Use of Shenghua Xinggao combined with mifepristone in treating embryonic residue after medical abortion

Abstract

The present application relates to the use and combination of Shenghua Xinggao and mifepristone in treating embryo residue after medical abortion. The use of Shenghua Xinggao and mifepristone in treating embryo residue after medical abortion can make the blood flow signal of residue disappear and HCG decrease rapidly, thereby greatly reducing the risk of surgical curettage for patients, and has important clinical value.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to the use and combined use of biochemical uterine ointment with mifepristone in the treatment of retained products of conception after miscarriage. Background Technology

[0002] Incomplete abortion is a common complication after medical abortion, referring to the expulsion of some pregnancy products from the body while others remain in the uterine cavity. This can lead to retained products of conception, intrauterine adhesions, and endometrial damage, thereby reducing fertility in women of childbearing age and even causing infertility. The reported incidence is 1%–6%, but can be as high as 15% after medical abortion. Current treatments for incomplete abortion mainly include curettage, conservative medical treatment, and expectant management. Curettage has a high effectiveness rate, but because it is an invasive procedure, it may be accompanied by surgical complications and cause some physical and psychological trauma to the patient.

[0003] Conservative drug treatment is suitable for those with moderate retained products of conception or those unwilling to undergo surgery. It is non-invasive and well-tolerated, but has limitations such as prolonged bleeding and the need for a second curettage in some patients. Inappropriate combinations of mifepristone and misoprostol, insufficient dosage, or individual differences in drug sensitivity due to genetic polymorphism can all lead to uterine atony and incomplete expulsion of pregnancy tissue. Expectant management is only suitable for those with retained products of conception ≤1.5cm, minimal bleeding, and high compliance. It does not require drug or surgical intervention, but has a slow onset of action, high uncertainty, and is prone to risks such as anemia and infection. Some patients may need to switch to other treatments. In summary, all three Western medicine approaches have shortcomings and cannot achieve the ideal of high efficiency, safety, and non-invasiveness, thus providing room for the application of integrated traditional Chinese and Western medicine treatment.

[0004] However, existing Chinese medicine compositions still need further optimization in terms of the types and proportions of Chinese herbal ingredients added to the prescriptions to reduce side effects and improve therapeutic efficacy. Moreover, they still need to be improved in terms of promoting patients' pregnancy rates and quality of life, making it difficult to meet patients' fertility needs.

[0005] Existing technologies suffer from drawbacks such as poor efficacy in treating retained products of conception after medical abortion, limited improvement in hemodynamics, poor reduction in HCG levels, and high surgical intervention rates. Therefore, to address these issues, this invention provides a clinical treatment method combining the traditional Chinese medicine formula Sheng Hua Xin Gong Gao with mifepristone for treating retained products of conception after abortion. Summary of the Invention

[0006] The purpose of this invention is to overcome the shortcomings of existing technologies and provide a biochemical uterine ointment for treating retained products of conception after miscarriage. It also provides the use of the biochemical uterine ointment in combination with mifepristone in the preparation of a drug for treating retained products of conception after miscarriage. This combined treatment can effectively treat retained products of conception after medical abortion, improve hemodynamics, reduce HCG levels, and decrease the rate of surgical intervention.

[0007] This invention provides the following technical solutions: In a first aspect, the present invention relates to the use of a combination of biochemical uterine ointment and mifepristone in the preparation of a medicament for treating retained products of conception after miscarriage, wherein the biochemical uterine ointment is made from the following raw materials in parts by weight: Angelica sinensis 10-20 parts, Ligusticum chuanxiong 10-15 parts, Prunus persica 5-15 parts, Zingiber officinale (processed) 2-8 parts, Glycyrrhiza uralensis (processed) 2-8 parts, Lithospermum erythrorhizon 5-15 parts, Leonurus japonicus 20-40 parts, Sargentodoxa cuneata 20-40 parts, Lycopus lucidus 5-15 parts, Sparganium stoloniferum 5-15 parts, Curcuma zedoaria 5-15 parts, Salvia miltiorrhiza 10-20 parts.

