Traditional Chinese medicine composition for preventing poor healing of incision after cesarean section as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for preventing poor healing of a cesarean section postoperative incision as well as a preparation method and application thereof, and relates to the technical field of medicines. The formula of the traditional Chinese medicine composition consists of rheum officinale, mirabilite, ligusticum wallichii, corydalis tuber, bletilla striata, raw liquorice and honeysuckle. The preparation method of the traditional Chinese medicine composition comprises the following steps: taking medicinal materials; grinding into powder; uniformly mixing; and sub-packaging. The traditional Chinese medicine composition disclosed by the invention has a remarkable clinical effect on preventing poor healing of the incision after the cesarean section and also has a certain effect on relieving pain of the incision after the cesarean section, the preparation method of the composition is simple, and the traditional Chinese medicine composition has a wide clinical application prospect and a great market development value.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a traditional Chinese medicine composition for preventing poor wound healing after cesarean section, and a preparation method and application thereof. Background Art

[0002] Cesarean sections are an indispensable part of modern medicine, offering a relatively safe method of delivery for pregnant women unable to deliver vaginally or those with severe obstetric complications and comorbidities. They are also a crucial means of saving the fetus's life. However, while cesarean sections offer significant safety benefits for both mother and fetus, they also carry numerous short- and long-term complications. The most common short-term complication is poor wound healing. Due to the physiological changes of pregnancy, pregnant women accumulate a thick layer of abdominal fat. Postoperatively, maternal immunity is weakened. Furthermore, coexisting conditions such as hypertension and diabetes can lead to fat liquefaction, infection, and hematoma formation in the abdominal incision, ultimately resulting in poor wound healing. Western medicine typically treats poor wound healing by reopening the incision, changing the dressing, and performing a secondary suture. This can be extremely painful for the mother during the postpartum period. Therefore, preventing poor wound healing after cesarean sections is crucial.

[0003] According to Traditional Chinese Medicine (TCM) syndrome differentiation and treatment, cesarean section surgery often results in significant loss of vital energy. Vital energy is the foundation of human life and the source of qi and blood biochemical transformation. Damage to vital energy leads to a sudden loss of yin and blood, weakening all meridians and often resulting in both qi and blood deficiency. Qi is the commander of blood, and blood is the mother of qi. When qi is deficient and unable to produce or transport blood, blood stasis forms, which in turn blocks the flow of qi, ultimately leading to qi weakness and blood stasis. Abdominal meridians are damaged after cesarean section, causing blood stasis and deficiency, impacting the biochemical transformation and circulation of qi and blood, making incisions difficult to heal. Traditional Chinese medicine decoctions are complex to prepare and have a poor taste, making them difficult for mothers to accept. Furthermore, incision healing is a localized problem, and oral medications are complex to metabolize, making it difficult for the drugs to reach the local area and take effect. Externally applied medicinal packs can promote local incision healing without toxic side effects, making them more acceptable to mothers.

[0004] In the prior art, the Chinese invention patent application that publication number is CN105477270A discloses a kind of Chinese medicine composition for the treatment of abdominal incision induration after cesarean section, this Chinese medicine composition formula is made up of Herba Lycopodii, Herba Taraxaci, Herba Artemisiae Argyi, Caulis Spatholobi, Spina Gleditsiae, Radix Vitis-viniferae, Herba Portulacae and Rhizoma Bletillae, there is the effect of promoting blood circulation and removing blood stasis, clearing away heat and toxic substances, cooling blood and reducing swelling, removing blood stasis and promoting granulation, can obviously accelerate the healing of abdominal incision after cesarean section. The Chinese invention patent application that publication number is CN105327272A discloses a kind of Chinese medicine composition for the treatment of abdominal wall incision fat liquefaction after cesarean section, this Chinese medicine composition formula is made up of Herba Adenophorae, Herba Curcumae, Herba Eupatorii and Rhizoma Suzuki, there is the effect of clearing away heat and dampness, promoting blood circulation and removing blood stasis, reducing swelling and evacuating pus, removing blood stasis and promoting granulation, better to incision fat liquefaction curative effect after cesarean section. Although above-mentioned prior art has achieved good clinical effect, there is still the problem that preparation process is complicated, production cost is high.

[0005] Based on this, the present invention uses rhubarb and Glauber's salt as the main medicines, Chuanxiong, Corydalis and Bletilla striata as the auxiliary medicines, and is supplemented with honeysuckle and raw licorice to develop a self-prescribed prescription called Junxiaosan, aiming to provide a clinical drug that can effectively prevent poor wound healing after cesarean section. Summary of the Invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine composition for preventing poor wound healing after cesarean section and a preparation method thereof.

[0007] Another object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for preventing poor wound healing after cesarean section.

[0008] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] The traditional Chinese medicine composition for preventing poor wound healing after cesarean section is composed of the following components in parts by mass: 5-15 parts of rhubarb, 50-150 parts of sodium sulfate, 20-40 parts of chuanxiong, 20-40 parts of yanhusuo, 20-40 parts of bletilla striata, 20-40 parts of raw liquorice and 20-40 parts of honeysuckle.

[0010] Preferably, the traditional Chinese medicine composition for preventing poor wound healing after cesarean section of the present invention is composed of the following components in parts by mass: 8-12 parts of rhubarb, 80-120 parts of Glauber's salt, 25-35 parts of Chuanxiong, 25-35 parts of Corydalis yanhusuo, 25-35 parts of Bletilla striata, 25-35 parts of raw licorice, and 25-35 parts of honeysuckle.

