Preparation method of medicinal and edible traditional Chinese medicine composition for preventing and treating pregnancy complications

Abstract

The invention discloses a preparation method of a medicinal and edible traditional Chinese medicine composition for preventing and treating pregnancy complications. The medicinal and edible traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 24 parts of radix rehmanniae, 12 parts of fructus gardeniae and 9 parts of folium mori. The composition embodies the essence of compatibility of monarch, minister, assistant and guide of a traditional Chinese medicine compound, the radix rehmanniae is used as a monarch drug, the fructus gardeniae is used as a minister drug, the folium mori is used as an assistant drug, and the composition is mainly characterized by nourishing the kidney, containing wood, clearing away fire, calming the liver and lightly dredging upper jiao and exactly conforms to the core pathogenesis of yin deficiency and yang hyperactivity of gestational hypertension. Modern pharmacological experiments prove that the three traditional Chinese medicinal materials all have definite antihypertensive activity, and the action mechanism shows the characteristic of multi-target synergism. The raw materials in the formula are homologous in medicine and food, free of toxic and side effects, mild in medicine property and capable of considering fetal elements, the three medicines all belong to clinical common miscarriage prevention or miscarriage prevention categories, worries about blood breaking and fetal movement are avoided, and the traditional Chinese medicine is suitable for being used in the pregnancy stage. The pharmaceutical composition disclosed by the invention can be used for relieving clinical symptoms of hypertensive patients in pregnancy and improving the outcome of bad pregnancy.

Description

Technical Field

[0001] This invention relates to a method for preparing a medicinal and edible herbal composition for the prevention and treatment of pregnancy complications, belonging to the field of traditional Chinese medicine. Background Technology

[0002] Preeclampsia (PE), a common and serious pregnancy complication, is a complex multisystem disease characterized by hypertension, proteinuria, or involvement of at least one organ or system after 20 weeks of gestation. The global incidence of PE is reported to be 5-10%, while in my country it is 3-5%, resulting in approximately 76,000 maternal deaths and 500,000 fetal deaths annually. The exact etiology and pathogenesis of PE are not fully understood. Currently, clinical treatment of PE primarily focuses on symptomatic management, such as antihypertensive and antispasmodic therapies. Existing clinical guidelines recommend oral labetalol and nifedipine for antihypertensive treatment of PE; however, these drugs are transplacental and may cause serious adverse outcomes such as intrauterine growth retardation, neonatal hypotension, bradycardia, hypoglycemia, and respiratory depression, limiting their clinical application. Magnesium sulfate, as a first-line antispasmodic drug for PE, also presents safety risks in clinical use. Retrospective studies have confirmed that prolonged use may induce maternal magnesium poisoning, which is significantly correlated with decreased neonatal Apgar scores. Currently, there is a lack of safe and effective specific treatments for premature birth (PE) in clinical practice. Termination of pregnancy, as the only curative treatment, often leads to a series of problems such as iatrogenic preterm birth and perinatal mortality, imposing a heavy medical and economic burden on families and society. Furthermore, PE prevention methods are very limited; aspirin, recommended by domestic and international clinical guidelines, may increase the risk of placental abruption and postpartum hemorrhage. Therefore, how to overcome the bottlenecks in PE prevention and treatment and develop safe and effective new strategies for PE prevention and treatment has become a major scientific problem urgently needing to be solved in the field of perinatal medicine.

[0003] Currently, Western medicine lacks safe and effective treatments for pregnancy-related ectopic pregnancy (PE), offering only symptomatic intervention or termination of pregnancy. Traditional Chinese medicine (TCM) theory classifies PE under the categories of "eclampsia," "pregnancy dizziness," and "pregnancy swelling," and its pathogenesis is closely related to the unique physiological state of pregnancy, characterized by "the gathering of essence and blood to nourish the fetus, easy hyperactivity of liver yang, and easy deficiency of spleen and kidney," primarily involving pathological mechanisms such as hyperactivity of liver yang and deficiency of both spleen and kidney. TCM, with its holistic regulatory and safe characteristics, possesses unique advantages in treating pregnancy-related diseases and improving pregnancy outcomes. In particular, natural compound formulas, represented by "medicine and food homology" herbs, are suitable for pregnant women due to their low toxicity, mild effects, and suitability for their use. Therefore, developing TCM preparations or health products for the prevention and treatment of PE based on "medicine and food homology" herbs is of great significance for improving pregnancy quality and promoting maternal and infant safety. Summary of the Invention

