CN113288991A - Traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and preparation method thereof - Google Patents

Traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and preparation method thereof Download PDF

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CN113288991A
CN113288991A CN202110707645.9A CN202110707645A CN113288991A CN 113288991 A CN113288991 A CN 113288991A CN 202110707645 A CN202110707645 A CN 202110707645A CN 113288991 A CN113288991 A CN 113288991A
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traditional chinese
chinese medicine
anxiety
depression
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乔楠
丁晓雯
方勇
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Nantong Hospital Of Traditional Chinese Medicine
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    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
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Abstract

The invention discloses a traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which is prepared from the following main raw materials: bupleuri radix, rhizoma Cyperi, radix Curcumae, Concha Ostreae, Bombyx Batryticatus, fructus Citri Sarcodactylis, fructus Citri, flos Rosae Rugosae, flos Pruni mume, fructus Akebiae, and herba Hyperici perforati. The invention also discloses a preparation method of the traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which comprises the following steps: pulverizing Bombyx Batryticatus into Bombyx Batryticatus powder, extracting with ethanol twice, filtering, and collecting the first extractive solution; extracting volatile oil of rose, flos Pruni mume and fructus Citri Sarcodactylis according to formula amount by steam distillation, and collecting to obtain second extractive solution; mixing the bupleurum, the rhizoma cyperi, the curcuma aromatica, the citron, the hypericum perforatum and the fructus akebiae according to the formula amount, adding sufficient distilled water, decocting for 30-60 minutes, and sieving by a 80-mesh sieve to obtain a third extracting solution; the traditional Chinese medicine cataplasm provided by the invention can be used for treating diseases and improving the quality of life; the cataplasma is convenient to use, and avoids the pain of oral administration of traditional Chinese medicines.

Description

Traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and a preparation method thereof.
Background
The hyperplasia of mammary glands, namely nodules of breast in traditional Chinese medicine, is a benign breast disease with abnormal development and degeneration of mammary glands, comprises mastopathy, cystic hyperplasia of breast and the like, is clinically manifested by breast pain, breast nodules or masses, accounts for more than 80% of breast diseases treated by breast pain agglomeration in China, and accounts for 65% of benign breast lesions. Although cyclomastopathy is a benign disease of the breast, only 1.17% of which eventually develops into breast cancer, the repeated breast pain and the presence of breast lumps place a great stress on the psychology of the patient, which is an important cause of the mood of the patient, and 11.8% of patients diagnosed with depression or anxiety, respectively, and 3.9% of patients diagnosed with depression or anxiety, respectively. The fluctuation of emotion can aggravate the clinical manifestations of patients and form a mutual influence situation. Therefore, one of the key points of treating the hyperplasia of mammary glands is to reduce the negative emotion of a patient, and the medicine intervention aiming at abnormal psychology is an indispensable part of treating the hyperplasia of mammary glands.
According to the traditional Chinese medicine, the nipple of the woman belongs to the liver, the breast belongs to the stomach, the liver channel is closely related to the breast disease of the woman, the liver is a rigid organ, likes and is resistant to depression, so that the emotional depression is easy to cause depression of the liver qi, so that the emotional depression is closely related to the occurrence and development of nodules of breast, and the theory is consistent with the psychological stress theory of modern medicine. The "orthodox surgery" section also says: "melancholy hurts liver, anxiety hurts spleen, accumulates heart and will not remember, causes the meridian stuffiness and astringent, coalesces into core", indicates that liver hurts by anxiety is an important factor for the development of nodules of breast.
Disclosure of Invention
The purpose of the invention is as follows: aiming at the problems or the defects in the prior art, the invention provides a traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression and a preparation method thereof.
