Compositions for the treatment of postpartum anxiety, methods of making and medicaments thereof

Abstract

This invention provides a composition for treating postpartum anxiety, its preparation method, and the drug itself. The composition for treating postpartum anxiety includes Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, Angelica sinensis, mulberry, Citrus medica, Trichosanthes kirilowii, and St. John's wort. The combined effects of these herbs work synergistically to strengthen the spleen and kidneys, soothe the liver and relieve depression, nourish blood and calm the mind, making them more suitable for postpartum anxiety, restlessness, and insomnia in women.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical formulation technology, and in particular to a composition for treating postpartum anxiety, a method for preparing the same, and a drug thereof. Background Technology

[0002] Currently, the treatment of postpartum anxiety disorder includes non-pharmacological and pharmacological therapies. Non-pharmacological therapies mainly include psychological counseling, music therapy, and external treatments using traditional Chinese medicine. Psychological counseling and music therapy are generally used as adjunctive therapies, in conjunction with medication or non-pharmacological treatments, to consolidate or enhance the therapeutic effect. Numerous studies have confirmed that traditional Chinese medicine external treatments such as acupuncture and massage have equal or even better efficacy than Western medicine in treating anxiety disorder, with fewer toxic side effects. However, due to patients' fear of needles and the inconvenience of carrying them, traditional Chinese medicine external treatments cannot be widely promoted.

[0003] Drug therapy is currently the dominant method for treating postpartum anxiety disorder, primarily using Western medicine. Clinically, medication for postpartum anxiety disorder is not differentiated from other anxiety disorders. Commonly used anti-anxiety medications include tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SSNRIs), reversible monoamine oxidase A inhibitors, irreversible monoamine oxidase A inhibitors, benzodiazepines, 5-HT1A antagonists such as buspirone, antihistamines, barbiturates, nerve blocks, beta-blockers, and anticonvulsants. Clinical studies have confirmed the efficacy of these anti-anxiety medications in treating anxiety disorders. However, there are limitations to their use in certain populations, such as pregnant or postpartum women with weakened constitutions, patients with cardiovascular or cerebrovascular diseases, and those with liver or kidney dysfunction. Furthermore, continuous use can easily lead to drug dependence, resulting in withdrawal syndrome, and various side effects such as allergies, endocrine disorders, forgetfulness, and memory impairment, as well as affecting breastfeeding and other issues, making it difficult for postpartum women to adhere to medication.

[0004] Therefore, there is an urgent need to provide a drug for treating postpartum anxiety. Summary of the Invention

[0005] Therefore, it is necessary to provide a composition, preparation method and medicine for treating postpartum anxiety.

[0006] The first aspect of this application provides a composition for treating postpartum anxiety, the composition comprising the following components:

[0007] Acanthopanax senticosus, rose, corydalis, ophiopogon japonicus, lotus seed heart, angelica sinensis, mulberry, citron, trichosanthes kirilowii, and forsythia suspensa.

[0008] In some embodiments, the composition comprises, by weight, the following components:

[0009] 20-30 parts of the Acanthopanax senticosus, 3-6 parts of the rose, 5-10 parts of the Corydalis yanhusuo, 6-15 parts of the Ophiopogon japonicus, 3-8 parts of the lotus seed heart, 10-15 parts of the Angelica sinensis, 9-15 parts of the mulberry, 5-10 parts of the Citrus medica, 10-15 parts of the Trichosanthes kirilowii and 9-15 parts of the St. John's wort.

[0010] In some embodiments, the composition comprises, by weight, the following components:

[0011] 25-30 parts of the Acanthopanax senticosus, 4-6 parts of the rose, 8-10 parts of the Corydalis yanhusuo, 10-12 parts of the Ophiopogon japonicus, 3-5 parts of the lotus seed heart, 10-12 parts of the Angelica sinensis, 12-15 parts of the mulberry, 8-10 parts of the Citrus medica, 10-13 parts of the Trichosanthes kirilowii and 9-10 parts of the St. John's wort.

[0012] In some embodiments, the composition further includes vitamin B;

[0013] Optionally, the vitamin B includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, and folic acid.

[0014] In some embodiments, the composition further comprises, by weight, 0.002-0.003 parts of vitamin B1, 0.002-0.004 parts of vitamin B2, 0.001-0.002 parts of vitamin B6, 0.000002-0.000003 parts of vitamin B12, 0.02-0.025 parts of niacin, 0.006-0.007 parts of pantothenic acid, and 0.0004-0.0005 parts of folic acid.

[0015] In some embodiments, the composition further includes calcium lactate.

[0016] In some embodiments, the composition further comprises 1.2 to 1.3 parts by weight of the calcium lactate.

[0017] The second aspect of this application provides a method for preparing the composition of the first aspect of this application for treating postpartum anxiety, comprising the following steps:

[0018] The Acanthopanax senticosus, the rose, the Corydalis yanhusuo, the Ophiopogon japonicus, the lotus seed heart, the mulberry, the Trichosanthes kirilowii, and the St. John's wort are mixed, decocted with water, and concentrated solution A is prepared.

[0019] The Angelica sinensis and Citrus medica were extracted to prepare concentrated solution B;

[0020] The concentrated solution A and the concentrated solution B are combined, dried, and pulverized to prepare the composition.

[0021] A third aspect of this application provides a medicament for treating postpartum anxiety, comprising the composition for treating postpartum anxiety of the first aspect of this application or prepared using the composition for treating postpartum anxiety of the first aspect of this application.

[0022] In some embodiments, the dosage form of the drug includes one of tablets, capsules, powders, granules, ointments, solutions, suspensions, and syrups.

[0023] The above-mentioned composition for treating postpartum anxiety uses Acanthopanax senticosus as the main ingredient, which has the effects of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind. When the spleen is healthy, qi and blood are generated sufficiently, which in turn nourishes the heart qi, replenishes blood, and calms the mind. Rose enters the liver and spleen meridians, soothing the liver and relieving depression, harmonizing blood and promoting qi circulation, regulating menstruation and relieving pain. Corydalis promotes qi and blood circulation and relieves pain. The combination of the two promotes qi and blood circulation, removes blood stasis and relieves pain, and is used for postpartum qi stagnation and blood stasis. Ophiopogon japonicus and lotus seed heart nourish heart yin, clear heart heat and calm the mind. Angelica sinensis and mulberry nourish blood, nourish yin and calm the mind. Citrus medica soothes the liver and stomach, dries dampness and resolves phlegm. Trichosanthes kirilowii clears heat and eliminates phlegm, widens the chest and disperses nodules. The two relieve the symptoms of phlegm-fire disturbing the upper body due to liver qi stagnation. In addition, St. John's wort astringes and stops bleeding, promotes menstruation and lactation. The above-mentioned herbs work together to strengthen the spleen and kidneys, soothe the liver and relieve depression, nourish blood and calm the mind, and are better suited for postpartum anxiety, restlessness and insomnia in women. Detailed Implementation

[0024] To facilitate understanding of the present invention, a more complete description will be given below with reference to relevant embodiments. Preferred embodiments of the present invention are shown below. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that a thorough and complete understanding of the disclosure of the present invention will be achieved.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0026] In this invention, the technical features described in an open-ended manner include both closed-ended technical solutions composed of the listed features and open-ended technical solutions that include the listed features.

[0027] In this invention, "optionally," "optionally," and "optional" mean that they are optional, that is, they are selected from either "with" or "without." If multiple "options" appear in a technical solution, unless otherwise specified and there are no contradictions or mutual constraints, each "option" is independent.

[0028] In this invention, numerical ranges are involved. Unless otherwise specified, the numerical ranges are considered continuous and include the minimum and maximum values ​​of the range, as well as every value between the minimum and maximum values. Furthermore, when the range refers to integers, it includes every integer between the minimum and maximum values ​​of the range. Additionally, when multiple ranges are provided to describe features or characteristics, the ranges may be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges to which they are included.