[0004] To overcome the above-mentioned shortcomings, the present invention aims to provide a traditional Chinese medicine composition for preventing and treating pregnancy complications and its preparation method. The composition is derived from both food and medicine sources, is readily available, and simultaneously regulates the liver, spleen, and kidneys, thereby alleviating pregnancy complications.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is: a medicinal and edible herbal composition for preventing and treating pregnancy complications, comprising the following raw materials in parts by weight (Ziqian Antai Yin No. 1 Formula, ZQATY1): Rehmannia glutinosa 24g, Gardenia jasminoides 12g, and Morus alba 9g.

[0006] The present invention is further configured such that the medicinal and edible herbal composition for preventing and treating pregnancy complications also includes the following raw materials in parts by weight (Ziqian Antai Yin No. 2 formula, ZQATY2): 24g Rehmannia glutinosa, 12g Gardenia jasminoides, 9g Morus alba leaves, 18g Uncaria rhynchophylla, 12g Gastrodia elata, 12g Lycium barbarum, 9g Paeonia suffruticosa, 9g Chrysanthemum morifolium, and 6g Citrus reticulata peel.

[0007] The present invention is further configured such that the medicinal and edible herbal composition for preventing and treating pregnancy complications further includes the following raw materials in parts by weight (Ziqian Antai Yin No. 3, ZQATY3): 5g of yam, 5g of coix seed, 2g of poria cocos, 2g of euryale seed, 1g of astragalus root, 3g of ganoderma lucidum, 1g of cistanche deserticola, 1g of cornus officinalis, 2g of dendrobium officinale, 1g of polygonatum odoratum, 5g of American ginseng, 1g of bitter orange flower, 5g of papaya, 3g of jujube seed, 1g of dried plum, 1g of hemp seed, 5g of honey, and 1g of licorice.

[0008] This invention also provides a method for preparing a medicinal and edible herbal composition for preventing and treating pregnancy complications, comprising the following steps:

[0009] (1) The raw material described in any one of claims 1-2 is used to extract volatile oil by steam distillation to obtain volatile oil and medicinal residue;

[0010] (2) The dregs were placed in a solvent for leaching, and the extract was obtained by filtration;

[0011] (3) Concentrated leachate;

[0012] (4) Add volatile oil, fresh orange juice and melted agar to the leachate;

[0013] (5) Sealed packaging of leachate;

[0014] Steps 3-4 are performed under negative pressure conditions.

[0015] A further feature of the present invention is that the solvent is water, 75% ethanol, or melted pork skin jelly.

[0016] The present invention is further configured such that: during the leaching process in step 1, the cell wall is broken by ultrasound at a frequency of 15-25KHZ.

[0017] A further provision of the present invention is that after the concentrated leachate is obtained, it is filtered using a filter with a pore size of less than 0.22 micrometers to remove particles and microorganisms from the leachate.

[0018] A further provision of the present invention is that, while the cell walls are being broken down by ultrasound, cellulase is added to the concentrated leachate.

[0019] Compared with existing technologies, the beneficial effects of this invention are as follows: The pharmaceutical composition of this invention is formulated according to the theory of traditional Chinese medicine prescriptions. Based on the core pathogenesis of "yin deficiency and yang hyperactivity" in gestational hypertension, the key principles are "nourishing the kidneys and nourishing the liver, clearing heat and calming the liver, and gently soothing the upper burner." Rehmannia glutinosa nourishes the kidneys and yin to treat the root cause, Gardenia jasminoides clears and reduces yang hyperactivity to treat the symptoms, and Morus alba gently soothes the upper burner to help the medicine reach the upper burner. The combination of these three herbs addresses both the root cause and the symptoms, and the medicinal properties are mild, cooling without stagnation, and nourishing without obstruction, taking care of the fetus. All three herbs fall under the category of commonly used clinical methods for protecting or stabilizing pregnancy, without the risk of bleeding or miscarriage, making it suitable for use during pregnancy. Modern pharmacological experiments have proven that this composition has clear antihypertensive activity, and its mechanism of action exhibits multi-target synergistic characteristics. Furthermore, because it is derived from both food and medicine, it has no toxic side effects, ensuring the safety of pregnant women. The pharmaceutical composition of this invention can be used to improve the TCM syndrome of liver yang hyperactivity and spleen and kidney deficiency, and to alleviate pregnancy reactions such as gestational hypertension and proteinuria in pregnant women. Attached Figure Description

[0020] Figure 1 This is a schematic diagram showing the changes in systolic blood pressure after intervention with a traditional Chinese medicine composition.