In order to achieve the purpose, the embodiment of the invention provides a traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which is characterized by being prepared from the following main raw materials in parts by weight: 5-30 parts of radix bupleuri, 5-30 parts of rhizoma cyperi, 5-30 parts of radix curcumae, 10-60 parts of oyster, 5-30 parts of stiff silkworm, 5-30 parts of fingered citron, 5-15 parts of citron, 5-30 parts of rose, 5-15 parts of flos mume, 5-30 parts of fructus akebiae, and 5-30 parts of hypericum perforatum.
Further, the health-care food is prepared from the following main raw materials in parts by weight: 7-15 parts of radix bupleuri, 10-20 parts of rhizoma cyperi, 8-18 parts of radix curcumae, 32-45 parts of oyster, 9-18 parts of stiff silkworm, 6-14 parts of fingered citron, 7-12 parts of citron, 12-20 parts of rose, 7-10 parts of flos mume, 8-18 parts of fructus akebiae and 16-25 parts of hypericum perforatum.
Preferably, the composition is prepared from the following main raw materials in parts by weight: 10 parts of radix bupleuri, 15 parts of rhizoma cyperi, 12 parts of radix curcumae, 37 parts of oyster, 13 parts of stiff silkworm, 10 parts of fingered citron, 11 parts of citron, 15 parts of rose, 8 parts of flos mume, 13 parts of fructus akebiae and 19 parts of hypericum perforatum.
The embodiment of the invention also provides a preparation method of the traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which is characterized by comprising the following steps:
(1) the preparation method comprises the following steps of crushing the batryticated silkworm according to the formula amount to prepare stiff silkworm powder, adding 65-90% ethanol for extraction twice, extracting for 2-3 hours each time, filtering, and collecting a first extracting solution;
(2) extracting volatile oil of rose, flos Pruni mume and fructus Citri Sarcodactylis according to formula amount by steam distillation, and collecting to obtain second extractive solution;
(3) mixing the bupleurum, the rhizoma cyperi, the curcuma aromatica, the citron, the hypericum perforatum and the fructus akebiae according to the formula amount, adding sufficient distilled water, decocting for 30-60 minutes, and sieving by a 80-mesh sieve to obtain a third extracting solution;
(4) crushing oyster shells according to the formula amount, adding sufficient distilled water, decocting for 60 minutes, and sieving with a 80-mesh sieve to obtain a fourth extracting solution;
(5) adding the first extracting solution obtained in the step (1), the second extracting solution obtained in the step (2) and the third extracting solution obtained in the step (3) into the fourth extracting solution obtained in the step (4), and drying under reduced pressure by adopting a cabinet type reduced-pressure dryer to obtain dry powder;
(6) further crushing the medicinal powder obtained in the step (4) into fine powder with the granularity of more than 100 meshes by using a traditional Chinese medicine ultrafine pulverizer;
(7) at an ozone concentration of 50g/m3Air flow speed of 40m/s and air source oxygen purity>85 percent, sterilizing the fine powder obtained in the step (5) by ozone at the sterilization temperature of less than 40 ℃, preserving the medicinal components under the maximum condition, and preparing the Chinese medicinal preparation;
(8) preparing a matrix: weighing a proper amount of medical thermosol, heating to 40-60 ℃ for dissolving, and stirring for 20-40 min;
(9) and (3) taking 80-150 g of the traditional Chinese medicine preparation prepared in the step (7) and 8-15 ml of the substrate prepared in the step (8), dissolving at 40-60 ℃, uniformly stirring to form a dry thick paste, taking 0.5g of the thick paste, coating the thick paste on non-woven fabric with the thickness of 1mm, cooling, covering with a polyethylene film, and packaging to obtain the traditional Chinese medicine preparation.
Further, the fine powder prepared in the step (5) requires: 100 percent of the mixture is sieved by a 100-mesh sieve, and 95 percent of the mixture is sieved by a 120-mesh sieve.
