Traditional Chinese medicine with the efficacy of killing embryo under fetus

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine for killing the embryo and expelling the fetus. By weight, it is composed of the following components: 30-50 parts of Lithospermum erythrorhizon, 15-20 parts of Malva verticillata seed, 15-20 parts of Myrrh, 15-20 parts of Achyranthes bidentata, 20-30 parts of Perilla frutescens, 15-25 parts of Leonurus japonicus, and 15-25 parts of Citrus aurantium. The herbal formula of this invention is refined, with strong synergistic effects, possessing both powerful embryo-killing and highly effective expulsion efficacy, and is suitable for treating ectopic pregnancy and retained products of conception.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine with the effect of killing the embryo and expelling the fetus. Background Technology

[0002] Ectopic pregnancy and retained products of conception are common gynecological emergencies and complex conditions. Ectopic pregnancy accounts for approximately 2%-3% of all pregnancies and is one of the leading causes of maternal mortality in early pregnancy. Retained products of conception often lead to irregular vaginal bleeding, infection, intrauterine adhesions, and even secondary infertility after childbirth or miscarriage. Currently, Western medicine primarily treats ectopic pregnancy with methotrexate (MTX) chemotherapy or laparoscopic surgery, while treating retained products of conception mainly relies on ultrasound-guided aspiration abortion or hysteroscopic surgery. While these methods are effective, they have limitations such as the liver and kidney toxicity of chemotherapy drugs, surgical trauma, anesthesia risks, high costs, and potential damage to the endometrium and impact on future fertility.

[0003] Traditional Chinese medicine has a long history of treating ectopic pregnancies and retained products of conception, removing blood stasis and promoting blood circulation. It has contributed to the conservative treatment of ectopic pregnancies and retained products of conception, but lacks universally recognized formulas that are specific in efficacy, have definite therapeutic effects, are simple to formulate, and have few side effects. Patent CN104147530B discloses a compound formula containing 13 medicinal herbs including Lithospermum erythrorhizon, centipede, and earthworm, focusing on clearing heat and detoxifying, breaking up blood stasis and eliminating masses. However, this large formula leads to a significant reduction in the dissolution rate and bioavailability of the core active ingredients, resulting in slow onset of action and insignificant effects. Furthermore, it contains multiple toxic drugs, causing significant side effects. Moreover, this invention only targets ectopic pregnancies and does not address retained products of conception. Patent CN102078565B discloses a formula containing Paeonia lactiflora, peach kernel, and... Preparations containing 15 medicinal herbs, including Trichosanthes kirilowii, leeches, and centipedes, also suffer from the problem of having a large number of herbs and containing many potent toxic herbs. Due to differences in the source of the herbs and the processing techniques, it is impossible to define the dosage threshold for safe clinical use, which can easily cause unpredictable toxic side effects to users. Patent CN108815259A discloses a 6-herb formula for treating ectopic pregnancy with qi stagnation and blood stasis, which focuses on calming the mind and promoting qi and blood circulation, but does not have the effect of terminating embryonic activity or promoting the expulsion of pregnancy products. Summary of the Invention

[0004] The present invention aims to overcome the technical problems of existing traditional Chinese medicines having a wide variety of ingredients, single functions, and significant toxic side effects, and to develop a traditional Chinese medicine with the effect of killing the embryo and expelling the fetus, for the treatment of ectopic pregnancy and retained products of pregnancy in the uterus.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0006] The first aspect of this invention provides a traditional Chinese medicine with the effect of killing the embryo and expelling the fetus. By weight, the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus is made from the following raw materials: 30-50 parts of Lithospermum erythrorhizon, 15-20 parts of Malva verticillata, 15-20 parts of Commiphora myrrha, 15-20 parts of Achyranthes bidentata, 20-30 parts of Perilla frutescens, 15-25 parts of Leonurus japonicus, and 15-25 parts of Citrus aurantium.

[0007] Furthermore, according to the traditional Chinese medicine with the effect of killing the embryo and aborting the fetus, the traditional Chinese medicine with the effect of killing the embryo and aborting the fetus is made from the following raw materials by weight: 30 parts of Lithospermum erythrorhizon, 15 parts of Malva verticillata, 15 parts of Myrrh, 15 parts of Achyranthes bidentata, 20 parts of Smilax china, 15 parts of Leonurus japonicus, and 15 parts of Citrus aurantium.

