CN107158167B - Traditional Chinese medicine film for treating necrotizing lymphadenitis and preparation method thereof - Google Patents
Traditional Chinese medicine film for treating necrotizing lymphadenitis and preparation method thereof Download PDFInfo
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- CN107158167B CN107158167B CN201710439038.2A CN201710439038A CN107158167B CN 107158167 B CN107158167 B CN 107158167B CN 201710439038 A CN201710439038 A CN 201710439038A CN 107158167 B CN107158167 B CN 107158167B
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Abstract
The invention relates to a traditional Chinese medicine composition for treating necrotizing lymphadenitis, a traditional Chinese medicine patch and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 20-40 parts of selfheal, 20-40 parts of coptis, 20-40 parts of phellodendron, 50-70 parts of ampelopsis japonica, 10-20 parts of Chinese violet, 10-30 parts of prepared frankincense, 10-30 parts of prepared myrrh and 5-15 parts of borneol. The traditional Chinese medicine film is prepared from the traditional Chinese medicine composition and the traditional Chinese medicine film substrate. The traditional Chinese medicine composition has quick response and obvious curative effect on necrotizing lymphadenitis, and target lymphadenectasis, lymphadenectasis and fever symptoms of a patient are obviously improved. The Chinese medicinal patch is prepared into a Chinese medicinal patch, is pasted on an affected part to directly reach a focus, promotes the recovery of local physiological functions through skin conduction stimulation, and can achieve the aim of quick healing.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating necrotizing lymphadenitis, a traditional Chinese medicine patch and a preparation method thereof.
Background
The lymphadenitis is nonspecific inflammation caused by acute and chronic inflammation of a drainage region of the lymph node, such as axillary lymphadenitis caused by infection of the upper limb, the breast, the chest wall, the back and the abdominal wall above the umbilicus, inguinal lymphadenitis can occur due to infection of the lower limb, the abdominal wall below the umbilicus, the perineum and the buttocks, and infection of the head, the face, the oral cavity, the neck and the shoulders, which causes the submandibular and cervical lymphadenitis.
The antibiotic treatment of the necrotizing lymphadenitis is ineffective, no accepted standard treatment scheme exists, and the treatment is mainly carried out according to symptoms, such as people with WBC reduction, the people with leukogenic treatment and people with high grade fever, and glucocorticoid is preferred. Although the hormone can relieve symptoms, some cases are hormone-dependent, relapse is easy after stopping taking the hormone, and the toxic and side effects of long-term use of the hormone are large, such as induction and aggravation of infection, digestive tract symptoms, mental central nervous disorder, steroid diabetes, steroid myopathy and the like.
Traditional Chinese medicine has certain curative effect in the treatment of the disease, such as: an article published in Hebei Chinese medicine 2011 in 1 month, namely 31 cases of treating necrotizing lymphadenitis by combining Chinese and western medicines, adopts self-prepared antiviral granules for oral administration, an external heat-clearing and swelling-eliminating ointment and western medicines for treating necrotizing lymphadenitis, wherein the heat-clearing and swelling-eliminating ointment mainly comprises the following components: saffron, raw rhubarb, Japanese ampelopsis root, coptis root, phellodendron bark, Chinese violet, prepared frankincense, prepared myrrh, camphor, dark plum, liquorice and maltose. Chinese patent 201310367489.1 discloses a traditional Chinese medicine for treating axillary acute purulent lymphadenitis caused by overfeeding of rhizoma zingiberis, which is prepared by soaking crushed bupleurum, daghestan sweetclover herb, fresh coptis root, olive, creeping rostellularia herb, potentilla discolor, dysosma versipellis, wikstroemia indica, root of Chinese barberry, garden euphorbia herb, rohdea japonica, radix sophorae tonkinensis, edible tulip, huperzia serrata, soapberry, cotton rose, herba orostachyos, cuckoo-bud, Chinese brake herb, flaccid knotweed herb, black nightshade, Japanese ampelopsis root, solanum lyratum thunb, dioscorea hispida, figwort root, Chinese lobelia, hypericum japonicum, sowthistle tasselflower herb, szechwan anemone root, radix tinosporae, umbellate rock jasmine and liquorice in water with slow fire, then decocting, filtering and removing residues to obtain a liquid medicine. The traditional Chinese medicine composition has a certain curative effect on necrotizing lymphadenitis, but has the defects of more medicine ingredients, slow response and complex preparation method of the medicine.
Disclosure of Invention
The first purpose of the present invention is to provide a traditional Chinese medicine composition for treating necrotizing lymphadenitis, which aims at the defects in the prior art.