[0021] Figure 2 This is a schematic diagram showing the changes in diastolic blood pressure after intervention with a traditional Chinese medicine composition.

[0022] Figure 3 This is a schematic diagram showing the changes in urinary protein concentration after intervention with a traditional Chinese medicine composition.

[0023] Figure 4 This is a schematic diagram showing the changes in average body weight of fetal mice after intervention with a traditional Chinese medicine composition.

[0024] Figure 5 This is a schematic diagram showing the changes in placental efficiency after intervention with a traditional Chinese medicine composition.

[0025] Figure 6 This is a schematic diagram showing the changes in the absorption rate of fetal mice after intervention with a traditional Chinese medicine composition.

[0026] Figure 7 This is a schematic diagram showing the change in the number of fetal mice after intervention with a traditional Chinese medicine composition;

[0027] Figure 8 This is a schematic diagram of placental pathological changes after intervention with a traditional Chinese medicine composition.

[0028] Figure 9 This is a schematic diagram showing the pathological changes in the main organs of pregnant mice after intervention with a traditional Chinese medicine composition. Detailed Implementation

[0029] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby providing a clearer and more explicit definition of the scope of protection of the present invention.

[0030] Example 1: 24g of Rehmannia glutinosa, 12g of Gardenia jasminoides, and 9g of Mulberry leaves were placed in a reaction vessel. The volatile oil was extracted by steam distillation to obtain volatile oil and residue. The residue was then leached in water and filtered to obtain an extract. The extract was concentrated; volatile oil, fresh orange juice, and melted agar were added to the extract; the extract was then sealed and packaged. The concentration of the extract and the addition of volatile oil, fresh orange juice, and melted agar were carried out under negative pressure.

[0031] Rehmannia glutinosa: Nourishes kidney water, replenishes yin and essence to control excessive yang. After pregnancy, essence and blood gather downward to nourish the fetus, resulting in a relative deficiency of maternal yin fluid. When water fails to nourish wood, liver yang is prone to become excessive. Using large doses of Rehmannia glutinosa directly enters the kidney and liver blood levels, which can not only replenish the yin and blood lost in nourishing the fetus, but also "strengthen the master of water to control the yang," fundamentally inhibiting the excessive liver yang. It is the main ingredient in the formula.

[0032] Gardenia: Clears heat from the Triple Burner, cools the blood and relieves irritability, assisting Rehmannia glutinosa in clearing and reducing excessive Yang. Liver Yang hyperactivity is often accompanied by internal heat. Gardenia, bitter and cold, enters the Heart, Liver, and Triple Burner meridians, guiding fire downwards and expelling heat through urination. Its blood-cooling effect also addresses fetal restlessness due to blood heat during pregnancy. Combined with the principal herb, Rehmannia glutinosa, it not only clears excess heat but also prevents the cloying stagnation of Yin-nourishing herbs, making it an essential auxiliary herb.

[0033] Mulberry leaves: Light and dispersing, calming the liver and improving eyesight, while also moisturizing dryness. Mulberry leaves are sweet, bitter, and cold in nature, entering the liver and lungs. Their light and upward-moving properties can disperse wind-heat in the upper burner, calm liver wind, and relieve dizziness and vertigo caused by pregnancy-induced hypertension. Their moisturizing properties also prevent the bitter and drying effects of gardenia from damaging yin, ensuring the entire formula is nourishing yet balanced, moisturizing without being cloying. The dosage should be light, serving as both an adjuvant and guiding herb, directing the other herbs upwards to the head and eyes, directly reaching the affected area.