[0008] Furthermore, the preparation method of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus is as follows:

[0009] S1. Weigh the raw material, place it in a clean container, add 6-8 times the total volume of purified water to the container, and soak for 30-40 minutes to obtain the soaked raw material;

[0010] S2. Pour the soaked raw materials into a decoction pot, heat over high heat until boiling, then reduce to low heat and simmer for 40-50 minutes. Filter with gauze to obtain the dregs and collect the liquid for later use.

[0011] S3. Add 4-6 times the volume of purified water to the dregs, pour them into a decoction pot, decoct for 30-40 minutes, then filter with gauze and collect the liquid for later use.

[0012] S4. Combine medicinal solution 1 and medicinal solution 2, stir evenly, and cool to room temperature to obtain the Chinese medicine.

[0013] Furthermore, the Chinese medicine with the effect of killing the embryo and terminating the pregnancy can be in the form of decoction, granules, capsules, tablets, pills or ointment.

[0014] Secondly, the present invention provides the application of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus in the preparation of a drug for treating ectopic pregnancy.

[0015] Thirdly, the present invention provides the application of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus in the preparation of a drug for treating diseases of retained products of pregnancy in the uterus.

[0016] This invention utilizes a comprehensive formula of seven herbs to achieve both embryo-killing and abortion simultaneously. Lithospermum erythrorhizon kills embryonic activity, myrrh and clematis vine help kill the embryo by removing blood stasis, mallow seed and motherwort promote embryo expulsion, and immature bitter orange regulates qi to assist in expulsion and prevent the formation of new blood stasis. The entire formula works synergistically to achieve both embryo-killing and abortion, with rapid onset and significant efficacy. Detailed Implementation

[0017] In order to make the objectives, technical solutions and advantages of the present application clearer and more understandable, the present application will be further described in detail below in conjunction with embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application. Reagents not described in detail separately in the present application are all conventional reagents and can be obtained from commercial channels; methods not described in detail specifically are all conventional experimental methods and can be known from the prior art.

[0018] It should be noted that the terms "first", "second", etc. in the description and claims of the present invention are used to distinguish similar objects and do not necessarily need to describe a specific order or sequence, nor do they play a substantial limiting role on the subsequent technical features.

[0019] In order to better understand the present invention rather than limit the scope of the present invention, all numbers representing dosages, percentages, and other numerical values used in the present application should be understood to be modified by the word "about" in all cases. Therefore, unless otherwise specified, the numerical parameters listed in the description and the appended claims are approximate values, which may be changed according to different desired properties. Each numerical parameter should at least be regarded as obtained based on the reported significant figures and by the conventional rounding method.

[0020] On the one hand, the present invention provides a traditional Chinese medicine with the efficacy of killing the embryo and inducing abortion. Calculated by mass parts, the traditional Chinese medicine is made from the following raw materials: 30 - 50 parts of Lithospermum erythrorhizon, 15 - 20 parts of Malva verticillata L., 15 - 20 parts of Myrrha, 15 - 20 parts of Cyathula officinalis Kuan, 20 - 30 parts of Sargentodoxa cuneata, 15 - 25 parts of Leonurus japonicus Houtt., 15 - 25 parts of Aurantii Fructus Immaturus.

[0021] This prescription is composed of Lithospermum erythrorhizon, Malva verticillata L., Myrrha, Cyathula officinalis Kuan, Sargentodoxa cuneata, Leonurus japonicus Houtt., and Aurantii Fructus Immaturus in compatibility, following the principle of monarch, minister, assistant, and courier in the prescription. Lithospermum erythrorhizon is used as the monarch drug, which cools the blood and promotes blood circulation, detoxifies and dissipates nodules to disperse the ectopic pregnancy mass, and has the efficacy of killing the embryo and inducing abortion, and clearing the ectopic tissue. Malva verticillata L. and Myrrha are used as minister drugs. Malva verticillata L. is smooth and promotes qi and opens the passage, guiding the fetus downward; Myrrha disperses stasis and relieves pain, assisting the monarch drug to enhance the power of promoting blood circulation and inducing abortion. The two work together to open up the downward passage and resolve stasis and nodules, serving as ministerial assistants. Cyathula officinalis Kuan, Sargentodoxa cuneata, and Leonurus japonicus Houtt. are used as assistant drugs. Cyathula officinalis Kuan promotes blood circulation and dredges the meridian, guiding blood (medicine) downward, making the medicinal power reach the affected area directly; Sargentodoxa cuneata (i.e., Sargentodoxa cuneata) promotes blood circulation and disperses stasis, detoxifies and relieves pain, and is good at eliminating the mutual binding of stasis and heat; Leonurus japonicus Houtt. is an important drug for gynecological menstruation and childbirth, specializing in promoting blood circulation and regulating menstruation, and can also promote the contraction of uterine smooth muscle. The three drugs comprehensively strengthen the effect of promoting blood circulation and removing the embryo from three aspects: guiding the meridian, dispersing stasis and clearing heat, and promoting contraction and discharge. Aurantii Fructus Immaturus is used as the courier drug, regulating qi and promoting qi movement, enhancing the effect of promoting blood circulation and removing stasis of the whole prescription, and guiding the stasis of the embryo after killing downward.

