Traditional Chinese medicine gel patch for treating intrauterine adhesion and preparation method thereof
By using the effective ingredients of traditional Chinese medicine gel patching, including mugwort, cinnamon, scented aphrodisiac, etc., combined with multi-step preparation and matrix molding, the complex problem of patching formula in the existing technology was solved, effective treatment of uterine adhesions was achieved, and the peaceful state of qi and blood in the uterus was restored.
Patent Information
- Application Number
- CN202411867358.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-18
- Publication Date
- 2025-03-07
AI Technical Summary
In the prior art, the composition of the application formula for uterine adhesion treatment is relatively complex, resulting in the need to improve the treatment efficiency.
A Chinese medicine gel patch is used, and its active ingredients include mugwort leaves, cinnamon, cymbidium atractylodes, black angelica, angelica, chuanxiong and borneol. It is prepared by soaking, decoction, precipitation, centrifugation and freeze-dried multiple steps to form a freeze-dried powder and combine it with the matrix to form.
The effective ingredients of this Chinese medicine gel patch include mugwort leaves as the monarch and cinnamon as the monarch. Combined with six Chinese medicines such as Xiangfu, the number of components is relatively small, focusing on warming the uterus, regulating qi, promoting blood circulation and nourishing blood, helping to improve uterine adhesions, restore the peaceful state of qi and blood in the uterus, and ensuring the maximum extraction of the efficacy of the medicine.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of traditional Chinese medicine gel application, and in particular to a traditional Chinese medicine gel application for treating intrauterine adhesion and a preparation method thereof. Background Art
[0002] Intrauterine adhesion (IUA), also known as intrauterine adhesion syndrome, intrauterine adhesion disease, and Asherma syndrome, refers to a gynecological disease caused by the shedding and damage of the basal layer of the endometrium due to intrauterine instrumentation, infection, and tuberculosis of the reproductive system, which causes adhesions to the uterine wall or cervix. It is an important cause of female infertility. In recent years, due to the gradual increase in artificial abortion operations and the continuous development of inspection technology, the incidence and diagnosis rate of IUA have increased significantly. Studies have shown that the incidence of postoperative re-adhesion is about 23.5%, and the recurrence rate of severe IUA patients is as high as 62.5%. The clinical treatment of IUA mainly reduces the occurrence of re-adhesion by placing stents, anti-infection, and sequential hormone therapy. However, the foreign body sensation of stents and adverse drug reactions pose challenges to patient compliance, resulting in the need to improve the efficiency of postoperative treatment. Traditional Chinese medicine has a good effect in treating IUA, improving secondary symptoms, and reducing the recurrence rate after surgery. Chinese medicine acupoint application embodies the ideas of "external treatment of internal diseases" and "meridian theory" in traditional Chinese medicine. It is the product of the perfect combination of Chinese medicine meridian theory and transdermal technology. It is widely used in the treatment of various clinical diseases because of its convenient operation, non-invasiveness and painlessness. "Lihua Pianwen" records that the application of medicine can "cut into the skin, penetrate the flesh, be absorbed by the breath, and melt into the body fluid". It points out that when the medicine is applied to the acupoint, the acupoint absorbs the medicine gas while the medicine stimulates the acupoint, and is infused into the body through the meridians and melted into the body fluid, thereby exerting the efficacy of the medicine.
[0003] For example, CN115518116A discloses an abdominal dressing for preventing and treating intrauterine adhesions and a preparation method thereof, which is made of the following raw materials in the following weight proportions: 28-32g of Astragalus, 14-16g of Cuscuta australis, 14-16g of Cistanche deserticola, 14-16g of Morus alba, 14-16g of Angelica sinensis, 14-16g of Ligusticum chuanxiong, 14-16g of Salvia miltiorrhiza, 14-16g of Paeonia lactiflora, 8-12g of Notoginseng flower, 8-12g of Citron, 14-16g of Stir-fried Atractylodes macrocephala, 14-16g of Poria, 14-16g of Alisma orientalis, and 14-16g of Cyathula capitata.
[0004] This abdominal patch is mainly effective in reducing the uterine artery pulsation index (PI) and resistance index (RI), increasing endometrial thickness, improving endometrial blood perfusion, and promoting endometrial repair.
