CN111905082A - External ointment for treating hyperplasia of mammary glands and preparation method thereof - Google Patents
External ointment for treating hyperplasia of mammary glands and preparation method thereof Download PDFInfo
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Abstract
The invention provides an external ointment for treating hyperplasia of mammary glands, which is prepared from active ingredients and a matrix, wherein the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 50-200 parts of nux vomica, 25-100 parts of curcuma zedoary, 40-160 parts of clove and 25-100 parts of borneol. The invention also comprises a preparation method of the external ointment. The traditional Chinese medicine composition provided by the invention has the effects of soothing liver, regulating qi, promoting blood circulation, removing blood stasis, relieving swelling and pain through compatibility of the medicines, so that lumps in breasts are dissolved and relieved, and the recurrence is not easy.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine external ointment, in particular to external ointment for treating hyperplasia of mammary glands and a preparation method thereof.
Background
Hyperplasia of mammary glands is a common gynecological disease, and occurs well in women aged 30-40 years. It is characterized by the growth of lumps in different parts of the breast, with soft texture, unclear borders, mobility, and often accompanied by pain of different degrees. Mastoplasia is a degenerative and progressive change in the structure of the ducts and lobules of the breast caused by endocrine dyscrasia, increased estrogen or progesterone proportion dyscrasia and increased estrogen receptors in the breast tissue. The hyperplasia of mammary glands is a common disease and a frequently encountered disease in the female breast diseases, and even seriously influences the life and work of patients.
At present, the main clinical treatment modes comprise western medicine treatment, traditional Chinese medicine and patent medicine oral administration and the like, but the defects of long period, inconvenient operation, large side effect and the like exist, so that the patients are difficult to insist. The existing application therapy is widely used for clinical treatment of various hyperplasias of human bodies due to the advantages of convenient operation, good effect, small side effect and the like. However, the existing external-use medicine has the defects of complex components, high cost and more complicated preparation method, and the wide application of the external-use ointment in the hyperplasia of mammary glands is limited.
Disclosure of Invention
In order to solve the defects of the prior art, the invention provides an external ointment for treating hyperplasia of mammary glands and a preparation method thereof.
The technical scheme adopted by the invention is as follows:
an external ointment for treating hyperplasia of mammary glands is prepared from active ingredients and a matrix, wherein the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 50-200 parts of nux vomica, 25-100 parts of curcuma zedoary, 40-160 parts of clove and 25-100 parts of borneol.
Preferably, the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 100 parts of nux vomica, 50 parts of curcuma zedoary, 80 parts of clove and 50 parts of borneol.
Further, the matrix components are glycerol, gelatin, water, PEG6000 and carbomer, and the mass ratio is 18: 8.5: 2: 5: 3.
Further, the mass ratio of the active ingredients to the matrix is 3: 7.
further, the use method of the paste comprises the following steps: after massaging the breast for 10 minutes, the ointment is pasted on the affected part once a day.
The invention also comprises a preparation method of the external ointment, which comprises the following steps:
s1, preparation of alcohol extract: pulverizing semen Strychni and flos Caryophylli into coarse powder, adding 10 times of 95% ethanol, soaking for 1 hr, heating and extracting for 1.5 hr, and filtering to obtain ethanol extract and residue; recovering ethanol in the ethanol extract under reduced pressure, and concentrating to obtain extract A with a relative density of 1.30-1.35 (60 ℃), for later use;
s2, preparation of an aqueous extract: soaking the medicine residues and the curcuma zedoary in 10 times of water by weight for half an hour, decocting twice, each time lasting for 1 hour, combining the decoctions, filtering, and concentrating the filtrate to obtain an extract B with the relative density of 1.30-1.35 (60 ℃);
s3, mixing the extracts: mixing the extract A and the extract B, grinding the borneol in parts by weight, adding the ground borneol in the mixed extract, and stirring to uniformly disperse the ground borneol and the mixed extract to obtain a traditional Chinese medicine extract;
s4, preparation of paste: preparing glycerol, gelatin, water, PEG6000 and carbomer into plaster matrix; adding the above Chinese medicinal extract, mixing, stirring, making into coating, slicing, covering with liner, and packaging to obtain the topical unguent.