[0034] This pharmaceutical composition is formulated based on traditional Chinese medicine (TCM) prescription theory. Based on the core pathogenesis of gestational hypertension characterized by "yin deficiency and yang excess," its therapeutic principles are "nourishing the kidneys and nourishing the liver, clearing heat and calming the liver, and gently soothing the upper burner." Rehmannia glutinosa nourishes the kidneys and yin to address the root cause; Gardenia jasminoides clears and reduces yang excess to address the symptoms; and Morus alba gently soothes the upper burner to aid the upward flow of the medicinal effects. This combination of three herbs addresses both the root cause and the symptoms, and is mild in nature, neither too cold nor too stagnant, and nourishing without causing stagnation. It also considers the fetus's health. All three herbs fall under the category of commonly used clinical methods for maintaining or stabilizing pregnancy, posing no risk of bleeding or miscarriage, making it suitable for use during pregnancy. Modern pharmacological experiments have demonstrated that this composition possesses clear antihypertensive activity, and its mechanism of action exhibits multi-target synergistic characteristics. Furthermore, because it is derived from both food and medicine, it has no toxic side effects, ensuring the safety of pregnant women. This pharmaceutical composition can be used to improve TCM syndromes such as liver yang excess and spleen and kidney deficiency, and to alleviate pregnancy-related symptoms such as gestational hypertension and proteinuria in pregnant women.

[0035] Example 2: Basically the same as Example 1, except that the raw materials also include: 18g of Uncaria rhynchophylla, 12g of Gastrodia elata, 12g of Lycium barbarum, 9g of Paeonia suffruticosa, 9g of Chrysanthemum morifolium, and 6g of Citrus reticulata peel.

[0036] Uncaria rhynchophylla: Sweet and slightly cold in nature, it enters the liver and pericardium meridians. Its main functions are clearing heat, calming the liver, extinguishing wind, and relieving convulsions. It is an essential medicine for treating preeclampsia and dizziness. Modern research has confirmed that its alkaloid components can inhibit the vasomotor center and dilate peripheral blood vessels to lower blood pressure.

[0037] Gastrodia elata: sweet, pungent, and neutral in nature; enters the liver meridian; relieves wind and stops spasms; calms liver yang.

[0038] Goji berries: sweet and neutral in nature, they enter the liver and kidney meridians, nourish the liver and kidneys, and benefit essence and eyesight.

[0039] Moutan bark: bitter, pungent, slightly cold; enters the heart, liver, and kidney meridians. It cools the blood and promotes blood circulation, clears liver fire, and counteracts the dryness of the principal herb, ensuring yin nourishment without causing blood stasis.

[0040] Chrysanthemum from Chuzhou: sweet, bitter, and slightly cold in nature; enters the lung and liver meridians; dispels wind and clears heat; calms the liver and improves eyesight; can relieve dizziness and red eyes caused by high blood pressure.

[0041] Orange peel: pungent, bitter, and warm in nature, it enters the spleen and lung meridians, and promotes qi circulation, resolves phlegm, harmonizes the middle jiao, and relieves adverse qi flow. Pregnancy-induced hypertension is often caused by spleen deficiency and phlegm obstruction, as well as stomach dysfunction. Orange peel can prevent the cloying and sluggish effects of yin-nourishing medicines and also addresses the condition of "spleen and kidney deficiency".

[0042] The formula contains multiple herbs that enter the liver meridian, and also affect the heart, kidney, spleen, and lung meridians. It combines cold and warm herbs, addressing both the root cause and the symptoms, and works together to "nourish the kidneys and liver to stabilize the fetus, clear heat and subdue yang to lower blood pressure, and resolve phlegm and harmonize the stomach to soothe the stomach," which aligns with the key points of TCM diagnosis and treatment for gestational hypertension.

