CN1393230A - Prescription for composite medicinal film prepared from chitosan and Chinese-medicinal materials - Google Patents

Abstract

A slow-releasing chitosan composite medicine membrane for promoting the heeling of skin ulcer is prepared from chitosan and 5 Chinese medicinal materials including arnebia root 15%, Chinese angelica root 15%, dahurian angelica root 10%, dragon's blood 10% and pearl 10%.

Description

The prescription of chitosan Chinese medicine compound herbal membrane

The present invention relates to a kind of Chinese medicine, particularly relate to a kind of Chinese medicine for the treatment of chronic skin ulcer disease.

Chronic skin ulcer (Chronic skin ulcer.CSU) claims intractable ulcer again at present, is a kind of common disease, and it comprises vascular ulcer, radiation ulcer and infective ulcer etc.The America and Europe, the sickness rate of chronic skin ulcer increases and seriousness has caused people's great attention recently. and according to London hospital of Britain imperial family, the sickness rate of pressure ulcer in this area is 5.0%-8.8%.Discover that the incidence rate of pressure ulcer in the crowd is 0.01%, then be 3% for one of Denmark seventies the inpatient.And in Ireland, the incidence rate of patients with spinal cord injury pressure ulcer is equally up to 5.8% among the public crowd.The increase of diabetic ulcer incidence rate is the subject matter that faces in American-European countries's wound surface in recent years. an investigation according to the U.S. shows, the incidence rate of diabetic foot is 20% in all patients that are in hospital because of diabetes, because of the diabetes amputee accounts for 50% of atraumatic amputation.One of Britain studies show that, annual expenditure because of the diabetic foot treatment can be up to 3.2 hundred million dollars.In addition, the treatment of venous leg ulcers and traumatic ulcer also is to face subject matter really in the present ulcer treatment of American-European countries.In China, still lack large sample crowd's survey result at present, " Epidemiological study of the chronic difficult healing wound surface of the Chinese inpatient " data that only has 1996 pairs of dogfaces etc. to finish can be for joining.Investigation shows, the epidemiologic feature of China's chronic ulcer with have significant difference abroad, main etiology in China's chronic ulcer is wound or wound concurrent infection, account for 72.2%, secondly be pressure ulcer 7.4%, and ulcer is relative rare in China due to the very common diabetes of western developed country and lower limb arteriovenous disease, is respectively 4.6% and 5.2%.From group of people at high risk and position, person between twenty and fifty wait all obviously increases of sickness rate really of work crowd and lower limb.In recent years, along with the raising of living standards of the people, the aged increases, and the sickness rate of diabetic foot ulcers, vascular ulcer becomes ascendant trend.Chronic ulcer has also increased the weight of the financial burden of society and family simultaneously not only from the human body with bring great misery to the patient mentally.Treat chronic ulcer at present clinically and divide operation treatment and non-operative treatment.Because operative treatment is a kind of auxiliary treatment means on control and correction cause of disease basis just.Therefore non-operative treatment is still clinical first-selection and effective treatment means.Non-operative treatment mainly divides three kinds.1, growth-factor medication: both at home and abroad modern medicine sets about developing growth-factor medication from various somatomedin such as epidermal growth factor (EGF), basic fibroblast growth factor (b-FGF), platelet derivation somatomedin (PDGF), transforming growth factor aspects such as (TGF-β) mostly to the research of CSU and treatment, present domestic clinical commonly used drug is the multiple agent of shellfish, and its main component is the basic fibroblast factor.2, physiotherapy: various skin ulcer naturopathy such as ultraviolet irradiation treatment, laser therapy, negative aeroion and hyperbaric oxygen therapy, ultrasound therapy, unidirectional current drug iontotherapy, electrical stimulating therapy have been obtained certain progress, but curative effect is still unstable, and being applied to clinical treatment has significant limitation.3. conventional Chinese medicine: do not see that abroad in recent years, domestic scholars has also been done a large amount of research and report to this disease with the report of treatment by Chinese herbs CSU.Human FGF Ointment in Treatment serious symptom decubital ulcer 21 examples such as Sun Jin obtain satisfactory effect, and the pure treated powder skin ulcer of human Bulbus Lilii disunion 25 examples such as Deng Hancheng obtain better curative effect.Usefulness treatment by Chinese herbs skin ulcer 41 examples such as Tan Qiumei obtain certain curative effect.Humans such as Xu Shouxiang gold Herba Alii fistulosi liquid ointment has carried out experimentation to rabbit chronic ulcer of skin promotion healing and has obtained certain achievement.People such as Ji Hui adopt compound vitamin B 12 oil preparationes treatment chronic skin ulcer 93 examples, and its analgesic effect is definite, and wound healing is fast, and cicatrix is little, is better than vaseline and adds antibiotics.Persons such as Wei Zhendong join thing with infections section medicines such as hydrargyrum oxydatum crudum, Calomelas, Borneolum Syntheticums and make QUFUSHENGJI SAN 1-5 number, in conjunction with Shengji Yuhong Gao and Shengji xiangpi mastic determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, are used for the experimental animal models skin ulcer and receive effect preferably.The heavy dose of Anisodamine of humans such as Ge Zukai (654-2) treatment 8 routine diabeticss accompany serious skin foot to infect and gangrene, all have obvious hemorheology and nail fold microcirculation to change.Obtain certain curative effect.People such as Hu Zengshi adopt plurality of Chinese to refine into ulcer curing agent ointment, observation is to the therapeutic effect of skin acute and chronic ulcer, and zoopery confirms that ulcer curing agent can reduce vascular permeability, has the obvious anti-inflammatory and anti effect, can promote the modification of the epithelial cell and the appendages of skin, find no toxic and side effects.The beautiful skin cream of humans such as Peng Linghui (Radix Rehmanniae, Radix Et Rhizoma Rhei, Calomelas etc.) treatment chronic ulcer obtains certain curative effect.Uncle's Xu equality human Chinese traditional drug taraxacum herb, Herba Portulacae Grandiflorae, Flos Lonicerae heat-clearing and toxic substances removing and the Radix Astragali, Radix Codonopsis benefiting vital QI and blood are cured radiation ulcer 2 examples.People such as Liu Jialei adopt the method for putrefaction-removing granulation-promoting, blood circulation promoting and blood stasis dispelling, intend KUIYANG SAN (Moschus, Borneolum Syntheticum, Olibanum, Myrrha etc.) external curing body surface acute and chronic ulcer 123 examples certainly, and total effective rate is 100%.People such as Ma Baifang use the Chymotrypsin soak and spray SHANGLIAOHOUFENG SAN treatment chronic skin ulcer 65 examples, satisfactory effect.People such as Liu Qiukui use insulin, gentamycin liquid external application for curing skin ulcer, obtain effect preferably.Peng Minggao adopts from intending fish scale cream (pearl white, Radix Glycyrrhizae powder, Oleum sesami) external application for curing chronic ulcer of the lower limb 32 examples, has obtained better curative effect.King's Lin Yanggen is the made multiple yellow granulation promoting Wound healing oil cream (Radix Et Rhizoma Rhei, egg yolk, Radix Arnebiae (Radix Lithospermi), Sanguis Draxonis, Margarita powder, Os Draconis) of principle according to " putrefaction-removing granulation-promoting ", adopt rat ulcer in body surface model and Mice Auricle to carry out zoopery, the result shows: multiple yellow granulation promoting Wound healing oil cream has the growth of the granulation tissue of promotion, improves the effect of local microcirculation with the good healing of accelerated in wounds.People such as Xi Jianyuan make Herba Xanthii worm spray, external staphylococcus, streptococcus etc. are had inhibitory action through pharmaceutical research, and the effect that promotes ulcer healing is arranged.By to domestic and international lot of documents consult and to the investigation of Chinese and western medicine hospital clinical, we find that operative treatment is as a kind of auxiliary treatment means on control and the correction cause of disease basis, therapeutic domain has significant limitation, especially for the patient of a large amount of geroderma ulcer, the patient of long-term chronic skin ulcer, operative treatment can not become first-selected and effective Therapeutic Method.And growth-factor medication because of can not be effectively antibiotic, create the good environment that is fit to ulcer healing, for intractable ulcer, as diabetic ulcer, the ulcer that inflammatory is high, radiation ulcer can not reach curative effect satisfactorily.Therapeutic Method with traditional Chinese medicine intractable ulcer is the exclusive characteristic of China occupies an important position in the clinical and scientific research of China for many years.A lot of in recent years Chinese medicine scholars have done a large amount of work as problem at Chinese medicine screening, form improvement, but are limited to the particularity in the Chinese medicine application, are difficult to overcome external patterns such as traditional plaster, powder.Brought bigger difficulty to clinical practice, the contact that is difficult to realize external used medicine comprehensively, slow release, requirement such as efficient, easy and simple to handle.Largely limited clinical using and promoting.