[0008] In some embodiments, the biochemical uterine ointment is made from the following parts by weight of active pharmaceutical ingredient: Angelica sinensis 15 parts, Ligusticum chuanxiong 12 parts, Prunus persica 9 parts, Zingiber officinale (processed) 6 parts, Glycyrrhiza uralensis (processed) 6 parts, Lithospermum erythrorhizon 10 parts, Leonurus japonicus 30 parts, Sargentodoxa cuneata 30 parts, Lycopus lucidus 10 parts, Sparganium stoloniferum 9 parts, Curcuma zedoaria 9 parts, Salvia miltiorrhiza 15 parts. Preferably: Angelica sinensis 15g, Ligusticum chuanxiong 12g, Prunus persica 9g, Zingiber officinale (processed) 6g, Glycyrrhiza uralensis (processed) 6g, Lithospermum erythrorhizon 10g, Leonurus japonicus 30g, Sargentodoxa cuneata 30g, Lycopus lucidus 10g, Sparganium stoloniferum 9g, Curcuma zedoaria 9g, Salvia miltiorrhiza 15g.

[0009] In some embodiments, the preparation method of the biochemical uterine cream is as follows: Weigh out each raw medicinal herb slice according to the prescription, soak in water, decoct to extract the supernatant, concentrate, add flavoring agent to continue to concentrate to form an ointment, sterilize and package. The amount of water used is 10-15 times the weight of the raw drug, preferably 12 times; The extraction was performed twice, and the decoction time was 1.5 hours. The concentration is a vacuum concentration; The flavoring agent is a sweetener, preferably sucrose, honey, xylitol, or erythritol.

[0010] In some embodiments, the preparation method of the biochemical uterine cream is as follows: Soak the above-mentioned raw medicinal materials in water, with the water volume being 10-15 times the weight of the raw materials, preferably 12 times; decoct and extract the supernatant, decoct for 1.5 hours, extract twice, and combine the decoctions; concentrate the combined decoction under reduced pressure, controlling the temperature at 50-80℃ and the vacuum degree (absolute value) ≥0.06MPa, until a clear paste with a relative density of 1.20-1.25 is measured at 60℃; add a sweetener to the clear paste, with the sweetener dosage being 30% of the amount of raw materials, and continue to concentrate under reduced pressure until a thick paste with a relative density of 1.35-1.40 is measured at 60℃; place the thick paste in a paste packaging machine, dispense it into sterile pharmaceutical packaging containers, seal them, sterilize them in a traditional Chinese medicine sterilization cabinet at 100℃ for 60 minutes, and cool to room temperature.

[0011] In some embodiments, the preparation method of the biochemical uterine cream is as follows: ① Soaking: Weigh out each raw medicinal herb slice according to the prescription amount and soak in 12 times the amount of purified water; ② Decoction extraction: Heating and decocting twice. The first decoction is for 1.5 hours, and the second decoction is for 1.5 hours with 10 times the amount of purified water. Filter, combine the two decoctions, let stand for 12 hours, and take the supernatant. ③ Reduced pressure concentration: Filter the supernatant and place it in a reduced pressure concentration tank. Control the temperature at 50-80℃ and the vacuum degree (absolute value) at ≥0.06MPa. Concentrate to 60℃ to obtain a clear paste with a relative density of 1.20-1.25. ④ To concentrate the extract, add sweetener to the clear extract at 30% of the amount of medicinal slices added, stir evenly, and continue to concentrate under reduced pressure until a thick extract with a relative density of 1.35 to 1.40 is obtained at 60℃. ⑤ Sterilization and Packaging: While the thick paste is still hot, place it in a paste packaging machine, distribute it into sterile pharmaceutical packaging containers, seal them, sterilize them at 100°C for 60 minutes using a traditional Chinese medicine sterilization cabinet, and cool them to room temperature to obtain the final product.

