A traditional Chinese medicine composition for warming the uterus, promoting menstruation, and eliminating masses, and its preparation method.

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and particularly to a TCM composition that warms the uterus, promotes menstruation, and eliminates masses. The TCM composition comprises the following herbs: safflower, peach kernel, bupleurum, leech, sparganium, turmeric, immature bitter orange, chuanxiong rhizome, cinnamon twig, red peony root, peony bark, cyperus rhizome, lindera root, fennel, sappanwood, aconite root, and cuscuta seed. This invention also proposes a method for preparing an external application of the TCM composition and its application. The TCM composition of this invention is suitable for treating gynecological conditions such as amenorrhea, ovarian cysts, polycystic ovary syndrome, and oligomenorrhea. It features a rigorous formulation, combining tonifying and purging methods to address both the symptoms and root cause. Based on years of clinical experience, it demonstrates significant efficacy, minimal irritation, and no side effects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically refers to a traditional Chinese medicine composition for warming the thoroughfare and conception vessels, promoting menstruation and eliminating masses, and a preparation method thereof. Background Art

[0002] "Treatise on the Causes and Manifestations of Various Diseases - Treatise on Masses and Lumps" states: "Masses and lumps are all caused by disharmony between cold and warmth, improper diet, and combination with visceral qi. Those that do not move are directly called masses. If there are masses and lumps but can be displaced, they are called lumps. Lumps mean false, indicating that they are falsely movable." It is equivalent to diseases such as amenorrhea, ovarian cysts, polycystic ovary syndrome, and hypomenorrhea in modern medicine.

[0003] For diseases such as amenorrhea, ovarian cysts, polycystic ovary syndrome, and hypomenorrhea, the main treatment method in modern medicine is "hormone replacement therapy". Since the body cannot produce hormones, exogenous hormones can only be supplemented to maintain normal endocrine levels. The following are several common treatment regimens: 1. Estrogen replacement therapy: Commonly used drugs include natural estrogens such as estradiol valerate and 17β-estradiol, and synthetic estrogens such as nilestriol; in addition, estradiol gel also has certain efficacy. 2. Progesterone: Commonly used drugs include natural progesterone micronized progesterone soft capsules and progesterone capsules; synthetic progesterones include progesterone derivatives, dydrogesterone, 17α-hydroxyprogesterone derivatives, etc. 3. Compound preparations of estrogen and progesterone: Commonly used drugs are estradiol valerate / estradiol cyproterone tablets, estradiol / estradiol dydrogesterone tablets. In addition, in modern medicine, if ovarian cysts persist, increase, have a risk of malignancy, or develop malignancy or torsion, surgical treatment is required.

[0004] In traditional Chinese medicine treatment regimens, it mainly starts from aspects such as "qi stagnation", "phlegm-dampness", "blood stasis", and "damp-heat toxin". 1. Qi stagnation and blood stasis type: It is treated by soothing the liver and regulating qi, promoting blood circulation to remove blood stasis, softening hardness and dissipating masses, and the prescription is modified from Ge Xia Zhu Yu Decoction. 2. Phlegm-dampness accumulation type: It is treated by promoting qi and resolving phlegm, dissipating masses and relieving fullness, and the prescription is modified from Fang Fu Dao Tan Pills. 3. Damp-heat and blood stasis type: It is treated by clearing heat and detoxifying, softening hardness and dissipating masses, and the prescription is modified from Yin Jia Pills. In addition, there are also traditional Chinese medicine treatment methods such as acupuncture, physical therapy, and traditional Chinese medicine enema.

[0005] However, at present, both hormone replacement therapy methods and traditional Chinese medicine treatment regimens have some defects. Hormone replacement therapy can cause adverse reactions and side effects, and the treatment cost is high. The course of traditional Chinese medicine physical therapy is long, and generally it can only stimulate the body surface meridians and cannot cure the disease. Therefore, it is necessary to design a traditional Chinese medicine composition with low cost, safe and convenient to use, and good treatment effect. Summary of the Invention

[0006] To address the problems mentioned in the background art, the present invention aims to provide a traditional Chinese medicine composition and its preparation method that warms the uterus, promotes menstruation, and eliminates masses, avoiding the side effects of hormone replacement therapy in modern medicine. Utilizing traditional Chinese medicine theory and combining it with existing clinical experience, this invention provides a formula based on syndrome differentiation for conditions such as amenorrhea, ovarian cysts, polycystic ovary syndrome, and oligomenorrhea, combining tonification and purgation to treat both the symptoms and the root cause, resulting in significant efficacy, minimal irritation, and no side effects.