[0022] The core functions of Lithospermum erythrorhizon are clearing heat and cooling blood, promoting blood circulation, and detoxifying and dispersing nodules. Traditionally, it is used to treat purplish-black rashes, sores, boils, eczema, and burns caused by excessive heat and toxins in the blood. Combined with this formula, it is suitable for ectopic pregnancies and retained products of conception due to blood stasis and heat accumulation. It can cool the blood and promote blood circulation, dissipate masses of blood stasis and heat accumulation in the uterus and uterine vessels, and improve the core pathogenesis of internal obstruction of blood stasis and heat. Pharmacological studies have shown that Lithospermum erythrorhizon has the effects of destroying trophoblast cells in embryonic villi, anti-inflammatory effects, improving local microcirculation, and inhibiting abnormal tissue proliferation.

[0023] The core functions of Malva verticillata seeds are to promote urination and relieve strangury, lubricate the pores, promote lactation, and moisten the intestines to relieve constipation. Traditionally, it is used for strangury, edema, insufficient lactation, and constipation due to intestinal dryness. In this formula, its properties of lubricating downward movement and clearing the lower abdomen are utilized to treat conditions where embryonic tissue or uterine cavity residue is obstructed, and the expulsion pathway is blocked, thus opening a path for the expulsion of abnormal tissue.

[0024] Myrrh's core effects are dispersing blood stasis, relieving pain, reducing swelling, and promoting tissue regeneration. Traditionally, it is used for chest pain, dysmenorrhea, postpartum abdominal pain due to blood stasis, traumatic injuries, carbuncles, and sores caused by blood stasis. In this formula, it primarily targets blood stasis pain caused by ectopic pregnancy and retained products of conception, enhancing the formula's ability to resolve blood stasis and alleviate local pain. Pharmacological studies have shown that it possesses anti-inflammatory, analgesic, and local blood circulation-improving pharmacological effects.

[0025] The effects of Achyranthes bidentata (Chuan Niu Xi) are to dispel blood stasis, promote menstruation, guide blood downwards, facilitate joint movement, and promote urination. Traditionally, it is used for amenorrhea, postpartum abdominal pain due to blood stasis, joint pain, and edema due to urinary tract infections caused by blood stasis. In this formula, its key role is to guide the medicinal power directly to the uterus and the affected area, primarily treating ectopic pregnancy and retained products of conception due to blood stasis in the lower abdomen and uterus, thus enhancing the formula's effect of dispelling blood stasis and promoting menstruation.

[0026] The core effects of *Hedyotis diffusa* are clearing heat and detoxifying, promoting blood circulation and relieving pain. Traditionally used for intestinal abscesses and abdominal pain, sores caused by heat toxins, amenorrhea and dysmenorrhea, postpartum blood stasis, and rheumatic pain. This formula is suitable for ectopic pregnancy, retained products of conception accompanied by blood stasis and heat accumulation, and local inflammatory stagnation. It can both promote blood circulation and dissipate blood stasis to resolve masses, and also clear heat and detoxify, improving local inflammatory reactions.

[0027] Motherwort, used in traditional Chinese medicine, is primarily used for its blood-activating and menstrual-regulating effects, as well as its diuretic and swelling-reducing properties. It is a classic gynecological and obstetric medicine. Traditionally, it is used to treat irregular menstruation, dysmenorrhea, amenorrhea, postpartum lochia retention, abdominal pain due to blood stasis, edema, and oliguria. This formula contains the core ingredient for treating postpartum and postoperative retained products of conception, specifically addressing issues such as lochia retention and retained products of conception. Pharmacological studies have shown that it can stimulate uterine smooth muscle and enhance uterine contractility. Clinically, it is widely used for postpartum lochia retention, retained products of conception after induced abortion, and other gynecological conditions.

