CN112353921A - Traditional Chinese medicine composition and application and preparation method thereof - Google Patents
Traditional Chinese medicine composition and application and preparation method thereof Download PDFInfo
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- CN112353921A CN112353921A CN202011146116.8A CN202011146116A CN112353921A CN 112353921 A CN112353921 A CN 112353921A CN 202011146116 A CN202011146116 A CN 202011146116A CN 112353921 A CN112353921 A CN 112353921A
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition, and application and a preparation method thereof. The traditional Chinese medicine composition is mainly prepared from 3-38 parts by weight of garden burnet, 2-26 parts by weight of pawpaw, 2-20 parts by weight of radix curcumae, 1-16 parts by weight of radix stephaniae tetrandrae, 2-18 parts by weight of rhizoma atractylodis, 2-15 parts by weight of rhizoma bletillae, 5-19 parts by weight of rhizoma corydalis, 5-30 parts by weight of cortex phellodendri, 1-9 parts by weight of borneol, 25-80 parts by weight of calcined gypsum, 20-78 parts by weight of calamine, 5-18 parts by weight of frankincense, 3-16 parts by weight of myrrh, 2-12 parts by weight of dragon's blood, 2-20 parts by weight of sappan wood, 3-16 parts by weight of rhizoma sparganii, 3-19 parts by weight of notopterygium root, 5. The traditional Chinese medicine composition is suitable for various long-term unhealed wounds with unknown reasons, can promote the healing of the wounds and has remarkable curative effect.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition, and application and a preparation method thereof, in particular to a traditional Chinese medicine composition with the effects of removing necrotic tissue, promoting granulation and astringing sores, and application and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines.
Background
The wound surface is the damage of normal skin (tissue) caused by external injury factors such as surgery, external force, heat, current, chemical substances, low temperature and internal factors of the body such as local blood supply disorder. Often accompanied by a breakdown in skin integrity and a loss of some amount of normal tissue.
Acute wounds refer to all wounds within the first 2 weeks from wound formation. Then, the healing process is partially or completely stopped due to the blockage of the healing process of the wound caused by certain adverse factors such as infection, foreign bodies and the like, so that the healing time of the wound exceeds 2 weeks, and the wound is called as a chronic wound.
Chronic wounds are wounds that are unable to reach an anatomically and functionally complete state through a normal, orderly and timely repair process. These wounds often delay healing or even do not heal, and there are often specific causes, such as diabetes, ischemia, stress, etc. Clinically, it is often a person who fails to heal after more than 1 month of treatment due to various reasons, and has no tendency to heal, and the 1 month is not completely absolute and depends on various factors such as the size of the wound surface, the cause of disease, the individual, the general health condition, and the like. In general, a wound is considered chronic when it cannot be reduced by 10% to 15% per week, or by 50% for more than 1 month.
The reasons for difficult healing of the wound surface are various, and generally, the wound surface has overlarge skin defect, such as common burns with more than II degrees in surgery, neck carbuncle, back carbuncle, large skin flaps after incision and drainage, and the like; wound infection, which is the most common cause affecting wound healing, is the possibility of infection of pseudomonas aeruginosa, mycobacterium tuberculosis and fungi besides the general infection of staphylococcus aureus, streptococcus and escherichia coli.
As early as the 20 th century, the foreign research field on wound repair has been deep to the cell, molecule and gene level, and with the deep research and the continuous deepening of international communication, the domestic research field of wound repair has also made major breakthroughs, for example, with the continuous development of tissue engineering technology, the wide application of biological materials and tissue substitutes has brought revolutionary breakthroughs for clinical treatment. However, because of the difference between clinical experimental animal models and human bodies, and the influence factors such as bacteria and hypoxia during the repair process, the success rate of the growth factors in clinical treatment is still limited, and meanwhile, there is still a big controversial debate on whether the growth factors induce tissue hyperproliferation or even cause cell transformation after the growth factors are applied to wound repair (including viscera repair, nervous system repair and the like in the future) and further generate canceration. As a traditional Chinese medicine with a long history, the traditional Chinese medicine plays a great role in promoting wound repair from old to present. The classification of ulcer medical science is available in the modern times. The "fifty-two prescriptions" is the earliest record of surgical diseases such as wound, and describes the treatments such as acupuncture, moxibustion, ironing, angulation and massage. In the long-term clinical practice of promoting wound repair, the traditional Chinese medicine treatment not only embodies the treatment concept of syndrome differentiation of the traditional Chinese medicine, but also forms the concepts and methods with distinct characteristics of pus lifting and decay removing, pus stewing and meat growing and the like, and in modern clinical research, the scientificity and the advancement of the concepts are continuously proved, and the traditional Chinese medicine treatment has more unique advantages.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition with the functions of promoting blood circulation, removing blood stasis, relieving pain and promoting tissue regeneration, which is mainly prepared from garden burnet, pawpaw, radix curcumae, radix stephaniae tetrandrae, rhizoma atractylodis, rhizoma bletillae, rhizoma corydalis, golden cypress, borneol, calcined gypsum, calamine, frankincense, myrrh, dragon's blood, sappan wood, rhizoma sparganii, notopterygium root and olive oil.