[0007] To solve the above-mentioned technical problems, the technical solution provided by the present invention is: a traditional Chinese medicine composition for warming the uterus, promoting menstruation and eliminating masses, and its preparation method. The traditional Chinese medicine composition consists of the following ingredients in parts by weight: 10-30g safflower, 10-30g peach kernel, 10-30g bupleurum, 10-30g leech, 10-30g sparganium, 10-30g turmeric, 10-30g immature bitter orange, 10-30g chuanxiong, 10-30g cinnamon twig, 10-30g red peony root, 10-30g peony bark, 10-30g cyperus rhizome, 10-30g lindera root, 10-30g fennel, 10-30g sappanwood, 3-5g aconite, and 10-30g cuscuta seed.

[0008] Furthermore, the aforementioned traditional Chinese medicine composition can be prepared into powder, medicinal dressing, or patch. The specific preparation steps for preparing the medicinal dressing and patch are as follows: Weigh out 10-30g of safflower, 10-30g of peach kernel, 10-30g of bupleurum, 10-30g of leech, 10-30g of sparganium, 10-30g of turmeric, 10-30g of immature bitter orange, 10-30g of chuanxiong, 10-30g of cinnamon twig, 10-30g of red peony root, 10-30g of peony bark, 10-30g of cyperus rhizome, 10-30g of lindera root, 10-30g of fennel, 10-30g of sappanwood, 3-5g of aconite, and 10-30g of cuscuta seed according to the following proportions. (1) Extraction of volatile oil: Extract the volatile oil of safflower, chuanxiong and cinnamon twig by steam distillation at a ratio of 1:7 and separate the volatile oil; pulverize the remaining medicines to 200-500 mesh and mix them. Store the volatile oil in a light-proof glass bottle or sealed container for later use, and seal the powder for later use.

[0009] (2) Take 1-20% volatile oil, 1-3% surfactant, 10-90% matrix and 10-90% water by mass percentage according to step (1). First, dissolve the volatile oil weighed in step (1) in 1 / 5 of the water, add surfactant and stir evenly, then add matrix and the remaining water, stir evenly, degas under vacuum, and transfer coating onto the polyurethane film base backing material to obtain the medical dressing patch.

[0010] (3) Take 80-90% powder, 5-10% volatile oil and rice wine respectively according to step (1). First mix the powder, then wrap it with volatile oil, then add rice wine and mix to form a paste. Place it on the carrier to obtain the patch.

[0011] Furthermore, the surfactant used is Tween 80.

[0012] Furthermore, the matrix is ​​selected from cellulose-based medical dressing matrix, alginate medical dressing matrix, or hydrogel medical dressing matrix.

[0013] Furthermore, the carrier in step (3) includes at least one of nonwoven fabric, gauze, adhesive tape, adhesive plaster, or medical rubber.

[0014] The beneficial effects of this invention are:

[0015] (1) The effects of the medicinal materials used are as follows: Safflower: has the effects of promoting blood circulation and regulating menstruation, dispersing blood stasis and relieving pain; Peach kernel: has the effects of promoting blood circulation and removing blood stasis, moistening the intestines and relieving constipation, relieving cough and asthma; Bupleurum: has the effects of dispersing and reducing fever, soothing the liver and relieving depression, and raising yang qi; Leech: has the effects of breaking up blood stasis and regulating menstruation, removing blood stasis and eliminating masses; Sparganium: has the effects of breaking up blood stasis and regulating qi, eliminating accumulation and relieving pain; Curcuma: has the effects of breaking up blood stasis and regulating qi, eliminating accumulation and relieving pain; Aurantium: has the effects of regulating qi and relieving chest tightness, promoting circulation and relieving bloating; Ligusticum: has the effects of promoting blood circulation and regulating qi. The following herbs have the effects of promoting qi circulation, dispelling wind, and relieving pain: Cinnamon twig: has the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang and transforming qi, and calming the rebellious qi; Lindera root: has the effects of promoting qi circulation and relieving pain, warming the kidneys and dispelling cold; Red peony root: has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain; Moutan bark: has the effects of clearing heat and cooling blood, activating blood and removing blood stasis; Aconite root: has the effects of restoring yang and rescuing from collapse, tonifying fire and assisting yang, and dispelling cold and dampness; Sappanwood: has the effects of activating blood and removing blood stasis, reducing swelling and relieving pain; Cyperus rhizome: has the effects of soothing the liver and relieving depression, regulating qi and relieving chest tightness, regulating menstruation and relieving pain.