The technical scheme of the invention has the following beneficial effects:
(1) the Chinese medicinal cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which is disclosed by the invention, contains the bupleurum, the rhizoma cyperi and the radix curcumae, and has the effects of soothing liver and relieving depression, regulating qi and activating blood; the contained fingered citron, buckeye and fructus akebiae have the effects of soothing liver-qi stagnation, regulating qi and relieving pain; the contained hypericum perforatum has the effects of soothing liver-qi stagnation, reducing swelling and relieving pain, and the effective components of the hypericum perforatum have certain depression resistance; the contained snakegourd fruit and stiff silkworm have the functions of reducing phlegm, softening hardness and dissipating stagnation, are key medicines for treating hyperplasia of mammary glands, and the effective components of the snakegourd fruit and stiff silkworm have certain sedative and analgesic effects; flos Rosae Rugosae and flos Pruni mume have effects of dispersing stagnated liver qi for relieving qi stagnation, promoting blood circulation and relieving pain; the whole formula has the effects of soothing liver-qi stagnation, reducing phlegm and resolving masses, and activating blood and relieving pain.
(2) The traditional Chinese medicine cataplasm aims at special crowds of physical diseases and psychological diseases, namely 'double heart diseases', and can treat diseases and improve the life quality; meanwhile, the cataplasm is convenient to use, and avoids the pain of oral administration of traditional Chinese medicines.
(3) In the preparation method process of the traditional Chinese medicine cataplasm, the materials are divided into a plurality of groups, and different extraction modes (ethanol extraction, steam distillation and decoction) are adopted to extract the effective components respectively, so that the effective components of the extracted medicine can be effectively protected, the cataplasm is more convenient to use, has the effect of treating hyperplasia of mammary glands and anxiety and depression, and has better clinical curative effect.
Detailed Description
In order to make the technical problems, technical solutions and advantages to be solved by the present invention clearer, the following detailed description is given with reference to specific embodiments.
The invention provides a traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression, which is prepared from the following main raw materials in parts by weight: 10 parts of radix bupleuri, 15 parts of rhizoma cyperi, 12 parts of radix curcumae, 37 parts of oyster, 13 parts of stiff silkworm, 10 parts of fingered citron, 11 parts of citron, 15 parts of rose, 8 parts of flos mume, 13 parts of fructus akebiae and 19 parts of hypericum perforatum.
According to the formula, the traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands complicated with anxiety and depression is prepared by taking the traditional Chinese medicine raw materials according to the formula amount according to the following preparation method, and the preparation steps are as follows:
(1) the preparation method comprises the steps of crushing the batryticated silkworm according to the formula amount, preparing stiff silkworm powder, adding 65-90% ethanol for extraction twice, extracting for 2-3 hours each time, filtering, and collecting a first extracting solution.
(2) Extracting volatile oil of rose, flos Pruni mume and fructus Citri Sarcodactylis with water vapor distillation method, and collecting to obtain second extractive solution.
(3) Mixing the bupleurum, the rhizoma cyperi, the curcuma aromatica, the citron, the hypericum perforatum and the fructus akebiae according to the formula amount, adding sufficient distilled water, decocting for 30-60 minutes, and sieving by a 80-mesh sieve to obtain a third extracting solution.
(4) Crushing oyster shells according to the formula amount, adding sufficient distilled water, decocting for 60 minutes, and sieving with a 80-mesh sieve to obtain a fourth extracting solution.
(5) Adding the first extracting solution obtained in the step (1), the second extracting solution obtained in the step (2) and the third extracting solution obtained in the step (3) into the fourth extracting solution obtained in the step (4), and drying under reduced pressure by adopting a cabinet type reduced-pressure dryer to obtain dry powder; the fine powder prepared in the step (5) requires: 100 percent of the mixture is sieved by a 100-mesh sieve, and 95 percent of the mixture is sieved by a 120-mesh sieve.
(6) And (5) further crushing the medicinal powder obtained in the step (4) into fine powder with the granularity of more than 100 meshes by using a traditional Chinese medicine ultrafine pulverizer.
(7) At an ozone concentration of 50g/m3Air flow speed of 40m/s and air source oxygen purity>And (3) performing ozone sterilization on the fine powder obtained in the step (5) at the sterilization temperature of less than 40 ℃ at 85 percent, preserving the medicinal components under the maximum condition, and preparing the Chinese medicinal preparation.
