A traditional Chinese medicine composition for treating subinvolution of uterus

Abstract

The present invention provides a traditional Chinese medicine composition for treating incomplete involution of the uterus. In its formula or raw materials, Codonopsis pilosula and Typha angustifolia are used as monarch drugs, Astragalus membranaceus and Sepia seu cuttlefish bone are used as ministerial drugs, and optionally, at least several adjuvant drugs and guiding drugs are further included. In a specific embodiment, it includes one or more of Verbena officinalis, Rubia cordifolia, Pyrola calliantha, Dipsacus asperoides, Lindera aggregata, Panax notoginseng, Leonurus japonicus, Rehmannia glutinosa, Angelica sinensis, Chinese date and Glycyrrhiza uralensis. The traditional Chinese medicine composition of the present invention is used to treat incomplete involution of the postpartum uterus with symptoms such as irregular vaginal bleeding, abdominal pain and lochia retention, and has a good therapeutic effect. It can also treat incomplete involution of the postpartum uterus with other symptom manifestations.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for treating incomplete uterine involution and belonging to qi deficiency and blood stasis syndrome and a preparation method thereof. Background Art

[0002] Among the Chinese patent medicines for the treatment of postpartum symptoms included in the current national drug standards are Chanfukang Granules, which are used to treat postpartum hemorrhage with the main symptom of "deficiency of both qi and blood", Buxue Yimu Granules, which are used to treat postpartum abdominal pain with the main symptom of "deficiency of both qi and blood and blood stasis", and Xinshenghua Granules, which are used to treat postpartum lochia with the main symptom of "deficiency of both qi and blood, blood deficiency with stasis, and blood stasis". For example, CN105456901A discloses an important composition for treating postpartum uterine involution, which is composed of Macleaya cordata, Sargentodoxa chinensis, horsefly, glutinous rice root, Sanguisorba officinalis charcoal, Pulsatilla scabra, Cimicifuga heracleifolia, Humulus scabra, Oroxylum indica, Polygonatum odoratum, Fructus trichosanthis, Peony bark, Coptis chinensis, Herba sperantophyllae, Plantago asiatica, Leonurus japonicus, Herba tongjingensis, Aconitum carmichaelii, Herba schizonepetae, Lily lily, Frankincense, Hibiscus scabra, Herba agrimonii, Herba Patriniae, Ochre, Eclipta prostrata, Herba catnip, Paris polyphyllae, Prunus mume, Costusroot, Amomum villosum, Pueraria root, Rhizoma Alismatis, Poria, Sophora japonica, Achyranthes bidentata, Millettia spatholobi and pangolin. The composition is large, contains pangolin protected animals, and is an external medicine with low drug utilization. CN105343784A discloses a formula composition, which includes 40 ingredients such as Lygodium japonicum, Ligustrum lucidum, Ilex, Macleaya cordata, Caulis Sargentodoxae, Sanguisorba officinalis, Pulsatilla chinensis, Cimicifuga heracleifolia, Peony Root, Polygonum multiflorum, Tripterygium wilfordii, Scorpio, Bombyx batryticatus, Clematis chinensis, Aster tataricus, Sargassum, Cnidium officinale, Trachelospermum officinale, Albizzia julibrissin, Fructus sylvestris, Pinellia ternata, Coptis chinensis, Herba schizonepetae, Solanum nigrum, Areca nut, Pyrrosia raphis, Lithospermum officinale, Lonicera japonica, Pheretima, Drynaria officinalis, Chrysanthemum, Saposhnikovia divaricata, Rhizoma Alismatis, Viola yedoensis, Verbena officinalis, Curcuma longa, Fructus arctii, Veratrum, etc. There are many kinds of drugs used, and it is not suitable for large-scale promotion and application. The functions are to promote blood circulation and dissipate blood stasis, regulate menstruation and dredge collaterals, and dissipate blood stasis and relieve pain. Patent CN104825687A discloses a method for treating the disease, which is consistent with the present invention, but the drug composition provided by the patent is: motherwort, rhizoma cyrtomii, stir-fried pollen, and schisandra chinensis, among which rhizoma cyrtomii is slightly toxic. The functional indications of the prescription focus on promoting blood circulation and removing blood stasis, clearing away heat and relieving pain.