[0005] CN118873593A discloses a Chinese medicine composition for preventing postoperative uterine cavity adhesion and warming uterus external application, characterized in that the structure is, from bottom to top, a sealing layer, a non-woven fabric layer, an adhesive layer, and a Chinese medicine extract layer;
[0006] The Chinese medicine extract in the Chinese medicine extract layer is made of the following components: 3-9 parts of cinnamon bark, 12-18 parts of processed Chuanwu, 12-18 parts of Qiannianjian, 12-18 parts of Qianghuo, 12-18 parts of Duhuo, 7-13 parts of safflower, 12-18 parts of Angelica dahurica, 12-18 parts of Chinese angelica, 7-13 parts of processed frankincense, 7-13 parts of processed myrrh, 12-18 parts of mistletoe, 12-18 parts of Dipsacus asper, 12-18 parts of Gleditsia sinensis, 12-18 parts of Acanthopanax senticosus, 12-18 parts of Radix Penicillii, 7-13 parts of Zanthoxylum bungeanum, 7-13 parts of Artemisia argyi, and 9-15 parts of stir-fried mustard seeds;
[0007] The Chinese medicine extract is made from the concentrated filtrate and volatile oil prepared from the above components;
[0008] The preparation method of the volatile oil comprises the following steps: grinding Notopterygium wilfordii, Acanthopanax senticosus, Zanthoxylum bungeanum and Artemisia argyi, adding distilled water 5 to 50 times the total weight of the above raw materials and soaking for 1 to 5 hours, heating to boiling and keeping slightly boiling until the amount of the volatile oil no longer increases, stopping heating, standing and absorbing the oil layer to obtain the volatile oil;
[0009] The preparation method of the concentrated filtrate comprises the following steps: soaking cinnamon bark, processed Chuanwu, Qiannianjian, Duhuo, safflower, angelica dahurica, angelica sinensis, processed frankincense, processed myrrh, mistletoe, Dipsacus asper, Gleditsia sinensis, Radix Angelicae Pubescentis, and fried mustard seeds in 6-10 times amount of water, boiling for 1-2 hours, and filtering; adding 6-10 times amount of water to the filter residue, boiling for 0.5-1 hour, filtering, combining the above filtrates, and concentrating to obtain a concentrated filtrate;
[0010] The concentrated filtrate and the volatile oil are combined to obtain the Chinese medicine extract.
[0011] This Chinese medicine composition warming uterus external application patch is mainly applied to the Guanyuan point 4 fingers below the navel, which can realize free-position treatment for patients; the warming uterus external application patch has the effect of continuous heat production, which can promote circulation absorption and warm the uterus, achieve targeted medication to the postoperative uterus, warm the meridians and relieve pain, replenish blood and activate blood circulation, remove blood stasis and dampness, and ultimately achieve the effect of preventing postoperative uterine cavity adhesion.
[0012] In summary, existing patches mainly focus on overall conditioning or repair of endometrial damage, and have the problem of relatively complex formula components. Summary of the invention
[0013] In view of the deficiencies in the prior art, the object of the present invention is to provide a Chinese medicine gel patch for treating intrauterine adhesions and a preparation method thereof, so as to solve the problem that the formula components of the patch in the prior art are relatively complex.
[0014] To achieve the above-mentioned object, the first aspect of the present invention adopts the following technical scheme: a Chinese medicine gel patch for treating intrauterine adhesions, comprising an effective ingredient, wherein the effective ingredient comprises the following raw materials in the following weight proportions:
[0015] 25-35 parts of mugwort leaves;
[0016] 15-25 parts cinnamon;
[0017] 15-25 parts of Cyperus rotundus;
[0018] 8-12 parts of Linderae strychnifolia;
[0019] 10-20 parts of Angelica dahurica;
[0020] 10-20 parts of Chinese Angelica;
[0021] 12-20 parts of Chuanxiong;
[0022] 5-10 portions of borneol.
[0023] Mechanism of action: Mugwort enters the liver, spleen, and kidney meridians, and has the effects of warming the meridians to stop bleeding, dispelling cold and relieving pain. "Compendium of Materia Medica" says, "When taken, mugwort leaves go through the three yin meridians and expel all cold and dampness, turning the killing air into harmony; moxibustion penetrates all meridians and treats hundreds of diseases, and people with serious illnesses are healthy and healthy, and its merits are also great." In the present invention, it is the main drug. Modern pharmacological studies have found that the volatile oil contained in cinnamon has antipyretic, analgesic, anticonvulsant effects, and can inhibit the contraction of the isolated uterus of mice, which is the same as the traditional effects of cinnamon in promoting blood circulation, dredge collaterals, dispelling cold and relieving pain. In the present invention, it is the minister drug. Combined with 6 traditional Chinese medicines such as Cyperus rotundus, the gel patch focuses on the effects of warming the uterus and regulating qi, promoting blood circulation and nourishing blood, helping to improve intrauterine adhesions and restore the balance of qi and blood in the uterus.