The second purpose of the present invention is to provide the use of the above-mentioned Chinese medicinal composition for overcoming the disadvantages of the prior art.
The third purpose of the invention is to provide a traditional Chinese medicine film for treating necrotizing lymphadenitis, aiming at the defects in the prior art.
In order to achieve the first purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for treating necrotizing lymphadenitis is prepared from the following raw material medicines in parts by weight: 20-40 parts of selfheal, 20-40 parts of coptis, 20-40 parts of phellodendron, 50-70 parts of ampelopsis japonica, 10-20 parts of Chinese violet, 10-30 parts of prepared frankincense, 10-30 parts of prepared myrrh and 5-15 parts of borneol.
Further, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 25-35 parts of selfheal, 25-35 parts of coptis, 25-35 parts of phellodendron, 50-70 parts of ampelopsis japonica, 10-20 parts of Chinese violet, 10-30 parts of prepared frankincense, 10-30 parts of prepared myrrh and 5-15 parts of borneol.
Further, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 30 parts of selfheal, 30 parts of coptis chinensis, 30 parts of phellodendron, 60 parts of Japanese ampelopsis, 15 parts of Chinese violet, 20 parts of prepared frankincense, 20 parts of prepared myrrh and 10 parts of borneol.
Further, the traditional Chinese medicine composition also comprises pharmaceutically acceptable auxiliary materials, wherein the pharmaceutically acceptable auxiliary materials comprise, but are not limited to mannitol, sorbitol, sodium metabisulfite, sodium bisulfite, sodium thiosulfate, cysteine hydrochloride, thioglycolic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, carbonate of monovalent alkali metal, acetate, phosphate or aqueous solution thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, brown sugar, mannitol, silicon derivatives, cellulose and derivatives thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, Tween 80, agar, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, β -cyclodextrin, phospholipid materials, kaolin, talcum powder, calcium stearate and magnesium stearate.
In order to achieve the second object, the invention adopts the technical scheme that:
the application of the traditional Chinese medicine composition in preparing a medicine for treating necrotizing lymphadenitis.
Furthermore, the necrotizing lymphadenitis belongs to the type of toxic heat congestion based on the differentiation of symptoms and signs in the traditional Chinese medicine.
In order to achieve the third object, the invention adopts the technical scheme that:
a traditional Chinese medicine patch for treating necrotizing lymphadenitis is prepared from the traditional Chinese medicine composition and a traditional Chinese medicine patch substrate.
Further, the preparation method of the traditional Chinese medicine film comprises the following steps:
(1) taking the traditional Chinese medicine composition according to the parts by weight, adding water into selfheal, coptis chinensis, golden cypress, Japanese ampelopsis root and philippine violet herb, decocting for 3 times, mixing decoctions, adding prepared frankincense, prepared myrrh and borneol when the decoctions are heated to 60 ℃ and preparing liquid medicine;
(2) taking 20 parts of polyvinyl alcohol, 3.5 parts of polyvinylpyrrolidone, 0.5 part of carbomer, 3 parts of glycerol and 5 parts of sodium alginate, and dispersing the carbomer in the glycerol to obtain liquid a;
(3) mixing the liquid a, polyvinylpyrrolidone and the liquid medicine to obtain liquid b;
(4) adding polyvinyl alcohol into the liquid b, stirring while heating to 85 ℃ to obtain a liquid c;
(5) and adding sodium alginate into the liquid c, and uniformly mixing to prepare the traditional Chinese medicine film.
Furthermore, the water addition amount is 1000 parts in the decoction process, and the decoction time is 1.5 hours.
The invention has the advantages that:
1. the traditional Chinese medicine composition disclosed by the invention has a quick response and a remarkable curative effect on necrotizing lymphadenitis, and target lymphadenectasis, lymphadenectasis and fever symptoms of a patient are remarkably improved.
2. The traditional Chinese medicine patch is prepared, is pasted on an affected part to directly reach a focus, promotes the recovery of local physiological functions through skin conduction stimulation, and can achieve the aim of quick healing.
3. No toxic and side effect, no drug resistance, few medicinal ingredients, easily obtained raw materials and low treatment cost.
4. In the prescription of the invention, the addition of the Chinese violet, the prepared frankincense and the prepared myrrh plays a role in synergy, and the treatment effect of the prescription is obviously improved.
5. The components and the proportion of the traditional Chinese medicine composition are screened by experiments, and the traditional Chinese medicine composition has the advantage of remarkable curative effect.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.