Specifically, the traditional Chinese medicine composition is mainly prepared from the following raw materials:
3-38 parts of garden burnet, 2-26 parts of pawpaw, 2-20 parts of radix curcumae, 1-16 parts of radix stephaniae tetrandrae, 2-18 parts of rhizoma atractylodis, 2-15 parts of rhizoma bletillae, 5-19 parts of rhizoma corydalis, 5-30 parts of cortex phellodendri, 1-9 parts of borneol, 25-80 parts of calcined gypsum, 20-78 parts of calamine, 5-18 parts of frankincense, 3-16 parts of myrrh, 2-12 parts of dragon's blood, 2-20 parts of sappan wood, 3-16 parts of rhizoma sparganii, 3-19 parts of notopterygium root, 5-15 parts of pseudo-ginseng and 90-420 parts of olive oil;
preferably, the traditional Chinese medicine composition is prepared from the following raw materials:
5-12 parts of garden burnet, 2-8 parts of pawpaw, 2-8 parts of radix curcumae, 2-9 parts of radix stephaniae tetrandrae, 3-8 parts of rhizoma atractylodis, 5-15 parts of rhizoma bletillae, 8-15 parts of rhizoma corydalis, 10-20 parts of cortex phellodendri, 1-8 parts of borneol, 30-55 parts of calcined gypsum, 35-70 parts of calamine, 5-12 parts of frankincense, 5-12 parts of myrrh, 2-8 parts of dragon's blood, 2-10 parts of suwood, 5-12 parts of rhizoma sparganii, 5-12 parts of notopterygium root, 8-15 parts of pseudo-ginseng and 120 parts of olive oil 100-one drugs;
preferably, the traditional Chinese medicine composition is prepared from the following raw materials:
8 parts of garden burnet, 6 parts of pawpaw, 6 parts of curcuma aromatica, 5 parts of radix stephaniae tetrandrae, 6 parts of rhizoma atractylodis, 9 parts of rhizoma bletillae, 13 parts of rhizoma corydalis, 15 parts of golden cypress, 6 parts of borneol, 51 parts of calcined gypsum, 52 parts of calamine, 8 parts of frankincense, 8 parts of myrrh, 5 parts of dragon's blood, 6 parts of sappan wood, 8 parts of rhizoma sparganii, 8 parts of notopterygium root, 12 parts of pseudo-ginseng and 120 parts of olive oil 100.
The invention also aims at a preparation method of the traditional Chinese medicine composition, which is characterized by mainly comprising the following steps:
step A: respectively crushing calcined gypsum and calamine, and removing water for later use; pulverizing Notoginseng radix and Borneolum Syntheticum respectively.
And B: extracting Olibanum, Myrrha, and sanguis Draxonis with diethyl ether to obtain extract.
And C: preparing radix Stephaniae Tetrandrae, fructus Chaenomelis, radix Curcumae, rhizoma Bletillae, and rhizoma Sparganii into coarse particles, adding oleum Olivarum, soaking for 24h, and standing; rhizoma corydalis, radix Sangusorbae, rhizoma Atractylodis, cortex Phellodendri, lignum sappan, and Notopterygii rhizoma by making into coarse granule, adding oleum Olivarum, soaking for 24 hr, and keeping;
step E: c, heating the radix stephaniae tetrandrae, the pawpaw, the radix curcumae, the rhizoma bletillae and the rhizoma sparganii soaked in the olive oil to be brown with strong fire, adding the rhizoma corydalis, the garden burnet, the rhizoma atractylodis, the cortex phellodendri, the sappan wood and the notopterygium root soaked in the olive oil in the step C, continuously heating until the medicinal materials are scorched, filtering, and continuously heating the filtrate to be in a water dripping bead forming state for later use;
step F: adding the calcined gypsum powder and calamine powder obtained in the step A into the filtrate obtained in the step E; cooling, adding the extract obtained in the step B, the pseudo-ginseng powder obtained in the step A and the borneol, and uniformly mixing to obtain the medicine.