[0012] In some embodiments, the biochemical uterine ointment is further prepared into an oral formulation.

[0013] In some embodiments, the oral preparation is an ointment, decoction, powder, capsule, tablet, granule or pill; preferably an ointment.

[0014] Secondly, the present invention also relates to a traditional Chinese medicine composition for treating retained embryonic tissue after miscarriage, wherein the traditional Chinese medicine composition is a biochemical uterine ointment, made from the following raw materials in parts by weight: Angelica sinensis 10-20 parts, Ligusticum chuanxiong 10-15 parts, Prunus persica 5-15 parts, Zingiber officinale (processed) 2-8 parts, Glycyrrhiza uralensis (processed) 2-8 parts, Lithospermum erythrorhizon 5-15 parts, Leonurus japonicus 20-40 parts, Sargentodoxa cuneata 20-40 parts, Lycopus lucidus 5-15 parts, Sparganium stoloniferum 5-15 parts, Curcuma zedoaria 5-15 parts, Salvia miltiorrhiza 10-20 parts; Preferably: Angelica sinensis 15 parts, Ligusticum chuanxiong 12 parts, Prunus persica 9 parts, Zingiber officinale (processed) 6 parts, Glycyrrhiza uralensis (processed) 6 parts, Lithospermum erythrorhizon 10 parts, Leonurus japonicus 30 parts, Sargentodoxa cuneata 30 parts, Lycopus lucidus 10 parts, Sparganium stoloniferum 9 parts, Curcuma zedoaria 9 parts, Salvia miltiorrhiza 15 parts. More preferably: Angelica sinensis 15g, Ligusticum chuanxiong 12g, Prunus persica 9g, Zingiber officinale (processed) 6g, Glycyrrhiza uralensis (processed) 6g, Lithospermum erythrorhizon 10g, Leonurus japonicus 30g, Sargentodoxa cuneata 30g, Lycopus lucidus 10g, Sparganium stoloniferum 9g, Curcuma zedoaria 9g, Salvia miltiorrhiza 15g.

[0015] In some embodiments, the use of the traditional Chinese medicine composition in the preparation of a medicament for treating retained embryonic tissue after miscarriage.

[0016] Thirdly, the present invention also relates to a pharmaceutical combination for treating retained embryonic tissue after miscarriage, the combination comprising Biochemical New Palace Cream and mifepristone.

[0017] In some embodiments, the biochemical uterine ointment in the drug combination can reduce residual blood flow signals in the uterine cavity and HCG levels in patients with retained embryonic tissue after mifepristone treatment for miscarriage, and reduce the risk of surgical intervention.

[0018] In some embodiments, Angelica sinensis in the Biochemical New Uterus Ointment invigorates blood and nourishes blood, having a bidirectional regulatory effect on the uterus. Its water-soluble, non-volatile crystalline components can excite uterine smooth muscle and promote uterine contractions, while its volatile oil can inhibit uterine muscle fibers, causing them to relax, thus having sedative, analgesic, and anti-inflammatory effects. Ligusticum chuanxiong invigorates blood and promotes qi circulation, which can contract the uterus, remove blood stasis, and promote the discharge of residual tissue. Peach kernel breaks up blood stasis, moistens dryness, and lubricates the intestines, assisting Ligusticum chuanxiong and Angelica sinensis in enhancing their blood-activating and stasis-removing effects, accelerating the discharge of residual tissue. Lithospermum erythrorhizon cools blood, invigorates blood circulation, detoxifies, and promotes rash eruption, while also clearing heat and preventing prolonged heat formation. Leonurus japonicus invigorates blood, regulates menstruation, promotes diuresis, and reduces swelling. This formula is a key medicine for gynecological blood stasis syndrome. It can effectively promote uterine contraction and help expel blood stasis and residual tissue. *Sargentodoxa cuneata* clears heat and detoxifies, invigorates blood and dispels wind, clearing pelvic heat and preventing infection. *Sparganium stoloniferum* and *Curcuma zedoaria* break up blood stasis, promote qi circulation, eliminate stagnation and relieve pain, enhancing the ability to remove blood stasis, and showing significant effects on stubborn blood stasis. *Salvia miltiorrhiza* invigorates blood, removes blood stasis, unblocks menstruation and relieves pain, assisting other medicines in enhancing blood-activating effects, and also nourishes blood and calms the mind, relieving postoperative abdominal pain and irritability. *Zingiber officinale* warms the meridians and stops bleeding, warms the middle jiao and relieves pain, warms and unblocks the Chong and Ren meridians, compensating for postoperative blood loss and fluid depletion, and internal generation of cold pathogens. *Glycyrrhiza uralensis* invigorates qi and harmonizes the middle jiao, harmonizing other medicines, while also invigorating qi and moderating the strong properties of the blood-activating and stasis-removing medicines in the formula.