EXAMPLE 1 preparation of a liquid medicine of the Chinese medicinal composition of the present invention
Taking raw material medicines: 30 parts of selfheal, 30 parts of coptis chinensis, 30 parts of phellodendron, 60 parts of Japanese ampelopsis, 15 parts of Chinese violet, 20 parts of prepared frankincense, 20 parts of prepared myrrh and 10 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the Chinese violet are decocted for 3 times by adding water, wherein the amount of water added for each time is 1000 parts, the decocting time is 1.5 hours, the decoction liquids are combined, and the decoction liquid is heated to 60 ℃ and then is brought into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 2 preparation of liquid medicine of the Chinese medicinal composition of the present invention
Taking raw material medicines: 40 parts of selfheal, 40 parts of coptis chinensis, 40 parts of phellodendron, 50 parts of Japanese ampelopsis, 20 parts of Chinese violet, 30 parts of prepared frankincense, 30 parts of prepared myrrh and 15 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the Chinese violet are decocted for 3 times by adding water, wherein the amount of water added for each time is 1000 parts, the decocting time is 1.5 hours, the decoction liquids are combined, and the decoction liquid is heated to 60 ℃ and then is brought into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 3 preparation of liquid medicine of the Chinese medicinal composition of the present invention
Taking raw material medicines: 20 parts of selfheal, 20 parts of coptis chinensis, 20 parts of phellodendron, 70 parts of Japanese ampelopsis, 10 parts of herba violae, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the herba violae are decocted for 3 times by adding 1000 parts of water each time for 1.5 hours, the decoction solutions are combined, and the decoction solution is heated to 60 ℃ and then is added into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 4 preparation of liquid medicine of the Chinese medicinal composition of the present Invention (IV)
Taking raw material medicines: 20 parts of selfheal, 20 parts of coptis chinensis, 20 parts of phellodendron, 50 parts of Japanese ampelopsis, 10 parts of herba violae, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the herba violae are decocted for 3 times by adding 1000 parts of water each time for 1.5 hours, the decoction solutions are combined, and the decoction solution is heated to 60 ℃ and then is added into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 5 preparation of liquid medicine of the Chinese medicinal composition of the present invention (V)
Taking raw material medicines: 40 parts of selfheal, 40 parts of coptis chinensis, 20 parts of phellodendron, 50 parts of Japanese ampelopsis, 10 parts of herba violae, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the herba violae are decocted for 3 times by adding 1000 parts of water each time for 1.5 hours, the decoction solutions are combined, and the decoction solution is heated to 60 ℃ and then is added into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 6 preparation of liquid medicine of the Chinese medicinal composition of the present invention (VI)
Taking raw material medicines: 40 parts of selfheal, 40 parts of coptis chinensis, 40 parts of phellodendron, 70 parts of Japanese ampelopsis, 10 parts of herba violae, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the herba violae are decocted for 3 times by adding 1000 parts of water each time for 1.5 hours, the decoction solutions are combined, and the decoction solution is heated to 60 ℃ and then is added into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 7 preparation of liquid medicine of the Chinese medicinal composition of the present invention (VII)
Taking raw material medicines: 40 parts of selfheal, 40 parts of coptis chinensis, 40 parts of phellodendron, 70 parts of Japanese ampelopsis, 20 parts of Chinese violet, 30 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, selfheal, coptis chinensis, phellodendron, Japanese ampelopsis and Chinese violet are decocted for 3 times by adding water, the amount of water added for each time is 1000 parts, the decocting time is 1.5 hours, decoction solutions are combined, the decoction solution is heated to 60 ℃, the prepared frankincense, the prepared myrrh and the borneol are brought in, and the liquid medicine is prepared.
EXAMPLE 8 preparation of liquid medicine of the Chinese medicinal composition of the present invention (eight)
Taking raw material medicines: 40 parts of selfheal, 40 parts of coptis chinensis, 40 parts of phellodendron, 70 parts of Japanese ampelopsis, 20 parts of Chinese violet, 30 parts of prepared frankincense, 30 parts of prepared myrrh and 15 parts of borneol, and the selfheal, the coptis chinensis, the phellodendron, the Japanese ampelopsis and the Chinese violet are decocted for 3 times by adding water, wherein the amount of water added for each time is 1000 parts, the decocting time is 1.5 hours, the decoction liquids are combined, and the decoction liquid is heated to 60 ℃ and then is added into the prepared frankincense, the prepared myrrh and the borneol to prepare the liquid medicine.