The third purpose of the invention is to provide the application of the traditional Chinese medicine composition, namely the application in preparing medicines for removing the necrotic tissue, promoting tissue regeneration and healing wound and the application in preparing medicines for promoting wound healing.
Preferably, the wound surface is acute wound surface or chronic wound surface;
preferably, the wound surface is a chronic wound surface;
preferably, the chronic wound includes, but is not limited to, traumatic ulcer, pressure ulcer, radiation ulcer, vascular ulcer, infectious ulcer, malignant ulcer;
preferably, the vascular ulcer is one of arterial ulcer, venous ulcer and mixed ulcer of lower limbs;
preferably, the lower limb arterial ulcer is an arterial ulcer caused by diseases such as arteriosclerotic occlusion, thromboangiitis obliterans, diabetic limb arterial lesions, vasculitis, and the like.
Specifically, the traumatic ulcer mainly refers to ulcer caused by fracture, burn, scald, electric injury or on the basis of tissue defect and pathological changes caused by fracture, burn, scald and electric injury; the pressure ulcer refers to ulcer generated by long-term excessive compression of a bone bulge part of a body, and mainly refers to pressure sore; the radioactive ulcer refers to body injury caused by whole or local body radiation or radionuclide contamination, and mainly refers to iatrogenic injury, i.e. skin injury caused by radioactive treatment of malignant tumor in vivo or body surface; the infectious ulcer mainly refers to ulcer caused by special infection such as fungi and tubercle bacillus, and also includes ulcer caused by general suppurative infection or tissue injury and pathological changes caused by general suppurative infection;
the fourth purpose of the invention is to provide a Chinese medicinal preparation of the Chinese medicinal composition, wherein the Chinese medicinal preparation is a clinically acceptable preparation; preferably, the clinically acceptable dosage form is one or more of oil, ointment, paste, plastics, liniment and other external dosage forms.
Compared with the prior art, the invention has the following remarkable technical effects:
(1) the traditional Chinese medicine composition is suitable for various unhealed wounds for long time caused by unknown reasons, such as the unhealed wounds caused by operation, infection, burn and diabetic foot, and sores and ulcers such as chilblain, ecthyma, bedsore and the like.
(2) Pharmacological experiments show that the traditional Chinese medicine composition can promote the healing of ulcer wounds of diabetic rats, increase the expression levels of bFGF, EGF and VFGF, promote the proliferation of fibroblasts and new capillaries, improve the blood circulation of the wounds, promote the growth of granulation tissues and the filling of the granulation tissues in the wounds, accelerate the growth of epithelial cells and finally accelerate the healing process of the wounds.
(3) Clinical experiments show that the traditional Chinese medicine composition can accelerate wound healing and promote rapid healing of hard-to-heal wounds.
Term definition
Dripping water to form beads: the medicinal oil extract is heated to a certain degree, and then a small amount of the medicinal oil is dripped into water, so that the medicinal oil is not diffused but is in the form of agglomerated mass, and the condition is called dripping beading.
Drawings
FIG. 1 typical case 1 of the present invention 1 appearance of skin on the back (before treatment)
FIG. 2 typical case 1 of the present invention, the appearance of the skin on the back (in treatment)
FIG. 3 typical case 1 of the present invention, the appearance of the skin on the back (after treatment)
FIG. 4 left lower limb skin appearance (before treatment) in typical case 2 of the present invention
FIG. 5 left lower limb skin appearance (in treatment) in typical case 2 of the present invention
FIG. 6 left lower limb skin appearance (after treatment) in typical case 2 of the present invention
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
The inventors note that the following examples are only some representative formulations and methods of preparation of the present invention, but it should be understood by those skilled in the art that the examples are not intended to limit the present invention in any way. Further, those skilled in the art can make many possible variations and modifications to the disclosed technical solution, or modify equivalent embodiments with equivalent variations, without departing from the scope of the technical solution of the present invention. Therefore, any simple modification, equivalent change and modification made to the following embodiments according to the technical spirit of the present invention should fall within the protection scope of the technical scheme of the present invention, unless the technical spirit of the present invention departs from the content of the technical scheme of the present invention.