[0003] The diseases treated by CN105169295A patent are consistent with the present invention, but the medicine composition provided by it is: jujube, Laojunxu, yam, longan meat, radix rehmanniae, Pseudostellariae Radix, Pteris ternatae, Cockscomb, Dendrobium, mulberry fruit, polygonatum, red burdock, cowpea, Imperatae rhizome, Corydalis, Cyathula officinalis, Polygonum cuspidatum, Leonurus japonicus, red yeast rice, Liu Ji Nu, madder, turmeric, licorice, saffron, and the present invention has four medicinal materials repeated, among which saffron is a precious medicinal material, and the number of medicinal flavors used is large. In terms of function and treatment, its effects of invigorating the spleen and replenishing qi, consolidating the kidney and absorbing blood, nourishing yin and nourishing blood, cooling blood and stopping bleeding, promoting blood circulation and removing blood stasis, breaking blood circulation and promoting qi, and relieving pain through menstruation are miscellaneous and not refined, which is different from the emphasis of the present invention. In terms of preparation method, it needs to be boiled in steps, powdered, and pilled, with complicated procedures and high cost.

[0004] CN104740274A discloses a medicine for postpartum uterine recovery, which is composed of green peel, costus root, jujube, tongcao, angelica, white peony root, trichosanthes root, motherwort, cyperus, tuckahoe, ophiopogon, magnolia bark, licorice, and brown sugar. It is a functional prescription for nourishing yin and blood, promoting blood circulation and regulating menstruation. The diseases treated by the patent CN102379913B are consistent with the present invention, but the medicine composition provided by it is: American ginseng and thistle, which is completely different from the present invention, among which American ginseng belongs to precious medicinal materials and has high application cost. In terms of function and indication, its focus is on replenishing qi and nourishing yin, clearing heat and stopping bleeding, which is different from the present invention. CN104721404A discloses a pharmaceutical composition for treating incomplete uterine involution, which is composed of dodder seed, wolfberry, northern adenophora, angelica, white peony root, donkey-hide gelatin, Chinese wolfberry bark, motherwort, pollen (fried charcoal), and schizonepeta spicate (fried charcoal). The main purpose of this formula is to nourish the kidney and nourish yin, nourish blood and remove blood stasis.

[0005] Some of the above formulas contain many medicinal flavors, some contain toxic medicinal flavors, some contain rare medicinal materials, and some contain nationally protected animals.

[0006] In addition, the prior art does not have a Chinese medicine for treating postpartum uterine involution specifically for irregular vaginal bleeding, abdominal pain and lochia retention. Summary of the invention

[0007] The invention provides a novel traditional Chinese medicine composition for treating postpartum uterine involution, which is safe and effective and has easily available raw materials.

[0008] The Chinese medicine composition for treating uterine involution of the invention comprises codonopsis pilosula and pollen typhae as main medicines, and astragalus and cuttlebone as auxiliary medicines.

[0009] In one embodiment, the traditional Chinese medicine composition further comprises any one of Verbena officinalis, Rubia cordifolia, Herba Lycopodii, Dipsacus asper, and Linderae umbellatae as an adjuvant.

[0010] In one embodiment, the traditional Chinese medicine composition comprises at least two of Verbena officinalis, Rubia cordifolia, Herba Lycopodii, Dipsacus asper, and Linderae umbellatae as adjuvants.

[0011] In one embodiment, the traditional Chinese medicine composition comprises verbena, rubia cordifolia, and pyrola as adjuvant drugs.

[0012] In one embodiment, the traditional Chinese medicine composition comprises dipsacus asperoides and lindera aggregata as adjuvant drugs.

[0013] In one embodiment, the traditional Chinese medicine composition comprises verbena, rubia cordifolia, dipsacus asperoides, and lindera aggregata as adjuvant drugs.

[0014] In one embodiment, the traditional Chinese medicine composition comprises verbena, rubia cordifolia, pyrola, dipsacus asperoides, and lindera aggregata as adjuvant drugs.

[0015] In one embodiment, the traditional Chinese medicine composition further comprises licorice or jujube as the guiding drug.

[0016] In one embodiment, the traditional Chinese medicine composition or its formula comprises 8 - 10 parts of codonopsis pilosula, 5 - 10 parts of pollen typhae, 5 - 10 parts of astragalus membranaceus, and 5 - 10 parts of cuttlebone.

[0017] In one embodiment, the traditional Chinese medicine composition or its formula further comprises 5 - 10 parts of verbena, 5 - 10 parts of rubia cordifolia, 8 - 10 parts of pyrola, 5 - 10 parts of dipsacus asperoides, 5 - 10 parts of lindera aggregata, and 1 - 2 parts of licorice.

[0018] In another embodiment, the traditional Chinese medicine composition or its formula further comprises 1 - 4 parts of notoginseng, 5 - 10 parts of motherwort herb, 4 - 8 parts of rehmannia glutinosa, and 3 - 6 parts of jujube.

[0019] In another embodiment, the traditional Chinese medicine composition or its formula further comprises 1 - 4 parts of notoginseng, 5 - 10 parts of motherwort herb, 4 - 8 parts of angelica sinensis, 4 - 8 parts of rehmannia glutinosa, and 1 - 2 parts of licorice.