Further, the preparation method of the plaster substrate comprises the following steps: weighing gelatin according to a certain proportion, adding the gelatin into water, boiling and dissolving, adding glycerol, and stirring and uniformly mixing; and then sequentially adding PEG6000 and carbomer, and uniformly stirring to obtain the plaster matrix.
The traditional Chinese medicinal materials have the following main effects:
nux vomica: unblock collaterals to alleviate pain, dissipate nodulation and resolve swelling. Can be used for treating rheumatism, numbness, paralysis, traumatic injury, carbuncle, cellulitis, and swelling and pain; sequela of poliomyelitis, rheumatoid arthralgia.
Zedoary turmeric: move qi and break blood, resolve food stagnation and alleviate pain. Can be used for treating abdominal mass, amenorrhea due to blood stasis, thoracic obstruction, heart pain, and pain due to food stagnation.
Clove: to warm the middle-jiao and descend the adverse flow of qi, tonify the kidney and strengthen yang. Can be used for treating deficiency-cold of spleen and stomach, singultus emesis, anorexia vomiting and diarrhea, psychroalgia of heart and abdomen, and sexual impotence due to kidney deficiency.
Borneol: induce resuscitation and refresh mind, clear heat and alleviate pain. Can be used for treating fever unconsciousness, convulsion, apoplexy with phlegm syncope, qi stagnation and sudden syncope, central nausea and coma, thoracic obstruction, cardialgia, conjunctival congestion, aphtha, sore throat, and purulence in ear canal.
The pharmacological effects of the invention are:
1. soothing liver, regulating qi, promoting blood circulation and removing blood stasis: according to the traditional Chinese medicine, the hyperplasia of mammary glands starts from liver depression, then blood stasis and phlegm are coagulated into blocks, lumps are formed in breasts, the nux vomica and the curcuma zedoary in the formula have the effects of soothing liver, regulating qi, promoting blood circulation and removing blood stasis, and the lumps in the breasts can be dissolved and relieved, so that the purpose of treatment is achieved, and the recurrence is not easy.
2. Relieving swelling and pain: the clinical symptoms of the hyperplasia of mammary glands are mostly expressed as breast periodic pain, distending pain and stronger touch pain; the effective component strychnine in the nux vomica has a paralysis effect on sensory nerve endings, so that the good pain relieving effect is achieved, and the clove and borneol in the nux vomica formula can enhance the swelling and pain relieving effects of the nux vomica.
The invention can dissolve the lumps in the breast by the compatibility of the medicines and is not easy to relapse.
Detailed Description
All materials, reagents and equipment selected for use in the present invention are well known in the art, but do not limit the practice of the invention, and other reagents and equipment well known in the art may be suitable for use in the practice of the following embodiments of the invention. The following examples are all conducted by Cantonese Biotech limited.
Example 1
An external ointment for treating hyperplasia of mammary glands is prepared from active ingredients and a matrix, wherein the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 50 parts of nux vomica, 25 parts of curcuma zedoary, 40 parts of clove and 25 parts of borneol; the matrix components are glycerol, gelatin, water, PEG6000 and carbomer, and the mass ratio is 18: 8.5: 2: 5: 3; the mass ratio of the active ingredients to the matrix is 3: 7.
the preparation method of the external ointment comprises the following steps:
s1, preparation of alcohol extract: pulverizing semen Strychni and flos Caryophylli into coarse powder, adding 10 times of 95% ethanol, soaking for 1 hr, heating and extracting for 1.5 hr, and filtering to obtain ethanol extract and residue; recovering ethanol in the ethanol extract under reduced pressure, and concentrating to obtain extract A with a relative density of 1.30-1.35 (60 ℃), for later use;
s2, preparation of an aqueous extract: soaking the medicine residues and the curcuma zedoary in 10 times of water by weight for half an hour, decocting twice, each time lasting for 1 hour, combining the decoctions, filtering, and concentrating the filtrate to obtain an extract B with the relative density of 1.30-1.35 (60 ℃);
s3, mixing the extracts: mixing the extract A and the extract B, grinding the borneol in parts by weight, adding the ground borneol in the mixed extract, and stirring to uniformly disperse the ground borneol and the mixed extract to obtain a traditional Chinese medicine extract;
s4, preparation of paste: weighing gelatin according to a certain proportion, adding the gelatin into water, boiling and dissolving, adding glycerol, and stirring and uniformly mixing; then sequentially adding PEG6000 and carbomer, and uniformly stirring to obtain the plaster matrix; adding the above Chinese medicinal extract, mixing, stirring, making into coating, slicing, covering with liner, and packaging to obtain the topical unguent.
