Use of Runu Neixiao Liquid in the preparation of medicine for treating uterine fibroids

Abstract

This invention discloses the use of Ruhe Neixiao Liquid in the preparation of drugs for treating uterine fibroids. Ruhe Neixiao Liquid can effectively treat uterine fibroids by reducing the uterine organ coefficient, reducing the thickness of the uterine myometrium, improving uterine pathological damage, and lowering serum estradiol / progesterone levels. This invention effectively expands the therapeutic functions of Ruhe Neixiao Liquid, providing new therapeutic drugs and methods for the clinical treatment of uterine fibroids, thereby providing technical support for guiding clinical medication.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine applications, specifically to the use of Ruhe Neixiao Liquid in the preparation of drugs for treating uterine fibroids. Background Technology

[0002] Uterine fibroids are the most common benign tumors of the female reproductive organs, occurring most frequently in women of reproductive age, accounting for approximately 51.87% of all benign tumors in women. In recent years, the incidence rate has been increasing annually, and the age of onset is trending younger. Uterine fibroids are a 53% indication for hysterectomy in women, seriously affecting their physical and mental health. To date, the etiology and pathogenesis of uterine fibroids remain unclear. Although there has been considerable and in-depth research, no breakthrough progress has been made. Western medicine treatments primarily rely on endocrine therapy and surgery. These drugs have significant adverse reactions such as nausea and vomiting, and because each drug targets only a specific mechanism, their spectrum of action is narrow, making it difficult to achieve broad-based efficacy. Surgical treatment is invasive, has a certain recurrence rate, and is not easily accepted by patients. Therefore, exploring more traditional Chinese medicine treatment methods is of significant clinical importance.

[0003] As for the currently available breast nodule-dissolving liquid, its main functions are to soothe the liver, promote blood circulation, soften and dissipate nodules, and regulate qi. The formula of this breast nodule-dissolving liquid consists of 12 Chinese herbs, including Fritillaria thunbergii and Angelica sinensis. Bupleurum chinense, with its bitter and neutral properties, is the main herb for soothing the liver and relieving depression; Angelica sinensis, Paeonia lactiflora, Rubia cordifolia, and Glycyrrhiza uralensis nourish and invigorate blood, dissipate blood stasis, and relieve pain; Cyperus rotundus and Curcuma longa soothe the liver and regulate qi; Prunella vulgaris, Fritillaria thunbergii, and Citrus reticulata seed resolve phlegm, dissipate nodules, and relieve pain; Echinops latifolius and Luffa cylindrica unblock the breast meridians, dissipate nodules, and guide the flow of qi. The combination of these herbs has the effects of soothing the liver, regulating qi, resolving phlegm, dissipating nodules, and relieving pain. Therefore, this medicine is usually used for breast distension and pain with lumps during menstruation, irregular menstruation or scanty, dark purple menstrual flow with lumps, and breast hyperplasia. Summary of the Invention

[0004] Therefore, the purpose of this invention is to provide a new use of Ruhe Neixiao Liquid in the treatment of uterine fibroids, and to provide more possibilities for the traditional Chinese medicine treatment of uterine fibroids.

[0005] The use of Ruhe Neixiao Liquid in the preparation of drugs for treating uterine fibroids.

[0006] The breast nucleus elimination solution is used to treat uterine fibroids by reducing the uterine organ coefficient.

[0007] The breast nucleus-clearing solution is used to treat uterine fibroids by reducing the thickness of the uterine myometrium.

[0008] The aforementioned breast nucleus-clearing solution is used to treat uterine fibroids by lowering serum estradiol (E2) and progesterone (P) levels.

[0009] The breast nucleus-clearing solution is used to treat uterine fibroids by improving uterine pathological damage, including but not limited to relieving smooth muscle fiber disorder, smooth muscle fiber hyperplasia and hypertrophy, and inflammatory cell infiltration.

[0010] The raw materials of the breast nucleus disinfectant include: Fritillaria thunbergii, Angelica sinensis, Paeonia lactiflora, Echinops latifolius, Rubia cordifolia, Cyperus rotundus, Bupleurum chinense, Citrus reticulata seed, Prunella vulgaris, Luffa cylindrica, Curcuma longa, and Glycyrrhiza uralensis.