[0020] The selection of the medicinal flavors in the present invention aims to achieve the effects of replenishing qi to arrest bleeding and promoting blood circulation to relieve pain, providing a treatment plan for treating subinvolution of uterus belonging to the syndrome of qi deficiency and blood stasis, which strengthens the healthy qi to dispel pathogenic factors, treats deficiency and excess simultaneously, combines promoting blood circulation and astringency, with astringency not causing blood stasis and promoting blood circulation not causing bleeding. The pharmaceutical composition of the present invention has a good therapeutic effect on treating subinvolution of uterus after childbirth characterized by irregular vaginal bleeding, abdominal pain, and lochiorrhea, and can also be used to treat subinvolution of uterus with other symptom manifestations. The formula of the present invention uses commonly available and easily obtained medicinal flavors in the market, with low cost, rich drug sources, and no toxic medicinal flavors, being suitable for application and promotion. Brief Description of the Drawings

[0021] Figure 1This is a pathological section (HE, ×100) of the uterine tissue of the test rats in the pharmacological experiment of the present invention. Among them, A is the normal control group; B is the model control group; C is the Chanfukang granule group; D is the low-dose group of the dry extract powder of this product; E is the medium-dose group of the dry extract powder of this product; F is the high-dose group of the dry extract powder of this product. Detailed implementation manners

[0022] According to the present invention, Codonopsis pilosula, Typha angustifolia, Astragalus membranaceus and Sepia seu Sepiellae are used as the main therapeutic components for treating subinvolution of the uterus due to qi deficiency and blood stasis. In this formula, Codonopsis pilosula and Typha angustifolia are used as the monarch drugs. Among them, Codonopsis pilosula is sweet in taste, neutral in nature and non-toxic, and can replenish the middle-jiao, boost qi, promote the production of body fluid, and is used to treat qi deficiency, qi-fluid deficiency, qi-blood deficiency and sallow complexion due to blood deficiency. Typha angustifolia is also sweet in taste and neutral in nature, and its efficacy is to stop bleeding, promote blood circulation to remove stasis, and promote diuresis. The combination of Codonopsis pilosula and Typha angustifolia has the effects of boosting qi and promoting blood circulation, promoting blood circulation and stopping bleeding, and has the effects of replenishing qi and promoting blood circulation to remove stasis, stopping bleeding and relieving pain.

[0023] In the formula of the present invention, Astragalus membranaceus and Sepia seu Sepiellae are used as the ministerial drugs. Among them, Astragalus membranaceus is sweet in taste and slightly warm in nature, and has the functions of strengthening the spleen and replenishing the middle-jiao, lifting yang and raising prolapse, benefiting the defensive qi and consolidating the exterior, and expelling toxins and promoting granulation. Sepia seu Sepiellae is salty and astringent in taste and warm in nature, and has the effects of astringing to stop bleeding, astringing sperm and arresting leucorrhea, regulating the stomach to relieve acid pain, and astringing dampness and promoting granulation. It is clinically used to treat hematemesis, epistaxis, metrorrhagia and metrostaxis, hematochezia, and external treatment of traumatic bleeding and other symptoms. The combination of these two ministerial drugs promotes Codonopsis pilosula to tonify deficiency, activate blood circulation and arrest bleeding, and also enhances the functions of Typha angustifolia in promoting blood circulation to remove stasis, stopping bleeding and relieving pain, and has no side effects of leaving stasis due to bleeding stoppage or bleeding due to promoting blood circulation to remove stasis.

[0024] Generally, adjuvant drugs and / or guiding drugs can be introduced into the above-mentioned formula. In some embodiments, the adjuvant drug is any one of Verbena officinalis, Rubia cordifolia, Pyrola calliantha, Dipsacus asperoides and Lindera aggregata. In some other embodiments, the adjuvant drug is a combination of two or more of Verbena officinalis, Rubia cordifolia, Pyrola calliantha, Dipsacus asperoides and Lindera aggregata. In one embodiment, the adjuvant drug is Verbena officinalis, Rubia cordifolia, Pyrola calliantha. In another embodiment, the adjuvant drug is a combination of Dipsacus asperoides and Lindera aggregata. In another embodiment, the adjuvant drug is a combination of Verbena officinalis, Rubia cordifolia, Dipsacus asperoides and Lindera aggregata. In yet another embodiment, the adjuvant drug is composed of Verbena officinalis, Rubia cordifolia, Pyrola calliantha, Dipsacus asperoides and Lindera aggregata. These six adjuvant drugs achieve the synergistic effects of tonifying the liver and kidney, strengthening the tendons and bones, promoting blood circulation to remove stasis, preventing heat transformation due to long-term stasis, promoting qi movement and blood circulation, and stopping pain when blood circulation is promoted and stasis is removed.