Example 1 preparation of oil
Prescription:
8g of garden burnet root, 6g of pawpaw, 6g of radix curcumae, 5g of radix stephaniae tetrandrae, 6g of rhizoma atractylodis, 9g of rhizoma bletillae, 13g of rhizoma corydalis, 15g of golden cypress, 6g of borneol, 51g of calcined gypsum, 52g of calamine, 8g of frankincense, 8g of myrrh, 5g of dragon's blood, 6g of sappan wood, 8g of rhizoma sparganii, 8g of notopterygium root, 12g of pseudo-ginseng and 120g of olive oil 100-.
The preparation method comprises the following steps:
step A: respectively crushing calcined gypsum and calamine, and removing water for later use; pulverizing Notoginseng radix and Borneolum Syntheticum respectively.
And B: extracting Olibanum, Myrrha, and sanguis Draxonis with diethyl ether to obtain extract.
And C: preparing radix Stephaniae Tetrandrae, fructus Chaenomelis, radix Curcumae, rhizoma Bletillae, and rhizoma Sparganii into coarse particles, adding oleum Olivarum, soaking for 24h, and standing; rhizoma corydalis, radix Sangusorbae, rhizoma Atractylodis, cortex Phellodendri, lignum sappan, and Notopterygii rhizoma by making into coarse granule, adding oleum Olivarum, soaking for 24 hr, and keeping;
step E: heating radix stephaniae tetrandrae, pawpaw, radix curcumae, rhizoma bletillae and rhizoma sparganii soaked in the olive oil in the step C to be brown, adding rhizoma corydalis, garden burnet root, rhizoma atractylodis, golden cypress, sappan wood and notopterygium root soaked in the olive oil in the step C, continuously heating the medicinal materials until the medicinal materials are scorched, filtering, and continuously heating the filtrate to be in a water dripping bead forming state for later use;
step F: adding the calcined gypsum powder and calamine powder obtained in the step A into the filtrate obtained in the step E; cooling, adding the extract obtained in the step B, the pseudo-ginseng powder obtained in the step A and the borneol, and uniformly mixing to obtain the medicine.
EXAMPLE 2 preparation of the paste
Prescription:
38g of garden burnet, 2g of pawpaw, 20g of radix curcumae, 1g of radix stephaniae tetrandrae, 18g of rhizoma atractylodis, 2g of rhizoma bletillae, 19g of rhizoma corydalis, 5g of golden cypress, 9g of borneol, 20g of calcined gypsum, 70g of calamine, 5g of frankincense, 16g of myrrh, 2g of dragon's blood, 20g of sappan wood, 3g of rhizoma sparganii, 19g of notopterygium root, 5g of pseudo-ginseng and 90g of olive oil
The preparation method comprises the following steps: after the preparation of the Chinese medicinal composition as described in example 1, the paste was prepared according to the conventional process.
EXAMPLE 3 preparation of the ointment
Prescription:
3g of garden burnet root, 26g of pawpaw, 2g of radix curcumae, 16g of radix stephaniae tetrandrae, 2g of rhizoma atractylodis, 15g of rhizoma bletillae, 5g of rhizoma corydalis, 30g of golden cypress, 1g of borneol, 78g of calcined gypsum, 30g of calamine, 18g of frankincense, 3g of myrrh, 12g of dragon's blood, 2g of sappan wood, 16g of rhizoma sparganii, 3g of notopterygium root, 15g of pseudo-ginseng and 420g of olive oil.
The preparation method comprises the following steps: after the traditional Chinese medicine composition is prepared by the method of the embodiment 1, the ointment is prepared according to the conventional process.
EXAMPLE 4 preparation of film coating Agents
Prescription:
8g of garden burnet root, 2g of pawpaw, 8g of radix curcumae, 2g of radix stephaniae tetrandrae, 8g of rhizoma atractylodis, 5g of rhizoma bletillae, 15g of rhizoma corydalis, 10g of golden cypress, 1g of borneol, 55g of calcined gypsum, 35g of calamine, 5g of frankincense, 12g of myrrh, 2g of dragon's blood, 10g of sappan wood, 5g of rhizoma sparganii, 12g of notopterygium root, 8g of pseudo-ginseng and 100g of olive oil.
The preparation method comprises the following steps: after the traditional Chinese medicine composition is prepared by the method of the embodiment 1, the film coating agent is prepared according to the conventional process.
EXAMPLE 5 preparation of the Liniment
Prescription:
5g of garden burnet root, 8g of pawpaw, 2g of radix curcumae, 9g of radix stephaniae tetrandrae, 3g of rhizoma atractylodis, 15g of rhizoma bletillae, 8g of rhizoma corydalis, 20g of golden cypress, 8g of borneol, 30g of calcined gypsum, 70g of calamine, 12g of frankincense, 5g of myrrh, 8g of dragon's blood, 2g of sappan wood, 12g of rhizoma sparganii, 5g of notopterygium root, 15g of sanqi and 120g of olive oil.