[0029] This document only specifically discloses some numerical ranges. However, any lower limit can be combined with any upper limit to form an unspecified range; and any lower limit can be combined with other lower limits to form an unspecified range, just as any upper limit can be combined with any other upper limit to form an unspecified range. Furthermore, each individually disclosed point or single value can itself serve as a lower or upper limit and be combined with any other point or single value or with other lower or upper limits to form an unspecified range.

[0030] Unless otherwise specified, the temperature parameters in this invention can be either constant temperature processing or processing within a certain temperature range. The constant temperature processing allows temperature fluctuations within the precision range controlled by the instrument.

[0031] In the description of the invention, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0032] Unless otherwise specified, all embodiments and optional embodiments of the present invention can be combined with each other to form new technical solutions. Unless otherwise specified, all technical features and optional technical features of the present invention can be combined with each other to form new technical solutions.

[0033] Unless otherwise specified, all steps of the present invention may be performed sequentially or randomly, preferably sequentially. As used herein, "medicine" includes any agent, compound, composition, or mixture that provides physiological and / or pharmacological effects in vivo or in vitro, and often provides beneficial effects. The scope of the physiological and / or pharmacological effects produced by the "medicine" in vivo is not particularly limited; it may have systemic effects or only local effects. The activity of the "medicine" is not particularly limited; it may be an active substance that can interact with other substances or an inert substance that does not interact with other substances.

[0034] Drug therapy is currently the dominant method for treating postpartum anxiety, primarily using Western medicine. Clinically, medication for postpartum anxiety is not differentiated from other anxiety disorders. Continuous use of Western medicine can easily lead to drug dependence, resulting in withdrawal syndrome, and various side effects such as allergies, endocrine disorders, amnesia, and memory impairment, as well as affecting breastfeeding and other problems, making it difficult for postpartum women to adhere to medication.

[0035] Traditional Chinese medicine has accumulated rich clinical experience in thousands of years of medical practice. It has a holistic treatment concept with multiple targets, multiple pathways and multiple links, and has few toxic side effects, which has attracted widespread attention. At present, there are reports on the use of traditional Chinese medicine to treat anxiety disorders, such as the use of Huanglian Ejiao Decoction with modifications to treat generalized anxiety disorder in the community (Diao Huaqiong, Tang Qisheng, Shao Jun, et al. Observation on the effect of Huanglian Ejiao Decoction with modifications to treat 42 cases of generalized anxiety disorder in the community [J]. Beijing Journal of Traditional Chinese Medicine, 2020, 39(12):1225-1228.), and the use of Danzhi Xiaoyao Powder with modifications to treat anxiety disorder (Xiong Fei, Song Peiran. Clinical observation on the effect of Danzhi Xiaoyao Powder with modifications to treat anxiety disorder [J]. Chinese Journal of Rational Drug Use, 2019, 16(1): 16-19.). In addition, in clinical practice, there is also the use of integrated traditional Chinese and Western medicine to treat anxiety disorders, such as Danzhi Xiaoyao San combined with tandospirone citrate tablets to treat anxiety disorders (Li Yin. Evaluation of the therapeutic effect of traditional Chinese medicine Danzhi Xiaoyao San on anxiety disorders [J]. China Medical Guide, 2021, 19(28): 1-3.).

[0036] Chinese patent publication number CN112426454A discloses a traditional Chinese medicine compound composition with anti-anxiety effects, its preparation method, and its application. This composition consists of extracts of white peony root, gardenia fruit, albizia flower, and peony bark, and can be used as a dietary supplement or health food ingredient for the prevention or treatment of anxiety disorders. Chinese patent publication number CN107136514A discloses a nutrient composition composed of vitamins D, K, and B12. This composition consists of 2μg-100μg of vitamin D, 0.2μg-200μg of vitamin B12, 20ug-100mg of vitamin K, and appropriate amounts of acceptable excipients. This nutrient composition is used for individuals with depression or depressive tendencies, those experiencing anxiety and insomnia, and those with mild Alzheimer's disease or memory loss. Chinese patent publication number CN109172663A discloses a pharmaceutical composition for treating or preventing anxiety and / or depression, and its application therein. The composition contains the following substances in parts by weight: 35-200 parts total saponins from Sanguisorba officinalis, 200-3000 parts quercetin, and 50-1000 parts γ-aminobutyric acid. This composition has good anti-anxiety and antidepressant effects and can be used to prepare anti-anxiety and antidepressant drugs, health products, or foods.

[0037] The aforementioned anti-anxiety Western medicines, traditional Chinese medicines, or combinations have a preventive or therapeutic effect on anxiety disorders, but are not specifically targeted at postpartum anxiety in women. Pregnant and postpartum women are a special group, bearing the responsibility of breastfeeding their infants, which greatly limits the medications they can use. After childbirth, women often experience blood and qi deficiency, physical weakness, decreased immunity, and susceptibility to illness. Coupled with emotional sensitivity, their physiological and psychological recovery requires careful conditioning. Therefore, there is an urgent need for a medication specifically designed to treat postpartum anxiety.

[0038] Based on the aforementioned issues, this application addresses the limitations of medication use for postpartum women by providing a composition for treating postpartum anxiety, comprising Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, Angelica sinensis, mulberry, Citrus medica, Trichosanthes kirilowii, and St. John's wort. This composition combines medicinal and edible Chinese herbs with nutritional components, offering both health benefits and therapeutic effects, promoting postpartum physical and mental recovery, and alleviating anxiety symptoms. Furthermore, the synergistic effects of the individual herbs provide benefits such as soothing the liver and spleen, replenishing qi, nourishing blood, calming the mind, and soothing the nerves. It can regulate qi and blood, enhance the mother's immunity, alleviate postpartum discomfort, and promote postpartum recovery.

[0039] The first aspect of this application provides a composition for treating postpartum anxiety, the composition comprising the following components: Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, Angelica sinensis, mulberry, Citrus medica, Trichosanthes kirilowii and St. John's wort.

[0040] Eleutherococcus senticosus (Rupr. et Maxim.) Harms, a plant belonging to the Araliaceae family, is a dried root, rhizome, or stem. It has a pungent and slightly bitter taste, is warm in nature, and enters the spleen, kidney, and heart meridians. It possesses the functions of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind. It is used for spleen and lung qi deficiency, physical weakness and fatigue, loss of appetite, lung and kidney deficiency, chronic cough and wheezing, kidney deficiency with lower back and knee pain, heart and spleen insufficiency, insomnia, and excessive dreaming. Eleutherococcus senticosus contains various active ingredients such as saponins, coumarins, flavonoids, organic acids, and polysaccharides. Modern medical research has found that Eleutherococcus senticosus can act on the central nervous system, regulating neurotransmitter levels, improving cerebral blood supply, promoting brain cell metabolism and repair, and has a good sedative and anticonvulsant effect on the central nervous system.

[0041] Rose petals are the dried flower buds of the Rosa rugosa Thunb. plant in the Rosaceae family. They have a sweet and slightly bitter taste, are warm in nature, and enter the liver and spleen meridians. They have the effects of regulating qi and relieving depression, soothing the liver and harmonizing blood, regulating menstruation and relieving pain. They can be used for women with liver qi stagnation, qi and blood imbalance, liver and stomach qi pain, poor appetite and nausea, injuries from falls, irregular menstruation, and dysmenorrhea.

[0042] Corydalis yanhusuo is the dried tuber of the poppy plant Corydalis yanhusuo WT. Wang. It has a pungent and bitter taste, is warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, and relieving pain. It is used for chest and rib pain, abdominal pain, angina pectoris, amenorrhea, dysmenorrhea, postpartum blood stasis, and traumatic swelling and pain.

[0043] Ophiopogon japonicus (Lf) Ker-Gawl., a plant in the Liliaceae family, is a dried tuberous root. It has a sweet and slightly bitter taste, is slightly cold in nature, and enters the heart, lung, and stomach meridians. It nourishes yin and generates fluids, moistens the lungs and clears the heart. It is used for dry cough due to lung dryness, consumptive cough due to yin deficiency, sore throat, thirst due to fluid depletion, internal heat and thirst, irritability and insomnia, and constipation due to intestinal dryness.