[0025] The present invention is not limited thereto, and other traditional Chinese medicine components can also be used as the adjuvant drugs in this formula. For example, in one embodiment, the adjuvant drugs are Panax notoginseng, Leonurus japonicus, and Rehmannia glutinosa. Among them, Panax notoginseng is sweet, tonifying, warm and dredging, with both dispersing and astringing properties, purging while tonifying, entering the liver and stomach meridians. It has strong abilities in both hemostasis and promoting blood circulation to remove stasis, and can also tonify deficiency, having the advantages of stopping bleeding without leaving stasis and promoting blood circulation without consuming qi; Leonurus japonicus is slightly cold, clearing and relieving, correcting the heatiness of Panax notoginseng, and is especially good at treating various diseases of blood stasis during menstruation and parturition. Rehmannia glutinosa nourishes the kidney water, fills the bone marrow, promotes blood circulation, tonifies the true yin, and treats metrorrhagia and menoxenia due to yin deficiency and blood deficiency. In another embodiment, the adjuvant drugs are Panax notoginseng, Leonurus japonicus, Rehmannia glutinosa, and Angelica sinensis. Among them, Angelica sinensis nourishes blood and promotes blood circulation, and is especially suitable for metrorrhagia and menoxenia with qi and blood deficiency due to blood deficiency and sallow complexion. These adjuvant drugs can be used independently or in combination with the aforementioned adjuvant drugs. However, according to the concept of the present invention, the types of adjuvant drugs do not need to exceed 10, preferably do not exceed 8, and more preferably do not exceed 6.

[0026] The formula of the present invention preferably further includes one or more guiding drugs. In a typical embodiment, the guiding drug is Glycyrrhiza uralensis; in another embodiment, the guiding drug is Ziziphus jujuba, which can regulate nutrient qi and defensive qi and relieve the properties of other drugs.

[0027] In the present invention, relatively larger amounts can be used for the monarch drug and ministerial drugs, which means that the dosage of each component of the adjuvant drugs and guiding drugs is not higher than, preferably lower than, that of the monarch drug and ministerial drugs. The total dosage of the ministerial drugs is preferably not higher than that of the monarch drug. Among the two monarch drugs, the dosage of Codonopsis pilosula is preferably not lower than that of Typha angustata. For example, the dosage of Codonopsis pilosula can be 1 to 2 times that of Typha angustata.

[0028] In the embodiments of the present invention, each traditional Chinese medicine can be formulated according to the ratio of 8 - 15 parts by mass of Codonopsis pilosula, 5 - 15 parts of Typha angustata, 5 - 15 parts of Astragalus membranaceus, and 5 - 10 parts of Sepia seu Sepiella. The typical dosage ratio can be 8 - 10 parts of Codonopsis pilosula, 5 - 10 parts of Typha angustata, 5 - 10 parts of Astragalus membranaceus, and 5 - 10 parts of Sepia seu Sepiella. In the preferred embodiment, the dosage ratio can be 8 - 10 parts of Codonopsis pilosula, 5 - 8 parts of Typha angustata, 5 - 8 parts of Astragalus membranaceus, and 5 - 8 parts of Sepia seu Sepiella.

[0029] When the formula includes the aforementioned adjuvant drugs, each adjuvant drug can be added in an amount of 5 - 15 parts, preferably 5 - 10 parts. When Glycyrrhiza uralensis is used as the guiding drug, the amount of Glycyrrhiza uralensis is preferably 1 - 5 parts, more preferably 1 - 2 parts. When Ziziphus jujuba is used as the guiding drug, the amount of Ziziphus jujuba is preferably 3 - 6 parts, more preferably 3 - 4 parts.

[0030] In a typical embodiment of the present invention, the components of the formula are 8-10 parts of Codonopsis pilosula, 5-10 parts of Pollen Typhae, 5-10 parts of Astragalus, 5-10 parts of Cuttlebone, 5-10 parts of Verbena, 5-10 parts of Rubia cordifolia, 8-10 parts of Deer's mouth, 5-10 parts of Dipsacus asper, 5-10 parts of Linderae scutellariae, and 1-2 parts of Licorice. The compatibility characteristics of this formula are reflected in two aspects: one is to strengthen the body and expel evil, treat both deficiency and excess, and take into account both the symptoms and the root causes. Strengthening the body is mainly based on invigorating qi and strengthening the spleen, supplemented by tonifying the liver and kidneys, taking care of the special physiological and pathological changes of women; expelling evil is mainly based on promoting blood circulation and removing blood stasis, removing blood stasis without hurting the body, and blood stasis will stop pain and bleeding. The second is to use both dredging and astringing, astringent does not leave blood stasis, and dredging does not stop bleeding. Its dredging is to promote blood circulation and remove blood stasis, regulate qi and remove stagnation; astringent is to remove blood stasis and stop bleeding, and heal injuries and continue tendons. Removing blood stasis and regulating qi does not stop bleeding, and astringent stops bleeding without leaving blood stasis.