EXAMPLE 9 preparation of the patch film of the present invention
(1) Taking 20 parts of polyvinyl alcohol, 3.5 parts of polyvinylpyrrolidone, 0.5 part of carbomer, 3 parts of glycerol and 5 parts of sodium alginate, and dispersing the carbomer in the glycerol to obtain liquid a;
(2) mixing the liquid a and polyvinylpyrrolidone with the liquid medicine prepared in the examples 1-8 to obtain a liquid b;
(3) adding polyvinyl alcohol into the liquid b, stirring while heating to 85 ℃ to obtain a liquid c;
(4) and adding sodium alginate into the liquid c, and uniformly mixing to prepare the traditional Chinese medicine film.
EXAMPLE 10 preparation of the ointment of the present invention
Taking the liquid medicine prepared in the embodiment 1-8, adding the beeswax and the yellow vaseline with the volume of the liquid medicine 1/5, decocting and stirring the mixture with slow fire, and cooling the mixture into paste to obtain the ointment.
Example 11 preparation of the Chinese medicinal gel of the present invention
Adding carbomer into glycerol, grinding to moisten, adding small amount of distilled water, grinding, transferring into a measuring cup, dissolving triethanolamine, ethylparaben and distilled water in appropriate amount, stirring to obtain gel, adding distilled water, stirring, adding the medicinal liquid prepared in examples 1-8, and grinding.
EXAMPLE 12 preparation of the inventive transdermal patch
Adding conventional matrix such as kaolin and glycerol into the medicinal liquid prepared in examples 1-8, stirring, coating on the back lining layer, and adding protective layer.
Example 13 clinical trial of the Chinese medicinal composition of the present invention for treating necrotizing lymphadenitis
1 data and method
1.1 diagnostic criteria
1.1.1 Western diagnostic standards
(1) Heat generation: there are more symptoms of the disease, such as upper respiratory tract infection, and the heat type is usually atony and heat, and the treatment with antibiotics is ineffective.
(2) Enlargement of lymph nodes: there may be swelling of lymph nodes on the body surface, such as the neck and axilla, and some patients may have transient hepatosplenomegaly and skin rash.
(3) Auxiliary inspection: lymph node biopsy is the only reliable diagnosis basis of the disease; hemograms often show leukopenia or normality.
1.1.2 the basis and syndrome differentiation of Chinese medicine diagnosis
The research adopts the traditional Chinese medicine syndrome of necrotizing lymphadenitis, and according to the guiding principle of clinical research on new traditional Chinese medicines in 2002 edition in second edition, on the basis of the traditional Chinese medicine diagnosis and treatment scheme of dominant disease species of scrofula disease of phlegm toxicity (necrotizing lymphadenitis) in traditional Chinese medicine and early-stage research in the traditional Chinese medicine department-traditional Chinese and western medicine combined hospital scrofula disease of the national traditional Chinese medicine administration key department, the traditional Chinese medicine syndrome differentiation belongs to the syndrome of excessive heat-toxin.
Syndrome of heat-toxin congestion: irregular high fever, multiple lymph nodes on the body surface fusing into clusters, moderate texture, deficient limit, poor mobility, obvious tenderness, normal skin color and slightly high skin temperature. And/or with flushing, nasal obstruction, fever, dysphoria, thirst, anorexia, headache, pharyngalgia, and constipation. Red tongue with yellow coating, surging and rapid or wiry and rapid pulse.
The traditional Chinese medicine is mainly based on syndrome differentiation standard, and if the symptoms are complex and the syndrome type is accompanied, the type is mainly determined by the more obvious symptoms. The doctor who is called senior high-tech and mainly used by the traditional Chinese medicine carries out dialectical confirmation of traditional Chinese medicine.
1.2 inclusion of data
The necrotic lymphadenitis meets the selection criteria, 180 patients with toxic heat congestion are sourced from scrofula departments of traditional Chinese and western medicine combined hospitals in Nanjing from 7 months to 4 months in 2015 to 2017, are randomly divided into 6 groups, and the 6 groups of patients are convenient to compare with each other in terms of sex, age, course of disease and clinical symptoms, have no statistical significance (P is more than 0.05) in difference, and have comparability.
1.3 methods of treatment
1 group of traditional Chinese medicines: the traditional Chinese medicine patch prepared by the method of the embodiment 9 of the invention (embodiment 1: 30 parts of selfheal, 30 parts of coptis, 30 parts of phellodendron, 60 parts of Japanese ampelopsis, 15 parts of Chinese violet, 20 parts of prepared frankincense, 20 parts of prepared myrrh and 10 parts of borneol) is given, the content of crude drugs is 30 g/patch, the patch is pasted on an affected part, the patch is replaced once a day each time, 7 days are a treatment course, and 2 treatment courses are continuously treated.