[0044] Lotus seed heart is the dried young leaf and embryonic root of the mature seed of Nelumbo nucifera Gaertn., a plant in the Nymphaeaceae family. It tastes bitter and is cold in nature. It enters the heart and kidney meridians and has the effects of clearing the heart and calming the mind, harmonizing the heart and kidneys, astringing essence and stopping bleeding. It is used for heat entering the pericardium, delirium, disharmony between the heart and kidneys, insomnia and seminal emission, and hematemesis due to blood heat.

[0045] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family. It has a sweet and pungent taste, is warm in nature, and enters the liver, heart, and spleen meridians. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and promoting bowel movements. It is a highly valued gynecological medicine, often used to treat various diseases caused by blood deficiency or blood stasis, such as sallow complexion due to blood deficiency, insomnia and palpitations caused by insufficient blood to nourish the heart and spirit, irregular menstruation, dysmenorrhea, amenorrhea, postpartum abdominal pain caused by blood stasis, and constipation caused by blood deficiency in the elderly or postpartum women.

[0046] Mulberry is the dried fruit spike of *Morus alba* L., a plant in the Moraceae family. It has a sweet and sour taste, is cold in nature, and enters the heart, liver, and kidney meridians. It has the effects of nourishing yin and blood, promoting body fluid production and moistening dryness. It is used for liver and kidney yin deficiency, dizziness and tinnitus, palpitations and insomnia, premature graying of hair, thirst due to fluid depletion, internal heat and thirst, and constipation due to intestinal dryness.

[0047] Buddha's Hand (Citrus medica L. var. sarcodactylis Swingle) is the dried fruit of the plant, belonging to the Rutaceae family and the Citrus genus. It has a pungent, bitter, and sour taste, and is warm in nature. It enters the liver, spleen, stomach, and lung meridians, and has the functions of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm. It is used for liver and stomach qi stagnation, chest and rib distension and pain, epigastric fullness, poor appetite and vomiting, and cough with excessive phlegm.

[0048] Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms, belonging to the Cucurbitaceae family, are dried, ripe fruits. They are sweet and slightly bitter in taste, cold in nature, and enter the lung, stomach, and large intestine meridians. They have the effects of clearing heat and resolving phlegm, relieving chest congestion and dissipating nodules, and moistening dryness and lubricating the intestines. They are used for lung heat cough, thick yellow phlegm, chest pain, chest tightness and fullness, lung abscess, intestinal abscess, mastitis, and constipation. Traditional Chinese medicine commonly uses Trichosanthes kirilowii to treat breast diseases. Modern pharmacological research shows that Trichosanthes kirilowii can promote blood circulation, improve oxygen and nutrient supply to breast tissue, promote lymphatic circulation, help eliminate breast toxins, and improve symptoms of breast diseases.

[0049] St. John's wort is the whole herb of *Hypericum perforatum* L., a plant in the Clusiaceae family. It has a bitter and astringent taste, is neutral in nature, and enters the liver meridian. It has the effects of astringing and stopping bleeding, regulating menstruation and promoting lactation, clearing heat and detoxifying, and promoting diuresis. It is used for hemoptysis, hematemesis, hemorrhage, metrorrhagia, traumatic bleeding, irregular menstruation, insufficient lactation in women, jaundice, sore throat, red and swollen eyes, sores in the mouth and nose, carbuncles and boils, etc.

[0050] Traditional Chinese medicine (TCM) believes that postpartum anxiety is caused by imbalances in the Qi, blood, Yin, and Yang of the five internal organs, deficiency of essence and blood, stagnation of Qi, and malnourishment of the heart and spirit. It may also be due to postpartum liver blood deficiency and impaired circulation, compounded by the common postpartum deficiency and blood stasis, leading to the accumulation of blood stasis and obstruction. This condition is characterized by a combination of deficiency and excess. The underlying deficiency is primarily due to kidney essence deficiency, deficiency of both heart and spleen, and deficiency of heart and gallbladder Qi; the excess is primarily due to liver Qi stagnation, phlegm turbidity, and blood stasis. Treatment should focus on strengthening the spleen, soothing the liver, tonifying the kidneys, replenishing Qi, nourishing the heart, and calming the spirit. This formula uses Acanthopanax senticosus as the main ingredient, which has the effects of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind. When the spleen is healthy, qi and blood are generated sufficiently, which in turn nourishes the heart qi, replenishes blood, and calms the mind. Rose enters the liver and spleen meridians, soothing the liver and relieving depression, harmonizing blood and promoting qi circulation, regulating menstruation and relieving pain. Corydalis promotes qi and blood circulation and relieves pain. The combination of the two promotes qi and blood circulation, removes blood stasis and relieves pain, and is used for postpartum qi stagnation and blood stasis. Ophiopogon japonicus and lotus seed heart nourish heart yin, clear heart heat and calm the mind. Angelica sinensis and mulberry nourish blood, nourish yin and calm the mind. Citrus medica soothes the liver and stomach, dries dampness and resolves phlegm. Trichosanthes kirilowii clears heat and eliminates phlegm, widens the chest and disperses nodules. The two relieve the symptoms of phlegm-fire disturbing the upper body due to liver qi stagnation. St. John's wort is added to astringe and stop bleeding, promote menstruation and lactation. The above herbs work together to strengthen the spleen and kidneys, soothe the liver and relieve depression, nourish blood and calm the mind, and are better suited for postpartum anxiety, restlessness and insomnia in women.

[0051] In some embodiments, the composition comprises, by weight, the following components:

[0052] 20-30 parts Acanthopanax senticosus, 3-6 parts rose, 5-10 parts Corydalis yanhusuo, 6-15 parts Ophiopogon japonicus, 3-8 parts lotus seed heart, 10-15 parts Angelica sinensis, 9-15 parts mulberry, 5-10 parts Citrus medica, 10-15 parts Trichosanthes kirilowii and 9-15 parts St. John's wort.

[0053] As an example, the weight parts of Acanthopanax senticosus in the composition can be, but are not limited to, 20 parts, 21 parts, 22 parts, 23 parts, 24 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, or any two of the above weight parts.

[0054] As an example, the weight parts of roses in the composition can be, but are not limited to, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, or any two of the above weight parts.

[0055] As an example, the weight parts of Corydalis in the composition can be, but are not limited to, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, or any two of the above weight parts.

[0056] As an example, the weight parts of Ophiopogon japonicus in the composition can be, but are not limited to, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 parts or any two of the above weight parts.

[0057] As an example, the weight parts of lotus seed hearts in the composition can be, but are not limited to, 3 parts, 3.5 parts, 4 parts, 4.5 parts, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, or any two of the above weight parts.

[0058] As an example, the weight parts of Angelica sinensis in the composition can be, but are not limited to, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, or any two of the above weight parts.

[0059] As an example, the weight parts of mulberry in the composition can be, but are not limited to, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, or any two of the above weight parts.

[0060] As an example, the weight parts of Buddha's Hand in the composition can be, but are not limited to, 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, or any two of the above weight parts.

[0061] As an example, the weight parts of Trichosanthes kirilowii in the composition can be, but are not limited to, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, or any two of the above weight parts.

[0062] As an example, the weight parts of St. John's wort in the composition can be, but are not limited to, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, 12 parts, 12.5 parts, 13 parts, 13.5 parts, 14 parts, 14.5 parts, 15 parts, or any two of the above weight parts.

[0063] It should be noted that a prescription is an organic whole composed of multiple herbs combined to treat a disease. Its efficacy is not the same as the simple sum of the commonly used dosages of each herb. The dosage of each herb in a prescription cannot usually be determined based on its commonly used dosage. The dosage ratio of herbs is determined by various factors such as the characteristics of the herbs and the compatibility of the principal, assistant, adjuvant, and guide herbs. It cannot be optimized simply by experimental methods such as comparison or orthogonal methods.