The preparation method comprises the following steps: the liniment is prepared by preparing the traditional Chinese medicine composition by the method of the example 1 according to the conventional process.
Secondly, the traditional Chinese medicine composition has the influence on the healing of the wound surface of a diabetic rat
In order to verify the efficacy of the Chinese medicinal composition in the aspects of removing necrosis, promoting granulation, healing wound, promoting wound healing and the like, the inventor develops pharmacodynamic test research and medicament clinical research. In the following, only a part of pharmacodynamic experiments of the most representative formulation of the present invention will be described as an example; the inventor also conducted pharmacodynamic experiments to obtain the same or similar effects, but the invention is not limited to the above embodiments.
The inventor explains that the following experimental studies are carried out on the basis of the safety of the drug proved by acute toxicity tests and long-term toxicity tests, and the administration dose in the experimental studies is within a safe dose range.
1 Material
1.1 animals:
SD rat, 180-220 g, license number of experimental animal: SYXK (lu) 20180008, acclimatized for one week prior to the experiment.
1.2 test substances
1.2.1 medicaments
The Chinese medicinal composition prepared according to the prescription and preparation method of example 1 (concentrated to 1mL of medicinal liquid containing 0.5g, 1g and 1.5g of raw medicinal materials as low, medium and high dosages);
recombinant human EGF gel (national standard Z20000004).
1.2.2 methods of use
The invention comprises the following steps: it is applied externally. The ointment is applied to the wound surface (the thickness is thinner than 1mm), and a new medicine is replaced every 4-6 hours. Before dressing change, the residual medicine and liquefied substance on the wound surface are wiped off. The medicine is used for exposing the wound surface.
Recombinant human EGF gel: used according to the pharmaceutical instruction.
2. Modeling, grouping and administration
2.1 Molding, grouping
SD rats are fed with high-fat and high-sugar feed for one month, 40 mg/kg of Streptozotocin (STZ) is injected into the abdominal cavity after fasting overnight, and the molding success is determined when the fasting blood sugar is more than 16.7mmol/L after 3 days.
Taking 50 rats with successful diabetes modeling, randomly dividing the rats into a model group, a recombinant human EGF gel group and an example 1 (high, medium and low) dose group, wherein each group comprises 10 rats; another 10 rats fed normally were selected as a blank group.
On day 5 after grouping, all rats had their backs depilated relatively flat, and the gentian violet was marked on an area of about 1.5cm by 1.5cm, and the skin was excised from this area as deep as the fascia.
2.2 administration of drugs
The recombinant human EGF gel group and the example 1 three dose groups were respectively smeared on the wound area with the corresponding drugs according to the above-mentioned "method of use 1.2.2", and the blank group and the model group were smeared with iodophor.
The administration was continued for 28 days.
3. Observation index
3.1 wound healing Rate
And (3) recording the sizes of the wound surfaces on transparent paper 7, 14 and 28 days after treatment, measuring the area of the wound surfaces, and comparing the area of the wound surfaces with the area of the wound surfaces (initial wound surface area) at 0 day after molding to obtain the healing rate of the wound surfaces of each group.
3.2 serum bFGF, EGF and VFGF level assays
On days 14 and 28 after treatment, blood is taken from the inner canthus of the rat, serum is separated, and the content of basic fibroblast growth factor (bFGF), Epidermal Growth Factor (EGF) and vascular endothelial growth factor (VFGF) in the serum of the rat is determined by an enzyme-linked immunosorbent assay.
3.2 statistical methods
Using SPSS22.0 softwareAnd (6) processing the data of the line. Counting data by mean ± standard deviationThe data of each group are subjected to a normal distribution test and a homogeneity test of variance, and the comparison among the groups is performed by using one-factor variance analysis. The difference is statistically significant when P is less than 0.05.
4 results and conclusions
4.1 wound healing Rate
On 7 th, 14 th and 28 th days after treatment, compared with the model group, the healing rates of the wound surfaces on the back of rats in the blank group, the recombinant human EGF gel group and the three dose groups in the embodiment 1 are obviously improved, and the difference has statistical significance (P is less than 0.01);
on day 28 after treatment, the healing rate of the wound surface of the high and medium dose groups of example 1 is higher than that of the recombinant human EGF gel group, and the difference has statistical significance (P < 0.01).