[0031] In a more preferred embodiment, the components of the formula are 8-10 parts of Codonopsis pilosula, 8-10 parts of Pollen Typhae, 5-8 parts of Astragalus, 5-8 parts of Cuttlebone, 5-8 parts of Verbena, 5-8 parts of Rubia cordifolia, 8-10 parts of Herba Lycopodii, 5-8 parts of Dipsacus asper, 5-8 parts of Linderae umbellatae, and 1-2 parts of Licorice.

[0032] The Chinese medicine composition of the present invention can be provided in the form of directly mixing the above-mentioned Chinese medicines, and can be decocted with water before taking. For example, add water to the medicinal materials until they are completely covered, soak for 0.5 hours, boil over high heat, then simmer for 30-40 minutes over low heat, add water for the second time until the medicinal materials are completely covered, and simmer for 20-40 minutes, filter through gauze, and combine the two medicinal solutions before drinking.

[0033] As a preferred embodiment, the Chinese medicine composition of the present invention is provided in the form of a Chinese medicine extract. In one embodiment, the Chinese medicine composition is prepared by the following steps:

[0034] 1) Combine Codonopsis pilosula, Pollen Typhae, Astragalus, Cuttlebone and other optional ingredients.

[0035] 2) Add 5 times the amount of water to the obtained mixture and soak for 0.5 hours.

[0036] 3) Take the soaking mixture obtained in step 2), bring to a boil over high heat, simmer over low heat for 40 minutes, and filter through gauze.

[0037] 4) Take the residue obtained in step 3), add 3 times the amount of water, bring to a boil over high heat, simmer over low heat for 40 minutes, and filter through gauze.

[0038] 5) Combine the filtrates and concentrate them into extracts or make them into dry powder.

[0039] Excipients may be introduced into the Chinese medicinal composition in the form of an extract to prepare a suitable dosage form.

[0040] In one embodiment, the extract obtained by the above method is directly made into pills without introducing any excipients, or a small amount of methyl cellulose is added as a binder.

[0041] In another embodiment, the traditional Chinese medicine composition of the present invention is made into a powder or granule, and the excipients that can be used include but are not limited to an appropriate amount of maltodextrin and 0.2% stevioside.

[0042] When the drug according to the present invention is provided as a mixture of Chinese herbal medicines, the dosage of each single herb of the monarch herb and ministerial herb is generally in the range of 5-15, and according to the above-mentioned ratio, 1-2 doses are taken daily for 7-14 consecutive days. Observation can be carried out after taking the medicine for 7 days, and the dosage can be reduced or the medicine can be stopped according to the situation.

[0043] When the drug of the present invention is provided in the form of a preparation, the dosage of the crude drug can be between 0.3-1.3 g / kg, preferably between 0.5-1 g / kg.

[0044] The following provides several examples to exemplarily show the concept and effects of the present invention. These examples should not be construed as limiting the embodiments of the present invention. Those skilled in the art can make slight adjustments to the formulations of these examples, such as reducing or increasing the components of one or more adjuvant herbs and envoy herbs, or replacing the components of one or more adjuvant herbs and envoy herbs.

[0045] Example 1

[0046] 1) Mix 8-10 parts of Codonopsis pilosula, 8-10 parts of Typha angustifolia, 5-8 parts of Astragalus membranaceus, 5-8 parts of Sepia seu cuttlebone, 5-8 parts of Verbena officinalis, 5-8 parts of Rubia cordifolia, 8-10 parts of Pyrola calliantha, 5-8 parts of Dipsacus asperoides, 5-8 parts of Lindera aggregata, and 1-2 parts of Glycyrrhiza uralensis.

[0047] 2) Add 5 times the amount of water to the obtained mixture and soak for 0.5 hour.

[0048] 3) Take the soaked mixture obtained in step 2), bring to a boil over high heat, and then simmer for 40 minutes, and filter through a gauze.

[0049] 4) Take the filter residue obtained in step 3), add 3 times the amount of water, bring to a boil over high heat, and then simmer for 40 minutes, and filter through a gauze.

[0050] 5) Combine the filtrates, concentrate and dry to obtain a dry extract powder.