[0028] The core functions of Citrus aurantium are regulating qi, relieving chest congestion, and promoting digestion to eliminate stagnation and distension. Traditionally, it is used for qi stagnation in the chest and hypochondrium, abdominal distension and pain, and indigestion. This formula follows the theory that "where qi flows, blood flows," primarily treating gynecological conditions involving both qi stagnation and blood stasis. It unblocks the qi mechanism in the lower abdomen, promotes uterine muscle contraction to expel residual tissue, and also promotes intestinal smooth muscle contraction, improving abdominal distension due to qi stagnation and helping to alleviate pelvic qi stagnation.

[0029] In some embodiments, the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus is made from the following raw materials: 30 parts of Lithospermum erythrorhizon, 15 parts of Malva verticillata, 15 parts of Myrrh, 15 parts of Achyranthes bidentata, 20 parts of Perilla frutescens, 15 parts of Leonurus japonicus, and 15 parts of Citrus aurantium.

[0030] In some embodiments, the preparation method of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus is as follows:

[0031] S1. Weigh the raw material, place it in a clean container, add 6-8 times the total volume of purified water to the container, and soak for 30-40 minutes to obtain the soaked raw material;

[0032] S2. Pour the soaked raw materials into a decoction pot, heat over high heat until boiling, then reduce to low heat and simmer for 40-50 minutes. Filter with gauze to obtain the dregs and collect the liquid for later use.

[0033] S3. Add 4-6 times the volume of purified water to the dregs, pour them into a decoction pot, decoct for 30-40 minutes, then filter with gauze and collect the liquid for later use.

[0034] S4. Combine medicinal solution 1 and medicinal solution 2, stir evenly, and cool to room temperature to obtain the Chinese medicine.

[0035] In some embodiments, the traditional Chinese medicine preparations with the effect of killing the embryo and expelling the fetus are decoctions, granules, capsules, tablets, pills or ointments.

[0036] Based on the same inventive concept, the present invention also provides the application of the above-mentioned traditional Chinese medicine with the effect of killing the embryo and expelling the fetus in the preparation of a treatment for ectopic pregnancy.

[0037] Based on the same inventive concept, the present invention also provides the application of the above-mentioned traditional Chinese medicine with the effect of killing the embryo and expelling the fetus in the preparation of a treatment for diseases of retained products of pregnancy in the uterus.

[0038] The present invention will be further illustrated 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.

[0039] The following examples are provided to better illustrate the present invention. However, the present invention is not limited to the specific embodiments described.

[0040] Example 1: Preparation of a traditional Chinese medicine with the effect of killing the embryo and expelling the fetus

[0041] 1.1 Preparation of decoction

[0042] By weight, the traditional Chinese medicine with the effect of killing the embryo and terminating the fetus in this embodiment is made from the following raw materials: 30 parts of Lithospermum erythrorhizon, 15 parts of Malva verticillata, 15 parts of Commiphora myrrha, 15 parts of Achyranthes bidentata, 20 parts of Perilla frutescens, 15 parts of Leonurus japonicus, and 15 parts of Citrus aurantium. The above-mentioned medicinal materials are mixed, and soaked in water equal to 8 times the total weight of the medicinal materials for 30 minutes. After boiling over high heat, the mixture is simmered over low heat for 40 minutes. The dregs are collected, and the filtrate is collected to obtain liquid 1. The dregs are then added to water equal to 6 times the total weight of the medicinal materials, and simmered for 30 minutes. Liquid 2 is then filtered out. Liquids 1 and 2 are combined and concentrated to a concentration of approximately 0.5g of raw medicinal material per milliliter to obtain the decoction. One dose is taken daily, decocted in water to obtain 400ml of liquid, and taken warm twice a day, morning and evening.