Note: in comparison with the control group,*P<0.05,@P<0.01;
in contrast to the model set,&P<0.01;
in contrast to the recombinant human EGF gel,¥P<0.05,#P<0.01。
4.3 serum bFGF, EGF and VFGF levels
On 14 th and 28 th days after treatment, compared with the model group, the serum of rats in the blank group, the recombinant human EGF gel group and the three dosage groups of the example 1 has obviously improved bFGF, EGF and VEGF contents (P is less than 0.01);
on day 28 after treatment, the serum bFGF, EGF and VEGF contents of rats in the high and medium dose groups of example 1 were higher than those in the recombinant human EGF gel group (P < 0.05, P < 0.01).
Note: in comparison with the control group,*P<0.05,@P<0.01;
in contrast to the model set,&P<0.01;
in contrast to the recombinant human EGF gel,¥P<0.05,P<0.01。
the bFGF can directly act on target cells of the wound, and fibroblast is divided and proliferated through mitogenic reaction to play a role in promoting wound healing. EGF is a cell factor widely existing in human bodies and animal bodies, EGF receptors exist on various cell membranes, the receptors are combined with EGF to form a receptor-EGF compound, and cell proliferation is induced or directly regulated through a series of biochemical reactions such as autophosphorylation and the like, so that the process of wound repair is started. VEGF is a multifunctional cytokine that acts specifically on vascular endothelial cells, and it not only causes increased vascular permeability, altered extracellular matrix components, but also induces neovascularization.
The traditional Chinese medicine composition can promote the healing of ulcer wounds of diabetic rats, increase the expression levels of bFGF, EGF and VFGF, promote the proliferation of fibroblasts and new capillaries, improve the blood circulation of the wounds, promote the growth of granulation tissues and the filling of the granulation tissues on the wounds, accelerate the growth of epithelial cells and finally accelerate the healing process of the wounds.
Third, clinical trial and typical case
(I) clinical curative effect observation of the traditional Chinese medicine composition for treating refractory wound surfaces
1 clinical data
36 patients with difficult wound surfaces, who were collected in the first affiliated hospital of zhengzhou university at 11 months to 12 months in 2018, were extracted to develop the study, all case data were reviewed, and 36 patients were divided into a control group and a treatment group according to different treatment measures. In 18 patients in the control group, 9 men and 9 women were aged 51-68 years, the age mean (55.36 +/-9.78) years, and the primary diseases comprise 3 cases of lower limb open fracture, 5 cases of pressure sore, 5 cases of diabetic foot, 3 cases of tissue ulcer after burn and 2 cases of ulcer after lower limb varicose vein. In 18 patients of the treatment group, 10 males and 8 females are aged 49-65 years, the age mean (52.95 +/-8.17) years, and primary diseases comprise 4 cases of lower limb open fracture, 3 cases of pressure sore, 6 cases of diabetic foot, 5 cases of tissue ulcer after burn and 3 cases of ulcer after lower limb varicose vein.
The basic data (mean age, primary disease, etc.) of patients in the treatment group and the control group have no statistical significance (P is more than 0.05).
2 test case criteria
2.1 Inclusion case criteria
The diagnosis standard of the difficult-to-heal wound surface is met; ② those 18-75 years old; patients or their family members voluntarily participate in research and can be actively matched with treatment.
2.2 criteria for excluded cases
Those who do not meet the inclusion case standards; ② those who have bleeding tendency or receive anticoagulation treatment recently; ③ for the people allergic to the traditional Chinese medicine; fourthly, patients with severe anemia, hypoproteinemia and infection; patients with serious multiple organ diseases of heart, liver and kidney.
3 methods of treatment
The two groups of patients adopt the conventional surgical disinfection, debridement and dressing change treatment on the day of admission, and the original diseases are actively treated.
The treatment group is smeared with the oil agent obtained in example 1 after the conventional surgical disinfection, debridement and drug replacement treatment, the thickness is thinner than 1mm, and new drugs are replaced every 4-6 hours. Before changing the dressing, the residual medicine and liquefied substance on the wound surface should be wiped off. The medicine is used for exposing the wound surface.
After the control group had been aseptically sheared to remove necrotic tissue or crust, longzhu ointment (national standard Z10950017) was applied topically according to the instructions for the use of the drugs.
The treatment course of the two groups is 10 days, and the treatment effect is determined after 2 treatment courses.