[0019] The beneficial effects of the present invention include, but are not limited to: Biochemical New Palace Ointment closely addresses the core pathogenesis of incomplete abortion, characterized by "multiple deficiencies and multiple blood stasis." Based on the principles of Sheng Hua Tang (a traditional Chinese medicine formula) for promoting blood circulation, removing blood stasis, warming the meridians, and nourishing blood, the formula is optimized to treat retained intrauterine pregnancy tissue. Its pharmacological design balances efficacy and convenience, addressing the pain points of traditional decoctions. It is formulated into small-package ointments that do not require decoction, making them convenient to carry and take. Furthermore, it retains the effective components of the medicinal materials, improves the taste, and enhances medication adherence.

[0020] This invention combines mifepristone with the traditional Chinese medicine Sheng Hua Xin Gong Ointment to effectively treat retained products of conception after medical abortion. This avoids the invasive procedures of traditional curettage, reduces surgical complications, protects the patient's reproductive health, and meets the patient's wishes.

[0021] The treatment plan of this invention effectively improves the patient's hemodynamic state, promotes blood circulation, nourishes blood and removes blood stasis through the conditioning effect of traditional Chinese medicine, and enhances the patient's overall health.

[0022] In terms of the final clinical outcomes and intervention value of this study, in the aspect of the final treatment outcome, the experimental group demonstrated excellent clinical efficacy. In the control group, nearly one-third of the patients were forced to switch to hysteroscopic surgery intervention due to ineffective conservative treatment. However, the surgical intervention rate in the experimental group with the addition of ShengHua XinGong Paste was only 3.8% (3 / 80). This result strongly proves that the combination of adding ShengHua XinGong Paste based on routine medical abortion is significantly associated with the disappearance of blood flow signals of residues and the rapid decline of HCG, thereby greatly reducing the risk of surgical uterine curettage for patients and having important clinical promotion value. Detailed implementation method Example

[0023] Preparation of ShengHua XinGong Paste: Prescription: Angelica sinensis 15g, Ligusticum chuanxiong 12g, Prunus persica 9g, Drynaria fortunei 6g, Glycyrrhiza uralensis 6g, Lithospermum erythrorhizon 10g, Leonurus japonicus 30g, Sargentodoxa cuneata 15g, Sparganium stoloniferum 9g, Curcuma zedoaria 9g, Salvia miltiorrhiza 15g.

[0024] Preparation method: ① Soaking Weigh each cut crude drug according to the prescription amount, add 12 times the amount of pure water and soak for 30 minutes.

[0025] ② Decoction Extract and heat for decoction twice. The first decoction is for 1.5 hours, and the second time add 10 times the amount of pure water and decoct for 1.5 hours. Filter, combine the two decoction liquids, let stand for 12 hours, and take the supernatant.

[0026] ③ Vacuum concentration Filter the supernatant, place it in a vacuum concentration tank, control the temperature at 50 - 80°C, and the vacuum degree (absolute value) ≥ 0.06 MPa, and concentrate to a clear paste with a relative density of 1.20 - 1.25 (measured at 60°C).