[0043] 1.2 Preparation of Granules

[0044] According to the proportions in Example 1.1, a total weight of 10 kg of medicinal materials was weighed. First, drinking water, eight times the total weight of the medicinal materials, was added and decocted for 1.5 hours, then the liquid was filtered. Then, six times the amount of water was added to the dregs, and the mixture was decocted for another 1.5 hours, and the liquid was filtered again. The two filtrates were combined and filtered through multiple layers of gauze and filter paper. The mixture was then concentrated at 60°C under reduced pressure to a thick paste with a relative density of 1.12 g / cm³, yielding approximately 3.5 kg of the thick paste.

[0045] Take the above-mentioned thick paste, add 2.8 kg of dextrin (equivalent to 80% of the paste's mass) as a molding excipient, and 0.5 kg of steviol glycosides as a flavoring agent (accounting for 1% of the total weight of the dried granules). Mix thoroughly in a mixer, granulate using wet granulation technology, and dry in a 60℃ hot air circulating oven until the moisture content is ≤8%. After granulation, package into 10 g packets to obtain granules. Dosage: One packet three times a day, dissolved in boiling water.

[0046] 1.3 Preparation of Capsules

[0047] The thick paste was prepared according to the method in Example 1.2, dried, pulverized into a fine powder, and passed through a 100-mesh sieve. The powder was then filled into capsule shells to form capsules with a weight of 0.4g each. The dosage is 4-6 capsules three times a day, orally.

[0048] 1.4 Tablet Preparation

[0049] ① Prepare the thick paste and fine powder according to the preparation method of granules in 1.2. Add appropriate excipients to the fine powder, including a diluent (selected from microcrystalline cellulose, starch, or lactose, at a dosage of 1 times the mass of the active ingredient), a binder (selected from hydroxypropyl methylcellulose solution or povidone solution, with a volume concentration of 10%, at a dosage of 0.2 times the mass of the active ingredient), and a disintegrant (selected from crospovidone or sodium carboxymethyl starch, at a dosage of 0.1 times the mass of the active ingredient). First, mix the active ingredient, diluent, and disintegrant in a three-dimensional motion mixer for 15 minutes. Then add the binder and stir evenly to form a soft mass. ② Granulation and drying: Place the soft mass in a gyratory granulator and granulate it through a 14-16 mesh sieve to obtain wet granules. Place the wet granules in a fluidized bed dryer and dry them at 70℃ until the moisture content of the granules drops to 5%, obtaining dry granules. ③ Granulation and mixing: Place the dry granules in a gyratory granulator and granulate them through a 16-18 mesh sieve. Then add magnesium stearate as a lubricant, with an amount of 0.03 times the mass of the active pharmaceutical ingredient. Mix the mixture in a three-dimensional motion mixer for 10 minutes to obtain tablet granules. Tableting involves placing the tablet granules in a rotary tablet press, setting the tablet weight to 0.5 grams per tablet, and pressing at a speed of 20–30 revolutions per minute to obtain a semi-finished tablet product. Coating: The semi-finished tablets are placed in a high-efficiency coating machine and coated with either hydroxypropyl methylcellulose or acrylic resin No. IV, a stomach-soluble coating material. The amount of coating material used is 3% of the weight of the semi-finished tablet (i.e., the tablet core). The coating temperature is 50℃, and the coating time is 60 minutes, until the tablet surface is smooth and the color is uniform, thus obtaining coated tablets. Take 4 tablets twice daily with warm water. The course of treatment is the same as for decoction.

[0050] 1.5 Preparation of pills (concentrated water-honey pills)

[0051] Weigh all medicinal materials according to the proportions in Example 1.1, with a total weight of 10 kg. Add 8 times (for the first decoction) and 6 times (for the second decoction) of water respectively, and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a thick extract with a relative density of 1.25 g / cm³ at 60°C. Mix the thick extract with an appropriate amount of refined honey (the mass ratio of extract to refined honey is 5:4), form a soft mass, shape into pills, and dry at below 70°C to obtain pills. Each 10 pills weigh approximately 2 g. The dosage is 6 g (30 pills) three times a day, taken with warm water.

[0052] 1.6 Preparation of Ointments (Decoctions)

[0053] Weigh all medicinal materials according to the proportions in Example 1.1, with a total weight of 5 kg. Add 8 times (for the first decoction) and 6 times (for the second decoction) of water respectively, and decoct twice, 2 hours each time. Combine the decoctions, filter, and let the filtrate stand to settle for 24 hours. Take the supernatant and concentrate it to a clear paste with a relative density of 1.30 g / cm³ at 60°C. Add an equal mass of refined honey to the clear paste, heat over low heat, and stir constantly until fully mixed. Reduce the paste to obtain the decoction preparation. When taking, take 15 g of the paste, dissolve it in warm water, and take it twice a day.