[0011] The aforementioned breast nucleus-clearing liquid is an oral liquid preparation. The dosage for oral liquid preparations is: 10ml each time, at least once a day, shake well before use; further, the total dosage is 20ml / day; even further, the total dosage is 40ml / day.

[0012] The technical solution of the present invention has the following advantages:

[0013] This invention provides a novel application for Ruhe Neixiao Liquid. Verification has shown that this liquid can effectively treat uterine fibroids by reducing the uterine organ coefficient, decreasing the thickness of uterine smooth muscle in model rats, lowering serum estradiol / progesterone levels, and improving uterine pathological damage. This invention expands the therapeutic functions of Ruhe Neixiao Liquid, providing new drugs and methods for the clinical treatment of uterine fibroids, thereby providing technical support for guiding clinical medication. Attached Figure Description

[0014] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0015] Figure 1 This is an HE staining image of the uterine tissue of the blank group rats in this invention.

[0016] Figure 2 This is an HE staining image of the uterine tissue of the rats in the model group of this invention.

[0017] Figure 3 This is an HE staining image of uterine tissue from rats in the mifepristone group in this invention.

[0018] Figure 4 This is an HE staining image of rat uterine tissue from the Cinnamon Twig and Poria group in this invention.

[0019] Figure 5 This is an HE staining image of uterine tissue from rats in the high-dose group of the breast nucleus elimination solution in this invention.

[0020] Figure 6This is an HE staining image of rat uterine tissue from the medium-dose group of the breast nucleus elimination solution in this invention.

[0021] Figure 7 This is an HE staining image of rat uterine tissue from the low-dose group of the breast nucleus elimination solution in this invention. Detailed Implementation

[0022] Example

[0023] The following is a verification of the effectiveness of Ruhe Neixiao Liquid in treating uterine fibroids:

[0024] 1. Establishment of a rat model of uterine fibroids

[0025] A rat model of uterine fibroids was established by intraperitoneal injection of estrogen and progesterone (estrogen-progesterone synergistic induction method). That is, estrogen and progesterone were administered concurrently throughout the entire process. In the induced uterine fibroid animal model, the estrogen-progesterone synergistic induction method resulted in lower animal mortality and more stable model establishment compared to the conventional estrogen-only induction method. Furthermore, it aligned with the pathogenesis of uterine fibroids, making it easier to observe the preventive and experimental therapeutic effects of the drugs. The specific process of the estrogen-progesterone synergistic induction method of this invention is as follows:

[0026] Female SD rats (SPF grade, weighing 180-200g) were randomly divided into four groups (n=12 per group) after acclimatization: blank control group, model group, mifepristone group, cinnamon and poria cocos group, high-dose Ruhu Neixiao liquid group, medium-dose Ruhu Neixiao liquid group, and low-dose Ruhu Neixiao liquid group. Except for the blank control group, all other groups received intraperitoneal injections of estradiol benzoate 0.5 mg / kg·d once daily and progesterone 4 mg / kg·d once weekly for 25 consecutive days. Then, they received intraperitoneal injections of estradiol benzoate 0.5 mg / kg·d and progesterone 4 mg / kg·d once daily for 5 consecutive days. The blank control group received an equal amount of corn oil intraperitoneally.

[0027] 2. Drug administration process

[0028] Mifepristone, Cinnamon Twig and Poria, and Ruhe Neixiao Liquid were prepared with water to the concentrations shown in Table 1. On the first day of modeling, each group of rats was administered the corresponding concentration of drug in Table 1 by oral gavage at a dose of 10 ml / kg body weight, once a day, for 30 consecutive days. The dosage of drugs in each group is shown in Table 1 below. The blank group and the model group were administered the same volume of purified water by gavage.

[0029] Table 1

[0030]

[0031] 3. Testing process

[0032] After the last administration, blood was collected from the abdominal aorta of the rats after anesthesia, and serum was prepared by centrifugation. The levels of estradiol and progesterone in the serum were measured. The rat uterus was weighed and the uterine organ coefficient was calculated. Three segments were taken from each side of the uterus along the upper, middle and lower branches. The six uterine segments were fixed in 4% paraformaldehyde, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and the histopathological changes of the uterine tissue of the model rats were observed.

[0033] The formula for calculating the organ coefficient is: organ wet weight (g) / animal body weight (g) × 100%.