[0011] Further preferably, the traditional Chinese medicine composition for preventing poor wound healing after cesarean section of the present invention is composed of the following components in parts by mass: 10 parts of rhubarb, 100 parts of Glauber's salt, 30 parts of Chuanxiong, 30 parts of Corydalis yanhusuo, 30 parts of Bletilla striata, 30 parts of raw licorice, and 30 parts of honeysuckle.

[0012] The preparation method of the Chinese medicine composition for preventing poor wound healing after cesarean section of the present invention comprises the following steps:

[0013] S1. Take herbs:

[0014] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0015] S2, powdering:

[0016] Powder each medicinal material separately;

[0017] S3. Mixing:

[0018] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0019] S4. Packaging:

[0020] Weigh the evenly stirred medicine powder and put it into a non-woven medicine bag.

[0021] Preferably, in the preparation method of the traditional Chinese medicine composition for preventing poor wound healing after cesarean section according to the present invention, the subpackaging in step S4 is specifically as follows: weighing 90-130 parts by mass of the evenly stirred medicinal powder, and putting it into a non-woven medicine bag of 6×12 cm in size.

[0022] Further preferably, in the preparation method of the traditional Chinese medicine composition for preventing poor wound healing after cesarean section according to the present invention, the subpackaging in step S4 is specifically as follows: weigh 100-120 parts by mass of the evenly stirred medicinal powder, and put it into a non-woven medicine bag of 6×12 cm in size.

[0023] More preferably, in the method for preparing the traditional Chinese medicine composition for preventing poor wound healing after cesarean section according to the present invention, the subpackaging in step S4 is specifically as follows: weigh 110 parts by mass of the evenly stirred medicinal powder, and put it into a non-woven medicine bag of 6×12 cm in size.

[0024] The invention relates to an application of the traditional Chinese medicine composition in the preparation of a medicine for preventing poor wound healing after cesarean section.

[0025] Beneficial effects of the present invention:

[0026] 1. The present invention provides a traditional Chinese medicine composition, Jun Xiao San, for preventing poor wound healing after cesarean section. Clinical research results show that the incidence of poor wound healing in the experimental group using Jun Xiao San was 11%, while the incidence of poor wound healing in the control group not using Jun Xiao San was as high as 26%, demonstrating that the traditional Chinese medicine composition has significant efficacy in preventing poor wound healing after cesarean section. The results of the assessment of the degree of incision pain after cesarean section show that the pain scores of patients in the experimental group using Jun Xiao San were lower than those in the control group not using Jun Xiao San, demonstrating that the traditional Chinese medicine composition also has a certain effect in relieving incision pain after cesarean section.

[0027] 2. The Chinese medicine composition for preventing poor wound healing after cesarean section provided by the present invention can promote local incision healing without toxic side effects. The prepared external application medicine package is easily accepted by patients, and the preparation method is simple, which has great market development value and broad clinical application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Comparison of the patient's incision after cesarean section and 2 weeks after surgery;

[0029] Figure 2 Comparison of the incisions after the second cesarean section and 2 weeks after the operation;

[0030] Figure 3 Comparison of the patients' incisions after triple cesarean section and 2 weeks after surgery;

[0031] Figure 4 Comparison of incisions after and 2 weeks after the four cesarean sections of patients;

[0032] Figure 5 Comparison of the incisions after and 2 weeks after the five cesarean sections of the patients;

[0033] Figure 6 Comparison of incisions after and 2 weeks after six cesarean sections in patients;

[0034] Figure 7 Comparison of incisions after and 2 weeks after seven cesarean sections;

[0035] Figure 8 Comparison of incisions after and 2 weeks after cesarean section in eight patients;

[0036] Figure 9 Comparison of incisions after and 2 weeks after nine cesarean sections;

[0037] Figure 10 Comparison of incisions after cesarean section and 2 weeks after surgery for 10 patients; DETAILED DESCRIPTION

[0038] The following is a detailed description of the technical solution of the present invention in conjunction with specific embodiments. The following embodiments are only for explanation and illustration, and do not constitute a limitation of the technical solution of the present invention.

[0039] Example 1

[0040] A Chinese herbal composition formula for preventing poor wound healing after cesarean section: 10g of rhubarb, 100g of sodium sulfate, 30g of chuanxiong, 30g of yanhusuo, 30g of bletilla striata, 30g of raw licorice, and 30g of honeysuckle.

[0041] A method for preparing a traditional Chinese medicine composition for preventing poor wound healing after cesarean section comprises the following steps:

[0042] S1. Take herbs:

[0043] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0044] S2, powdering:

[0045] Powder each medicinal material separately;

[0046] S3. Mixing:

[0047] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0048] S4. Packaging:

[0049] Weigh 110 g of the evenly stirred powder and put it into a non-woven medicine bag of 6×12 cm in size.

[0050] Example 2

[0051] A Chinese herbal composition formula for preventing poor wound healing after cesarean section: 5g of rhubarb, 50g of sodium sulfate, 20g of chuanxiong, 20g of yanhusuo, 20g of bletilla striata, 20g of raw licorice, and 20g of honeysuckle.

[0052] A method for preparing a traditional Chinese medicine composition for preventing poor wound healing after cesarean section comprises the following steps:

[0053] S1. Take herbs:

[0054] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0055] S2, powdering:

[0056] Powder each medicinal material separately;

[0057] S3. Mixing:

[0058] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0059] S4. Packaging:

[0060] Weigh 90 g of the evenly stirred powder and put it into a non-woven medicine bag of 6×12 cm in size.