(8) Preparing a matrix: weighing a proper amount of the medical thermosol, heating to 40-60 ℃ for dissolving, and stirring for 20-40 min.
(9) And (3) taking 80-150 g of the traditional Chinese medicine preparation prepared in the step (7) and 8-15 ml of the substrate prepared in the step (8), dissolving at 40-60 ℃, uniformly stirring to form a dry thick paste, taking 0.5g of the thick paste, coating the thick paste on non-woven fabric with the thickness of 1mm, cooling, covering with a polyethylene film, and packaging to obtain the traditional Chinese medicine preparation.
Rat experiments prove that the cataplasm prepared by the formula and the method has no toxic or side effect.
The following experimental data are combined to prove that the cataplasm prepared by the invention can be used for treating hyperplasia of mammary glands with anxiety and depression.
180 patients with standard breast surgery outpatients in traditional Chinese medicine hospital of Nantong city of 1 month to 7 months in 2019 are selected and divided into a treatment group and a control group according to a random digital table method, wherein 90 patients are selected. The patients in the two groups have no significant difference in age, onset time and onset part, and have comparability (P >0.05), which is shown in Table 1. The study was approved by the ethical committee of the institute of traditional Chinese medicine in south China.
The treatment method comprises the following steps: control group: the granule (approved by the department of pharmacy of traditional Chinese medicine, Nantong city, SU YAO character Z040001364) is administered with 200ml warm boiled water 1 dose per day in the morning and evening, 2 weeks is 1 course of treatment, and 3 courses of treatment are given in total.
Treatment groups: the cataplasm of the invention is externally applied for 3 courses on the basis of a control group.
Observation indexes are as follows: 1. anxiety, depression score: in a resting state, the emotional state of a tester is evaluated by using an anxiety self-rating scale (SAS) and a depression self-rating scale (SDS) compiled by Zung, the higher the score is, the more serious the anxiety and the depression is, the total score is 80 by adopting a four-grade scoring method, the score is converted into a percentile standard score, and the sum of the standard scores of the two scales is calculated. All points were scored as questionnaires at the time of group entry and 6 weeks after treatment.
2. Laboratory index
(1) Hormone level detection: estradiol (E2), progesterone (P) and Prolactin (PRL) levels were collected once each at the time of enrollment and 3 months after treatment, the reagents were provided by Roche; (2) color Doppler ultrasound examination: the maximum blood flow velocity (Vmax), the minimum blood flow velocity (Vmin) and the blood flow Resistance Index (RI) of the breast hemodynamic index level are detected by using a color Doppler ultrasonic diagnostic apparatus (Siemens S2000, probe frequency of 18 mHz). Collected once after 6 weeks of group entry and treatment.
Statistical method
Statistical analysis of the data was performed using SPSS 20.0. For data conforming to normal distribution, metering data is expressed in (x +/-s), independent sample t test is adopted among groups, paired sample t test is adopted in groups, and counting data is subjected to 2 test; non-parametric tests are used for data that do not conform to normal distributions. P <0.05 indicates that the difference is statistically significant.
As a result: example 1
In the study process of the invention, the data collected from the control group and the treatment group were compared, 90 persons were selected for each group, and the time of onset and the single and double-sided incidence rates were counted, with the statistical results shown in table 1.
TABLE 1 comparison of two general data sets
Figure BDA0003131980780000051
Figure BDA0003131980780000052
Note: and the chi-square test is used as the test result, T is the statistic of the T test, chi-2 is the statistic of the chi-square test, P is the judgment on the result, and P <0.05 represents that the difference has statistical significance.
The results show that: the differences in age, time of onset and distribution of unilateral or bilateral onset were not statistically significant (P >0.05) in the treated groups compared to the control group.