[0027] ④ Paste collection Add a sweetening agent to the clear paste, and the addition amount is 30% of the crude drug input amount. Stir evenly, and continue to vacuum concentrate to a thick paste with a relative density of 1.35 - 1.40 (measured at 60°C).

[0028] ⑤ Sterilization and packaging趁热Place the thick paste in a paste packaging machine, package it into a medicinal aseptic packaging container, seal it, and sterilize it using a Chinese patent medicine sterilization cabinet (100°C, 60 minutes), and cool it to room temperature to obtain the finished product of ShengHua XinGong Paste. Example

[0029] Clinical trial of ShengHua XinGong Paste combined with mifepristone in the treatment of incomplete abortion patients with intrauterine residues after medical abortion 1. Materials and methods 1.1 General Information 160 patients with incomplete abortion with intrauterine retention after medical abortion who met the inclusion criteria were selected from the outpatient and inpatient departments of our hospital from September 2024 to August 2025. They were randomly divided into a control group (mifepristone tablets) and an experimental group (mifepristone tablets combined with Sheng Hua Xin Gong ointment), with 80 patients in each group.

[0030] 1.2 Inclusion criteria: ① Short duration of retained products of conception (vaginal bleeding time ≤ 14 days); ② Ultrasound showed mixed-like structures or slightly strong echoes with or without blood flow signals in the uterine cavity, and the diameter of the retained tissue in the uterine cavity was small (diameter ≤ 2.5 cm); ③ Positive serum β-HCG (low level).

[0031] 1.3 Exclusion criteria: ① Vaginal bleeding exceeding the usual menstrual flow; ② Potential infection risk requiring surgical treatment; ③ Damage to vital organs such as the heart, liver, and kidneys, or presence of drug allergies or contraindications, especially misoprostol analogue allergies which can cause laryngeal edema and, in severe cases, anaphylactic shock; ④ Suspected ectopic pregnancy; ⑤ Inability to rule out gestational trophoblastic disease; ⑥ Patients unwilling to receive conservative drug treatment; ⑦ Those without follow-up opportunities.

[0032] 1.4 Treatment methods (1) Control group: On the first day of enrollment, the control group took 25mg mifepristone tablets orally twice a day for 3 consecutive days, with a total dose of 150mg (6 tablets) on an empty stomach or 2 hours after eating. (National Drug Certificate No. H10950347, Zhejiang Xianju Pharmaceutical Co., Ltd. 25mg) No food or drink for 2 hours before and after taking the medicine to avoid food stimulation that could aggravate the adverse reactions of misoprostol such as nausea and vomiting. (2) Experimental group: On the basis of the control group, the experimental group took the traditional Chinese medicine Sheng Hua Xin Gong Gao (Example 1) orally twice a day, 100ml each time, after meals, for a total of 14 days. Both groups of patients were instructed not to lie in bed after taking the medicine, to move around more, and to avoid spicy food and alcohol. Serum β-hCG levels were measured in both groups of patients at weeks 1, 2 and 4 after enrollment. Transvaginal color Doppler ultrasound was performed to observe changes in the size of intrauterine remnants and blood flow signals before and after treatment, as well as whether hysteroscopic treatment was ultimately necessary.

[0033] 1.5 Observation indicators (1) Intrauterine residue status by color Doppler ultrasound: The diameter (cm) of intrauterine residue before and after treatment was measured by transvaginal color Doppler ultrasound; (2) Changes in blood flow signal of intrauterine residue; (3) Serum β-hCG level; (4) Whether hysteroscopy was performed in the outcome.

[0034] 1.6 Statistical Analysis Statistical analysis was performed using SPSS 26.0 software. For continuous variables such as age, gestational age, and number of miscarriages, normality was first tested using the Shapiro-Wilk test. Since the data were not normally distributed, statistical descriptions were expressed as median and interquartile range (IQR). The Mann-Whitney U test was used for comparisons between groups. For categorical variables such as residual size, blood flow signal, HCG level, and clinical outcome (whether hysteroscopic surgery was performed), statistical descriptions were expressed as frequency and percentage (n(%)). Fisher's Exact Test was used for comparisons between groups. The standardized mean difference (SMD) was calculated to assess baseline balance between groups. All tests were two-sided, and a p-value < 0.05 was considered statistically significant.