And (3) traditional Chinese medicine 2 groups: the traditional Chinese medicine patch prepared by the method of the embodiment 9 of the invention (embodiment 2: 40 parts of selfheal, 40 parts of coptis, 40 parts of phellodendron, 50 parts of Japanese ampelopsis, 20 parts of Chinese violet, 30 parts of prepared frankincense, 30 parts of prepared myrrh and 15 parts of borneol) is given, the content of crude drugs is 30 g/patch, the patch is pasted on an affected part, the patch is replaced once every two days, 7 days are a treatment course, and 2 treatment courses are continuously carried out.
3 groups of traditional Chinese medicines: the traditional Chinese medicine patch prepared by the method of the embodiment 9 of the invention (embodiment 3: 20 parts of selfheal, 20 parts of coptis, 20 parts of phellodendron, 70 parts of Japanese ampelopsis, 10 parts of Chinese violet, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol) is given, the content of crude drugs is 30 g/patch, the patch is pasted on an affected part, the patch is replaced once every two days, 7 days are a treatment course, and 2 treatment courses are continuously carried out.
4 groups of traditional Chinese medicines: the traditional Chinese medicine patch prepared by the method of the embodiment 9 of the invention is given (the traditional Chinese medicine composition comprises 60 parts of selfheal, 60 parts of coptis chinensis, 60 parts of phellodendron, 30 parts of Japanese ampelopsis, 30 parts of herba violae, 10 parts of prepared frankincense, 10 parts of prepared myrrh and 5 parts of borneol, the preparation method of the liquid medicine is the same as that of the embodiment 1), the content of the crude drug is 30 g/patch, the patch is pasted on an affected part, the patch is replaced once a day, 7 days are a treatment course, and 2 treatment courses are continuously treated.
5 groups of traditional Chinese medicines: the traditional Chinese medicine patch prepared by the method of embodiment 9 of the invention is given (traditional Chinese medicine composition: 41 parts of selfheal, 41 parts of coptis chinensis, 41 parts of phellodendron amurense, 71 parts of Japanese ampelopsis and 21 parts of borneol, and the preparation method of the liquid medicine comprises the steps of adding 1000 parts of water into selfheal, coptis chinensis, phellodendron amurense and Japanese ampelopsis for 3 times, decocting for 1.5 hours, combining the decoction, adding borneol into the decoction when the decoction is heated to 60 ℃, and preparing the liquid medicine), wherein the content of the crude drug is 30 g/patch, and the patch is applied to an affected part, one patch is replaced once a day each time, 7 days is a treatment course, and 2 treatment courses are continuously treated.
6 groups of traditional Chinese medicines: the traditional Chinese medicine patch prepared by the method of the embodiment 9 of the invention is given (traditional Chinese medicine composition: 15 parts of saffron, 15 parts of raw rhubarb, 30 parts of coptis chinensis, 30 parts of phellodendron, 60 parts of ampelopsis japonica, 15 parts of Chinese violet, 20 parts of prepared frankincense, 20 parts of prepared myrrh, 10 parts of camphor, 5 parts of dark plum, 5 parts of liquorice and 5 parts of maltose, the saffron, the raw rhubarb, the coptis chinensis, the phellodendron, the Japanese ampelopsis root and the Chinese violet are decocted for 3 times by adding water, the amount of water is 1000 parts each time, the decocting time is 1.5 hours, the decoction solutions are combined, the prepared frankincense, the prepared myrrh, the camphor, the dark plum, 5 parts of liquorice and the maltose are added when the decoction solution is heated to 60 ℃, the decoction solution is prepared, the crude drug content is 30 g/patch and is pasted on an affected part, the patch each time, the replacement is carried.
1.4 Observation index and therapeutic evaluation
1.4.1 general items and Biochemical assays
Observing the main indicators (body temperature, target lymph node maximum diameter, pain level, WBC) immediately after treatment, i.e., days 7 and 14; the routine blood, the liver and kidney functions and the blood sedimentation are detected before and after treatment.