[0043] Example 3: 24g of Rehmannia glutinosa, 12g of Gardenia jasminoides, 9g of Mulberry leaf, 18g of Uncaria rhynchophylla, 12g of Gastrodia elata, 12g of Lycium barbarum, 9g of Paeonia suffruticosa, 9g of Chrysanthemum morifolium, 6g of Citrus reticulata peel, 5g of Dioscorea opposita, 5g of Coix lacryma-jobi, 2g of Poria cocos, 2g of Euryale ferox, 1g of Astragalus membranaceus, 3g of Ganoderma lucidum, 1g of Cistanche deserticola, 1g of Cornus officinalis, 2g of Dendrobium officinale, 1g of Polygonatum odoratum, 5g of Panax quinquefolius, 1g of Citrus aurantium, 5g of Chaenomeles speciosa, 3g of Ziziphus jujuba var. spinosa, 1g of Prunus mume, 1g of Cannabis sativa, 5g of honey, and 1g of Glycyrrhiza uralensis were placed in a reaction vessel. The volatile oil was extracted by steam distillation, yielding volatile oil and residue. The residue was then leached in water, with cellulase added to the concentrated extract during the leaching process. The extract was then subjected to ultrasonic treatment at a frequency of 15-25 kHz to disrupt the cell walls. The extract was then filtered. Alternatively, the extract can be concentrated by distillation. The leachate was then filtered using a filter with a pore size of less than 0.22 micrometers to remove particles and microorganisms. Volatile oil, fresh orange juice, and melted pork skin jelly were added to the leachate; the leachate was then sealed and packaged; the leachate was concentrated; the addition of volatile oil, fresh orange juice, and melted agar to the leachate was carried out under negative pressure.

[0044] The volatile oils can be evenly dispersed in the pork skin jelly, forming a solidified mass as the temperature decreases, making it easy to eat and refreshing. The active ingredients in the medicinal residue are extracted using a leaching method at a lower temperature, avoiding their decomposition at high temperatures. Cellulase and ultrasound promote the breaking down of plant cell walls. Large molecules within the cells pass through the broken cell walls and are released into the extract, increasing the content of active ingredients. A filter with a pore size of less than 0.22 microns removes impurities and microorganisms. Orange juice is rich in vitamins and antioxidants, and it enhances the flavor, neutralizing any bitterness.

[0045] Job's tears invigorate the spleen, clear heat, and promote diuresis; Poria cocos invigorates the spleen, eliminates dampness, and calms the mind; Euryale ferox invigorates the spleen, strengthens the spleen, consolidates the kidneys, and stops diarrhea; Dioscorea opposita invigorates the spleen and consolidates the kidneys; Astragalus membranaceus invigorates the spleen, replenishes qi, and raises yang. These ingredients, as the main herbs, achieve the effects of invigorating the spleen, eliminating dampness, consolidating the fetus, and stabilizing the pregnancy. Ganoderma lucidum nourishes the liver and kidneys and calms the mind; Cistanche deserticola warms and tonifies kidney yang without causing dryness; Cornus officinalis astringes and consolidates essence. These three herbs work together to address kidney deficiency and unstable fetal development, improving symptoms such as lower back and knee weakness, dizziness, and tinnitus. Dendrobium officinale, Polygonatum odoratum, and American ginseng work together to nourish yin and generate fluids, preventing fetal restlessness caused by yin deficiency and internal heat or insufficient body fluids. Ziziphus jujuba var. spinosa nourishes blood and calms the mind; Prunus mume astringes and stops diarrhea and relieves insomnia during pregnancy. Hemp seed moistens the intestines and promotes bowel movements, preventing constipation during pregnancy and avoiding obstruction of the bowels affecting fetal development. Bitter orange blossom regulates qi and relieves abdominal distension, while papaya harmonizes the stomach and eliminates dampness, thus alleviating indigestion or abdominal bloating during pregnancy, serving as an adjuvant. Honey and licorice harmonize the other herbs and moderate their effects. This combination focuses on strengthening the spleen and eliminating dampness, tonifying the kidneys and consolidating the Chong meridian, while also nourishing yin and generating fluids, regulating qi and harmonizing the middle jiao. By targeting multiple points to harmonize the spleen, kidneys, qi, and blood of pregnant women, it achieves the effect of stabilizing the pregnancy.

[0046] Example 1 formula is named Ziqian Antai Decoction No. 1 (ZQATY1), Example 2 formula is named Ziqian Antai Decoction No. 2 (ZQATY), and Example 3 formula is named Ziqian Antai Decoction No. 3 (ZQATY3).

[0047] Example 4: Establishment of a mouse model: C57BL / 6 mice in the estrous cycle were selected and mated in a 1:3 male-to-female ratio. The day the vaginal plug fell off was defined as day 1 of gestation. Modeling began on day 10 of gestation. Blood pressure of pregnant mice was monitored using a mouse blood pressure monitor. The presence of hypertension indicated successful modeling. On day 18 of gestation, urine from pregnant mice was collected using a standard metabolic cage to measure changes in urinary protein.