[0035] 2. Results 2.1 Baseline comparison between the two groups of patients Table 1 Comparison of basic information between the two groups of patients

[0036] Baseline Comparison: Evaluation of the homogeneity of baseline data. This study included 160 patients, randomly divided into a control group (mifepristone group) and an experimental group (mifepristone combined with Sheng Hua Xin Gong ointment), with 80 patients in each group. The two groups were completely identical in demographic parameters such as age (median 27.0 years), gestational age (7.0 weeks), and number of miscarriages (1.5 times). Furthermore, at week 1 of enrollment, there were no statistically significant differences between the two groups in terms of intrauterine remnant size, positive blood flow signal rate, and proportion of patients with high HCG levels (>2500 U / L) (P > 0.05). This indicates that the baseline characteristics of the two groups were highly homogeneous, and the study results were highly comparable.

[0037] 2.2 Comparison of residual uterine cavity, residual blood flow signal, HCG value changes and outcomes between the two groups at weeks 1, 2 and 4.

[0038] Table 2. Changes in residual uterine tissue, residual blood flow signal, HCG levels, and outcomes in both groups at weeks 1, 2, and 4.

[0039] Comparison of residual uterine tissue, residual blood flow signals, HCG levels, and outcomes at weeks 1, 2, and 4 after enrollment: dynamic evolution of clinical indicators during treatment. Follow-up results showed that traditional Chinese medicine intervention was effective in improving hemodynamics. By week 2 of treatment, the positive rate of blood flow signals in the experimental group had decreased to 88.8%, significantly lower than the 98.8% in the control group (P=0.018). By week 4, the advantage of the experimental group further expanded: its positive rate of blood flow signals decreased significantly to 8.8%, far superior to the 98.8% in the control group (P<0.001); at the same time, the HCG levels of all patients (100%) in the experimental group were successfully reduced to below 2500 U / L, while 63.7% of patients in the control group still had high levels, and the difference was statistically significant (P<0.001).

[0040] Outcomes: Final clinical outcomes and intervention value. Regarding the final treatment outcome, the experimental group demonstrated superior clinical efficacy. In the control group, 38.8% (31 / 80) of patients ultimately underwent hysteroscopic surgery due to ineffective conservative treatment, while the surgical intervention rate in the experimental group, which also received the Sheng Hua Xin Gong ointment, was only 3.8% (3 / 80), a difference that was statistically significant (P < 0.001).

[0041] The experimental results of this invention demonstrate that the combination of this invention's biochemical uterine ointment with conventional medical abortion treatment is significantly associated with the disappearance of blood flow signals in the uterine cavity and a rapid decrease in HCG, thereby greatly reducing the risk of patients undergoing surgical curettage and has important clinical application value.

[0042] The above description is merely an embodiment of this application, and the scope of protection of this application is not limited to these specific embodiments, but is determined by the claims of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the technical concept and principles of this application should be included within the scope of protection of this application.

Claims

1. The use of biochemical uterine ointment combined with mifepristone in the preparation of a drug for treating retained products of conception after miscarriage, characterized in that, The biochemical uterine ointment is made from the following raw materials in parts by weight: Angelica sinensis 10-20 parts, Ligusticum chuanxiong 10-15 parts, Prunus persica 5-15 parts, Zingiber officinale (processed) 2-8 parts, Glycyrrhiza uralensis (processed) 2-8 parts, Lithospermum erythrorhizon 5-15 parts, Leonurus japonicus 20-40 parts, Sargentodoxa cuneata 20-40 parts, Lycopus lucidus 5-15 parts, Sparganium stoloniferum 5-15 parts, Curcuma zedoaria 5-15 parts, Salvia miltiorrhiza 10-20 parts.