[0024] Furthermore, a matrix is also included.
[0025] Furthermore, the matrix is made of the following raw materials in the following weight proportions:
[0026] PVP-K30 1-1.5 parts;
[0027] CMC-Na 1.5-2 parts;
[0028] NP700 1-1.5 parts;
[0029] PAA 0.5-1 part.
[0030] The second aspect of the present invention adopts the following technical scheme: a method for preparing a Chinese medicine gel patch for treating intrauterine adhesions as described in the first aspect of the present invention, comprising the preparation of an effective component, wherein the preparation process of the effective component is as follows:
[0031] Weigh each component and soak the remaining components except borneol in water, and obtain residue and primary extract after first decoction and separation;
[0032] Add water to the residue, boil it again and separate it to obtain a secondary extract;
[0033] The first extract and the second extract were combined and then precipitated at room temperature;
[0034] Then, the supernatant is obtained by centrifugal extraction, and the supernatant is concentrated into a thick extract;
[0035] The thick extract is frozen and dried under reduced pressure to obtain a decoction freeze-dried powder;
[0036] The borneol is mixed with the freeze-dried powder of the water decoction, and then crushed, sieved and refrigerated to obtain the freeze-dried powder.
[0037] Furthermore, the reduced pressure drying conditions are that the pressure is less than 50 Pa and the temperature is less than -50°C.
[0038] Furthermore, the refrigeration temperature is -20°C.
[0039] Furthermore, the method further comprises the preparation of a matrix, wherein the preparation process of the matrix is as follows:
[0040] Weigh each component, add PVP-K30, CMC-Na and NP700 into the first solvent and mix well to form phase I;
[0041] PAA is dissolved in the second solvent, and then the pH value is adjusted to 7 by a pH adjuster to form phase II.
[0042] Furthermore, the first solvent is glycerol, and the second solvent is double distilled water at a temperature of 37°C.
[0043] Furthermore, the pH regulator is triethanolamine.
[0044] Furthermore, it also includes patch forming preparation, and the patch forming preparation process is as follows:
[0045] Take part of the prepared freeze-dried powder and mix it evenly with phase I and phase II, and then apply it on the carrier;
[0046] Then it is flattened and covered with a protective film, and then cured at room temperature.
[0047] Compared with the prior art, the present invention has the following beneficial effects:
[0048] 1. The effective ingredients of this Chinese medicine gel patch are wormwood leaf as the main medicine, cinnamon bark as the auxiliary medicine, and 6 Chinese medicines such as cyperus rotundus. The number of its components is relatively small, and it focuses on the effects of warming the uterus and regulating qi, promoting blood circulation and nourishing blood, helping to improve intrauterine adhesions and restore the balance of qi and blood in the uterus;
[0049] 2. Each component of the active ingredients in this traditional Chinese medicine gel patch undergoes multiple steps such as soaking, double decoction, precipitation, centrifugation, concentration, and freeze-drying to obtain freeze-dried powder, thereby effectively extracting the maximum amount of useful ingredients contained therein for use, ensuring the quality and efficacy of this traditional Chinese medicine gel patch. BRIEF DESCRIPTION OF THE DRAWINGS
[0050] Figure 1 The figure is the result of pathological examination of uterine tissues of rats in each group in Example 1 of the present invention (200×);
[0051] Figure 2 This is a diagram showing the effect of NGFT application on the expression of rat tissue protein in Example 1 of the present invention;
[0052] Figure 3 The figure is the result of pathological examination of uterine tissues of rats in each group in Example 2 of the present invention (200×);
[0053] Figure 4 This is a diagram showing the effect of NGFT application on the expression of rat tissue protein in Example 2 of the present invention;
[0054] Figure 5 The figure is the result of pathological examination of uterine tissues of rats in each group in Example 3 of the present invention (200×);
[0055] Figure 6 This is a diagram showing the effect of NGFT application on the expression of rat tissue protein in Example 3 of the present invention. DETAILED DESCRIPTION
[0056] The present invention is further described in detail below through specific embodiments:
[0057] Example 1
[0058] 1. Preparation of NGFT patch
[0059] 1.1. Preparation of active ingredients
[0060] NGFT Chinese medicine compatibility, by weight: 30g of mugwort, 20g of cinnamon bark, 20g of cyperus, 10g of lindera, 15h of angelica root, 15g of angelica root, 15g of chuanxiong, and 6g of borneol. In this empirical prescription, mugwort enters the liver, spleen, and kidney meridians, and has the effects of warming the meridians to stop bleeding, dispelling cold and relieving pain. It is often used for epistaxis, metrorrhagia, menorrhagia, fetal bleeding, lower abdominal cold pain, cold menstruation, uterine cold infertility, etc., and is the main medicine.