[0064] In some embodiments, the composition comprises, by weight, the following components:

[0065] 25-30 parts Acanthopanax senticosus, 4-6 parts rose, 8-10 parts Corydalis yanhusuo, 10-12 parts Ophiopogon japonicus, 3-5 parts lotus seed heart, 10-12 parts Angelica sinensis, 12-15 parts mulberry, 8-10 parts Citrus medica, 10-13 parts Trichosanthes kirilowii and 9-10 parts St. John's wort.

[0066] In some embodiments, the composition comprises, by weight, the following components:

[0067] 27 parts Acanthopanax senticosus, 6 parts rose, 10 parts Corydalis yanhusuo, 10 parts Ophiopogon japonicus, 5 parts lotus seed heart, 12 parts Angelica sinensis, 15 parts mulberry, 10 parts Citrus medica, 10 parts Trichosanthes kirilowii and 10 parts St. John's wort.

[0068] In some embodiments, the composition also includes vitamin B. Vitamin B is a water-soluble vitamin that works synergistically to regulate metabolism, maintain healthy skin and muscles, enhance the function of the immune and nervous systems, and promote cell growth and division (including promoting red blood cell production and preventing anemia).

[0069] In some alternative implementations, vitamin B includes vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, and folic acid.

[0070] Vitamin B1, also known as thiamine or antineuritis factor, participates in the formation of coenzymes in the body, maintaining normal carbohydrate metabolism and the functions of the nervous and digestive systems. Insufficient intake can cause vitamin B1 deficiency diseases, such as beriberi, neuritis, and indigestion.

[0071] Vitamin B2, also known as riboflavin, is a component of the cofactor of flavonoid enzymes in the body. It primarily participates in biological oxidation and energy metabolism, as well as cell growth and metabolism. It promotes growth and development, maintains the integrity of skin and cell membranes, and is an essential nutrient for tissue metabolism and repair, such as strengthening liver function and regulating adrenaline secretion. Furthermore, vitamin B2 participates in the metabolism of vitamin B6 and niacin, serving as a prime example of the synergistic effect of B vitamins.

[0072] Vitamin B6, also known as pyridoxine, includes pyridoxine, pyridoxal, and pyridoxamine. It is a component of certain coenzymes in the human body and participates in a variety of metabolic reactions, especially amino acid metabolism. Its functions include helping to synthesize antibodies, produce gastric acid, utilize fats and proteins, and excrete nitrogenous waste from the body.

[0073] Vitamin B12, also known as cobalamin or cyanocobalamin, is the only vitamin containing metal ions. Its functions include: (1) promoting the development and maturation of red blood cells, keeping the body's hematopoietic function in a normal state, and preventing pernicious anemia; maintaining the health of the nervous system; (2) improving folic acid utilization and promoting the metabolism of carbohydrates, fats and proteins; (3) maintaining the metabolism and function of the myelin sheath of nerves, and is an indispensable vitamin for the healthy functioning of the nervous system; it helps to eliminate irritability, improve concentration, enhance memory and balance; when vitamin B12 is deficient, it can cause neurological disorders, spinal cord degeneration, and severe mental symptoms.

[0074] Niacin, also known as vitamin B3, nicotinic acid, or vitamin PP, is converted into nicotinamide in the human body. It is an important component of coenzyme 1 and coenzyme 2 and is used to treat migraines, headaches, cerebral artery thrombosis, pulmonary embolism, etc. When the body is deficient in niacin, it will affect lipid synthesis and metabolism.

[0075] Pantothenic acid, also known as vitamin B5, is generally recognized as being closely related to the nutritional status of hair and skin. It helps the body fight infectious diseases, alleviates the side effects and toxicity of many antibiotics, and reduces allergy symptoms. Pantothenic acid deficiency can easily cause blood and skin abnormalities, and lead to hypoglycemia.

[0076] Folic acid, also known as pteroylglutamic acid, is composed of pteridine, para-aminobenzoic acid, and L-glutamic acid. It is essential for the body's utilization of sugars and amino acids and is necessary for cell growth and reproduction. In the body, folic acid functions as tetrahydrofolate. Pregnant and lactating women require several times more folic acid than normal individuals. Folic acid deficiency can cause significant harm to both mother and child, such as recurrent miscarriage, premature birth, low birth weight, fetal indigestion, and growth retardation. It is also associated with senile dementia, depression, and neonatal neurological disorders.

[0077] In some embodiments, the composition further comprises, by weight, 0.002-0.003 parts of vitamin B1, 0.002-0.004 parts of vitamin B2, 0.001-0.002 parts of vitamin B6, 0.000002-0.000003 parts of vitamin B12, 0.02-0.025 parts of niacin, 0.006-0.007 parts of pantothenic acid, and 0.0004-0.0005 parts of folic acid.

[0078] As an example, the weight parts of vitamin B1 in the composition may be, but are not limited to, 0.002 parts, 0.0021 parts, 0.0022 parts, 0.0023 parts, 0.0024 parts, 0.0025 parts, 0.0026 parts, 0.0027 parts, 0.0028 parts, 0.0029 parts, 0.003 parts, or any two of the above weight parts.

[0079] As an example, the weight parts of vitamin B2 in the composition may be, but are not limited to, 0.002 parts, 0.0022 parts, 0.0024 parts, 0.0026 parts, 0.0028 parts, 0.003 parts, 0.0032 parts, 0.0034 parts, 0.0036 parts, 0.0038 parts, 0.004 parts, or any two of the above weight parts.

[0080] As an example, the weight parts of vitamin B6 in the composition may be, but are not limited to, 0.001 parts, 0.0011 parts, 0.0012 parts, 0.0013 parts, 0.0014 parts, 0.0015 parts, 0.0016 parts, 0.0017 parts, 0.0018 parts, 0.0019 parts, 0.002 parts, or any two of the above weight parts.

[0081] As an example, the weight parts of vitamin B12 in the composition may be, but are not limited to, 0.000002 parts, 0.0000025 parts, 0.000003 parts, or any two of the above weight parts.

[0082] As an example, the weight parts of nicotinic acid in the composition may be, but are not limited to, 0.02 parts, 0.021 parts, 0.022 parts, 0.023 parts, 0.024 parts, 0.025 parts, or any two of the above weight parts.

[0083] As an example, the weight parts of pantothenic acid in the composition may be, but are not limited to, 0.006 parts, 0.0061 parts, 0.0062 parts, 0.0063 parts, 0.0064 parts, 0.0065 parts, 0.0066 parts, 0.0067 parts, 0.0068 parts, 0.0069 parts, 0.007 parts, or any range between any two of the above weight parts.

[0084] As an example, the weight parts of folic acid in the composition may be, but are not limited to, 0.0004 parts, 0.00042 parts, 0.00044 parts, 0.00046 parts, 0.00048 parts, 0.0005 parts, or any two of the above weight parts.

[0085] In some exemplary embodiments, vitamin B includes, by weight, 0.002 parts of vitamin B1, 0.003 parts of vitamin B2, 0.002 parts of vitamin B6, 0.000003 parts of vitamin B12, 0.022 parts of niacin, 0.007 parts of pantothenic acid and 0.0004 parts of folic acid.

[0086] In some embodiments, the composition further includes calcium lactate. Calcium lactate is a chemically synthesized organic calcium that promotes bone and teeth calcification, maintains normal nerve and muscle excitability, and reduces capillary permeability. It can be used for the prevention and treatment of calcium deficiency, such as osteoporosis, tetany, osteomalacia, rickets, and for calcium supplementation in children, pregnant and lactating women, postmenopausal women, and the elderly.

[0087] In some optional embodiments, the composition further comprises 1.2 to 1.3 parts by weight of calcium lactate. For example, the weight parts of calcium lactate in the composition can be, but are not limited to, 1.2 parts, 1.21 parts, 1.22 parts, 1.23 parts, 1.24 parts, 1.25 parts, 1.26 parts, 1.27 parts, 1.28 parts, 1.29 parts, 1.3 parts, or any two of the above weight parts. Optionally, the composition further comprises 1.2 parts by weight of calcium lactate.