[0048] Example 1, Example 2, Example 3, and the control group: Intervention methods for each group: After successful modeling at 13 days of gestation, pregnant mice were selected for testing. Mice were divided into 4 groups, each group was administered 1 g / mL of the extract by gavage once a day, 0.2 mL each time. A control group was also set up, for a total of 4 groups. Control group mice were administered the same dose of sterile saline by gavage. After the intervention, serum, urine, placental, and other specimens were collected from each group of mice for subsequent testing. Blood pressure, urine protein, and embryonic development were observed, and placental histopathological changes were observed by staining. Major organs, including heart, liver, spleen, lung, kidney, and colon, were collected, fixed in 4% paraformaldehyde, routinely embedded in paraffin, sectioned to a thickness of 4 μm, and stained with hematoxylin and eosin (H&E). Histological changes were observed under an optical microscope to assess the potential toxicological effects of drug treatment.

[0049] The results are as follows:

[0050] Figure 1 The x-axis represents the number of days of gestation (e.g., GD10 represents day 10 of gestation), indicating the time progression of the observation; the y-axis represents the systolic blood pressure of the mice (in mmHg). The control group (CON) consisted of normally pregnant mice, representing normal blood pressure levels; the model group (PE) consisted of L-NAME-induced PE mouse models, representing the state of gestational hypertension. ZQATY1, ZQATY2, and ZQATY3 represented the traditional Chinese medicine intervention groups in the mouse models, respectively. The results showed that the systolic blood pressure of the mice in the traditional Chinese medicine intervention groups was significantly lower than that in the model group (P < 0.05), and the blood pressure was close to that of the control group, indicating that traditional Chinese medicine has a therapeutic effect on PE.

[0051] Figure 2 The horizontal axis represents the number of days of gestation (e.g., GD10 represents day 10 of gestation), indicating the time progression of the observation; the vertical axis represents the diastolic blood pressure of the mice (in mmHg). The control group (CON) consisted of normally pregnant mice, representing normal blood pressure levels; the model group (PE) consisted of L-NAME-induced PE mouse models, representing the state of gestational hypertension. The results in the figure above show that the diastolic blood pressure of the mice in the traditional Chinese medicine intervention group was significantly lower than that in the model group (P < 0.05) and close to that of the control group, indicating that traditional Chinese medicine has a therapeutic effect on PE.

[0052] Figure 3 The horizontal axis represents the experimental groups (control group, model group, and traditional Chinese medicine intervention group). The vertical axis represents urinary protein concentration (unit: mg / L), indicating the degree of renal function impairment. The bar chart represents the average value of each group. Significance: Elevated urinary protein is one of the typical manifestations of PE. If the urinary protein concentration is significantly lower in the traditional Chinese medicine intervention group than in the model group, it indicates that the intervention is effective and improves renal function impairment. The results in the above figure show that the proteinuria in mice in the traditional Chinese medicine intervention group was significantly lower than that in the model group (P < 0.05), indicating that traditional Chinese medicine has a therapeutic effect on PE.

[0053] Figure 4 The horizontal axis represents the experimental groups (control group, model group, and traditional Chinese medicine intervention group). The vertical axis represents the weight of mouse fetuses (in g), and the bar chart represents the mean ± standard deviation of each group. The results in the above figure show that the fetal weight of mice in the traditional Chinese medicine intervention group increased (P < 0.05), indicating that traditional Chinese medicine improved placental function and the fetal development environment. This suggests that traditional Chinese medicine has a therapeutic effect on PE.

[0054] Figure 5 The horizontal axis represents the experimental groups (control group, model group, and traditional Chinese medicine intervention group). The vertical axis represents placental efficiency. Calculation method: fetal mouse weight / placental weight. This reflects the placental supply efficiency; higher placental efficiency indicates better placental function. The bar chart represents the mean ± standard deviation of each group. The results in the above figure show that placental efficiency in the traditional Chinese medicine intervention group showed an increasing trend, indicating that traditional Chinese medicine has a therapeutic effect on PE.