[0061] Example 3

[0062] A formula of a traditional Chinese medicine composition for preventing poor wound healing after cesarean section: 15g of rhubarb, 150g of sodium sulfate, 40g of Chuanxiong, 40g of Corydalis yanhusuo, 40g of Bletilla striata, 40g of raw liquorice, and 40g of honeysuckle.

[0063] A method for preparing a traditional Chinese medicine composition for preventing poor wound healing after cesarean section comprises the following steps:

[0064] S1. Take herbs:

[0065] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0066] S2, powdering:

[0067] Powder each medicinal material separately;

[0068] S3. Mixing:

[0069] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0070] S4. Packaging:

[0071] Weigh 130 g of the evenly stirred powder and put it into a non-woven medicine bag of 6×12 cm in size.

[0072] Example 4

[0073] A Chinese herbal composition formula for preventing poor wound healing after cesarean section: 8g of rhubarb, 80g of sodium sulfate, 25g of chuanxiong, 25g of yanhusuo, 25g of bletilla striata, 25g of raw licorice, and 25g of honeysuckle.

[0074] A method for preparing a traditional Chinese medicine composition for preventing poor wound healing after cesarean section comprises the following steps:

[0075] S1. Take herbs:

[0076] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0077] S2, powdering:

[0078] Powder each medicinal material separately;

[0079] S3. Mixing:

[0080] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0081] S4. Packaging:

[0082] Weigh 100 g of the evenly stirred powder and put it into a non-woven medicine bag of 6×12 cm in size.

[0083] Example 5

[0084] A formula of a traditional Chinese medicine composition for preventing poor wound healing after cesarean section: 12g of rhubarb, 120g of sodium sulfate, 35g of chuanxiong, 35g of yanhusuo, 35g of bletilla striata, 35g of raw licorice, and 35g of honeysuckle.

[0085] A method for preparing a traditional Chinese medicine composition for preventing poor wound healing after cesarean section comprises the following steps:

[0086] S1. Take herbs:

[0087] Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle;

[0088] S2, powdering:

[0089] Powder each medicinal material separately;

[0090] S3. Mixing:

[0091] Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly;

[0092] S4. Packaging:

[0093] Weigh 120 g of the evenly stirred powder and put it into a non-woven medicine bag of 6×12 cm in size.

[0094] In order to further verify the reliability of the present invention and screen out the best solution, the inventors conducted a series of experiments as follows: 1. Source of the classic prescription

[0095] The prescription for Junxiaosan is a self-made prescription formulated according to the nature, flavor, meridians, and main therapeutic effects of the medicine.

[0096] Rhubarb is the dried root and rhizome of Rheum palmatum L., Rheum tanguticum Maxim. ex Balf., or Rheum officinale Baill. (all Polygonaceae). It is bitter and cold in nature, and enters the spleen, stomach, large intestine, liver, and pericardium meridians. It has the effects of purging, clearing away heat and purging fire, cooling the blood and detoxifying, removing blood stasis and promoting menstruation, and promoting dampness and jaundice. It is used to treat constipation caused by excess heat, vomiting and bleeding due to blood heat, red eyes and swollen throat, carbuncles and furuncles, abdominal pain due to intestinal carbuncles, amenorrhea due to blood stasis, postpartum blood stasis, traumatic injuries, damp-heat dysentery, jaundice and dark urine, stranguria, and edema; it is also used externally for burns and scalds.

[0097] Glauber's salt is a refined crystal from the sulfate mineral, Glauber's salt. It tastes salty and bitter, has a cold nature, and enters the stomach and large intestine meridians. It has laxative effects, moisturizing and softening hard masses, and clearing heat and reducing swelling. It is used to treat excess heat, abdominal distension and pain, constipation, and intestinal carbuncle swelling and pain; and externally treats breast abscesses and hemorrhoidal swelling and pain.

[0098] Chuanxiong is the dried rhizome of the plant Ligusticum chuanxiong Hort. of the Apiaceae family. It has a pungent and warm nature and enters the liver, gallbladder, and pericardium meridians. It promotes blood circulation and qi, dispels wind and relieves pain. It is used to treat chest pain, heart pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps and masses, headaches, and rheumatic pain.

[0099] Corydalis yanhusuo is the dried tuber of Corydalis yanhusuo (Papaver somniferum). It is pungent and bitter in taste, warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, promoting qi, and relieving pain. It is used to treat chest, flank, and abdominal pain, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain from falls.

[0100] Bletilla striata (Bletilla striata) is the dried tuber of the orchid family Bletilla striata (Thunb.) Reichb.f. It tastes bitter, sweet, and astringent, and is slightly cold in nature. It enters the lung, liver, and stomach meridians, and has astringent, hemostatic, swelling-reducing, and tissue-stimulating properties. It is used to treat hemoptysis, hematemesis, bleeding from trauma, sores, swelling, and chapped skin.

[0101] Honeysuckle is the dried buds or early blooming flowers of Lonicera japonica Thunb. (Caprifoliaceae). It is sweet and cold in nature, and enters the lung, heart, and stomach meridians. It clears heat and detoxifies, dispersing wind-heat, and is used to treat carbuncles, furuncles, sore throat, erysipelas, dysentery with heat toxins, wind-heat colds, and fever caused by febrile diseases.