[0061] Soak the above 7 kinds of Chinese medicine except borneol in 3L double distilled water for 30min, decoct for 1h for the first time, separate the extract and the residue, and keep the extract; add 2L double distilled water to the drug residue, decoct and extract for 0.5h, and combine the two extracts.
[0062] After precipitation at room temperature for 12 hours, the supernatant was obtained by centrifugal extraction at a speed of 800 rpm / min. The supernatant was boiled and concentrated into a thick extract. The thick extract was frozen at -20°C and transferred to a clean tray, and then placed in a low-temperature freeze dryer (the working conditions of the low-temperature freeze dryer are pressure <50 Pa and temperature <-50°C) and dried under reduced pressure to obtain a decoction freeze-dried powder.
[0063] Mix 6 g of borneol with the freeze-dried powder of the decoction and grind them, pass through a No. 6 sieve, put them into a clean ziplock bag, and store them in a refrigerator at -20°C for later use to form freeze-dried powder.
[0064] 1.2. Preparation of Matrix
[0065] Accurately weigh the following matrix: 1.25 g PVP-K30, 1.75 g CMC-Na, 1.25 g NP700, 0.75 g PAA; evenly mix PVP-K30, CMC-Na and NP700 in 3.5 ml glycerol to form phase I.
[0066] PAA was dissolved in 5.0 ml of double distilled water at 37°C, and the pH value was adjusted to 7.0 with triethanolamine to form Phase II.
[0067] 1.3. Preparation of patch molding
[0068] After evenly mixing phase I and phase II with 5 g of freeze-dried powder, immediately apply them on 2 pieces of 4 cm square non-woven gauze, flatten them and cover them with polyethylene film. Curing them at room temperature for 24 hours will give the finished NGFT patch, which will be sealed and stored for later use.
[0069] Example 2
[0070] The only difference from Example 1 is that:
[0071] By weight: Artemisia argyi 25g, cinnamon bark 15g, Cyperus rotundus 15g, Linderae 8g, Angelica dahurica 10h, Angelica sinensis 10g, Ligusticum chuanxiong 12g, Borneol 5g;
[0072] Accurately weigh the following matrix: 1 g PVP-K30, 1.5 g CMC-Na, 1 g NP700, 0.5 g PAA.
[0073] Example 3
[0074] The only difference from Example 1 is that:
[0075] By weight: 35g of mugwort, 25g of cinnamon bark, 25g of cyperus rotundus, 12g of lindera striata, 20g of angelica dahurica, 20g of angelica sinensis, 20g of ligusticum chuanxiong, and 10g of borneol.
[0076] Accurately weigh the following matrix: 1.5 g PVP-K30, 2 g CMC-Na, 1.5 g NP700, 1 g PAA.
[0077] Example 1 was tested as follows.
[0078] 2. Materials and experimental methods
[0079] 2.1 Experimental Animals
[0080] Forty female SD rats were purchased from Chongqing Kanger Biological and housed in the clean animal laboratory of Chongqing Academy of Animal Science at a temperature of 22-25°C and a relative humidity of 55%±5%, with free access to food.
[0081] 2.2 Main drugs and reagents
[0082] The NGFT patch prepared according to Example 1 of the present invention;
[0083] ELISA kits were purchased from Chongqing Xihua Biotechnology: IL-1β (catalog number PI 402), TNF-α (catalog number PT715), IL-6 (catalog number PI427), TGF-β1 primary antibody (catalog number: ab215715), Smad2 primary antibody (catalog number: ab40855), Smad3 primary antibody (catalog number: ab40854), GAPDH primary antibody (catalog number: ab9485), secondary antibody (catalog number: A0208);
[0084] The positive drug estradiol valerate gel produced by Wuhan Jianmin.