4 observation index
The healing condition of the wound surface: according to the 'diagnosis standard of surgical diseases', a wound surface measuring ruler is used for evaluating the healing condition of the wound surface, and a wound surface observation table is filled every day, wherein the contents comprise the area, the depth, the color and the stage of the wound surface, the necrotic tissue condition of the wound surface, secretion, exudate, slough shedding and granulation growth condition.
Wound healing time: the wound surface area is less than 5% of the total area, or the healing area is more than 95% of the total area.
5 criteria for therapeutic efficacy
According to the standard of curative effect of diagnosis of traditional Chinese medicine diseases.
The healing is that the new granulation tissue grows out completely and the wound surface is healed completely.
The method has the following advantages: the wound surface is reduced, part of the wound surface is ruddy, the new granulation tissue is partially grown, and inflammatory effusion is reduced.
The wound surface has no obvious change or deterioration.
6 statistical method
SPSS22.0 statistical analysis software was used for processing. The measured data is expressed by mean (x) + -standard deviation(s), and the comparison among groups adopts t test; the comparison between the counted data sets was performed by the X2 test.
7 results
7.1 comparison of therapeutic effects of two groups
TABLE 3 comparison of the curative effects of two groups of patients with refractory wound
7.2 comparison of wound healing time between two groups
TABLE 4 comparison of wound healing time of two groups of patients with refractory wound
Group of | Number of examples | Slough shedding time | Appearance time of new granulation |
Treatment group | 18 | 4.25±1.71* | 9.64±2.65@ |
Control group | 18 | 5.97±2.54 | 13.54±1.95 |
Note: in comparison with the control group,*P<0.05,@P<0.01。
the traditional Chinese medicine composition can accelerate wound healing, promote rapid healing of hard-to-heal wounds, improve clinical symptoms of patients and relieve pain of the patients.
(II) the traditional Chinese medicine composition treats various clinical typical cases of long-term unhealed wound surfaces
1. Xu certain, male, 19 years old. Dark scabs appear at the incision of a patient after VSD extraction after VSD implantation is extracted due to 'scoliosis internal fixation', and a small amount of liquid seeps out of the part after the dark scabs fall off. Ultrasonic prompting: the sinus tract at the incision in the lumbar and dorsal part of the patient is formed. The diagnosis of the formation of the sinus tract at the incision of the lumbar and the back is collected in the hospital, one sinus tract leads to the vertebral canal which is not arranged on the two sides of the spinous process, a small amount of pus is contained, and the effect is poor after the infusion of antibiotics and debridement. Then, targeted treatment is adopted, the original wound surface is enlarged by externally applying the traditional Chinese medicine composition, corroded necrotic tissues are removed firstly, and the sinus wound is healed after the physique of a patient is adjusted for 1 month.
2. Zhangqi, male, 37 years old. The patients have pain, bleeding and walking disorder of the left lower limb caused by trauma, are subjected to symptomatic support treatment (detailed) in local hospitals, have poor effect, and are subjected to 'fracture between the distal end of the left femur and the condyle, tibial plateau fracture incision reduction internal fixation, popliteal blood vessel exploration and repair + left crus periosteum incision decompression surgery'. The patient returns to the local hospital to continue the treatment. The patients have the continuous aggravation of the left lower limb infection, and the patients are subjected to the double diagnosis in our hospital. The physical examination shows that: wounds of the left calf and the left knee are infected with necrosis, and black tissue necrosis with exposed tibia, poor peripheral blood circulation and no palpation of the dorsum manus artery can be seen. Necrosis after trauma surgery of the left lower limb was diagnosed. After successively performing left lower limb dilatation, multiple times of left lower limb chronic ulcer repair, left lower limb dilatation, left thigh tubular flap forming, left lower limb dilatation, tibia internal fixation and extraction, pedicle flap transfer and VSD drainage tube external application, continuous negative pressure suction, a large amount of pyorrhea remained in the exposed area of the subcutaneous and tibial bones and partial skin margin inactivation and necrosis. The traditional Chinese medicine composition is externally used for half a month, patients complain that the pain of the left lower limb is relieved, the wound of the left lower limb can be healed, the local epidermis is damaged, the skin of the left calf shank is partially damaged, the wound does not obviously ooze, and the later patients return to the local treatment.