[0102] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all from the Leguminosae family. It is sweet and neutral in nature, entering the Heart, Lung, Spleen, and Stomach meridians. It tonifies the spleen and replenishes Qi, clears away heat and toxins, eliminates phlegm and relieves cough, relieves pain, and harmonizes various medicinal properties. It is used to treat spleen and stomach deficiency, fatigue, palpitations, shortness of breath, cough with excessive sputum, acute pain in the abdomen and limbs, carbuncles, sores, and alleviates drug toxicity and potency.

[0103] The prescription of this study uses rhubarb and Glauber's salt as the main medicines, which are used to clear away heat and purge fire, cool blood and detoxify, and remove blood stasis and promote menstruation; Chuanxiong, Corydalis yanhusuo, and Bletilla striata are used as the auxiliary medicines, which are used to promote blood circulation and qi, remove blood stasis and relieve pain; honeysuckle is used as the adjuvant medicine to enhance the effect of clearing heat and detoxifying; and raw licorice is used as the guiding medicine to harmonize all the medicines.

[0104] 2. Prescription and preparation method

[0105] 2.1 Prescription

[0106] The prescription for dispersing all the symptoms is 10g of rhubarb, 100g of Glauber's salt, 30g of Chuanxiong, 30g of Corydalis yanhusuo, 30g of Bletilla striata, 30g of raw licorice, and 30g of honeysuckle.

[0107] 2.2 Preparation method

[0108] (1) Selection of medicinal materials: Rhubarb, Glauber's salt, Chuanxiong, Corydalis yanhusuo, Bletilla striata, raw licorice, and honeysuckle provided by the boutique pharmacy of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine.

[0109] (2) Powdering: Powder each medicine separately.

[0110] (3) Stirring: Mix the powder according to the prescription ratio and stir to make it uniform.

[0111] (4) Packaging: Put the evenly mixed powder into 6×12 cm non-woven medicine bags, 110 g of powder per bag, and place them on a drying medicine rack for later use.

[0112] Each patient routinely uses 6 bags of powder. If there are incision problems such as exudation and bruising, the dosage can be appropriately increased, depending on the patient's incision healing condition.

[0113] 3. Clinical research

[0114] (1) Research subjects

[0115] Between January and March 2024, 200 women undergoing cesarean section in the obstetrics department of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine were randomly divided into two groups: a control group of 100 and an experimental group of 100. This study was submitted to the ethics committee of our hospital for ethical review before the start of the experiment, and all enrolled patients signed informed consent before treatment.

[0116] (2) Inclusion criteria

[0117] Women who gave birth by cesarean section in the obstetrics department of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine from January 2024 to March 2024.

[0118] (3) Exclusion criteria

[0119] Pregnant women will not be included in the study if they have any of the following conditions: 1. Women who have given birth vaginally; 2. Women who are unwilling to accept the external application of Juxiaosan; 3. Women who have skin diseases such as impetigo, herpes zoster, eczema, etc.; 4. Women who are allergic to any of the drugs in Juxiaosan; 5. Women who have immune diseases; 6. Mental or neurotic patients; 7. Alcoholics or drug addicts.

[0120] (4) Shedding standard

[0121] All subjects who have passed the screening and entered the randomized trial and signed the informed consent form, regardless of when or why they withdraw, as long as they have not completed the observation period specified in the treatment plan, will be regarded as dropout cases, including the following situations: 1. Withdrawal decided by the researcher, for example, when the condition of the subject using the trial drug does not improve to a certain extent within a certain period of time, although the prescribed course of treatment has not been completed, in order to protect the subject, the subject is allowed to withdraw from the trial and receive other effective treatments; 2. Those who have adverse events and serious adverse events and are not suitable to continue to participate in the trial.

[0122] (5) Elimination criteria

[0123] After randomization, it is found that the inclusion or exclusion criteria are seriously violated; the subjects did not use the trial drug after randomization, or the drug dosage was less than 10% of the prescribed dosage; other drugs that are prohibited from being used in combination were used, which affects the effectiveness and safety judgment; there are serious missing data or no data after randomization.

[0124] (6) Intervention measures and follow-up

[0125] Patients in the experimental group began applying the topical dressing 6 hours after cesarean section (changing one pack every 8 hours, 3 packs / day) for one week. Routine dressing changes began on the first day after surgery, once a day. They were discharged on the third day after surgery. After discharge, they applied the topical dressing on their own. The pain disappeared. They returned to the hospital 2 weeks after surgery for a review of the incision condition and completed a visual analog scale and numerical rating scale to assess the pain of the mothers. The control group began routine dressing changes on the first day after surgery, once a day. They were discharged on the third day after surgery. They returned to the hospital 2 weeks after surgery for a review of the incision condition and completed a visual analog scale and numerical rating scale to assess the pain of the mothers.

[0126] (7) Observation indicators

[0127] All subjects received drug treatment for 1 week when entering the study and returned to the hospital 2 weeks after cesarean section to observe the healing of the incision and complete the visual analog scale and numerical rating scale.

[0128] Efficacy indicators: 1. Whether the incision has redness, swelling, fever, pain, induration, exudation, pus discharge, or dehiscence; 2. Visual analog scale; 3. Numerical rating scale.

[0129] (8) Statistical analysis

[0130] SPSS 17.0 was used to analyze the enumeration data using the chi-square test and Fisher's exact test, and the measurement data were analyzed using the t-test and Wilcoxon rank-sum test. Differences were considered statistically significant when the P value was < 0.05.