[0055] Figure 6 The horizontal axis represents the experimental groups (control group, model group, and traditional Chinese medicine intervention group), and the vertical axis represents the fetal absorption (fetal death) rate (%). A lower absorption rate indicates a better pregnancy outcome. The bar chart represents the mean ± standard deviation of each group. The results in the above figure show that the fetal absorption rate (%) in the traditional Chinese medicine intervention group showed a significant decreasing trend, indicating that traditional Chinese medicine improved pregnancy safety and had a therapeutic effect on PE.

[0056] Figure 7 The horizontal axis represents the experimental groups (control group, model group, and traditional Chinese medicine intervention group), and the vertical axis represents the number of live offspring in fetal mice. A higher number of live offspring indicates a better pregnancy outcome. The bar chart represents the mean ± standard deviation of each group. The results in the above figure show that the number of live offspring in the traditional Chinese medicine intervention group showed a significant increasing trend, indicating that the treatment improved embryonic developmental disorders caused by PE, and that traditional Chinese medicine has a therapeutic effect on PE.

[0057] Figure 8 Placental tissue H&E staining (×400) showed that in the control group, the placental tissue structure was intact, blood vessels were full, the labyrinth area was regularly arranged, and cells were tightly packed. In the model group, placental tissue cells showed significant edema, enlarged intercellular spaces, disordered vascular structure, and vacuolation and necrosis, indicating severe placental perfusion impairment. If cell arrangement returned to tightness, blood vessel fullness increased, and edema decreased, it indicated improvement in pathological changes and suggested recovery of placental function. This suggests that traditional Chinese medicine has a therapeutic effect on placental perfusion injury (PE).

[0058] Figure 9 HE staining images of organs such as the heart, liver, spleen, lungs, kidneys, and colon were used to evaluate the toxicity and safety of the traditional Chinese medicine formula. Results showing that the structures of the major organs remained intact, without inflammation, hemorrhage, or necrosis indicated good drug safety and no obvious toxic side effects.

[0059] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it. They should not be used to limit the scope of protection of the present invention. All equivalent changes or modifications made in accordance with the spirit and essence of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A pharmafood traditional Chinese medicine composition for preventing and treating pregnancy complications, characterized in that, The raw materials include the following ingredients by weight: raw land 24, gardenia 12, mulberry leaves 9.

2. The pharmafood Chinese medicine composition for preventing and treating pregnancy complications according to claim 1, characterized in that, The raw materials include the following ingredients by weight: raw land 24, gardenia 12, mulberry leaves 9, Uncaria 18, Gastrodia 12, medlar 12, Danpi 9, Chuzhuyuhua 9, orange red 6.

3. The pharmafood Chinese medicine composition for preventing and treating pregnancy complications according to claim 1, characterized in that, The raw materials include the following ingredients by weight: raw land 24, gardenia 12, mulberry leaves 9, Uncaria 18, Gastrodia 12, medlar 12, Danpi 9, Chuzhuyuhua 9, orange red 6.

4. A method for preparing a medicinal and food homologous traditional Chinese medicine composition for preventing and treating pregnancy complications, characterized in that, The method includes the following steps: (1) The raw materials of any one of claims 1-3 are extracted with water vapor distillation to obtain volatile oil and dregs; (2) The dregs are soaked in a solvent to obtain a soaking liquid; (3) The soaking liquid is concentrated; (4) The volatile oil, fresh orange juice and melted agar are added to the soaking liquid; (5) The soaking liquid is sealed and packaged; The steps 3-4 are performed under negative pressure.

5. The method of claim 4, wherein the preparation method of the pharmacological and edible Chinese medicine composition for preventing and treating pregnancy complications is characterized by, The agar is replaced by pork skin jelly.

6. The method of claim 5, wherein the preparation method of the pharmacological and edible Chinese medicine composition for preventing and treating pregnancy complications is characterized by, During the soaking process of step 2, the cell walls are broken by ultrasonic waves with a frequency of 15-25 KHZ.

7. The method of claim 4, wherein the preparation method of the pharmacological and edible Chinese medicine composition for preventing and treating pregnancy complications is characterized by, After the soaking liquid is concentrated, it is filtered through a filter with a pore size of less than 0.22 microns to remove particles and microorganisms in the soaking liquid.

8. The method of claim 6, wherein the preparation method of the pharmacological and edible Chinese medicine composition for preventing and treating pregnancy complications is characterized by, The cellulase is added to the concentrated soaking liquid while the cell walls are broken by ultrasonic waves.

Images