Claims (10)
1. A traditional Chinese medicine composition is characterized by being mainly prepared from the following raw materials:
3-38 parts of garden burnet, 2-26 parts of pawpaw, 2-20 parts of radix curcumae, 1-16 parts of radix stephaniae tetrandrae, 2-18 parts of rhizoma atractylodis, 2-15 parts of rhizoma bletillae, 5-19 parts of rhizoma corydalis, 5-30 parts of cortex phellodendri, 1-9 parts of borneol, 25-80 parts of calcined gypsum, 20-78 parts of calamine, 5-18 parts of frankincense, 3-16 parts of myrrh, 2-12 parts of dragon's blood, 2-20 parts of sappan wood, 3-16 parts of rhizoma sparganii, 3-19 parts of notopterygium root, 5-15 parts of pseudo-ginseng and 90-420 parts of olive oil.
2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared from the following raw materials:
5-12 parts of garden burnet, 2-8 parts of pawpaw, 2-8 parts of radix curcumae, 2-9 parts of radix stephaniae tetrandrae, 3-8 parts of rhizoma atractylodis, 5-15 parts of rhizoma bletillae, 8-15 parts of rhizoma corydalis, 10-20 parts of cortex phellodendri, 1-8 parts of borneol, 30-55 parts of calcined gypsum, 35-70 parts of calamine, 5-12 parts of frankincense, 5-12 parts of myrrh, 2-8 parts of dragon's blood, 2-10 parts of sappan wood, 5-12 parts of rhizoma sparganii, 5-12 parts of notopterygium root, 8-15 parts of pseudo-ginseng and 120 parts of olive oil 100-one drugs.
3. The traditional Chinese medicine composition of claim 2, which is prepared from the following raw materials:
8 parts of garden burnet, 6 parts of pawpaw, 6 parts of curcuma aromatica, 5 parts of radix stephaniae tetrandrae, 6 parts of rhizoma atractylodis, 9 parts of rhizoma bletillae, 13 parts of rhizoma corydalis, 15 parts of golden cypress, 6 parts of borneol, 51 parts of calcined gypsum, 52 parts of calamine, 8 parts of frankincense, 8 parts of myrrh, 5 parts of dragon's blood, 6 parts of sappan wood, 8 parts of rhizoma sparganii, 8 parts of notopterygium root, 12 parts of pseudo-ginseng and 120 parts of olive oil 100.
4. The preparation method of the traditional Chinese medicine composition as claimed in any one of claims 2 or 3, which mainly comprises the following steps:
step A: respectively crushing calcined gypsum and calamine, and removing water for later use; respectively pulverizing Notoginseng radix and Borneolum Syntheticum;
and B: extracting Olibanum, Myrrha, and sanguis Draxonis with diethyl ether to obtain extract;
and C: preparing radix Stephaniae Tetrandrae, fructus Chaenomelis, radix Curcumae, rhizoma Bletillae, and rhizoma Sparganii into coarse particles, adding oleum Olivarum, soaking for 24 hr, and keeping; rhizoma corydalis, radix Sangusorbae, rhizoma Atractylodis, cortex Phellodendri, lignum sappan, and Notopterygii rhizoma by making into coarse granule, adding oleum Olivarum, soaking for 24 hr, and keeping;
step E: c, heating the radix stephaniae tetrandrae, the pawpaw, the radix curcumae, the rhizoma bletillae and the rhizoma sparganii soaked in the olive oil to be brown with strong fire, then adding the rhizoma corydalis, the garden burnet, the rhizoma atractylodis, the cortex phellodendri, the sappan wood and the notopterygium root soaked in the olive oil in the step C, continuously heating until the medicinal materials are scorched, filtering, and continuously heating the filtrate to be in a water dripping bead forming state for later use;
step F: adding the calcined gypsum powder and calamine powder obtained in the step A into the filtrate obtained in the step E; cooling, adding the extract obtained in the step B, the pseudo-ginseng powder obtained in the step A and the borneol, and uniformly mixing to obtain the medicine.
5. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for removing necrotic tissue, promoting tissue regeneration, and healing wounds.
6. Use of a Chinese medicinal composition as claimed in any one of claims 1-3 in the preparation of a medicament for promoting wound healing.
7. The use of claim 6, wherein the wound is acute wound, chronic wound; preferably, the wound surface is a chronic wound surface.
8. The use of claim 7, wherein the chronic wound includes, but is not limited to, traumatic ulcers, pressure ulcers, radiation ulcers, vascular ulcers, infectious ulcers, malignant ulcers.
9. The use of claim 8, wherein the vascular ulcer is one of a lower limb arterial ulcer, a venous ulcer, and a mixed ulcer.
10. A Chinese medicinal preparation comprising the Chinese medicinal composition of any one of claims 1 to 3, which is a clinically acceptable dosage form; preferably, the clinically acceptable dosage form is one or more of oil, ointment, paste, plastics, liniment and other external dosage forms.
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