[0016] (2) Based on years of clinical experience in traditional Chinese medicine, the applicant of this invention has conducted in-depth research on gynecological diseases. This formula is modified from Xuefu Zhuyu Decoction in Wang Qingren's "Corrections of Errors in Medical Classics", which has the effects of warming the uterus, promoting menstruation and eliminating masses. Peach kernel and safflower are the principal herbs. Peach kernel breaks up blood stasis and removes blood stasis, while safflower invigorates blood, removes blood stasis and relieves pain. Both herbs have the power to invigorate blood and remove blood stasis, and they are good at entering the heart and liver meridians. Safflower is light and ascending, reaching the upper part of the body, clearing the meridians and collaterals, and is good at removing blood stasis in the upper part of the body. Peach kernel is heavy and descending, tending to enter the lower part of the body and is good at breaking up blood stasis in the internal organs. The combination of the two herbs has the effects of invigorating blood, breaking up blood stasis, clearing the meridians and removing blood stasis. Sparganium rhizome and Curcuma rhizome enter the liver and spleen meridians, respectively. Sparganium rhizome is more effective at breaking up blood stasis, while Curcuma rhizome is more effective at breaking up qi stagnation. Both can break up blood stasis, promote qi circulation, eliminate stagnation, and relieve pain. Leech breaks up blood stasis, unblocks menstruation, and eliminates masses. Ligusticum chuanxiong is good at regulating menstruation, promoting blood circulation, and regulating menstruation. All these herbs serve as assistant herbs to help the principal herb promote blood circulation and remove blood stasis. Cinnamon twig is pungent and warm in nature, which can warm and unblock the meridians, carrying the medicine to the Chong meridian and uterus, warming the Chong and uterus. Bupleurum root soothes the liver and relieves depression, and promotes the ascent of clear yang. Aurantium breaks up qi stagnation and eliminates masses. The combination of these two herbs regulates qi and removes stagnation. When qi flows, blood flows. Both serve as adjuvant herbs. All these herbs work together to warm the Chong and uterus, unblock menstruation, and eliminate masses, thus eliminating blood stasis, cold coagulation, and masses, thereby curing the disease.

[0017] (3) The traditional Chinese medicine composition of the present invention has simple components, avoiding the adverse reactions and side effects of taking exogenous hormones. The medicated dressings and patches made therefrom have good efficacy for gynecological diseases such as amenorrhea, ovarian cysts, polycystic ovary syndrome, and oligomenorrhea. They can not only stimulate the meridians on the body surface to exert a therapeutic effect, but also promote the transdermal delivery of drugs to the affected area. The formula is reasonable, has no toxic side effects, and the efficacy is safe and reliable. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the initial color Doppler ultrasound of patient 1 in a treatment embodiment of the present invention.

[0019] Figure 2 This is a schematic diagram of a prescription for patient 1 in a treatment embodiment of the present invention.

[0020] Figure 3 This is a schematic diagram of a follow-up color Doppler ultrasound of patient 1 in a treatment embodiment of the present invention.

[0021] Figure 4 This is a schematic diagram of the initial color Doppler ultrasound of patient two in the treatment embodiment of the present invention.

[0022] Figure 5 This is a schematic diagram of a prescription for patient two in a treatment embodiment of the present invention.

[0023] Figure 6 This is a schematic diagram of a follow-up color Doppler ultrasound of patient two in a treatment embodiment of the present invention.

[0024] Figure 7 This is a schematic diagram of the initial color Doppler ultrasound of patient three in the treatment embodiment of the present invention.

[0025] Figure 8 This is a schematic diagram of a prescription for patient three in a treatment embodiment of the present invention.

[0026] Figure 9 This is a color Doppler ultrasound diagram of patient three during a follow-up visit in a treatment embodiment of the present invention.

[0027] Figure 10 This is a schematic diagram of the initial color Doppler ultrasound of patient four in the treatment embodiment of the present invention.