[0131] (9) Research results

[0132] Two weeks after cesarean section, women in the experimental and control groups returned to the hospital for observation of cesarean section wound redness, swelling, fever, pain, induration, exudate, pus discharge, and dehiscence. The results showed that in the experimental group, 1 case developed redness and swelling, 2 cases developed fever, 1 case developed pain, 3 cases developed induration, 1 case developed exudate, 2 cases developed pus discharge, and 1 case developed dehiscence, for a total of 11 cases. The incidence of poor wound healing in the experimental group was 11%. In the control group, 3 cases developed redness and swelling, 2 cases developed fever, 7 cases developed pain, 8 cases developed induration, 2 cases developed exudate, 1 case developed pus discharge, and 3 cases developed dehiscence, for a total of 26 cases. The incidence of poor wound healing in the control group was 26%. Table 1 shows the statistical results of wound healing in each group two weeks after cesarean section, and Table 2 shows the comparison of VAS and NRS scores between the experimental and control groups.

[0133] Table 1 Statistics of incision healing in each group 2 weeks after cesarean section

[0134]

[0135] Note: There is statistical significance when the experimental group and the control group are compared, P<0.05.

[0136] Table 2 Comparison of VAS and NRS scores between the experimental group and the control group (points, x±S)

[0137]

[0138]

[0139] Note: P>0.05, which is not statistically significant when comparing the experimental group and the control group.

[0140] The results show that the number of patients with poor incision healing in the experimental group was significantly lower than that in the control group, indicating that the clinical efficacy of this research product in preventing poor incision healing after cesarean section is significant; the visual analog scale and digital rating scale were used to compare the pain levels of the incision after cesarean section in the experimental group and the control group. The results showed that the pain scores of the mothers in the group using Junxiaosan were lower than those in the control group, proving that Junxiaosan has the effect of relieving incision pain after cesarean section.

[0141] (10) Typical Cases

[0142] Patient 1: Ran X, 30 years old, female, pregnancy history: G3P1, gestational age: 38+2 weeks.

[0143] Admission: The patient was admitted on January 2, 2024, due to "38+2 weeks of amenorrhea and request for hospitalization for delivery." Complete examinations revealed no significant abnormalities. Physical examination: Vital signs were stable, with a 13cm longitudinal surgical scar in the lower abdomen and no tenderness in the lower uterine segment. Fundus height was 35cm; abdominal circumference was 111cm; the patient was in cephalic presentation and engaged in the pelvis. Fetal position: LOA, fetal heart rate: 136 beats / minute; estimated fetal weight: 3500g. Admission diagnosis: 1. G3P1 gestational age 38+2 weeks LOA; 2. Pregnancy complicated by uterine scar.

[0144] Diagnosis and treatment process: After admission, the patient actively completed relevant auxiliary examinations and underwent a cesarean section the next day after admission. Incomplete uterine rupture was found during the operation. Since multiple surgeries are prone to poor incision healing, external application of dissipative medication was applied to the incision starting 6 hours after the operation to prevent poor incision healing.

[0145] Follow-up: 14 days after the operation, the mother did not complain of discomfort, was in good spirits, had a good appetite and sleep, and had normal bowel movements. There was no redness, swelling, induration, or exudate from the abdominal incision. Physical examination: The abdomen was slightly distended, the uterine fundus was 4 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after the operation Figure 1 shown.

[0146] Patient 2: Xiong X, 29 years old, female, pregnancy history: G1P0, gestational age: 39 weeks.

[0147] Admission: The patient was admitted on February 1, 2024, due to "39 weeks of amenorrhea and request for hospitalization for delivery." Complete examinations revealed no significant abnormalities. Physical examination: Vital signs were stable, with an old vertical scar approximately 12 cm long in the lower abdomen, a 36 cm high uterine fundus, an abdominal circumference of 99 cm, a cephalic presentation, and engagement. Fetal position: LOA, fetal heart rate 140 beats / min, and an estimated fetal weight of 3500 g. The patient had previously undergone laparotomy at another hospital for an ectopic pregnancy. Admission diagnosis: 1. G1P0 gestation at 39 weeks LOA; 2. Pregnancy complicated by α-thalassemia; 3. Obesity during pregnancy.

[0148] Diagnosis and Treatment: Following admission, the patient underwent a thorough evaluation and underwent a cesarean section the following day. The original vertical scar was removed and the operation went smoothly. During surgery, minor adhesions were found between the adnexa and the surrounding greater omentum. Due to maternal obesity and anemia, which predisposes to fat liquefaction, the skin and subcutaneous tissue were sutured with silk sutures. Six hours after surgery, a topical compress was applied to the incision to prevent poor healing.

[0149] Follow-up: 14 days after surgery, the mother did not complain of discomfort, was in good spirits, had a good appetite and sleep, and had normal bowel movements. There was no redness, swelling, induration, exudate, or suppuration in the abdominal incision. Physical examination: The abdomen was slightly distended, the uterine fundus was 3 fingers below the umbilicus, the uterus was not tender, the lochia was dark red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery Figure 2 shown.

[0150] Patient 3: Zuo X, 40 years old, female, pregnancy history: G5P2, gestational age: 37+3 weeks.

[0151] Admission: Admitted on January 20, 2024, due to "amenorrhea for 37+3 weeks, requiring an elective cesarean section." Complete examinations revealed no significant abnormalities. Physical examination: Vital signs were stable, with a 12-cm transverse, old surgical scar in the lower abdomen. The lower uterine segment was nontender, with a 33-cm uterine fundus height and an abdominal circumference of 99 cm. Admission diagnosis: 1. G5P2, 37+3 weeks' gestation; 2. Pregnancy complicated by uterine scarring (second cesarean section); 3. Advanced multiparous age; 4. Pregnancy complicated by obesity.