[0054] Example 2: Clinical efficacy trial for treating ectopic pregnancy

[0055] 2.1 Research Design and Research Subjects

[0056] This research protocol has passed ethical review, all participants voluntarily signed informed consent forms, and the researchers adhered to ethical standards.

[0057] The patients were aged 22-38 years, with a mean age of (28.5±4.2) years and a duration of amenorrhea of ​​37-58 days. Patients were randomly assigned to a treatment group and a control group using a random number table, with 30 patients in each group.

[0058] Inclusion criteria: ① Stable vital signs and no signs of active internal bleeding; ② Serum β-HCG level between 500-2000 IU / L; ③ Vaginal ultrasound showing an ectopic pregnancy mass in the adnexal region with a maximum diameter ≤4.0 cm and no primitive cardiac tube pulsation detected; ④ Normal liver and kidney function and coagulation function.

[0059] 2.2 Treatment methods

[0060] The treatment group received oral administration of the traditional Chinese medicine granules prepared in Example 2 of this invention (preparation method is the same as in Example 1 of the instructions). Dosage: 10g each time, 3 times daily, dissolved in warm water. The control group received oral administration of mifepristone tablets, 50mg each time, twice daily. The treatment course for both groups was 14 days. During treatment, the use of other traditional Chinese medicines that promote blood circulation and remove blood stasis, or drugs that affect hormone levels, was prohibited. Mifepristone is a currently recognized drug for medical abortion, with good embryo-killing effects, used for ectopic pregnancies and retained products of conception. Using it as a control in this study is of comparative significance.

[0061] 2.3 Observation Indicators and Detection Methods

[0062] 1. Symptom observation: Record and assess the location, nature, degree and duration of the patient's abdominal pain, as well as the amount, color and duration of vaginal bleeding, in detail and daily until the symptoms disappear, and record the specific time when the symptoms disappear.

[0063] 2. Serum β-HCG monitoring: Venous blood was collected before treatment, on day 7 and day 14 after treatment. Chemiluminescence assay and matching kit (Abbott Laboratories, USA, batch number 71474UD03) were used. This method is based on the double antibody sandwich chemiluminescence principle. The sample addition, incubation, washing, luminescence signal reading and concentration calculation were automatically completed by a fully automated immunoassay analyzer (Abbott Laboratories, USA, I2000SR). Quality control was performed on each batch of tests. The results were reported in international units (IU / L) to determine the serum β-HCG level.

[0064] 3. Ultrasound examination: Transvaginal ultrasound examinations were performed by the same sonographer (who was unaware of the grouping) before treatment, on the 7th, 14th and 21st day after treatment, to measure the three-dimensional diameter (length × width × height) of the adnexal mass, calculate its volume change, and observe the pelvic effusion.

[0065] 2.4 Criteria for Evaluating Therapeutic Effect

[0066] The national college textbook "Obstetrics and Gynecology" (10th edition) establishes the following efficacy standards:

[0067] Cure: Clinical symptoms such as abdominal pain and irregular vaginal bleeding completely disappear; serum β-HCG levels drop to normal (<5 IU / L) in two consecutive tests; ultrasound re-examination shows that the adnexal mass has completely disappeared or its maximum diameter has decreased by >50%.

[0068] Effective: Clinical symptoms are significantly reduced or disappear; serum β-HCG levels decrease by >50% compared to before treatment; ultrasound shows no increase in mass size.

[0069] Ineffective: The above "effective" criteria were not met, or the patient was switched to surgical treatment due to worsening abdominal pain, enlargement of the mass, or persistently elevated blood β-HCG levels during the treatment period.

[0070] 2.5 Baseline data and efficacy results

[0071] There were no statistically significant differences between the two groups of patients in baseline data such as age, parity, number of days of amenorrhea, pretreatment serum β-HCG level, and maximum diameter of the mass (P>0.05) (see Table 1), indicating comparability.