[0028] Figure 11 This is a schematic diagram of a prescription for patient four in a treatment embodiment of the present invention. Detailed Implementation

[0029] The present invention is illustrated below with specific embodiments, which are not intended to limit the scope of the invention.

[0030] Example 1

[0031] 20g of safflower, 30g of peach kernel, 30g of bupleurum, 30g of leech, 30g of sparganium, 30g of turmeric, 30g of immature bitter orange, 30g of chuanxiong, and 20g of cinnamon twig were selected, pulverized and mixed. The volatile oil was extracted by steam distillation at a weight ratio of 1:7 with water, and the volatile oil was separated. 10% of the reserved volatile oil, 3% of Tween 80, 23% of a mixture of cellulose-based medical excipient matrix, alginate-based medical excipient matrix, and hydrogel-based medical excipient matrix, and 64% of water were taken by mass percentage. First, the weighed volatile oil was dissolved in 1 / 5 of the water, and Tween 80 was added and stirred evenly. Then, the mixture of cellulose-based medical excipient matrix, alginate-based medical excipient matrix, and hydrogel-based medical excipient matrix, and the remaining water were added, stirred evenly, vacuum dehydrated, and transferred onto a polyurethane film backing material to obtain the medicated dressing.

[0032] One course of treatment is 5 days, with 5 patches per day, each patch containing 10g. The dosage for 5 patches per day is as follows: 1 patch for each of the 2 Zigung acupoints; 1 patch for the Shenque acupoint; 1 patch for the Guanyuan acupoint; and 1 patch for the Qihai acupoint.

[0033] Example 2

[0034] First, select 30g of Lindera root and 5g of Aconitum carmichaelii root, grind them to 200-500 mesh, and mix them to obtain a powder. Then, select 20g of Carthamus tinctorius root, 30g of Prunus persica kernel, 30g of Bupleurum chinense root, 30g of Hirudo medicinalis root, 30g of Sparganium stoloniferum rhizome, 30g of Curcuma zedoaria rhizome, 30g of Citrus aurantium fruit, 30g of Ligusticum chuanxiong rhizome, 20g of Cinnamomum cassia twig, and 20g of Cuscuta chinensis seed, grind them to 200-500 mesh, mix them, and extract the volatile oil using steam distillation at a weight ratio of 1:7 with water. Separate the volatile oil. Take 80-90% of the powder, 5-10% of the volatile oil, and rice wine by mass percentage. First, mix the powder and encapsulate it with the volatile oil, then add rice wine and mix to form a paste. Place the paste on at least one carrier selected from non-woven fabric, gauze, adhesive tape, plaster, or medical rubber to obtain a patch.

[0035] One course of treatment is 5 days, with 5 patches per day, each patch containing 10g. The dosage for 5 patches per day is as follows: 1 patch for each of the 2 Zigung acupoints; 1 patch for the Shenque acupoint; 1 patch for the Guanyuan acupoint; and 1 patch for the Qihai acupoint.

[0036] Example 3

[0037] Take 10g of cinnamon twig, 30g of immature bitter orange peel, 30g of peach kernel, 30g of bupleurum root, 30g of sparganium rhizome, 30g of chuanxiong rhizome, 30g of safflower, 30g of turmeric rhizome, and 30g of leech, grind them into powder, and mix them into a powder.

[0038] The powder is decocted in cold water to make a soup. One course of treatment lasts 5 days, with 5-7 doses per course.

[0039] Clinical treatment examples

[0040] 1. Patient 1: Zhu Xiaoyan, female, 40 years old

[0041] The patient first visited on February 20, 2022, complaining of irregular menstruation, mood swings, dry mouth and thirst, poor sleep, and once-daily bowel movements two months prior, all without apparent cause. LMP: November 2021 (specific date unknown). Her menstrual flow was usually light, lasting only 3 days.

[0042] Auxiliary examination: On February 20, 2022, a gynecological ultrasound at Panlong Hospital in Yunzhong revealed: (1) uterine fibroids (intramural); (2) multiple Nabothian cysts on the cervix; (3) left ovary size: 3.2*2.3cm, with a 2.3*2.0cm cystic dark area inside; right ovary size: 2.2*1.9cm, with a 1.2*1.1cm cystic dark area inside. Figure 1 .

[0043] Clinical cases included in this application used the modified Chinese herbal combination, two courses of decoction, each course consisting of 5-7 doses, decocted in cold water. The prescription is available at [link to prescription]. Figure 2 .