2. The use according to claim 1, characterized in that, The biochemical uterine ointment is made from the following raw materials in parts by weight: Angelica sinensis 15 parts, Ligusticum chuanxiong 12 parts, Prunus persica 9 parts, Zingiber officinale (processed) 6 parts, Glycyrrhiza uralensis (processed) 6 parts, Lithospermum erythrorhizon 10 parts, Leonurus japonicus 30 parts, Sargentodoxa cuneata 30 parts, Lycopus lucidus 10 parts, Sparganium stoloniferum 9 parts, Curcuma zedoaria 9 parts, Salvia miltiorrhiza 15 parts. Preferably: Angelica sinensis 15g, Ligusticum chuanxiong 12g, Prunus persica 9g, Zingiber officinale (processed) 6g, Glycyrrhiza uralensis (processed) 6g, Lithospermum erythrorhizon 10g, Leonurus japonicus 30g, Sargentodoxa cuneata 30g, Lycopus lucidus 10g, Sparganium stoloniferum 9g, Curcuma zedoaria 9g, Salvia miltiorrhiza 15g.

3. The use according to claim 1 or 2, characterized in that, The preparation method of the biochemical uterine cream is as follows: Weigh out each raw medicinal herb slice according to the prescription, soak in water, decoct to extract the supernatant, concentrate, add flavoring agent to continue to concentrate to form an ointment, sterilize and package. The amount of water used is 10-15 times the weight of the raw drug, preferably 12 times; The extraction was performed twice, and the decoction time was 1.5 hours. The concentration is a vacuum concentration; The flavoring agent is a sweetener, preferably sucrose, honey, xylitol, or erythritol.

4. The use according to claim 3, characterized in that, The preparation method of the biochemical uterine cream is as follows: ① Soaking: Weigh out each raw medicinal herb slice according to the prescription amount and soak in 12 times the amount of purified water; ② Decoction extraction: Heating and decocting twice. The first decoction is for 1.5 hours, and the second decoction is for 1.5 hours with 10 times the amount of purified water. Filter, combine the two decoctions, let stand for 12 hours, and take the supernatant. ③ Reduced pressure concentration: Filter the supernatant and place it in a reduced pressure concentration tank. Control the temperature at 50-80℃ and the vacuum degree (absolute value) at ≥0.06MPa. Concentrate to 60℃ to obtain a clear paste with a relative density of 1.20-1.

25. ④ To concentrate the extract, add sweetener to the clear extract at 30% of the amount of medicinal slices added, stir evenly, and continue to concentrate under reduced pressure until a thick extract with a relative density of 1.35 to 1.40 is obtained at 60℃. ⑤ Sterilization and Packaging: While the thick paste is still hot, place it in a paste packaging machine, distribute it into sterile pharmaceutical packaging containers, seal them, sterilize them at 100°C for 60 minutes using a traditional Chinese medicine sterilization cabinet, and cool them to room temperature to obtain the final product.

5. The use according to claim 3, characterized in that, The biochemical uterine ointment is prepared into an oral preparation; the oral preparation is an ointment, decoction, powder, capsule, tablet, granule or pill; preferably an ointment.

6. A traditional Chinese medicine composition for treating retained embryonic tissue after miscarriage, characterized in that, The traditional Chinese medicine composition is the biochemical uterine ointment as described in claim 1 or 2.

7. The use of the traditional Chinese medicine composition according to claim 6 in the preparation of a medicament for treating retained embryonic tissue after miscarriage.

8. A pharmaceutical combination for treating retained embryonic tissue after miscarriage, characterized in that, The combination consists of the biochemical uterine ointment as described in claim 1 or 2 and mifepristone.

9. The pharmaceutical combination according to claim 8, characterized in that, The aforementioned biochemical uterine ointment can reduce embryonic residue after mifepristone treatment for miscarriage, improve hemodynamics, reduce HCG levels, and decrease the rate of surgical intervention.

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