[0088] Understandably, women are physically weak after childbirth, especially breastfeeding mothers who lose a significant amount of nutrients daily. Supplementing with vitamin B and calcium lactate can promote red blood cell growth, enhance the body's hematopoietic capacity, boost metabolism, aid digestion, relieve fatigue, reduce anxiety, promote milk production, and promote wound healing, thus helping the mother recover. Simultaneously, vitamin B and calcium lactate help maintain normal nerve function, uphold normal neurophysiological indicators, improve metabolism, and effectively prevent and alleviate postpartum symptoms such as restlessness and anxiety.

[0089] The composition for treating postpartum anxiety provided in this application is selected and formulated based on the principles of traditional Chinese medicine (TCM) diagnosis and treatment, resulting in a synergistic effect among the various medicinal ingredients. It possesses the functions of soothing the liver and spleen, replenishing qi, nourishing blood, calming the mind, and soothing the nerves. It can regulate qi and blood, improve the mother's immunity, alleviate postpartum discomfort symptoms, and promote postpartum recovery. Addressing the limitations of medication use for postpartum women, this composition combines medicinal and edible TCM ingredients with nutritional components, providing both health maintenance and treatment, facilitating postpartum physical and mental recovery, and alleviating anxiety symptoms. Furthermore, the raw materials in this composition are widely available, safe, non-toxic, and non-addictive, making it suitable for long-term use by postpartum women.

[0090] The second aspect of this application provides a method for preparing the composition of the first aspect of this application for treating postpartum anxiety, comprising the following steps: mixing Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii and St. John's wort, adding water and decocting to prepare concentrated solution A; extracting Angelica sinensis and Citrus medica to prepare concentrated solution B; combining concentrated solution A and concentrated solution B and then drying and pulverizing to prepare the composition.

[0091] In some embodiments, concentrate A and concentrate B are combined, dried and pulverized, vitamin B and calcium lactate are added, and mixed to prepare a composition.

[0092] In some embodiments, Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii and St. John's wort are mixed, decocted twice with 8 to 10 times the amount of water, each time for 1 to 2 hours, filtered, and the filtrates are combined to prepare concentrated solution A.

[0093] In some embodiments, Angelica sinensis and Citrus medica are added to 8 times the amount of 80% ethanol, heated and refluxed twice, each time for 1 hour, filtered, and the ethanol extracts are combined. The filtrate is concentrated under reduced pressure to prepare concentrate B.

[0094] It should be noted that the "multiple amount" mentioned above refers to the volume-to-mass ratio; for example, adding 8 to 10 times the amount of water means that the volume of water is 8 mL / g to 10 mL / g of the medicinal materials.

[0095] In some embodiments, the preparation method of the composition includes the following steps: A mixture of Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii, and St. John's wort is added and decocted twice with 8-10 times the amount of water, each time for 1-2 hours. The mixture is filtered, and the filtrates are combined to prepare concentrated solution A. Angelica sinensis and Citrus medica are added with 8 times the amount of 80% ethanol and extracted twice by reflux, each time for 1 hour. The extracts are filtered, and the ethanol extracts are combined. The filtrates are concentrated under reduced pressure to prepare concentrated solution B. Concentrated solutions A and B are combined, dried, and pulverized. Vitamin B and calcium lactate are added and mixed to prepare the composition.

[0096] A third aspect of this application provides a medicament for treating postpartum anxiety, comprising the composition for treating postpartum anxiety of the first aspect of this application or prepared using the composition for treating postpartum anxiety of the first aspect of this application.

[0097] In some exemplary embodiments, the dosage form of the drug includes one of tablets, capsules, powders, granules, ointments, solutions, suspensions, and syrups.

[0098] As an example, tablets can be regular tablets, chewable tablets, etc., without specific limitations. Capsules can be soft capsules, hard capsules, etc., without specific limitations.

[0099] In some embodiments, the drug also includes pharmaceutically acceptable excipients.

[0100] For example, when a drug is an oral formulation, the excipients added can be selected from one or more combinations of fillers, wetting agents, binders, disintegrants, lubricants, flavoring agents, encapsulants, coating agents, etc. Fillers can include one or more of various starches, various dextrins, D-mannitol, maltose, xylitol, sorbitol, microcrystalline cellulose, isomaltulose, milk powder, low-substituted hydroxypropyl cellulose, pregelatinized starch, etc. Wetting agents can include one or more of purified water and ethanol. Binders can include one or more of sodium carboxymethyl cellulose, povidone K30, hydroxypropyl cellulose, starch paste, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, gelatinized starch, etc. Disintegrants can include one or more of dry starch, crospovidone, crospovidone carboxymethyl cellulose sodium, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, etc. Lubricants can include one or more of magnesium stearate, talc, sodium lauryl sulfate, micronized silica gel, etc. Flavoring agents can include one or more of edible flavorings, sweeteners, fruit powders, etc. The embedding material may include one or more of dextrin, starch, gum arabic, etc. The coating agent may include one or more of polyethylene glycol, titanium dioxide, silica, magnesium stearate, glycerol, castor oil, etc. The technical solution of the present invention will be described in detail below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. For experimental methods in the following embodiments where specific conditions are not specified, priority should be given to the guidelines given in this invention, or experimental manuals or conventional conditions in the art may be followed, or the conditions recommended by the manufacturer may be followed, or experimental methods known in the art may be referenced.

[0101] In the specific embodiments described below, the measurement parameters involving raw material components may have slight deviations within the weighing accuracy range unless otherwise specified. For temperature and time parameters, acceptable deviations due to instrument testing accuracy or operational precision are permissible.

[0102] I. Preparation of a composition for treating postpartum anxiety

[0103] Example 1

[0104] 1. Prescription composition: Acanthopanax senticosus 30 g, rose 6 g, Corydalis yanhusuo 5 g, Ophiopogon japonicus 15 g, lotus seed heart 3 g, Angelica sinensis 10 g, mulberry 13 g, citron 5 g, Trichosanthes kirilowii 13 g, St. John's wort 15 g, vitamin B1 2 mg, vitamin B2 2 g, vitamin B6 1 mg, vitamin B12 2 μg, niacin 25 mg, pantothenic acid 6 mg, folic acid 0.5 mg, calcium lactate 1300 mg.

[0105] 2. Preparation process: Mix Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii, and St. John's wort evenly, add 10 times the amount of water and decoct for 1.5 hours, filter, add 8 times the amount of water to the dregs and decoct for 1 hour, filter, combine the filtrates and concentrate to obtain concentrated solution A; add 8 times the amount of 80% ethanol to Angelica sinensis and Citrus medica, heat and reflux twice, extract for 1 hour each time, filter, combine the ethanol extracts, and concentrate the filtrates under reduced pressure to obtain concentrated solution B; mix concentrated solution A and concentrated solution B, dry, pulverize into fine powder, add vitamin B and calcium lactate, mix, and obtain the final product.

[0106] Example 2

[0107] 1. Prescription composition: Acanthopanax senticosus 20 g, rose 4 g, Corydalis yanhusuo 10 g, Ophiopogon japonicus 6 g, lotus seed heart 8 g, Angelica sinensis 15 g, mulberry 12 g, Citrus medica 10 g, Trichosanthes kirilowii 15 g, St. John's wort 15 g, vitamin B1 3 mg, vitamin B2 4 mg, vitamin B6 2 mg, vitamin B12 2 μg, niacin 20 mg, pantothenic acid 7 mg, folic acid 0.5 mg, calcium lactate 1300 mg.

[0108] 2. The preparation process is the same as in Example 1.