Example 2
An external ointment for treating hyperplasia of mammary glands has the components and the preparation method similar to those of the embodiment 1, except that the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 100 parts of nux vomica, 50 parts of curcuma zedoary, 80 parts of clove and 50 parts of borneol.
Example 3
An external ointment for treating hyperplasia of mammary glands has the components and the preparation method similar to those of the embodiment 1, except that the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 200 parts of nux vomica, 100 parts of curcuma zedoary, 160 parts of clove and 100 parts of borneol.
Toxicology experiments:
1. acute toxicity test of skin
Taking 20 SPF-grade experimental rabbits with the weight of about 2kg and half of each sex, dividing the experimental rabbits into a blank control group (matrix 10.0 g/rabbit), wherein the experimental group is the external ointment of the invention: intact skin and broken skin, 2 doses each: the medicine is taken (10.0 g/body, 2 g/body), and each group contains 5 medicines. The two sides of the spinal column of the back of the rabbit are unhaired, and the unhairing area is about 12cmx15 cm. After unhairing, the skin was examined 24h for injury. Injured rabbits are not suitable for toxicity testing of intact skin. Preparation of damaged skin: a "#" shaped incision was made in the skin sanitized in the depilatory area using a disposable syringe needle. The length and width are about 5cm respectively, and the depth is 2-3mm, so as not to damage subcutaneous tissue and have blood seepage. Applying the topical ointment to depilated area, raising each animal in cages, keeping for 24 hr, washing residual medicine with warm water, observing animal body weight, diet, defecation, activity, skin, hair, eye, mucous membrane and respiration from 1, 24, 48, 72 hr to 7 days, and comparing with control group.
The test results show that the rabbits of the intact skin group and the damaged skin group are observed from 1, 24, 48, 72 hours to 7 days after the removal of the drug, and the actions, activities, fur luster, eyes, conjunctiva, respiration and diet of the rabbits are found to be normal, the smearing part has no erythema, edema and the like, no toxic symptoms are seen, no death is seen, and no difference is found compared with the matrix control group. The difference in net weight gain of rabbits was not significant between the intact skin group and the damaged skin group (P >0.05) compared to the vehicle control group. The test result shows that the external ointment has no acute toxic reaction and good safety when being applied through the skin.
2. Skin allergy test
30 SPF-grade white guinea pigs are randomly divided into 3 groups, namely a substrate group, a emplastrum group and a positive control group, wherein each group comprises 10 animals and half animals. In the 24 hours before administration, the guinea pigs were depilated from both sides of the dorsal spine in an area of 4cm × 4 cm. Sensitizing and contacting: the external ointment (with the drug content of 0.5g) is taken to be arranged on the hairless area on the left side. The matrix group (weight 0.5g), the positive control group were raised in cages with 0.2mL of 1% 2-4-dinitrochlorobenzene (batch No. 921001) for 6h, repeated 1 time in the same manner on day 7 and 14 for a total of 3 times. (contact stimulation: 14 days after the last sensitization of the tested medicine, the external ointment (with the medicine content of 0.5g) is pasted on the right depilating area of the back, 0.5g of the matrix is used for the matrix group, 0.2ml of 0.1% of 2, 4-dinitrochlorobenzene is used for the positive control group, the tested medicine is removed after 6 hours, the immediate observation is carried out, then the skin allergy condition is observed again after 24, 48 and 72 hours, and the observation is carried out to see whether the animal has severe general allergy such as asthma, unstable standing or shock.