1.4.2 evaluation of therapeutic Effect
The swelling reduction (with the maximum lymph node as a target lymph node), pain relief (local pain condition), body temperature reduction and white blood rise of the medicine are evaluated, the swelling degree (the maximum diameter of the target lymph node), pain, body temperature and WBC are used as main curative effect observation indexes, a scoring method is adopted for recording and evaluating curative effect, ① pain degree is 0-no pain, 1-slight pain, no consciousness pain, target lymph node with tenderness, 2-pain in affected part with self-pain, and a patient can feel pain in the affected part by himself but can tolerate the pain, and daily work can be carried out② the swelling degree of the target lymph nodes is 0 minutes without swollen lymph nodes, 1 minute with light swelling degree and the diameter of the target lymph nodes not more than 1.0cm, 2 minutes with swelling degree, 3 minutes with heavy swelling, the diameter of the target lymph nodes is more than 2.5cm, the heating degree of ③ is 0 minutes without heat, T is not more than 37 ℃, 1 minute is a low-heat type, T is more than 37 ℃ and not more than 38 ℃, 2 minutes is a medium-heat type, T is more than 38 ℃ and not more than 39 ℃, 3 minutes is a high-heat type and an ultrahigh-heat type, T is more than 39 ℃, the reduction degree of ④ WBC is 0 minute without reduction, and 4.0 × 109WBC not more than L, 1 point-slight decrease, 3.5 × 109/L＜WBC≤4.0×109L, 2 min-moderate reduction, 3.0 × 109/L＜WBC≤3.5×109/L, score 3-Severe reduction, 2.0 × 109/L＜WBC≤3.0×109/L. (Note: in view of ethical considerations, this study excluded WBC ≦ 2.0 × 109HN L patients of/L.)
1.4.3 evaluation of safety
5 assessment criteria (positively relevant, likely irrelevant, positively irrelevant). Analyzing the discomfort condition of the patient and assisting the abnormal comparison evaluation standard of the examination result, and combining the three to calculate the adverse reaction rate. And the degree of adverse reactions was recorded in detail. Further test arrangement is determined by observers according to the state of illness, patients should be tracked timely and for a long time after taking medicine out, and the processing process and the result are recorded. Reporting to the ethical committee if necessary.
1.5 statistical methods
Statistical processing was performed using the SPSS15.0 statistical software package. Data to
Showing that the comparison before and after the treatment in the group uses paired t test, the measurement index between different groups adopts t test or variance analysis designed in groups, and the counting index adopts chi2And (4) checking, wherein a correlation analysis method is adopted among different detection items.
2 results
2.1 comparison of the degree of enlargement of target lymph nodes in each group
Compared with the traditional Chinese medicine composition before treatment, on the 7 th day and the 14 th day of treatment, the groups 1 to 3 of the traditional Chinese medicines can obviously reduce the swollen lymph nodes, and the difference has statistical significance (P <0.05), which shows that the traditional Chinese medicine composition can obviously reduce the swollen degree of the lymph nodes of patients. On the 7 th day and the 14 th day of treatment, compared with the traditional Chinese medicine groups 1-3, the target lymph node swelling degree of the traditional Chinese medicine groups 1-3 is obviously smaller than that of the traditional Chinese medicine group 4 (P is less than 0.05) under the condition of the same dosage, which shows that the traditional Chinese medicine composition has the advantage of obvious effect in a proper proportioning range. On the 7 th day and the 14 th day of treatment, compared with the 5 groups of traditional Chinese medicines, the target lymph node swelling degree of the 1-3 groups of traditional Chinese medicines is smaller than that of the 5 groups of traditional Chinese medicines (P is less than 0.05) under the condition of the same dosage, which indicates that the addition of Chinese violet, prepared frankincense and prepared myrrh in the prescription plays a role in synergy, and the treatment effect of the prescription on the lymph node swelling symptom is obviously improved. On the 7 th day and the 14 th day of treatment, compared with the traditional Chinese medicine 6 groups, the target lymph node swelling degree of the traditional Chinese medicine 1-3 groups is smaller than that of the traditional Chinese medicine 6 group (P is less than 0.05) under the condition of the same dosage, which shows that the traditional Chinese medicine composition has the advantage of remarkable curative effect.