[0109] Example 3

[0110] 1. Prescription composition: Acanthopanax senticosus 30 g, rose 3 g, Corydalis yanhusuo 10 g, Ophiopogon japonicus 12 g, lotus seed heart 5 g, Angelica sinensis 12 g, mulberry 9 g, Citrus medica 10 g, Trichosanthes kirilowii 15 g, St. John's wort 9 g, vitamin B1 2 mg, vitamin B2 2 mg, vitamin B6 1 mg, vitamin B12 3 μg, niacin 25 mg, pantothenic acid 6 mg, folic acid 0.4 mg, calcium lactate 1200 mg.

[0111] 2. The preparation process is the same as in Example 1.

[0112] Example 4

[0113] 1. Prescription composition: Acanthopanax senticosus 27 g, rose 6 g, Corydalis yanhusuo 10 g, Ophiopogon japonicus 10 g, lotus seed heart 5 g, Angelica sinensis 12 g, mulberry 15 g, Citrus medica 10 g, Trichosanthes kirilowii 10 g, St. John's wort 10 g, vitamin B1 2 mg, vitamin B2 3 mg, vitamin B6 2 mg, vitamin B12 3 μg, niacin 22 mg, pantothenic acid 7 mg, folic acid 0.4 mg, calcium lactate 1200 mg.

[0114] 2. The preparation process is the same as in Example 1.

[0115] Comparative Example 1

[0116] 1. The difference between the formulation of Comparative Example 1 and Example 4 is that vitamin B and calcium lactate were not added to the composition; instead, dextrin of the same mass as vitamin B and calcium lactate was used as a substitute. Specifically, the composition is: Acanthopanax senticosus 27 g, rose 6 g, Corydalis yanhusuo 10 g, Ophiopogon japonicus 10 g, lotus seed heart 5 g, Angelica sinensis 12 g, mulberry 15 g, Citrus medica 10 g, Trichosanthes kirilowii 10 g, St. John's wort 10 g, and dextrin 1236.4 mg.

[0117] 2. Preparation process: Mix Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii, and St. John's wort evenly, add 10 times the amount of water and decoct for 1.5 hours, filter, add 8 times the amount of water to the dregs and decoct for 1 hour, filter, combine the filtrates and concentrate to obtain concentrated solution A; add 8 times the amount of 80% ethanol to Angelica sinensis and Citrus medica and heat under reflux to extract twice, each time for 1 hour, filter, combine the ethanol extracts, and concentrate the filtrates under reduced pressure to obtain concentrated solution B; mix concentrated solution A and concentrated solution B, dry, pulverize into fine powder, add dextrin of the same weight as vitamin B and calcium lactate in Example 4, mix, and obtain the final product.

[0118] Comparative Example 2

[0119] 1. The difference between the formulation of Comparative Example 2 and Example 4 is that Comparative Example 2 does not contain any traditional Chinese medicine components, and dextrin is used as a substitute; specifically: vitamin B1 2 mg, vitamin B2 3 mg, vitamin B6 2 mg, vitamin B12 3 μg, niacin 22 mg, pantothenic acid 7 mg, folic acid 0.4 mg, calcium lactate 1200 mg, and dextrin in equal weight to the fine powder of traditional Chinese medicine extract in the composition of Example 4.

[0120] 2. Preparation process: Mix vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, and calcium lactate, and add dextrin of the same weight as the fine powder of the traditional Chinese medicine extract in the composition of Example 4. Mix to obtain the final product.

[0121] Comparative Example 3

[0122] 1. The difference between the formulation of Comparative Example 3 and Example 4 is that vitamin B was not added, and the same mass of dextrin was used to replace vitamin B. Specifically:

[0123] Acanthopanax senticosus 27 g, rose 6 g, corydalis 10 g, ophiopogon japonicus 10 g, lotus seed heart 5 g, angelica sinensis 12 g, mulberry 15 g, citron 10 g, trichosanthes kirilowii 10 g, forsythia suspensa 10 g, calcium lactate 1200 mg, dextrin 36.4 mg.

[0124] 2. Preparation process: Mix Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii, and St. John's wort evenly, add 10 times the amount of water and decoct for 1.5 hours, filter, add 8 times the amount of water to the dregs and decoct for 1 hour, filter, combine the filtrates and concentrate to obtain concentrated solution A; add 8 times the amount of 80% ethanol to Angelica sinensis and Citrus medica and heat under reflux to extract twice, each time for 1 hour, filter, combine the ethanol extracts, and concentrate the filtrates under reduced pressure to obtain concentrated solution B; mix concentrated solution A and concentrated solution B, dry, pulverize into fine powder, add calcium lactate, add dextrin of the same weight as vitamin B in Example 4, mix, and obtain the final product.

[0125] II. Efficacy Test

[0126] 1. Elevated cross-maze test

[0127] The elevated cross maze test is a classic experimental model for evaluating anxiety responses in rodents. Rodents have a natural tendency to explore new environments, but they also dislike bright light and open spaces. The elevated cross maze utilizes the paradoxical conflict between the rodents' exploratory behavior towards novel environments and their fear of suspended open arms to simulate clinical anxiety disorders. In the experiment, the animal's selective preference for the suspended open arms is negatively correlated with its anxiety level; that is, increased time spent in the open arms and increased frequency of entry suggest a reduction in the severity of the "anxiety disorder." If administration of anti-anxiety medication leads to increased time spent in the open arms and increased frequency of entry, it suggests that the medication has an anti-anxiety effect.

[0128] (1) Experimental setup

[0129] The elevated cross maze consists of two opposing open arms (50cm x 10cm) and two opposing closed arms (50cm x 10cm x 40cm), with the upper parts of the closed arms open. There is a 10cm x 10cm open area in the center of the maze, which is 50cm above the ground. Video surveillance cameras are installed above the maze to record the animals' activities within it.

[0130] (2) Experimental methods

[0131] One week prior to the experiment, rats were weighed daily and petted for 1-5 minutes for 7 consecutive days to reduce their fear of the experimenters. Considering factors such as birth time, offspring number, and postpartum weight, adult SPF-grade postpartum SD rats (weighing 160g-200g) were randomly divided into 9 groups: a normal group (equal amount of dextrin), a positive control group (diazepam group), experimental groups (Examples 1-4), and control groups (Comparative Examples 1-3), with 10 rats in each group. They were acclimatized for 2 days. Two days later, the drug was dissolved in water and administered via gavage for 15 days, with daily weight checks. The normal group received an equal amount of dextrin via gavage, the positive control group received 2 mg / kg / day, and the drug group and control group received a combined dose of 484 mg / kg / day. During the gavage administration period, rats were fed standard feed with free access to water and food.

[0132] Thirty minutes after the last administration, hold the rats with their backs to the experimenter and place them in the central area of ​​the junction of the open and closed arms, with the rats' heads facing the open arm. Ensure that each rat is placed in the same position thereafter. Simultaneously, record the number of times the mice enter the open arm (OE) and the closed arm (CE) within 5 minutes, as well as the time spent in each arm (the criteria for entering and exiting the arms should be strictly defined, with all four limbs entering the arm or both forepaws exiting the arm as the standard). Calculate the percentage of each group's mice entering the open arm and the time spent in the open arm relative to the total number of times they entered the two arms and the total time spent in the two arms (OE% and OT%), respectively. This is used as an indicator of anxiety (the experiment was conducted daily from 09:00 to 15:00). During the experiment, the experimenter must maintain a distance of 1 meter from the maze. After recording, return the experimental animals to their cages. Clean the maze and wipe it with a 5% acetic acid solution or 75% alcohol to eliminate the influence of animal odor on subsequent experimental animals.

[0133] 2. Bright and dark chamber test

[0134] The light-dark box experiment utilizes the paradoxical conflict between rodents' desire to explore novel environments and their aversion to bright light. Anxious animals enter the box less frequently and spend less time in the bright light. The light-dark box experiment is a classic model of anxiety in animals and is widely used to assess anxiety levels in rodents.