The external ointment of the invention has the following test results on skin sensitization: the matrix group has no skin allergy such as erythema and edema; only individual animals of the external ointment group of the present invention immediately had mild erythema response. The sensitization rate is 6%, and the reaction has subsided by 24 hours; the positive control group has obvious skin allergic reaction conditions such as erythema, edema and the like, the integral value is very high, and the sensitization rate reaches 100 percent. No serious systemic allergic reactions such as asthma, unstable stance or shock occurred in any of the 3 groups of guinea pigs. The results show that: the external ointment and the substrate of the invention have no sensitization reaction on skin, and the external ointment of the invention occasionally has erythema reaction on individual animals but can disappear by self.
The curative effect experiment:
content of study
The method comprises the steps of collecting patients with cyclomastopathy and periodic breast pain in the lactation center of a traditional Chinese medicine hospital within one year, bringing the patients into 60 patients with cyclomastopathy, performing baseline VAS scoring and VAS scoring after 1 month of treatment, judging the curative effect and safety of the medicine, calculating the mean value and standard deviation by using SPSS statistical software, performing matched t test, and prompting whether the patients have statistical benefit after treatment (P is 000).
(II) research method
The primary study objective was to score patients on a simplified McGill pain questionnaire (SF-MPQ) as follows:
(III) embodiment
1. Case inclusion criteria were met with the following:
(1) the diagnosis standard of the hyperplasia of mammary glands is met;
(2) the existing periodic premenstrual breast pain symptoms exist, the VAS score of the pain is more than or equal to 4 minutes, and the disease duration is more than or equal to 3 months;
(3) premenopausal women aged 18-55 years (including 18, 55 years);
(4) chinese and western medicines for treating hyperplasia of mammary glands and relieving breast pain are not used in nearly three months, and hormone preparations, oral contraceptives and hormone replacement therapy medicines are not used in nearly half a year;
(5) clinical examination of the breast, at least one palpable nodule or mammary gland is thickened;
(6) the local skin of the breast is normal and has no damage;
(7) voluntarily underwent clinical trials and signed informed consent.
If any of the above answers is "no", the subject is not able to participate in the experiment.
Exclusion criteria:
(1) meets the diagnosis standard of the hyperplasia of mammary glands but does not have the periodic breast pain symptom;
(2) patients with combined mastitis, breast malignant tumors and other breast diseases with surgical indications;
(3) those who have undergone breast plastic surgery or breast surgery within about 3 months;
(4) combined with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases, hemopoietic system diseases, etc., or serious diseases (such as tumor or AIDS) affecting the survival of peptic ulcer diseases, or mental or legal disability patients;
(5) ovariectomizer (whole or partial);
(6) chest pain in the front and sides of the chest caused by other diseases;
(7) pregnant or lactating women, or those with a pregnancy plan in the last trimester;
(8) allergic constitution, or known to be allergic to the components of the prescription.
(9) Other pathologies that reduce or complicate the likelihood of grouping, such as occurence of missed visits due to changes in the working environment, and the inability to give adequate informed consent due to mental and behavioral disorders, as judged by the researcher;
(10) patients who participated in other clinical trials within the last month.
2. The clinical research method comprises the following steps:
preparation before application operation: 1 record before the trial, including demographic data: age, height, weight, menstruation, marriage, occupation, cultural degree, etc.; general clinical data: diseases and medication are combined; general physical examination items: blood pressure, heart rate, pulse, respiration, etc.
The aim and the method for the fixed doctor to give the patient a waiting for the experimental study prove that the patient agrees to sign an informed consent form, and the patient is pasted by a training nurse after the cooperation is obtained.
The ointment of example 2, named ru lunshu (vitamin milk rest pain prescription) for external use in this experiment, was used for the treatment by applying the ointment directly to both breasts. The application time is that the application is started after the menstruation is clean, 1 time per day and 4-6 hours per time. Treatment course, 1 treatment course is 1 menstrual cycle, and no medicine is taken during menstrual period.