TABLE 1 comparison of the degree of target lymph node swelling during treatment of each group
| Group of | n | Before treatment | Treatment day 7 | Day 14 of treatment |
| Chinese medicine 1 group | 30 | 2.83±0.37 | 0.94±0.21 | 0.12±0.04 |
| Chinese medicine 2 groups | 30 | 2.76±0.35 | 1.22±0.16 | 0.14±0.05 |
| Chinese medicine 3 groups | 30 | 2.77±0.41 | 1.18±0.18 | 0.14±0.21 |
| Chinese medicine 4 groups | 30 | 2.84±0.36 | 2.15±0.42 | 1.20±0.28 |
| Chinese medicine 5 groups | 30 | 2.81±0.43 | 2.06±0.45 | 1.18±0.36 |
| Chinese medicine 6 groups | 30 | 2.78±0.46 | 2.08±0.52* | 1.06±0.32 |
2.3 comparison of pain level in target lymph nodes
Compared with the traditional Chinese medicine composition before treatment, the traditional Chinese medicine composition 1 can obviously reduce the target lymph node swelling and pain degree on the 7 th day and the 14 th day of treatment, and the difference has statistical significance (P is less than 0.05), which indicates that the traditional Chinese medicine composition can obviously reduce the target lymph node swelling and pain degree. Compared with the traditional Chinese medicines 2-3, on the 7 th day of treatment, the target lymph node pain degree of the traditional Chinese medicine 1 group is obviously lower than that of the traditional Chinese medicines 2-3, and on the 14 th day of treatment, the difference between the traditional Chinese medicine 1 group and the traditional Chinese medicines 2-3 has no statistical significance (P is more than 0.05), which indicates that the traditional Chinese medicine 1 group has faster effect. On the 7 th day and the 14 th day of treatment, compared with the group of traditional Chinese medicines 4, the target lymph node pain degree of the group of traditional Chinese medicines 1 is significantly smaller than that of the group of traditional Chinese medicines 4 (P <0.05) under the condition of the same dosage, which indicates that the traditional Chinese medicine ratio in example 1 has the best treatment effect on the target lymph node pain symptom. On the 7 th day and the 14 th day of treatment, compared with the 5 groups of traditional Chinese medicines, the target lymph node pain degree of the 1 group of traditional Chinese medicines is obviously lower than that of the 5 groups of traditional Chinese medicines (P is less than 0.05) under the condition of the same dosage, which indicates that the addition of the Chinese violet, the prepared frankincense and the prepared myrrh in the prescription plays a role of synergy, and the treatment effect of the prescription on the lymph node pain symptoms is obviously improved. On the 7 th day and the 14 th day of treatment, compared with the traditional Chinese medicine 6 groups, the target lymph node pain degree of the traditional Chinese medicine 1 group is obviously lower than that of the traditional Chinese medicine 6 group (P is less than 0.05) under the condition of the same dosage, which indicates that the traditional Chinese medicine composition has the advantage of obvious curative effect.
TABLE 2 comparison of pain levels in target lymph nodes during treatment of each group
2.4 comparison of the degree of Heat Generation of each group
Compared with the traditional Chinese medicine composition before treatment, on the 7 th day and the 14 th day of treatment, the traditional Chinese medicine 1-3 groups can obviously reduce fever, and the difference has statistical significance (P is less than 0.05), which shows that the traditional Chinese medicine composition can obviously reduce fever. On the 7 th day and the 14 th day of treatment, compared with the 4 groups of traditional Chinese medicines, the fever degree of the 1-3 groups of traditional Chinese medicines is obviously lower than that of the 4 groups of traditional Chinese medicines under the condition of the same dosage, which indicates that the traditional Chinese medicine composition has the advantage of obvious effect in a proper proportioning range. On the 7 th day and the 14 th day of treatment, compared with the 5 groups of traditional Chinese medicines, the fever degree of the 1-3 groups of traditional Chinese medicines is obviously lower than that of the 5 groups of traditional Chinese medicines (P is less than 0.05) under the condition of the same dosage, which indicates that the addition of the Chinese violet, the prepared frankincense and the prepared myrrh in the prescription plays a role of synergy, and the treatment effect of the prescription on fever symptoms is obviously improved. On the 7 th day and the 14 th day of treatment, compared with the traditional Chinese medicine 6 groups, the fever degree of the traditional Chinese medicine 1 group is obviously lower than that of the traditional Chinese medicine 6 group (P is less than 0.05) under the condition of the same dosage, which shows that the traditional Chinese medicine composition has the advantage of obvious curative effect.
TABLE 3 comparison of fever levels during treatment of each group
| Group of | n | Before treatment | Treatment day 7 | Day 14 of treatment |
| Chinese medicine 1 group | 30 | 2.18±0.56 | 0.48±0.66 | 0.00±0.00 |
| Chinese medicine 2 groups | 30 | 2.15±0.48 | 0.52±0.64 | 0.00±0.00 |
| Chinese medicine 3 groups | 30 | 2.22±0.52 | 0.58±0.62 | 0.00±0.00 |
| Chinese medicine 4 groups | 30 | 2.19±0.47 | 1.24±0.82 | 0.72±0.44 |
| Chinese medicine 5 groups | 30 | 2.14±0.58 | 1.28±0.84 | 0.78±0.52 |
| Chinese medicine 6 groups | 30 | 2.20±0.48 | 1.25±0.84 | 0.76±0.58 |
2.5 comparison of WBC reduction levels in groups
Compared with the traditional Chinese medicine before treatment, the traditional Chinese medicine 1-3 groups can improve WBC on both 7 days and 14 days. On the 7 th day and the 14 th day of treatment, compared with the traditional Chinese medicine groups 4-6, the WBC concentration of the traditional Chinese medicine groups 1-3 is obviously higher than that of the traditional Chinese medicine groups 4-6 under the condition of the same dosage, and the difference has statistical significance (P is less than 0.05).