[0044] On April 18, 2022, a follow-up gynecological ultrasound at Yunzhong Panlong Hospital showed that the ovarian cyst had disappeared. Figure 3 .

[0045] 2. Patient Two: Ba Yanan, female, 24 years old

[0046] The patient first visited on March 28, 2022, complaining of scanty menstruation and irregular menstrual cycles, and requested treatment. LMP: February 20, 2022.

[0047] Auxiliary examination: On March 28, 2022, a gynecological ultrasound at Panlong Hospital in Yunzhong showed: (1) Endometrial thickness of approximately 0.6cm; (2) Left ovary size: 3.8*3.2cm, with a 2.9*2.4cm cystic dark area inside, indicating a left ovarian cyst; (3) Right ovary size: 2.7*1.7cm, with... Figure 4 .

[0048] Clinical cases included in this application used the modified Chinese herbal combination, three courses of decoction, each course consisting of 5-7 doses, decocted in cold water. The prescription is available at [link to prescription]. Figure 5 .

[0049] On June 16, 2022, a follow-up gynecological ultrasound at Yunzhong Panlong Hospital showed that the ovarian cyst had disappeared. Figure 6 .

[0050] 3. Patient 3: Li Xuehong, female, 44 years old

[0051] The patient first visited on June 26, 2021, complaining of two months of missed menstruation and denying pregnancy. For the past year, she had experienced recurrent delayed menstruation, each time delayed by more than 10 days, with each period lasting 2-3 days, scanty, dark in color, and containing blood clots. LMP: April 20, 2021. She reported morning swelling in her fingers, lower back and knee weakness, normal vaginal discharge, fair appetite, normal sleep, and normal bowel movements. Her tongue was purplish-dark with a white, greasy coating, and her pulse was thready and hesitant.

[0052] Auxiliary examination: On February 26, 2021, a gynecological ultrasound was performed at the Maternal and Child Health Hospital of Hongta District, Yuxi City: (1) Endometrial thickness 1.7cm, with uneven echogenicity; (2) Cystic mass in the left ovary, nature to be determined; (3) Left ovarian cyst (left ovary size: 5.0*3.1cm, with a 3.5*3.3cm cystic mass detected inside; right ovary size: 1.5*0.9cm) Figure 7 .

[0053] The clinical cases included this prescription, and the instructions for use involved modifications to the herbal combination. Three courses of decoction were administered, each course consisting of 5-7 doses, decocted in cold water. The prescription document can be found here. Figure 8 .

[0054] On July 27, 2022, a follow-up gynecological transvaginal ultrasound was performed at the Hongta District Maternal and Child Health Hospital in Yuxi City. The ovarian cyst had disappeared. Figure 9 .

[0055] 4. Patient Four: Xiong Jian, female, 32 years old

[0056] The patient first visited on April 25, 2022, complaining of missed menstruation for seven months and denying pregnancy. She had previously received traditional Chinese medicine treatment at another hospital with good results, hence her visit to this clinic.

[0057] Auxiliary examination: On April 25, 2022, a gynecological ultrasound at Yunzhong Panlong Hospital showed: Uterus body: 5.4*4.3*3.0cm, endometrial thickness 0.6cm; Left ovary: 3.5*2.3cm; Right ovary: 3.7*2.2cm; more than 10 follicles were detected bilaterally, all with a diameter less than 1.0cm. Diagnosis: Bilateral polycystic ovarian abnormalities on sonographic images. Figure 10 .

[0058] The clinical cases included, and the instructions for use involved modifications to the traditional Chinese medicine combination. Three courses of decoction were administered, each course consisting of five doses, decocted in cold water. The prescription can be found here. Figure 11 .

[0059] Follow-up: On May 11, 2022, menstruation resumed after taking the medication.

[0060] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for warming the uterus, promoting menstruation, and eliminating masses, characterized in that, It is composed of the following ingredients in parts by weight: 10g safflower, 20g peach kernel, 15g raw Bupleurum chinense, 10g leech, 10g Sparganium stoloniferum, 10g Curcuma zedoaria, 15g Citrus aurantium, 12g Ligusticum chuanxiong, 10g cinnamon twig, 15g peony bark, 15g roasted Cyperus rotundus, 15g Lindera strychnifolia, 15g fennel, 15g sappanwood, 20g Cuscuta chinensis, 20g roasted jujube kernel, and 6g licorice.

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