[0085] 2.3 IUA model replication and treatment
[0086] With reference to the Guidance for Clinical Research of New Chinese Medicines, 32 SD rats were randomly divided into a control group, an IUA model group, a NGFT treatment group, and a positive control group according to their body weight, with 8 rats in each group.
[0087] The control group was not treated, and the IUA model group, NGFT treatment group and positive control group were treated as follows:
[0088] Rats were anesthetized by intraperitoneal injection of 20% urethane at a dose of 1 ml / 100 g body weight, placed in a supine position, and a 2-3 cm longitudinal incision was made along the midline of the abdomen to remove the left uterus of the rat. A longitudinal incision of about 3 mm was made in the upper third of the uterus, and the uterine cavity was scraped with a 2 mm diameter curette until a rough feeling appeared. The uterine cavity was flushed with normal saline and the incision was sutured.
[0089] After 2 weeks of treatment and feeding, the abdominal hair of the rats in the IUA model group, the NGFT treatment group and the positive control group were smeared with a Na2S solution with a mass concentration of 6% and wiped dry. Then, the NGFT treatment group was pasted with the NGFT patch prepared by the present invention on the lower abdomen of the rats, the IUA model group was pasted with a blank matrix gel without drugs on the same part of the rats and tied with a medical tape to prevent falling off, and the positive drug control group was pasted with a positive drug estradiol valerate gel on the same part of the rats and tied with a medical tape to prevent falling off; the dressings of the IUA model group, the NGFT treatment group and the positive control group were changed once a day for 24 consecutive days.
[0090] 2.4 Rat uterine histopathological examination
[0091] Rats were anesthetized by intraperitoneal injection of 20% urethane at a dose of 1 ml / 100 g body weight, blood was collected from the abdominal aorta and the rats were killed. The uterus of the rats was dissected, and a part of the uterine tissue was fixed in 4% neutral formaldehyde for 24 hours. After embedding, white slices were cut, and routine staining was performed using the H&E kit, 5 fields of view were taken from each slice under a microscope, and the endometrial thickness was measured in a blind manner, and the number of endometrial glands was calculated.
[0092] 2.5 Determination of inflammatory factor levels in rat uterine tissue
[0093] A portion of the uterine tissue was homogenized with a homogenizer, centrifuged at 12000 rpm / min for 15 min at 4°C, and the supernatant was taken. The levels of TNF-α, IL-6, and IL-1β were detected according to the instructions of the kit.
[0094] 2.6 Determination of TGF-β1, Smad2 and Smad3 protein levels in rat uterine tissue
[0095] A portion of uterine tissue was placed in a tissue homogenizer, and tissue lysis buffer was added. After grinding and homogenization on an ice box, the mixture was centrifuged at 12000r / min and 4℃ for 15min. The supernatant was taken and the total protein concentration was determined by BCA kit. The samples were loaded and separated by electrophoresis. The samples were blocked with blocking buffer and incubated overnight with TGF-β1, Smad2, Smad3, and GAPDH primary antibodies (1:1000 dilution) at 4℃. The samples were incubated with goat anti-rabbit IgG antibody (1:2000 dilution) at room temperature for 2h. The samples were washed 3 times and photographed with a gel imager. The photos were quantitatively analyzed using ImageJ1.8.0 software.
[0096] 2.7 Data processing methods
[0097] The above experimental data were analyzed using SPSS23.0 software, and multiple groups of quantitative data were compared using one-way analysis of variance. P < 0.05 was defined as indicating statistically significant differences, and Prism 10.0 software was used for drawing graphs.
[0098] 3. Experimental results
[0099] 3.1 Effect of NGFT application on the expression level of inflammatory factors in rat tissues
[0100] As shown in Table 1, the expression levels of inflammatory factors TNF-α, IL-6, and IL-1β in the uterine tissue of rats in the IUA model group were significantly higher than those in the control group (P<0.05); after treatment, the expression levels of TNF-α, IL-6, and IL-1β in rats in the NGFT treatment group were significantly lower than those in the IUA model group (P<0.05). This indicates that NGFT application has a good therapeutic effect on rats in the IUA model group.