(1) Clinical symptom score and anxiety and depression score comparison of treatment group and control group
The difference between the clinical symptom score and the anxiety and depression score before treatment of the treatment group and the control group has no statistical significance and has comparability (P is more than 0.05); the clinical symptom score and the anxiety and depression score are reduced by comparing before and after treatment in the two groups, and the difference has statistical significance (P is less than 0.05); the clinical symptom score and the anxiety and depression score after treatment in the treatment group are lower than those in the control group, and the difference has statistical significance (P <0.05), which is shown in table 2.
TABLE 2 comparison of two groups of clinical symptom scores and anxiety-depression scores
Figure BDA0003131980780000061
Figure BDA0003131980780000062
As can be seen from table 2, the symptom score and anxiety-depression score were decreased before and after treatment in the treatment group and the control group, P <0.001, and the difference was statistically significant.
The results show that: the symptom score and the anxiety and depression score are reduced compared before and after treatment in the treatment group and the control group, which indicates that the cataplasm provided by the invention can be applied externally for 3 courses and has a certain effect on treating hyperplasia of mammary glands and anxiety and depression. The symptom scores and the anxiety and depression scores of the treated group and the control group after treatment are compared, and the effect of the cataplasm external application combined with the breast nodule eliminating granule for oral administration for 3 courses of treatment on the hyperplasia of mammary glands and the anxiety and depression is better than the effect of the breast nodule eliminating granule for internal administration of the control group.
(2) The total effective rate of the treatment group and the control group is compared
The curative group and the control group are compared with the curative, obvious effect, effective and total effective rate.
TABLE 3 comparison of the two groups of total effective rates
Figure BDA0003131980780000063
As can be seen from Table 3, the total effective rate of the treatment group was higher than that of the control group, and the difference was statistically significant (P < 0.05).
(3) Laboratory index comparison of treatment and control groups
Compared with the pretreatment hormone level (E2, P (progesterone), PRL) and the ultrasonic hemodynamics index (Vmax, Vmin and RI) of the control group, the difference has no statistical significance and has comparability (P > 0.05); the results of comparing the intra-and post-treatment data for the treated and control groups are shown in tables 4 and 5:
TABLE 4 comparison of hormone levels in the treated and control groups
Figure BDA0003131980780000071
Figure BDA0003131980780000072
Note: in the treatment group and the control group, the levels of E2 and PRL are reduced and the level of P (progesterone) is increased in the pre-treatment control and the post-treatment control, and the difference has statistical significance (P is less than 0.001).
TABLE 5 comparison of the ultrasonic hemodynamic indices of the treated and control groups
Figure BDA0003131980780000073
Figure BDA0003131980780000074
Note: compared with the treatment group and the control group before and after treatment, the ultrasonic hemodynamics indexes Vmax and Vmin are increased, the RI is decreased, and the difference has statistical significance.
As can be seen from tables 4 and 5, the hormone levels and the ultrasound hemodynamic indices before and after treatment in the treatment group and the control group were improved, and the differences had statistical significance (P < 0.05); compared with serum indexes and ultrasonic indexes after treatment in two groups, E2, PRL and RI in the treatment group are lower than those in the control group, P (progesterone), Vmax and Vmin are higher than those in the control group, and the difference has statistical significance (P is less than 0.05). Therefore, after the cataplasm is used for treatment, the hormone level and the hemodynamics of a patient under ultrasound can be obviously improved, female progestogen and prolactin are definitely related to the pathogenesis of hyperplasia of mammary glands, the female progestogen is related to the generation of anxiety and depression, and the hemodynamics of the mammary glands under ultrasound reflects the lightness and heaviness of the hyperplasia of the mammary glands.
When the cataplasm of the present invention is used, it should be noted that: the use is forbidden for skin allergy patients; secondly, sensitive parts such as nipple areola and the like are avoided when the patch is applied.