[0051] Pharmacological test of the product of Example 1

[0052] A model of incomplete involution of the uterus with qi deficiency and blood stasis after childbirth was established by exhaustive swimming of female SD rats combined with iron dextran and uterine inoculation with Escherichia coli. By observing indicators such as the general state of the rats, writhing response, hemodynamics, estrogen and progesterone levels, and endometrial histopathology, the pharmacological effects of the dry extract powder of this product on the model of incomplete involution of the uterus with qi deficiency and blood stasis in SD rats after childbirth were evaluated. In this experiment, the maternal health granules were used as the control product, which was provided by Shenzhen Sanshun Pharmaceutical Co., Ltd. Maternal health granules are a Chinese patent medicine with a relatively high acceptance rate for postpartum rehabilitation at present. The clinically proposed dosage of the dry extract powder of this traditional Chinese medicine composition is 52 g of crude drug per day. Calculated based on the average adult body weight of 60 kg, it is approximately 0.87 g of crude drug / kg (52 g of crude drug ÷ 60 kg ≈ 0.87 g of crude drug / kg). After conversion according to the body surface area, the equivalent dose for rats is 4.68 g of crude drug / kg (52 g of crude drug × 0.018 / 0.2 kg = 4.68 g of crude drug / kg).

[0053] (1) Monitoring of general state, body weight and observation of lochia

[0054] During the experiment, the rats in each group were weighed and generally observed. The results showed that no obvious symptoms of poor condition or incomplete lochia were observed in the rats of each group. As shown in Table 1, compared with the normal control group, the body weight of the rats in the model control group increased significantly before drug administration (P ≤ 0.01), and this continued until the end of drug administration; compared with the model control group, there was no significant change in the body weight of the rats in each drug administration group.

[0055] Table 1 Effects of the dry extract powder of this product on the body weight of postpartum model rats( n = 10)

[0056]

[0057] Note: Compared with the normal control group ++ P ≤ 0.01.

[0058] (2) Effects on pain induced by oxytocin

[0059] As shown in Table 2, compared with the normal control group, the writhing latency of the rats in the model control group was significantly reduced (P ≤ 0.05), and the number of writhing times was significantly increased (P ≤ 0.01); compared with the model control group, the writhing latency of the rats in the maternal health granule group and the middle and high dose groups of the dry extract powder of this product was significantly increased (P ≤ 0.01 or P ≤ 0.05), and there was no significant change in the writhing latency of the rats in the low dose group of the dry extract powder of this product. Compared with the model control group, the number of writhing times of the rats in the maternal health granule group and the low, middle and high dose groups of the dry extract powder of this product was significantly reduced (P ≤ 0.01 or P ≤ 0.05). It was proved that this product had obvious analgesic effects when administered at three doses.

[0060] Table 2 Effects of the dry extract powder of this product on pain induced by oxytocin in rats( n = 10)

[0061]

[0062]

[0063] Note: Compared with the normal control group + P ≤ 0.05, ++ P ≤ 0.01; compared with the model control group * P ≤ 0.05, **P ≤ 0.01.

[0064] (3) Effects on hemodynamic detection

[0065] As shown in Table 3, compared with the normal control group, the platelet aggregation rate of rats in the model control group increased significantly (P ≤ 0.01); compared with the model control group, the platelet aggregation rates of the Qianfukang Granule group and the high-dose group of the dry extract powder of this product were significantly decreased (P ≤ 0.05), and the platelet aggregation rates of the remaining drug administration groups showed a decreasing trend, but there was no statistical difference. It shows that this product can significantly improve blood stasis symptoms when administered at the high-dose group.

[0066] Table 3 Effects of the dry extract powder of this product on platelet aggregation in rats ( n = 10)

[0067]

[0068] Note: Compared with the normal control group, ++ P ≤ 0.01; compared with the model control group * P ≤ 0.05, ** P ≤ 0.01.

[0069] (4) Effects on estrogen and progesterone

[0070] As shown in Table 4, compared with the normal control group, the estrogen and progesterone PRL, E2, and PROG of rats in the model control group were significantly decreased (P ≤ 0.01); compared with the model control group, the PRL of the Qianfukang Granule group and the low-, medium-, and high-dose groups of the dry extract powder of this product were significantly increased (P ≤ 0.01), the E2 of the Qianfukang Granule group and the high-dose group of the dry extract powder of this product were significantly increased (P ≤ 0.01 or P ≤ 0.05), and the PROG of the Qianfukang Granule group and the low- and high-dose groups of the dry extract powder of this product were significantly increased (P ≤ 0.05). This proves that this product has an obvious therapeutic effect on postpartum qi deficiency and blood stasis model rats in terms of estrogen and progesterone secretion and other aspects.

[0071] Table 4 Effects of the dry extract powder of this product on estrogen and progesterone in SD rats ( n = 10)

[0072]

[0073]

[0074] Note: Compared with the normal control group + P ≤ 0.05, ++ P ≤ 0.01; compared with the model control group * P ≤ 0.05, ** P ≤ 0.01.

[0075] (5) Effect on uterine organ coefficient

[0076] As shown in Table 5, there were no significant changes in uterine weight and uterine organ coefficient among groups.