[0101] Table 1. Comparison of TNF-α, IL-1β, and IL-6 in rat uterine tissue (x - ±s, n=8)
[0102] Group <![CDATA[TNF-α(ng·L -1 )]]> <![CDATA[IL-1β(ng·L -1 )]]> <![CDATA[IL-6(ng·L -1 )]]> Control group 107.24±2.63 279.13±1.62 304.62±4.65 IUA Model Group <![CDATA[162.33±3.19 ** ]]> <![CDATA[297.32±2.47 * ]]> <![CDATA[461.32±25.51 ** ]]> NGFT treatment group <![CDATA[151.73±4.24 # ]]> <![CDATA[272.38±2.33 ## ]]> <![CDATA[449.73±15.39 # ]]> Positive control group <![CDATA[153.57±6.79 # ]]> <![CDATA[284.49±3.77 # ]]> <![CDATA[451.66±16.57 # ]]>
[0103] Note: Compared with the normal control group, ** P<0.01; compared with the IUA model group, # P<0.05, ## P<0.01.
[0104] 3.2 Effects of NGFT application on rat histopathology
[0105] Effects of NGFT application on tissue histopathology in IUA rats Figure 1 As shown in Table 2. The results showed that the uterine tissue cell structure of the rats in the control group was normal, with no obvious pathological changes; compared with the control group, the rats in the IUA model group showed increased endometrial thickness and a significant decrease in the number of glands (P<0.05), irregular arrangement of tissue cells, and inflammatory infiltration; after NGFT application and positive drug treatment, the arrangement of tissue cells was restored, the decrease in endometrial thickness and the increase in the number of glands were restored (P<0.05), and the inflammatory infiltration was reduced. This shows that NGFT application has a good therapeutic effect on rats in the IUA model group.
[0106] Table 2. Comparison of rat endometrial thickness and gland number (x - ±s, n=6)
[0107] Group Endometrial thickness (μm) Number of glands Control group 307.92±8.23 8.870±1.81 IUA Model Group <![CDATA[574.56±11.17 ** ]]> <![CDATA[2.875±0.835 ** ]]> NGFT treatment group <![CDATA[439.67±24.29 ## ]]> <![CDATA[5.000±0.76 ## ]]> Positive control group <![CDATA[458.92±16.31 ## ]]> <![CDATA[4.375±0.74 ## ]]>
[0108] 3.3 Effect of NGFT application on tissue protein expression in rats
[0109] Effects of NGFT application on the levels of TGF-β1, Smad2, and Smad3 proteins in uterine tissue of IUA rats Figure 2As shown, the results showed that compared with the normal control group, the levels of TGF-β1, Smad2 and Smad3 proteins in the uterine tissue of the IUA model group were significantly increased (P<0.05); compared with the IUA model group, the levels of TGF-β1, Smad2 and Smad3 proteins in the uterine tissue of the NGFT treatment group and the positive control group were significantly decreased (P<0.05), which indicates that NGFT application has a significant therapeutic effect on IUA model rats.
[0110] The following results were obtained for both Example 2 and Example 3 according to the above experiments.
[0111] The test results obtained in Example 2 are as follows:
[0112] Table 3. Comparison of TNF-α, IL-1β, and IL-6 in rat uterine tissue (x - ±s, n=8)
[0113] Group <![CDATA[TNF-α(ng·L -1 )]]> <![CDATA[IL-1β(ng·L -1 )]]> <![CDATA[IL-6(ng·L -1 )]]> Control group 109.55±2.24 278.62±2.53 305.42±14.17 IUA Model Group <![CDATA[167.32±2.47 ** ]]> <![CDATA[293.55±3.04 * ]]> <![CDATA[460.82±17.75 ** ]]> NGFT treatment group <![CDATA[152.56±3.19 # ]]> <![CDATA[270.82±3.23 ## ]]> <![CDATA[443.25±13.33 # ]]> Positive control group <![CDATA[154.16±3.74 # ]]> <![CDATA[282.46±3.59 # ]]> <![CDATA[453.17±15.71 # ]]>
[0114] Note: Compared with the normal control group, * P<0.05, ** P<0.01; compared with the IUA model group, # P<0.05, ## P<0.01.
[0115] Table 4. Comparison of rat endometrial thickness and gland number (x - ±s, n=6)
[0116]
[0117]
[0118] Note: Compared with the normal control group, ** P<0.01; compared with the IUA model group, # P<0.05, ## P<0.01.