The main curative effect indexes are as follows: a simplified McGill pain questionnaire (SF-MPQ) was administered at the time of enrollment, on the day of treatment at the end of treatment period 1, and after 1 month of follow-up visit in all cases. A Pain Rating Index (PRI) consisting of descriptors for 11 sensory classes and 4 affective classes, and a Present Pain Intensity (PPI) and a Visual Analogue Scale (VAS). All descriptors are 0, 1, 2, 3 for no pain, mild pain, moderate pain and severe pain, respectively. From this classification, the PRI or the total PRI is determined. Visual Analogue Scale (VAS) by the national institute of health, USA clinical research center. 0 indicates no pain, the larger the number the greater the intensity of pain, and 10 the most severe pain. Mild pain, VAS is more than 0 and less than or equal to 4; moderate pain is 4 < VAS < 6; severe pain: VAS is more than 6 and less than or equal to 10. The existing pain intensity (PPI) is divided into 6 grades of no pain (0), mild discomfort (1), discomfort (2), difficult pain (3), terrible pain (4) and extreme pain (5), and the grades are respectively counted as 0, 1, 2, 3, 4 and 5.
Secondary research indexes: record if adverse reactions occurred during the treatment period. Statistical analysis of all data results was performed using STATA software.
Pain index:
and (3) curing: pain symptoms disappear after treatment;
the effect is shown: the reduction in pain SF-MPQ score by more than 51% following treatment;
the method has the following advantages: a 19-50% reduction in pain SF-MPQ score scale score after treatment;
and (4) invalidation: there is less than 19% reduction in pain SF-MPQ score scale score after treatment.
The reduction ratio is [ (total fraction of baseline-total fraction after treatment) ÷ total fraction of baseline ] × 100%
3. The experimental results are as follows:
statistical benefit after treatment was suggested by statistical analysis of VAS scores for 60 patients enrolled in the group, calculation of mean, standard deviation and paired t-test using SPSS statistical software (P ═ 000). The VAS score record table and VAS score statistical analysis table for this experiment are as follows:
(1) VAS score record table:
(2) VAS score statistical analysis Table:
from the data, the treatment effect of the Rurenshu (vitamin milk pain relieving formula) external ointment adopted in the experiment is obvious, and no serious adverse reaction occurs.
Typical clinical cases are:
1. when the breast is detected by molybdenum target of mammary gland, the breast gland is slightly fibrocystic hyperplasia; color B-ultrasonic examination, uneven thickening of double mammary gland duct, multiple non-echo areas (3-8mm), and consideration of mammary gland multiple cyst acoustic image. Complaints are: breast distending pain, stabbing pain, pricking pain, aggravation in nearly 3 months, menstrual pain 1 week before menstruation. The treatment mode comprises the following steps: massaging breast for 10 min, and applying Columbus (vitamin milk stopping pain prescription) topical ointment on the root of breast and Ashi point; the pain score is reduced from 8 to 2 after 3 times of treatment, and the breast pain basically disappears after 2 courses of treatment without adverse reaction.
2. The pain of breasts before and after menstruation for nearly 3 months of Li Yi and women, aggravated in nearly 1 month, obvious from the lower edge of the left breast, touch pain, and no obvious space occupying lump in patients after color B ultrasonic examination considering the sound image of bilateral hyperplasia of mammary glands. The treatment mode comprises the following steps: massaging breasts for 10 minutes, applying the Ru lunshu (vitamin milk pain relieving formula) external ointment to an affected part once a day, and reducing the pain score from 9 points to 2 points after 3 times of treatment; the patients had clear relief from the pain by revisiting.
3. Zhu, woman, self-reported symptoms: breast pain and distending pain 1 week before menstruation, and tenderness pain caused by the heavy weight of the lower edge of the breast; b ultrasonic examination indicates that: right breast anechoic, BI-RADS 2 (considering galactocyst acoustic image), bilateral hyperplasia of mammary glands. Following standard treatment: the breast is massaged for 10 minutes, the Rulunshu (vitamin milk pain relieving formula) external ointment is applied to an affected part, the pain score is reduced from 6-7 to 0-1 after 1 time of treatment, and the pain is relieved obviously after one week.