[0152] Treatment: Following admission, the patient underwent a thorough examination and underwent a cesarean section the following day. The procedure went smoothly. Due to the mother's advanced age, obesity, and previous surgeries, she began applying a topical compress to the incision six hours after the procedure to prevent poor wound healing.

[0153] Follow-up: 14 days after surgery, the mother did not complain of discomfort, but was slightly less energetic, had a good appetite, poor sleep, and normal bowel movements. There was no redness, swelling, induration, exudate, or suppuration in the abdominal incision. Physical examination: The abdomen was slightly distended, the uterine fundus was 3 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery Figure 3 shown.

[0154] Patient 4: Song X, 31 years old, female, pregnancy history: G1P0, gestational age: 37+3 weeks.

[0155] Admission: Admitted on January 11, 2024, due to amenorrhea for 37+3 weeks and headaches for 2 days. Completed laboratory tests revealed: hyperlipidemia, low protein, and random urine protein (3+). Other examinations were unremarkable. Physical examination: P 100 bpm, BP 143 / 95 mmHg, R 20 bpm, bilateral lower extremity edema, abdominal skin edema, uterine fundus height 34 cm, abdominal circumference 100 cm, cephalic presentation, unengaged; fetal position: LOA; fetal heart rate 140 bpm; estimated fetal weight: 3000 g. Admission diagnosis: 1. G1P0 gestational age 37+3 weeks LOA; 2. Preeclampsia; 3. Gestational diabetes; 4. Thrombophilia.

[0156] Diagnosis and treatment process: After admission, the patient actively completed relevant auxiliary examinations and underwent cesarean section on the next day after admission. A transverse abdominal incision was made (median transverse incision 14 cm, 3 cm above the pubic symphysis). During the operation, obvious edema of all layers of tissue was found, and the ascites was about 200 mL. The operation went smoothly. Because the mother had high blood pressure and gestational diabetes, which were high-risk factors for poor wound healing, and the mother had thrombophilia, she needed anticoagulation after surgery, which was prone to subcutaneous hematoma. Therefore, the use of dissipating external application was started 6 hours after the operation to prevent poor wound healing.

[0157] Follow-up: 14 days after surgery, the mother reported mild pain in the abdominal incision, but was in good spirits, had good appetite and sleep, and had normal bowel movements. The abdominal incision was slightly red, with no induration, bleeding, exudate, or suppuration. Physical examination showed a slightly distended abdomen, with the uterine fundus at 3 finger widths below the umbilicus, no uterine tenderness, red lochia, small amount, and no odor. The abdominal incision II / nail healed. Conservative treatment with dispersing external application was continued. Comparison of the patient's incision after and 2 weeks after cesarean section. Figure 4 shown.

[0158] Patient 5: Guo X, 32 years old, female, pregnancy history: G4P0, gestational age: 37+5 weeks.

[0159] Admission: Admitted to the hospital on January 25, 2024 due to "37+5 weeks of amenorrhea and 2 hours of vaginal discharge". Complete relevant examination tips: PLT 97X10 9 / L, other examinations were unremarkable. Physical examination: Vital signs were stable, uterine fundus height 34cm; abdominal circumference 100cm; cephalic presentation, engagement, fetal position LOA, fetal heart rate 130 beats / minute; estimated fetal weight 3000g. Admission diagnosis: 1. G4P0 gestational age 37+5 weeks LOA; 2. Premature rupture of membranes; 3. Singleton pregnancy after assisted reproductive technology; 4. History of adverse maternal and natal outcomes; 5. Pregnancy complicated by obesity; 6. Gestational thrombocytopenia.

[0160] Diagnosis and treatment process: After admission, the patient actively completed relevant auxiliary examinations. She had undergone abdominal right salpingectomy due to "ectopic pregnancy" in the past and underwent cesarean section on the day of admission. The original incision was taken during the operation (median vertical incision, 3 cm wide, 3 cm deep, 3 cm above the pubic symphysis). The operation went smoothly. Due to maternal thrombocytopenia, postoperative coagulation may be affected, hematoma may occur, and obesity may also affect the healing of the incision. Therefore, the incision was applied with dissipative external medicine 6 hours after the operation to promote incision healing.

[0161] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. There was no redness or swelling in the abdominal incision, no induration, no bleeding, no exudate, and no suppuration. Physical examination: The abdomen was slightly distended, the uterine fundus was 3 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery Figure 5 shown.

[0162] Patient six: Guo X, female, 31 years old, pregnancy history: G4P0, gestational age: 38 weeks.

[0163] Condition at Admission: Admitted on February 5, 2024, due to "38 weeks of amenorrhea and request for hospitalization for delivery." Completed tests revealed bile acid levels of 14.10 μmol / L, with no other significant abnormalities. Physical examination: BP 153 / 115 mmHg, P 115 bpm, R 20 bpm, normal cardiopulmonary function. Abdominal: uterine fundus height 37 cm; abdominal circumference 104 cm; cephalic presentation, unengaged; fetal position: LOA; fetal heart rate: 142 bpm; estimated fetal weight: 2700 / 2400 g. Admission Diagnosis: 1. G4P1 gestational age 38 weeks LOA / LSA; 2. Dichorionic diamno-amniotic twin pregnancy; 3. Severe preeclampsia; 4. Intrahepatic cholestasis of pregnancy.