[0072] Table 1. Comparison of baseline data between the two groups of patients with ectopic pregnancy (x̄±s)

[0073]

[0074] The clinical efficacy comparison between the two groups of ectopic pregnancy patients is shown in Table 2. The total effective rate in the treatment group was 76.7%, and the cure rate was 63.3%; the total effective rate in the control group was 76.7%, and the cure rate was 60.0%. There was no significant difference in the total effective rate and cure rate between the two groups. The time required for serum β-HCG to drop to normal levels (<5 IU / L) was 18.5 days in the treatment group and 18.6 days in the control group, with no significant difference between the two groups. The time required for mass absorption was 18.7 days in the treatment group and 26.4 days in the control group, with the treatment group taking significantly less time than the control group. The study suggests that the effect of traditional Chinese medicine on ectopic pregnancy is comparable to that of mifepristone, but the absorption time of the mass is shorter in the traditional Chinese medicine group than in the mifepristone group.

[0075] Table 2 Comparison of clinical efficacy between the two groups of patients with ectopic pregnancy

[0076]

[0077] 2.6 Typical Cases

[0078] Patient Li, a 29-year-old woman in the treatment group, presented with right lower abdominal pain for 3 days after 39 days of amenorrhea. Upon admission, serum β-HCG was 1850 IU / L. Transvaginal ultrasound revealed a heterogeneous mass approximately 2.8 cm × 2.5 cm in size in the right adnexal region, without cardiac activity, and she was diagnosed with a right ectopic pregnancy (unruptured). She was treated with the herbal granules of this invention. After 7 days of medication, the abdominal pain disappeared, and a follow-up serum β-HCG level dropped to 120 IU / L. Medication was continued until day 14, when serum β-HCG returned to normal levels (<5 IU / L). A follow-up ultrasound on day 21 showed that the original adnexal mass had largely resolved. No drug-related adverse reactions occurred during the treatment period.

[0079] 2.7 Safety Evaluation

[0080] One patient in the treatment group experienced mild nausea at the beginning of medication; no specific treatment was given, and the symptoms resolved spontaneously within two days. Two patients in the positive control group developed mild oral ulcers. No clinically significant abnormalities were observed in liver and kidney function or complete blood counts before and after treatment in either group, and no serious adverse events occurred.

[0081] Example 3: Clinical efficacy trial in treating retained products of pregnancy in the uterus

[0082] 3.1 Research Design and Research Subjects

[0083] This was a randomized, controlled clinical trial, and all procedures complied with ethical guidelines. Eighty consecutive patients who had undergone induced abortion at our hospital were included. Transvaginal ultrasound confirmed retained products of conception, with the largest diameter of the retained products ranging from 1.0 to 2.5 cm, and accompanied by postoperative vaginal bleeding lasting ≥10 days. Patients were randomly assigned to a treatment group and a control group using a random number table, with 40 patients in each group.

[0084] Before treatment, detailed records were kept of all patients' age, obstetric history, gestational age at miscarriage, size of retained products of conception (volume measured by 3D ultrasound), serum β-HCG level, vaginal bleeding, and TCM syndrome type. There were no statistically significant differences in any baseline data between the two groups (P>0.05), making them comparable.

[0085] 3.2 Treatment methods

[0086] The treatment group received oral administration of the traditional Chinese medicine granules prepared in Example 3 of this invention, 10g each time, three times a day, dissolved in warm water. The control group received oral administration of commercially available Leonurus japonicus granules, 15g each time, three times a day. The treatment course for both groups was 7 days. No other uterine contraction agents or hemostatic drugs were used during the treatment period.

[0087] 3.3 Observation indicators and efficacy criteria

[0088] 3.3.1. Main observation indicators: record the time of discharge of residual substances after medication and the time of cessation of vaginal bleeding.

[0089] 3.3.2. Ultrasound follow-up: Transvaginal ultrasound examinations were performed on the 3rd and 7th days after the end of the treatment course to observe whether there were any abnormal echoes in the uterine cavity and to measure the thickness of the endometrium.

[0090] 3.3.3. Criteria for Evaluating Therapeutic Effect:

[0091] Cure: During medication, there was clear discharge of residual tissue, and vaginal bleeding completely stopped within 3 days after the end of the treatment course; ultrasound re-examination showed clear uterine cavity lines with no abnormal echoes, and the endometrial thickness was uniform and ≤10 mm.

[0092] Effective: Vaginal bleeding reduced by >50%, and ultrasound showed a reduction of >50% in the maximum diameter of the remaining tissue.