TABLE 4 comparison of WBC changes for groups
| Group of | n | Before treatment | Treatment day 7 | Day 14 of treatment |
| Chinese medicine 1 group | 30 | 3.28±0.86 | 3.92±0.82 | 5.62±1.52 |
| Chinese medicine 2 groups | 30 | 3.16±0.82 | 3.86±0.86 | 5.48±1.54 |
| Chinese medicine 3 groups | 30 | 3.25±0.84 | 3.81±0.85 | 5.42±1.48 |
| Chinese medicine 4 groups | 30 | 3.22±0.82 | 3.32±0.87 | 4.25±1.42 |
| Chinese medicine 5 groups | 30 | 3.34±0.71 | 3.26±0.82 | 4.21±1.36 |
| Chinese medicine 6 groups | 30 | 3.12±0.85 | 3.28±0.86 | 4.26±1.46 |
2.6 evaluation of safety
Indexes such as blood routine, liver and kidney functions and the like of patients in each group before and after treatment are within a normal range; the patients have no obvious complaints and abnormal physical signs, which indicates that all the medicines have higher clinical safety.
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (9)
1. The traditional Chinese medicine composition for treating necrotizing lymphadenitis is characterized by being prepared from the following raw material medicines in parts by weight: 20-40 parts of selfheal, 20-40 parts of coptis, 20-40 parts of phellodendron, 50-70 parts of ampelopsis japonica, 10-20 parts of Chinese violet, 10-30 parts of prepared frankincense, 10-30 parts of prepared myrrh and 5-15 parts of borneol.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 25-35 parts of selfheal, 25-35 parts of coptis, 25-35 parts of phellodendron, 55-65 parts of Japanese ampelopsis, 13-17 parts of Chinese violet, 15-25 parts of prepared frankincense, 15-25 parts of prepared myrrh and 8-12 parts of borneol.
3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of selfheal, 30 parts of coptis chinensis, 30 parts of phellodendron, 60 parts of Japanese ampelopsis, 15 parts of Chinese violet, 20 parts of prepared frankincense, 20 parts of prepared myrrh and 10 parts of borneol.
4. The Chinese medicinal composition of claim 1, wherein the Chinese medicinal composition further comprises pharmaceutically acceptable adjuvants.
5. Use of the Chinese medicinal composition of any one of claims 1-4 in the preparation of a medicament for the treatment of necrotizing lymphadenitis.
6. The use of claim 5, wherein the necrotizing lymphadenitis is syndrome-resolved excessive toxic heat type in TCM.
7. A traditional Chinese medicine patch for treating necrotizing lymphadenitis, which is characterized by being prepared from the traditional Chinese medicine composition of any one of claims 1 to 3 and a traditional Chinese medicine patch substrate.
8. The preparation method of the traditional Chinese medicine film as claimed in claim 7, which is characterized by comprising the following steps:
(1) taking the traditional Chinese medicine raw materials according to the parts by weight of any one of claims 1 to 3, decocting selfheal, coptis root, phellodendron bark, Japanese ampelopsis root and herba violae in water for 3 times, mixing decoctions, heating the decoctions to 60 ℃, adding prepared frankincense, prepared myrrh and borneol, and preparing liquid medicine;
(2) taking 20 parts of polyvinyl alcohol, 3.5 parts of polyvinylpyrrolidone, 0.5 part of carbomer, 3 parts of glycerol and 5 parts of sodium alginate, and dispersing the carbomer in the glycerol to obtain liquid a;
(3) mixing the liquid a, polyvinylpyrrolidone and the liquid medicine to obtain liquid b;
(4) adding polyvinyl alcohol into the liquid b, stirring while heating to 85 ℃ to obtain a liquid c;
(5) and adding sodium alginate into the liquid c, and uniformly mixing to prepare the traditional Chinese medicine film.
9. The preparation method according to claim 8, wherein the amount of water added in the decoction process is 1000 parts, and the decoction time is 1.5 hours.
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