[0135] The light-dark chamber (45cm*27cm*27cm) had two sections, one light and one dark, each occupying half the space. Both chambers were covered, and a 7.5cm*7.5cm doorway separated them for animals to pass through. The light-dark chamber had white walls and was illuminated by white light from above; the dark chamber had black walls and was illuminated by red light from above. At the start of the experiment, each animal was placed facing the wall in the center of the light area. A camera system recorded the rat's time spent in the light area and the number of times it entered the area over 5 minutes. Each time an animal's four paws entered a compartment was counted as one entry. Animal grouping and administration of medication via gavage were performed using the same method as in the elevated cruciate maze experiment.

[0136] 3. Results of efficacy tests

[0137] (1) The results of the elevated cross maze test are shown in Table 1.

[0138] Table 1. Results of the elevated cruciate maze test in rats

[0139]

[0140] Note: * p < 0.05 compared with the positive control group.

[0141] (2) The results of the light and dark chamber test are shown in Table 2.

[0142] Table 2. Results of the light-dark chamber test in rats

[0143]

[0144] Note: * p < 0.05 compared with the positive control group.

[0145] The results in Tables 1 and 2 show that the composition provided in this application for treating postpartum anxiety has a better anxiolytic effect than diazepam in postpartum rats.

[0146] III. Preparation of Granules for Treating Postpartum Anxiety

[0147] Example 5

[0148] 1. Prescription composition: Acanthopanax senticosus 27 g, rose 6 g, Corydalis yanhusuo 10 g, Ophiopogon japonicus 10 g, lotus seed heart 5 g, Angelica sinensis 12 g, mulberry 15 g, Citrus medica 10 g, Trichosanthes kirilowii 10 g, St. John's wort 10 g, vitamin B1 2 mg, vitamin B2 3 mg, vitamin B6 2 mg, vitamin B12 3 μg, niacin 22 mg, pantothenic acid 7 mg, folic acid 0.4 mg, calcium lactate 1200 mg.

[0149] 2. Preparation process: Mix Acanthopanax senticosus, rose, Corydalis yanhusuo, Ophiopogon japonicus, lotus seed heart, mulberry, Trichosanthes kirilowii, and St. John's wort evenly, add 10 times the amount of water and decoct for 1 hour, filter, add 8 times the amount of water to the dregs and decoct for 1 hour, filter, combine the filtrates, and concentrate to obtain concentrate A; add 8 times the amount of 80% ethanol to Angelica sinensis and Citrus medica, heat under reflux twice, extract for 1 hour each time, filter, combine the ethanol extracts, and concentrate the filtrate under reduced pressure to obtain concentrate B; mix concentrate A and concentrate B, dry, pulverize into a fine powder, add vitamin B and calcium lactate, mix, then add 10g of dextrin and 15mg of stevioside to make granules, thus obtaining the final product.

[0150] Comparative Example 4

[0151] Medication: Jiuwei Zhenxin Granules.

[0152] Jiuwei Zhenxin Granules are a marketed traditional Chinese medicine with the effects of nourishing the heart and spleen, replenishing qi and calming the mind. It is used for generalized anxiety disorder with deficiency of both heart and spleen, characterized by symptoms such as excessive thinking and worry, insomnia or dreaminess, palpitations, loss of appetite, fatigue, dizziness, excessive sweating, frequent sighing, sallow complexion, pale tongue with thin white coating, and wiry or deep and thready pulse.

[0153] Prescription: Ginseng (without the root), Ziziphus jujuba seed, Schisandra chinensis, Poria cocos, Polygala tenuifolia, Corydalis yanhusuo, Asparagus cochinchinensis, Rehmannia glutinosa, Cinnamomum cassia.

[0154] IV. Clinical Trials

[0155] 1. Patient's condition

[0156] Seventy patients (aged 21-45 years) with postpartum anxiety disorder were selected from February 2020 to May 2022. All participants met the diagnostic criteria for generalized anxiety disorder according to the Chinese Classification and Diagnostic Criteria for Mental Disorders, Third Edition (CCMD-3) and the diagnostic criteria for anxiety disorder according to the Traditional Chinese Medicine (TCM) guidelines for the diagnosis and treatment of common internal medicine diseases (ZYYXH / T132—2008) issued by the China Association of Traditional Chinese Medicine. Their Hamilton Anxiety Rating Scale (HAMA) scores were ≥14 and <29, and their Self-Rating Anxiety Scale scores were ≥50 and <70. Patients with severe physical diseases such as heart, liver, and kidney, or organic brain diseases were excluded; patients with severe mental illness symptoms such as bipolar disorder or schizophrenia were excluded, and all patients had no severe suicidal tendencies. Patients who had taken antidepressants, antipsychotics, sedatives, clonidine, or other medications that affect mood within the past month were also excluded. All participants signed informed consent forms, and participation in the trial was voluntary.

[0157] Dropout: Subjects who experience allergic reactions, adverse events, worsening of their condition, contracting other diseases, or poor compliance during the trial; those who withdraw voluntarily for any reason; those who use medication or other treatments on their own during the trial and do not cooperate with the treatment; and those whose patient information is incomplete and may affect the assessment of the efficacy and safety of the medication.

[0158] Experimental groups: Example group (35 cases), Comparative group (Jieyu Anshen Granules) (35 cases)

[0159] Experimental Methods: Treatment was based on the traditional Chinese medicine preparations (Comparative Example 4) and the granules (Example 5). One dose was taken daily, dissolved in water half an hour after breakfast, lunch, and dinner. One course of treatment lasted 7 days, with a total of 6 courses. Patients were instructed to avoid raw, cold, spicy, and pungent foods during treatment and to prevent colds. Due to differences in patient constitution and condition, symptom improvement varied; dosage was adjusted as needed during treatment.

[0160] 2. Efficacy evaluation criteria

[0161] (1) Observation indicators

[0162] The reduction rates of HAMA scale scores (as shown in Table 3), TCM syndrome scale scores (as shown in Table 4), and the Self-Rating Anxiety Scale (SAS, developed by William W.K. Zung in 1971, as shown in Table 5) were used as observation indicators, and were assessed once before and once after treatment.

[0163] HAMA Anxiety Scale scoring criteria: a score of less than 7 indicates no anxiety; a score of 7-14 indicates possible anxiety; a score of 14-21 indicates mild anxiety; a score of 21-29 indicates moderate anxiety; and a score of more than 29 indicates severe anxiety.

[0164] Traditional Chinese Medicine Syndrome Scoring Scale: Based on the "Common Internal Medicine Syndromes in Traditional Chinese Medicine" published by the China Association of Traditional Chinese Medicine in 2008.

[0165] The "Guidelines for the Diagnosis and Treatment of Diseases" have established a TCM syndrome scale with a total score of 42 points. The higher the score, the more severe the condition.

[0166] Table 3. Hamilton Anxiety Rating Scale (HAMA)

[0167]

[0168] Table 4. Traditional Chinese Medicine Syndrome Scoring Scale

[0169]

[0170] Table 5. Self-Rating Anxiety Scale (SAS)

[0171]

[0172] It should be noted that when taking the anxiety self-assessment, positively scored questions are scored as 1, 2, 3, 4 points, and negatively scored questions are scored as 4, 3, 2, 1 points. Add up the scores of all 20 questions to get the total raw score. The standard score is equal to the integer part of the total raw score multiplied by 1.25. A lower score is better. A standard score below 50 is considered normal, 50-59 indicates mild anxiety, 60-69 indicates moderate anxiety, and 70 and above indicates severe anxiety.

[0173] (2) Efficacy evaluation criteria

[0174] The HAMA scale score and the reduction rate of the TCM syndrome scale score were used as the criteria for evaluating the efficacy.

[0175] HAMA score reduction rate: Efficacy index = {(Pre-treatment score - Post-treatment score) ÷ Pre-treatment score} × 100%, and the efficacy index is graded as follows:

[0176] Cured: Score reduction rate ≥ 75%

[0177] Effective: Score reduction rate ≥ 50% but < 75%

[0178] Valid: Deduction rate ≥30% but <50%

[0179] Invalid: Deduction rate < 30%

[0180] Total effective dose = cure + significant effect + effective dose.