[0164] Diagnosis and Treatment: After admission, the patient underwent a cesarean section the following day, delivering two live infants. Hemorrhage was 800 mL, and uterine binding was performed to control bleeding. Due to the heavy bleeding, poor postoperative immunity, and the intraoperative uterine binding procedure, high blood pressure, and postoperative liver function tests, the patient's albumin level was 25.44 g / L. These factors are all high-risk factors for postoperative infection and poor wound healing. Therefore, a topical application of dissipative medication was applied to the wound six hours after surgery to promote healing and prevent poor wound healing.

[0165] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. There was no redness or swelling in the abdominal incision, no induration, no bleeding, no exudate, and no suppuration. Physical examination: The abdomen was slightly distended, the uterine fundus was 4 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. A routine blood test showed: HGB 120g / L, and liver function test showed: albumin 35g / L. Comparison of the patient's incision after cesarean section and 2 weeks after surgery: Figure 6 shown.

[0166] Patient seven: Luo X, female, 35 years old, pregnancy history: G3P1, gestational age: 39+1 weeks.

[0167] Admission situation: Admitted to the hospital on February 18, 2024 due to "39+1 weeks of amenorrhea and request for hospitalization for delivery." Weight gain during pregnancy was 17kg. Previously, a cesarean section was performed in another hospital. Due to severe skin allergies, the incision healed poorly. The incision gradually healed about 3 months after the surgery. Complete relevant examinations showed no obvious abnormalities. Physical examination: Vital signs are stable, cardiopulmonary (-), abdomen: uterine fundus height 32cm; abdominal circumference 104cm; head first presentation, engaged, fetal position: LOA, fetal heart rate: 144 beats / minute; fetal weight estimated: 3500g. Admission diagnosis: 1. G3P1 39+1 weeks of gestation LOA; 2. Pregnancy complicated by uterine scar; 3. Obesity during pregnancy.

[0168] Diagnosis and treatment process: After admission, the patient actively completed relevant auxiliary examinations and underwent a cesarean section on the second day after admission. A longitudinal incision of about 12 cm long was made 2 fingers above the pubic symphysis. The operation was successful. Because the mother was elderly, obese, and had an allergic constitution, it was very likely that the incision would heal poorly after the operation. Therefore, an external application of dissipative solution was used on the incision starting 6 hours after the operation to promote incision healing.

[0169] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. The area around the abdominal incision was red and swollen, with no induration, bleeding, exudate, or suppuration. Physical examination: The abdomen was slightly distended, the uterine fundus was 3 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / B had healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery: Figure 7 shown.

[0170] Patient 8: Peng X, female, 29 years old, pregnancy history: G1P0, gestational age: 39+2 weeks.

[0171] Admission: The patient was admitted on February 20, 2024, due to amenorrhea for 39+2 weeks, lower abdominal pain, and spotting for 4+ hours. Complete examinations revealed no significant abnormalities. Physical examination: stable vital signs, negative cardiopulmonary function. Abdominal: uterine fundus height 38cm; abdominal circumference 107cm; cephalic presentation, engaged, fetal position: LOA; fetal heart rate: 126 beats / minute; estimated fetal weight: 3500g. Admission diagnosis: 1. G1P0 gestational age 39+2 weeks LOA; 2. Gestational obesity.

[0172] Diagnosis and treatment process: After admission, relevant auxiliary examinations were actively completed. The pregnant woman and her family requested a vaginal trial delivery and closely observed the progress of labor. After the cervix was dilated 7 cm, the fetal head stopped descending. B-ultrasound showed that the fetus was in occiput posterior position. Considering the relative cephalopelvic disproportion, vaginal delivery was difficult and the delivery was transferred to cesarean section. The postoperative VTE score was 3 points. Considering that the mother needed to start anticoagulant treatment 24 hours after the operation, subcutaneous hematoma might occur, resulting in poor wound healing, so she started to use Quanzhisan 6 hours after the operation to prevent poor wound healing. On the second day after the operation, the mother was found to have subcutaneous bruising, and she continued to apply Jinhuangsan externally until the next follow-up visit.

[0173] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. There was no redness or swelling in the abdominal incision, no induration, no bleeding, no exudate, and no suppuration. Physical examination: The abdomen was slightly distended, the uterine fundus was 3 fingers below the umbilicus, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery Figure 8 shown.

[0174] Patient nine: Chen X, female, 29 years old, pregnancy history: G2P1, gestational age: 38+4 weeks.

[0175] Admission: She was admitted on March 13, 2024, due to "38+4 weeks of amenorrhea and a request for hospitalization for delivery." Complete examinations revealed no significant abnormalities. Physical examination: Vital signs were stable, cardiopulmonary function was negative. Abdominal examination: uterine fundus height 34 cm, abdominal circumference 116 cm, cephalic presentation, engaged, fetal position: LOA; fetal heart rate: 158 beats / min; estimated fetal weight: 3400 g. Admission diagnosis: 1. G2P1 gestational age 38+4 weeks LOA; 2. Pregnancy complicated by uterine scarring; 3. Pregnancy complicated by obesity.