[0093] Ineffective: If vaginal bleeding does not improve or increases, and the remaining tissue does not change or increases in size, a dilation and curettage (D&C) procedure will eventually be required.

[0094] 3.4 Therapeutic Results

[0095] The experimental results are shown in Table 3. In the treatment group, 33 cases were cured, 5 cases were effective, and 2 cases were ineffective, with a total effective rate of 95.0% and a cure rate of 82%. In the control group, 22 cases were cured, 8 cases were effective, and 10 cases were ineffective, with a total effective rate of 75.0% and a cure rate of 55%. The difference in total effective rate between the two groups was statistically significant (P<0.05). The average time for residual tissue discharge was 3.2 days in the treatment group and 5.1 days in the control group, with the treatment group being significantly shorter than the control group (P<0.001). The average time for vaginal bleeding to stop was 5.8 days in the treatment group and 8.3 days in the control group, with the treatment group being significantly shorter than the control group (P<0.001).

[0096] Table 3. Comparison of clinical efficacy between the two groups of patients with retained products of pregnancy.

[0097]

[0098] 3.5 Typical Cases

[0099] Patient Wang, 32 years old, presented with persistent vaginal spotting 15 days after a medical abortion. Ultrasound examination revealed a mixed echogenic mass approximately 1.8 cm × 1.2 cm in size within the uterine cavity, diagnosed as retained products of pregnancy. She was treated with the herbal granules of this invention. On the third day of treatment, intact fleshy tissue was expelled, and the vaginal bleeding significantly decreased; the bleeding completely stopped on the fifth day; a follow-up ultrasound on the seventh day showed a clear uterine cavity line, an endometrial thickness of approximately 6 mm, and no abnormal echoes. She experienced no significant discomfort during the treatment period.

[0100] 3.6 Safety Evaluation

[0101] One patient in the treatment group reported mild bloating after taking the medication, which resolved spontaneously within one day without treatment. One patient in the control group experienced mild diarrhea. No other serious adverse reactions occurred in either group, and liver and kidney function and blood routine test results remained normal before and after treatment.

[0102] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application.

Claims

1. A traditional Chinese medicine having the efficacy of killing the embryo under the fetus, characterized in that, The traditional Chinese medicine with the effect of killing the embryo and terminating the fetus, by weight, is made from the following raw materials: 30-50 parts of Lithospermum erythrorhizon, 15-20 parts of Malva verticillata, 15-20 parts of Commiphora myrrha, 15-20 parts of Achyranthes bidentata, 20-30 parts of Perilla frutescens, 15-25 parts of Leonurus japonicus, and 15-25 parts of Citrus aurantium.

2. The traditional Chinese medicine with the effect of killing the embryo and expelling the fetus according to claim 1, characterized in that, The traditional Chinese medicine with the effect of killing the embryo and terminating the fetus, by weight, is made from the following raw materials: 30 parts of Lithospermum erythrorhizon, 15 parts of Malva verticillata, 15 parts of Myrrh, 15 parts of Achyranthes bidentata, 20 parts of Perilla frutescens, 15 parts of Leonurus japonicus, and 15 parts of Citrus aurantium.

3. The traditional Chinese medicine according to claim 2, characterized in that, The preparation method is as follows: S1. Weigh the raw material, place it in a clean container, add 6-8 times the total volume of purified water to the container, and soak for 30-40 minutes to obtain the soaked raw material; S2. Pour the soaked raw materials into a decoction pot, heat over high heat until boiling, then reduce to low heat and simmer for 40-50 minutes. Filter with gauze to obtain the dregs and collect the liquid for later use. S3. Add 4-6 times the volume of purified water to the dregs, pour them into a decoction pot, decoct for 30-40 minutes, filter with gauze, and collect the liquid for later use. S4. Combine medicinal solution 1 and medicinal solution 2, stir evenly, and cool to room temperature to obtain the Chinese medicine.

4. The traditional Chinese medicine with the effect of killing the embryo and expelling the fetus according to any one of claims 1-3, characterized in that: The Chinese medicine preparations mentioned are decoctions, granules, capsules, tablets, pills, or ointments.

5. The use of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus as described in any one of claims 1-4 in the preparation of a drug for treating ectopic pregnancy.

6. The use of the traditional Chinese medicine with the effect of killing the embryo and expelling the fetus as described in any one of claims 1-4 in the preparation of a medicine for treating diseases of retained products of pregnancy in the uterus.

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