby obtaining the traditional Chinese medicine preparation.

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

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