[0181] The reduction rate of TCM syndrome scores is calculated using the same method as the reduction rate of HAMA scores. The efficacy index is graded as follows:

[0182] Cure: The main clinical symptoms and signs disappear, and the score reduction rate before and after treatment is ≥95%.

[0183] Significant effect: The main clinical symptoms and signs disappear, and the score reduction rate before and after treatment is ≥70% but <95%.

[0184] Effective: Improvement in main clinical symptoms and signs; reduction in treatment score ≥30% but <70%.

[0185] Ineffective: No improvement or worsening of main clinical symptoms and signs, with a score reduction rate of <30% before and after treatment.

[0186] Total effective dose = cure + significant effect + effective dose.

[0187] Safety monitoring: Routine items: body temperature, pulse, respiration, blood pressure; routine blood and urine tests, liver and kidney function tests, etc.

[0188] 3. Test Results

[0189] SPSS 23.0 statistical analysis software was used for data processing and analysis. Quantitative data are expressed as mean ± standard deviation (X±s), and comparisons between groups for categorical data are performed using the chi-square test (X). 2 Tests were performed. Independent samples t-tests were used for comparisons between two groups, paired t-tests were used for comparisons before and after treatment within a group, and rank-sum tests were used for comparisons of ordinal data. A p-value < 0.05 was considered statistically significant.

[0190] In the experiment, 2 cases dropped out in the comparative example group 4 and 1 case dropped out in the example group 5. There were 67 actual cases in the experiment, including 33 cases in the comparative example group and 34 cases in the example group.

[0191] The disease distribution of the two groups of patients before treatment is shown in Table 6:

[0192] Table 6. Distribution of Disease Severity Based on HAMA Score

[0193]

[0194] Note: Mild: 14 ≤ score < 21 points; Moderate: 21 ≤ score < 29 points; Severe: score ≥ 29 points.

[0195] The rank-sum test showed that there was no significant difference in the disease distribution of the two groups of selected cases, and the two groups were comparable.

[0196] Table 7 shows a comparison of HAMA scores, TCM syndrome scores, and SAS scores before and after treatment in the two groups:

[0197] Table 7. Comparison of HAMD scores before and after treatment in the two groups

[0198]

[0199] The comparison of efficacy between the two groups based on HAMA scores and TCM syndrome scores is shown in Table 8:

[0200] Table 8. Comparison of therapeutic effects between the two groups

[0201]

[0202] As shown in Tables 6-8, before the experiment, the HAMA scores, TCM syndrome scores, and SAS scores of both groups showed no statistically significant differences (P > 0.05) according to independent samples t-tests. Comparing the HAMA scores, TCM syndrome scores, and SAS scores before and after treatment in both Comparative Example 4 and Example 5, the t-test showed P ≤ 0.01, indicating that both groups could reduce the scores of patients with generalized anxiety disorder. After treatment, comparing the HAMA scores, TCM syndrome scores, and SAS scores of Comparative Example 4 and Example 5, the t-test showed P ≤ 0.01, indicating that Example 5 significantly reduced the HAMA scores, TCM syndrome scores, and SAS scores of patients with postpartum anxiety disorder more effectively than Comparative Example 4.

[0203] Comparison of efficacy between the two groups: The efficacy was assessed based on the HAMA score and TCM syndrome score after treatment in both groups, and the total clinical effective rate was calculated. The total effective rates of HAMA score and TCM syndrome score between the two groups were compared using the rank-sum test, and P < 0.05. There was a statistically significant difference in the total effective rates of HAMA score and TCM syndrome score between the control group (Group 4) and the example group (Group 5), indicating that the efficacy of the example group was superior to that of the control group (Group 4).

[0204] Adverse reaction observation: No adverse reactions were found in either group of cases during the trial. No gastrointestinal symptoms such as nausea, vomiting, or diarrhea occurred, and no cases of symptom exacerbation were observed.

[0205] In summary, the composition provided in this application for treating postpartum anxiety is beneficial for postpartum physical and mental recovery, relieves anxiety symptoms, and can effectively treat or prevent postpartum anxiety.

[0206] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0207] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A composition for treating postpartum anxiety, characterized in that, The composition is made of the following components in parts by weight: 20-30 parts Acanthopanax senticosus, 3-6 parts rose, 5-10 parts Corydalis yanhusuo, 6-15 parts Ophiopogon japonicus, 3-8 parts lotus seed heart, 10-15 parts Angelica sinensis, 9-15 parts mulberry, 5-10 parts Citrus medica, 10-15 parts Trichosanthes kirilowii, 9-15 parts St. John's wort, 0.002-0.003 parts vitamin B1, 0.0 0.02-0.004 parts of vitamin B2, 0.001-0.002 parts of vitamin B6, 0.000002-0.000003 parts of vitamin B12, 0.02-0.025 parts of niacin, 0.006-0.007 parts of pantothenic acid, 0.0004-0.0005 parts of folic acid, and 1.2-1.3 parts of calcium lactate.

2. The composition for treating postpartum anxiety as described in claim 1, characterized in that, The composition is made of the following components in parts by weight: 25-30 parts of the Acanthopanax senticosus, 4-6 parts of the rose, 8-10 parts of the Corydalis yanhusuo, 10-12 parts of the Ophiopogon japonicus, 3-5 parts of the lotus seed heart, 10-12 parts of the Angelica sinensis, 12-15 parts of the mulberry, 8-10 parts of the Citrus medica var. sarcodactylis, 10-13 parts of the Trichosanthes kirilowii, 9-10 parts of the St. John's wort, and 0.002-0.003 parts of the vitamin B.

1. 0.002-0.004 parts of the vitamin B2, 0.001-0.002 parts of the vitamin B6, 0.000002-0.000003 parts of the vitamin B12, 0.02-0.025 parts of the niacin, 0.006-0.007 parts of the pantothenic acid, 0.0004-0.0005 parts of the folic acid, and 1.2-1.3 parts of the calcium lactate.

3. A method for preparing a composition for treating postpartum anxiety as described in any one of claims 1 to 2, characterized in that, Includes the following steps: The Acanthopanax senticosus, the rose, the Corydalis yanhusuo, the Ophiopogon japonicus, the lotus seed heart, the mulberry, the Trichosanthes kirilowii, and the St. John's wort are mixed, decocted with water, and concentrated solution A is prepared. The Angelica sinensis and Citrus medica were reflux-extracted using 80% ethanol to prepare concentrated solution B; The concentrated solution A and the concentrated solution B are combined, dried and pulverized, and then vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid and calcium lactate are added to prepare the composition.

4. The method for preparing the composition for treating postpartum anxiety as described in claim 3, characterized in that, The Angelica sinensis and Citrus medica were subjected to reflux extraction using 8 times the volume of 80% ethanol.

5. The method for preparing the composition for treating postpartum anxiety as described in claim 3 or 4, characterized in that, By volume-mass ratio, the Acanthopanax senticosus, the rose, the Corydalis yanhusuo, the Ophiopogon japonicus, the lotus seed heart, the mulberry, the Trichosanthes kirilowii, and the St. John's wort are mixed, decocted twice with 8 to 10 times the amount of water, each time for 1 to 2 hours, filtered, and the filtrates are combined to prepare concentrated solution A.

6. A medication for treating postpartum anxiety, characterized in that, It is prepared using the composition for treating postpartum anxiety as described in any one of claims 1 to 2 and pharmaceutically acceptable excipients.

7. The medicament for treating postpartum anxiety as described in claim 6, characterized in that, The pharmaceutically acceptable excipients are selected from one or more combinations of fillers, wetting agents, binders, disintegrants, lubricants and flavoring agents.

8. The drug as described in claim 6, characterized in that, The dosage form of the drug includes one of the following: tablets, capsules, powders, granules, ointments, solutions, suspensions, and syrups.

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