4. While some women have self-reported significant (2 years) pain in the lateral side of the breasts, mostly premenstrual pain and lateral pain, tenderness, bad mood, aggravated pain, and irregular pain in the last 2-3 months. Following standard treatment: massaging the breast for 10 minutes, applying the Rulunshu (vitamin milk pain relieving formula) external ointment to an affected part, immediately relieving pain after treatment, and reducing the pain score from 9 points to 0 point; the pain basically disappears after 20 days of return visit, and the effect is obvious.
5. Chen and ren, premenstrual distending pain (many years), stabbing pain in both breasts in the last month, aggravated at night, stabbing pain 4-5 times a day, about 3-5 seconds each time; through the following treatment: the breast is massaged for 10 minutes, the Rulunshu (vitamin milk pain relieving formula) external ointment is applied to an affected part, the pain score is reduced from 8 to 2, the pain is obviously relieved after 3 days of return visit, and the patient is satisfied.
The present invention is not limited to the above-described embodiments, and various modifications and variations of the present invention are intended to be included within the scope of the claims and the equivalent technology of the present invention if they do not depart from the spirit and scope of the present invention.
Claims (7)
1. The external ointment for treating the hyperplasia of mammary glands is characterized by being prepared from active ingredients and an adhesive plaster matrix, wherein the active ingredients are extracted from the following traditional Chinese medicines in parts by weight: 50-200 parts of nux vomica, 25-100 parts of curcuma zedoary, 40-160 parts of clove and 25-100 parts of borneol.
2. The external ointment according to claim 1, wherein the active ingredients are extracted from the following Chinese herbs by weight: 100 parts of nux vomica, 50 parts of curcuma zedoary, 80 parts of clove and 50 parts of borneol.
3. The external ointment as claimed in claim 1, wherein the plaster base comprises glycerin, gelatin, water, PEG6000 and carbomer at a mass ratio of 18: 8.5: 2: 5: 3.
4. The topical ointment of claim 1, wherein the mass ratio of the active ingredient to the base is 3: 7.
5. The external use ointment according to claim 1, characterized in that it is used by a method comprising: after massaging the breast for 10 minutes, the ointment is pasted on the affected part once a day.
6. The process for producing the external ointment according to claim 1, which comprises the steps of:
s1, preparation of alcohol extract: pulverizing semen Strychni and flos Caryophylli into coarse powder, adding 10 times of 95% ethanol, soaking for 1 hr, heating and extracting for 1.5 hr, and filtering to obtain ethanol extract and residue; recovering ethanol in the ethanol extract under reduced pressure, and concentrating to obtain extract A with a relative density of 1.30-1.35 (60 ℃), for later use;
s2, preparation of an aqueous extract: soaking the medicine residues and the curcuma zedoary in 10 times of water by weight for half an hour, decocting twice, each time lasting for 1 hour, combining the decoctions, filtering, and concentrating the filtrate to obtain an extract B with the relative density of 1.30-1.35 (60 ℃);
s3, mixing the extracts: mixing the extract A and the extract B, grinding the borneol in parts by weight, adding the ground borneol in the mixed extract, and stirring to uniformly disperse the ground borneol and the mixed extract to obtain a traditional Chinese medicine extract;
s4, preparation of paste: preparing glycerol, gelatin, water, PEG6000 and carbomer into plaster matrix; adding the above Chinese medicinal extract, mixing, stirring, making into coating, slicing, covering with liner, and packaging to obtain the topical unguent.
7. The method for preparing the external paste according to claim 6, wherein the method for preparing the patch base comprises: weighing gelatin according to a certain proportion, adding the gelatin into water, boiling and dissolving, adding glycerol, and stirring and uniformly mixing; and then sequentially adding PEG6000 and carbomer, and uniformly stirring to obtain the plaster matrix.
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| CN112237621A (en) * | 2020-11-30 | 2021-01-19 | 南阳理工学院 | Traditional Chinese medicine emulsifiable paste for treating hyperplasia of mammary glands and preparation method thereof |
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