[0119] The test results obtained in Example 3 are as follows:
[0120] Table 5. Comparison of TNF-α, IL-1β, and IL-6 in rat uterine tissue (x - ±s, n=8)
[0121] Group <![CDATA[TNF-α(ng·L -1 )]]> <![CDATA[IL-1β(ng·L -1 )]]> <![CDATA[IL-6(ng·L -1 )]]> Control group 110.29±2.91 272.62±2.07 307.15±13.59 IUA Model Group <![CDATA[165.46±3.28 ** ]]> <![CDATA[295.37±2.66 * ]]> <![CDATA[462.85±15.62 ** ]]> NGFT treatment group <![CDATA[155.83±4.064 # ]]> <![CDATA[271.42±2.57 ## ]]> <![CDATA[451.22±20.67 # ]]> Positive control group <![CDATA[156.77±5.42 # ]]> <![CDATA[286.82±2.75 # ]]> <![CDATA[455.63±18.74 # ]]>
[0122] Note: Compared with the normal control group, * P<0.05, ** P<0.01; compared with the IUA model group, # P<0.05,## P<0.01.
[0123] Table 6. Comparison of rat endometrial thickness and gland number (x - ±s, n=6)
[0124] Group Endometrial thickness (μm) Number of glands Control group 310.65±7.56 9.375±1.88 IUA Model Group <![CDATA[544.15±29.90 ** ]]> <![CDATA[2.625±0.52 ** ]]> NGFT treatment group <![CDATA[421.46±21.22 ## ]]> <![CDATA[4.500±0.76 ## ]]> Positive control group <![CDATA[447.49±17.56 ## ]]> <![CDATA[3.875±0.83 ## ]]>
[0125] Note: Compared with the normal control group, ** P<0.01; compared with the IUA model group, # P<0.05, ## P<0.01.
[0126] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the purpose and scope of the technical solution of the present invention, which should be included in the scope of the claims of the present invention.
Claims
1. A Chinese medicine gel patch for treating intrauterine adhesions, characterized in that: The active ingredient comprises an active ingredient, which is made of the following raw materials in the following weight proportions:
2. A Chinese medicine gel patch for treating intrauterine adhesions according to claim 1, characterized in that: Also included is a matrix.
3. A Chinese medicine gel patch for treating intrauterine adhesions according to claim 2, characterized in that: The matrix is made of the following raw materials in the following weight proportions:
4. A method for preparing a Chinese medicine gel patch for treating intrauterine adhesions according to claim 3, characterized in that: Including the preparation of active ingredients, the preparation process of the active ingredients is as follows: Weigh each component and soak the remaining components except borneol in water, and obtain residue and primary extract after first decoction and separation; Add water to the residue, boil it again and separate it to obtain a secondary extract; The first extract and the second extract were combined and then precipitated at room temperature; Then, the supernatant is obtained by centrifugal extraction, and the supernatant is concentrated into a thick extract; The thick extract is frozen and dried under reduced pressure to obtain a decoction freeze-dried powder; The borneol is mixed with the freeze-dried powder of the water decoction, and then crushed, sieved and refrigerated to obtain the freeze-dried powder.
5. The method for preparing a Chinese medicine gel patch for treating intrauterine adhesion according to claim 4, characterized in that: The conditions for the reduced pressure drying are that the pressure is less than 50 Pa and the temperature is less than -50°C.
6. The method for preparing a Chinese medicine gel patch for treating intrauterine adhesions according to claim 4, characterized in that: The refrigerated temperature is -20°C.
7. A method for preparing a Chinese medicine gel patch for treating intrauterine adhesions according to any one of claims 4 to 6, characterized in that: The method also includes the preparation of a matrix, wherein the preparation process of the matrix is as follows: Weigh each component, add PVP-K30, CMC-Na and NP700 into the first solvent and mix well to form phase I; PAA is dissolved in the second solvent, and then the pH value is adjusted to 7 by a pH adjuster to form phase II.
8. The method for preparing the Chinese medicine gel patch for treating intrauterine adhesion according to claim 7, characterized in that: The first solvent is glycerol, and the second solvent is double distilled water at a temperature of 37°C.
9. The method for preparing a Chinese medicine gel patch for treating intrauterine adhesions according to claim 7, characterized in that: The pH regulator is triethanolamine.
10. A method for preparing a Chinese medicine gel patch for treating intrauterine adhesions according to any one of claims 7 to 9, characterized in that: It also includes a patch forming preparation, and the patch forming preparation process is as follows: Take part of the prepared freeze-dried powder and mix it evenly with phase I and phase II, and then apply it on the carrier; Then it is flattened and covered with a protective film, and then cured at room temperature.