[0077] Table 5 Effect of the dry extract powder of this product on uterine organ coefficient of rats

[0078]

[0079] Note: Compared with the normal control group, ++ P ≤ 0.01.

[0080] (6) Effect on histopathology of endometrium

[0081] ① Effect on endometrial tissue morphology

[0082] As Figure 1 shown, there were no obvious abnormalities in the endometrial tissue of the normal control group. Compared with the normal control group, in the model control group, endometrial epithelial cells were necrotic and shed, with a small amount of congestion, hemorrhage, edema, and macrophage infiltration. Compared with the model control group, the degree of endometrial tissue inflammation in the Qianfukang granule group and the low, medium, and high dose groups of the dry extract powder of this product was alleviated after administration.

[0083] ② Effect on endometrial tissue pathological score

[0084] As shown in Table 6, compared with the normal control group, in the model control group, the necrosis and shedding of endometrial epithelial cells, infiltration of inflammatory cells, vascular congestion / hemorrhage, and total pathological score of rats were significantly increased (P ≤ 0.01); compared with the model control group, in the Qianfukang granule group and the high dose group of the dry extract powder of this product, the necrosis and shedding of endometrial epithelial cells were significantly reduced (P ≤ 0.01 or P ≤ 0.05); compared with the model control group, in the low and high dose groups of the dry extract powder of this product, the scores of endometrial vascular congestion and hemorrhage were significantly reduced (P ≤ 0.05); compared with the model control group, in the Qianfukang granule group and the low, medium, and high dose groups of the dry extract powder of this product, the infiltration of endometrial inflammatory cells and total pathological score were significantly reduced (P ≤ 0.01 or P ≤ 0.05).

[0085] Table 6 Effect of the dry extract powder of this product on endometrial pathological score of rats

[0086]

[0087] Note: Compared with the normal control group, ++ P ≤ 0.01; compared with the model control group * P ≤ 0.05, ** P ≤ 0.01.

[0088] The above experimental results show that: (1) The low, medium, and high doses (4.68, 9.36, 18.72 g crude drug / kg) of the dry extract powder of this product can significantly increase the writhing latency time of rats with incomplete involution of the postpartum uterus, reduce the number of writhing times, and the high dose (18.72 g crude drug / kg) has a more obvious effect; (2) The high dose (18.72 g crude drug / kg) of the dry extract powder of this product can significantly reduce the platelet aggregation rate of model rats; (3) The low, medium, and high doses (4.68, 9.36, 18.72 g crude drug / kg) of the dry extract powder of this product can significantly increase the PRL level in the serum of model rats, the high dose (18.72 g crude drug / kg) can significantly increase the E2 level in the serum of model rats, and the low and high doses (0.86, 18.72 g crude drug / kg) can significantly increase the PROG level in the serum of model rats; (4) The low, medium, and high doses (4.68, 9.36, 18.72 g crude drug / kg) of the dry extract powder of this product can all improve and relieve the degree of endometrial lesions, and the high dose (18.72 g crude drug / kg) has a more obvious effect. It is suggested that the dry extract powder of this product has obvious therapeutic effects on postpartum rats with qi deficiency and blood stasis in terms of anti-inflammatory and analgesic effects, qi deficiency and blood stasis, and estrogen and progesterone secretion.

[0089] Example 2:

[0090] Patient: Li ××, female, 26 years old, address: Changsha City, Hunan Province

[0091] Symptoms of the disease: Although one month has passed since the patient gave birth, the lochia has not stopped flowing, and the face is pale. After examination, it was diagnosed as incomplete involution of the uterus and excessive blood volume.

[0092] Treatment: According to the formula of 8 parts of Codonopsis pilosula, 6 parts of Typha angustifolia, 6 parts of Astragalus membranaceus, 8 parts of Sepia seu cuttlefish bone, 5 parts of Verbena officinalis, 5 parts of Rubia cordifolia, 8 parts of Pyrola calliantha, and 2 parts of Glycyrrhiza uralensis, treat with the obtained medicinal liquid, 1 dose per day. After taking the medicine for 7 days, return for a follow-up visit. The vaginal bleeding has significantly slowed down. Then, continue to take the medicine for 7 days for consolidation. The vaginal bleeding has completely stopped, and the patient has recovered.

[0093] Example 3

[0094] Patient: Jin ××, female, 28 years old, address: Changsha City, Hunan Province

[0095] Symptoms: Although she had given birth nearly two months ago, she was weak and had a lot of lochia. After a gynecological examination, she was diagnosed with "incomplete uterine involution".