While the foregoing is directed to the preferred embodiment of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (5)

1. A traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression is characterized by being prepared from the following main raw materials in parts by weight: 5-30 parts of radix bupleuri, 5-30 parts of rhizoma cyperi, 5-30 parts of radix curcumae, 10-60 parts of oyster, 5-30 parts of stiff silkworm, 5-30 parts of fingered citron, 5-15 parts of citron, 5-30 parts of rose, 5-15 parts of flos mume, 5-30 parts of fructus akebiae, and 5-30 parts of hypericum perforatum.
2. The traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression according to claim 1 is characterized by being prepared from the following main raw materials in parts by weight: 7-15 parts of radix bupleuri, 10-20 parts of rhizoma cyperi, 8-18 parts of radix curcumae, 32-45 parts of oyster, 9-18 parts of stiff silkworm, 6-14 parts of fingered citron, 7-12 parts of citron, 12-20 parts of rose, 7-10 parts of flos mume, 8-18 parts of fructus akebiae and 16-25 parts of hypericum perforatum.
3. The traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression according to claim 1 is characterized by being prepared from the following main raw materials in parts by weight: 10 parts of radix bupleuri, 15 parts of rhizoma cyperi, 12 parts of radix curcumae, 37 parts of oyster, 13 parts of stiff silkworm, 10 parts of fingered citron, 11 parts of citron, 15 parts of rose, 8 parts of flos mume, 13 parts of fructus akebiae and 19 parts of hypericum perforatum.
4. A preparation method of the traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands and anxiety depression according to any one of claims 1 to 3, which is characterized by comprising the following steps:
(1) the preparation method comprises the following steps of crushing the batryticated silkworm according to the formula amount to prepare stiff silkworm powder, adding 65-90% ethanol for extraction twice, extracting for 2-3 hours each time, filtering, and collecting a first extracting solution;
(2) extracting volatile oil of rose, flos Pruni mume and fructus Citri Sarcodactylis according to formula amount by steam distillation, and collecting to obtain second extractive solution;
(3) mixing the bupleurum, the rhizoma cyperi, the curcuma aromatica, the citron, the hypericum perforatum and the fructus akebiae according to the formula amount, adding sufficient distilled water, decocting for 30-60 minutes, and sieving by a 80-mesh sieve to obtain a third extracting solution;
(4) crushing oyster shells according to the formula amount, adding sufficient distilled water, decocting for 60 minutes, and sieving with a 80-mesh sieve to obtain a fourth extracting solution;
(5) adding the first extracting solution obtained in the step (1), the second extracting solution obtained in the step (2) and the third extracting solution obtained in the step (3) into the fourth extracting solution obtained in the step (4), and drying under reduced pressure by adopting a cabinet type reduced-pressure dryer to obtain dry powder;
(6) further crushing the medicinal powder obtained in the step (4) into fine powder with the granularity of more than 100 meshes by using a traditional Chinese medicine ultrafine pulverizer;
(7) at an ozone concentration of 50g/m3Air flow speed of 40m/s and air source oxygen purity>85 percent, sterilizing the fine powder obtained in the step (5) by ozone at the sterilization temperature of less than 40 ℃, preserving the medicinal components under the maximum condition, and preparing the Chinese medicinal preparation;
(8) preparing a matrix: weighing a proper amount of medical thermosol, heating to 40-60 ℃ for dissolving, and stirring for 20-40 min;
(9) and (3) taking 80-150 g of the traditional Chinese medicine preparation prepared in the step (7) and 8-15 ml of the substrate prepared in the step (8), dissolving at 40-60 ℃, uniformly stirring to form a dry thick paste, taking 0.5g of the thick paste, coating the thick paste on non-woven fabric with the thickness of 1mm, cooling, covering with a polyethylene film, and packaging to obtain the traditional Chinese medicine preparation.
5. The preparation method of the traditional Chinese medicine cataplasm for treating hyperplasia of mammary glands with anxiety and depression according to claim 4, wherein the fine powder prepared in the step (5) requires: 100 percent of the mixture is sieved by a 100-mesh sieve, and 95 percent of the mixture is sieved by a 120-mesh sieve.
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