[0034] 4. Test Results

[0035] (1) The effect on the uterine organ coefficient of the model rat is shown in Table 2 below.

[0036] Table 2

[0037]

[0038] Compared with the model group: * P<0.05; ** P<0.01.

[0039] As shown in Table 2, the uterine organ coefficient values ​​of the model group rats were significantly higher than those of the blank group after modeling (all p < 0.05), indicating successful modeling. The uterine organ coefficient of the high-dose Ruhe Neixiao liquid group was significantly lower than that of the model group (p < 0.05), indicating that Ruhe Neixiao liquid has a certain therapeutic effect on uterine fibroids.

[0040] (2) The effect on the thickness of the myometrium in the model rats was shown in Table 3 below.

[0041] Table 3

[0042]

[0043]

[0044] Compared with the model group: * p<0.05, ** p<0.01.

[0045] As shown in Table 3, the average, minimum, and maximum thickness of the uterine myometrium in the model group were significantly increased compared with the blank group (all p < 0.01), indicating that the model was successfully replicated. The average, minimum, and maximum thickness of the uterine myometrium in the high-dose group of Ruhuneixiao liquid were significantly decreased compared with the model group (p < 0.01, p < 0.01, p < 0.05, respectively); the average, minimum, and maximum thickness of the uterine myometrium in the medium-dose group of Ruhuneixiao liquid were significantly decreased compared with the model group (p < 0.01, p < 0.05, p < 0.01, respectively), indicating that Ruhuneixiao liquid can significantly reduce the thickness of the uterine myometrium and has a certain therapeutic effect on uterine fibroids.

[0046] (3) The effects on serum E2 and P levels in model rats were shown in Table 4 below.

[0047] Table 4

[0048]

[0049] Compared with the model group: * p<0.01.

[0050] As shown in Table 4, the serum E2 and P levels in the model group rats were significantly increased, with significant differences compared to the blank group (all p < 0.01), indicating that the model was successfully replicated. The high, medium, and low doses of Ruhe Neixiao liquid all significantly reduced the serum E2 and P levels in the model rats, with significant differences compared to the model group (all p < 0.01), indicating that Ruhe Neixiao liquid treats uterine fibroids by regulating the levels of hormones E2 and P in the body.

[0051] (4) Effects on pathological changes in uterine tissue of model rats, the detection results are as follows: Figures 1-7 As shown.

[0052] pass Figure 1 and Figure 2 The comparison shows that under this modeling condition, pathological changes can be induced in the uterine tissue of the model rats, mainly manifested as significant thickening of uterine smooth muscle, significant enlargement of myocyte nuclei, disordered arrangement of muscle fibers, unclear boundary between the inner circular muscle and the outer longitudinal muscle layers, and the presence of a woven pattern with interlacing phenomena. Connective tissue hyperplasia and inflammatory cell infiltration are visible between the muscle fibers. Figures 5-7 and Figure 2The comparison showed that each group treated with Ruhun Neixiao Liquid could significantly alleviate the pathological damage to the uterus in the model rats. This was mainly reflected in the fact that no significant thickening of the uterine smooth muscle was observed in the Ruhun Neixiao Liquid group, the disordered arrangement of smooth muscle fibers was significantly alleviated, the hyperplasia and hypertrophy of smooth muscle fibers were significantly reduced, and the infiltration of inflammatory cells was alleviated. This indicates that Ruhun Neixiao Liquid has a certain therapeutic effect on the pathological damage to the uterine fibroids in rats under this model condition.

[0053] In summary, Ruhe Neixiao Liquid can significantly reduce the uterine organ coefficient and serum estradiol (E2) and progesterone (P) levels in model rats, significantly reduce the thickness of uterine smooth muscle in model rats, improve the pathological damage of uterine tissue in model rats, and has a significant therapeutic effect on uterine fibroids.

[0054] Obviously, the above embodiments are merely examples for clarity of explanation and are not intended to limit the implementation methods. Those skilled in the art will readily appreciate that other variations or modifications based on the above descriptions are possible. It is not necessary and impossible to enumerate all implementation methods here. Obvious variations or modifications arising therefrom remain within the scope of protection of the present invention.

Claims

1. The use of Ruhe Neixiao Liquid in the preparation of drugs for treating uterine fibroids.

Images