[0096] Treatment: Use the prescription of 10 parts of Codonopsis pilosula, 5 parts of Pollen Typhae, 5 parts of Astragalus, 6 parts of Verbena, 5 parts of Rubia cordifolia, 8 parts of Herba Lycopodii, 5 parts of Cuttlebone, 5 parts of Dipsacus asper, 6 parts of Linderae scutellariae, and 1 part of Licorice to treat the patient, 1 dose per day. After taking the medicine for 7 days, the patient was followed up for a follow-up visit. The vaginal bleeding had basically disappeared and the symptoms were significantly relieved. The patient was advised to take the medicine for another 2 days and recovered.

[0097] Example 4

[0098] Patient: Huang XX, female, 28 years old, address: Liuyang City, Hunan Province

[0099] Symptoms: Although it has been one and a half months since delivery, the lochia is still dripping and the amount of bleeding is very large, and the pain is severe. After gynecological examination, the diagnosis is: incomplete uterine involution and heavy bleeding.

[0100] Treatment: Take 10 parts of Codonopsis pilosula, 10 parts of Pollen Typhae, 10 parts of Astragalus, 5 parts of Verbena, 5 parts of Rubia cordifolia, 8 parts of Herba Lycopodii, 10 parts of Cuttlebone, 10 parts of Dipsacus asper, 5 parts of Linderae scutellariae, and 2 parts of Licorice, one dose per day. Come back for a follow-up visit 7 days after taking the medicine. The vaginal bleeding has significantly decreased, and the pain has been relieved. The patient is advised to take the medicine for another 4 days, and the pain is gone, as are all symptoms.

[0101] Example 5

[0102] Patient: Wang XX, female, 25 years old, address: Liuyang City, Hunan Province

[0103] Symptoms: Although it has been two months since the birth, the lochia is still dripping and the amount of bleeding is very heavy. After gynecological examination, the diagnosis is: incomplete uterine involution and heavy bleeding.

[0104] Treatment: According to the prescription of 10 parts of Codonopsis pilosula, 7 parts of Pollen Typhae, 5 parts of Astragalus, 5 parts of Verbena, 5 parts of Rubia cordifolia, 10 parts of Herba Luzi, 5 parts of Cuttlebone, 5 parts of Dipsacus asper, 6 parts of Linderae sibiricum, and 1 part of Licorice, one dose per day, a follow-up visit after 7 days of medication, vaginal bleeding was significantly reduced, pain was significantly alleviated, and the patient was advised to take the medicine for another 7 days, the pain was eliminated, and all symptoms disappeared

[0105] Example 6

[0106] Patient: Xing XX, female, 28 years old, address: Changsha City, Hunan Province

[0107] Symptoms: Although it has been one month since delivery, the lochia is still dripping and not clean, the amount of bleeding is heavy, the color is dark red or purple, or there are a few blood clots, pain, fatigue. After gynecological examination, the diagnosis is: incomplete uterine involution and heavy bleeding.

[0108] Treatment: 10 parts of Codonopsis pilosula, 10 parts of Typha angustifolia, 10 parts of Astragalus membranaceus, 10 parts of Sepia officinalis, 5 parts of Rehmannia glutinosa, 5 parts of Lindera aggregata, 4 parts of Angelica sinensis, 3 parts of Chinese date. Take 1 dose per day. Have a follow-up visit 7 days after taking the medicine. There is no vaginal bleeding and the pain is relieved. Instruct the patient to take the medicine for another 4 days, and the pain is basically eliminated.

[0109] Example 7

[0110] Patient: Gao XX, female, 32 years old, Address: Changsha City, Hunan Province

[0111] Symptoms of the disease: Although it has been one month after childbirth, the lochia is still not clean, purple and dark in color with lumps, and the lower abdomen is painful and refuses to be pressed. After gynecological examination, the diagnosis is: incomplete involution of the uterus and heavy blood volume.

[0112] Treatment: 10 parts of Codonopsis pilosula, 10 parts of Typha angustifolia, 10 parts of Astragalus membranaceus, 10 parts of Sepia officinalis, 2 parts of Panax notoginseng, 6 parts of Leonurus japonicus, 4 parts of Angelica sinensis, 4 parts of Rehmannia glutinosa, 2 parts of Glycyrrhiza uralensis. Take 1 dose per day. Have a follow-up visit 7 days after taking the medicine. The vaginal bleeding is less and the pain is basically eliminated. Instruct the patient to take the medicine for another 2 days, and all symptoms disappear.

Claims

1. A traditional Chinese medicine composition for treating incomplete involution of the uterus, and its composition is as follows: 8-10 parts of Codonopsis pilosula, 8-10 parts of Typha angustifolia, 5-8 parts of Astragalus membranaceus, 5-8 parts of Sepia seu Sepiella, 5-8 parts of Verbena officinalis, 5-8 parts of Rubia cordifolia, 8-10 parts of Pyrola calliantha, 5-8 parts of Dipsacus asperoides, 5-8 parts of Lindera aggregata, 1-2 parts of Glycyrrhiza uralensis.

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