[0176] Diagnosis and Treatment: After admission, relevant auxiliary examinations were actively completed. A cesarean section was performed the next day. The original incision (a midline longitudinal incision, approximately 14 cm long, 3 cm wide, and 2 cm deep) was removed, and the original surgical scar and incisional fat (subcutaneous fat thickness of approximately 7 cm) were removed. Severe abdominal adhesions and partial loss of the uterine myometrium were found. A live baby was delivered during the operation. The operation was successful and a uterine repair was performed. 300 mL of intraoperative blood loss occurred. Because the mother had a vertical incision, the original scar was wide, the incision tension was high, and it was difficult to heal, so a dissipating incision compress was applied 6 hours after the operation to prevent poor incision healing.

[0177] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. The abdominal incision was slightly hard, with no redness, swelling, bleeding, exudate, or suppuration. Physical examination: The abdomen was slightly distended, the uterine fundus was located between the umbilical symphysis, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Continued use of the product resolved the problem. Comparison of the patient's incision after cesarean section and 2 weeks after surgery. Figure 9 shown.

[0178] Patient 10: Zhang X, female, 32 years old, pregnancy history: G1P0, gestational age: 38+6 weeks.

[0179] Admission: She was admitted on March 25, 2024, due to "amenorrhea at 38+6 weeks, requiring hospitalization for delivery." Complete examinations revealed no significant abnormalities. Physical examination: stable vital signs, cardiopulmonary function (negative), abdominal: uterine fundus height 35cm; abdominal circumference 110cm; cephalic presentation, engaged, fetal position: LOA; fetal heart rate: 140 beats / minute; estimated fetal weight: 3600g. Admission diagnosis: 1. G1P0 gestation at 38+6 weeks LOA; 2. Gestational diabetes; 3. Pregnancy complicated by obesity.

[0180] Diagnosis and treatment process: After admission, the patient actively completed relevant auxiliary examinations and underwent cesarean section on the second day after admission. During the operation, the mother suffered from sudden cardiac and respiratory arrest, followed by postpartum hemorrhage. Because there was no coagulation, amniotic fluid embolism was considered. The amniotic fluid embolism rescue plan was immediately activated and an MDT team was formed to rescue her. After cardiopulmonary resuscitation, lowering pulmonary hypertension, massive blood transfusion, and supplementation of coagulation substances, the mother was out of danger. Because the mother had undergone a major rescue, hemorrhagic anemia, and needed anticoagulation after surgery, it was very likely that the abdominal incision would heal poorly. Therefore, the use of dissipated antibiotics was started 6 hours after the operation to promote incision healing.

[0181] Follow-up: 14 days after surgery, the mother had no complaints of discomfort, was in good spirits, had good appetite and sleep, and had normal bowel movements. There was no induration, redness, swelling, bleeding, exudation, or suppuration in the abdominal incision. Physical examination: The abdomen was slightly distended, the uterine fundus was located between the umbilical symphysis, the uterus was not tender, the lochia was red, small in volume, and had no odor. The abdominal incision II / nail healed. Comparison of the patient's incision after cesarean section and 2 weeks after surgery. Figure 10 shown.

[0182] Although the present invention has been described in detail above using general descriptions, specific embodiments, and experiments, it will be apparent to those skilled in the art that modifications and improvements may be made based on the present invention. Therefore, such modifications and improvements, which do not depart from the spirit of the present invention, are intended to be within the scope of protection claimed herein.

Claims

1. A Chinese medicine composition for preventing poor wound healing after cesarean section, characterized in that: The invention is composed of the following components in parts by mass: 5-15 parts of rhubarb, 50-150 parts of sodium sulfate, 20-40 parts of chuanxiong, 20-40 parts of yanhusuo, 20-40 parts of bletilla striata, 20-40 parts of raw liquorice and 20-40 parts of honeysuckle.

2. The Chinese medicine composition according to claim 1, characterized in that The invention is composed of the following components in parts by mass: 8-12 parts of rhubarb, 80-120 parts of sodium sulfate, 25-35 parts of chuanxiong, 25-35 parts of yanhusuo, 25-35 parts of bletilla striata, 25-35 parts of raw liquorice and 25-35 parts of honeysuckle.

3. The Chinese medicine composition according to claim 2, characterized in that The invention is composed of the following components in parts by mass: 10 parts of rhubarb, 100 parts of sodium sulfate, 30 parts of chuanxiong, 30 parts of yanhusuo, 30 parts of bletilla striata, 30 parts of raw liquorice and 30 parts of honeysuckle.

4. The method for preparing the Chinese medicine composition for preventing poor wound healing after cesarean section according to any one of claims 1 to 3, wherein: Here are the steps: S1. Take herbs: Take slices of rhubarb, sodium sulfate, chuanxiong, yanhusuo, bletilla striata, raw licorice, and honeysuckle; S2, powdering: Powder each medicinal material separately; S3. Mixing: Weigh the powder of each medicinal material according to the formula ratio, mix them and stir evenly; S4. Packaging: Weigh the evenly stirred medicine powder and put it into a non-woven medicine bag.

5. The preparation method according to claim 4, characterized in that The subpackaging in step S4 is specifically as follows: 90-130 parts by mass of the evenly stirred medicine powder are weighed and placed into a non-woven medicine bag of 6×12 cm in size.

6. The preparation method according to claim 5, characterized in that The subpackaging in step S4 is specifically as follows: 100-120 parts by mass of the evenly stirred medicinal powder are weighed and placed into a non-woven medicine bag of 6×12 cm in size.

7. The preparation method according to claim 6, characterized in that The subpackaging in step S4 is specifically as follows: 110 parts by mass of the evenly stirred medicine powder are weighed and put into a non-woven medicine bag of 6×12 cm in size.

8. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for preventing poor wound healing after cesarean section.

Images