The object of the present invention is to provide a kind of fill a prescription simple, slow release efficient, fully cover, permeability is strong, be easy to absorb, the prescription of chitosan Chinese medicine compound herbal membrane that the skin ulcer healing is fast.

In order to achieve the above object, the technical solution used in the present invention is: with next compositions in weight percentage:

Radix Arnebiae (Radix Lithospermi): 15%

Radix Angelicae Sinensis: 15%

The Radix Angelicae Dahuricae: 10%

Sanguis Draxonis: 10%

Margarita: 10%

Chitosan: 40%

Advantage of the present invention:

The present invention adopts five kinds of Chinese medicines to make chitosan Chinese medicine compound herbal membrane, and this medicine adopts the spray liniment form, and medicine nature film forming has slow-releasing, high osmosis, absorbability, changes the healing that the medicine film can promote skin ulcer after spraying.

Below enforcement of the present invention is done and is described in further detail:

The present invention selects Radix Arnebiae (Radix Lithospermi) 15 grams, Radix Angelicae Sinensis 15 grams, the Radix Angelicae Dahuricae 10 grams, Sanguis Draxonis 10 grams, Margarita 10 grams, chitosan 40 grams for use.With said medicine through after the micronizing in ultra high shear formula stripping instrument extraction stripping effective ingredient, and separating and extracting liquid proposes effective ingredient; While after cleaning, micronizing, is made molecular ion attitude aqueous solution to Margarita through physical chemistry and plysiochemical method.Reuse micro-emulsion technology and microcapsule technology four kinds of Chinese medicines effectively extract composition and Margarita molecular ion attitude aqueous solution composition in the emulsifying instrument, make the microcapsule insecticide film with quantitative release function and the human body that relies on composition in the chitosan aqueous solution can absorption, porous, semipermeable membrane character, finally make the chitosan compound herbal membrane.

Clinical and the zoopery of the present invention:

Clinical observation: example surplus my institute clinical practice treatment intractable ulcer 60 in 1997, received relieving pain, effects such as wound healing is good: among the 66 routine patients, male's 45 examples, women's 21 examples are the ulcer that occurs in calf, simultaneously with varicose veins of the lower extremity person 27 examples, the elder of the course of disease 18 years, the shortest person 70 days.16 * 11 * 0.8cm of area maximum, 2 minimum * 2cm.The relevant skin infection diagnosis and treatment grade III Standard of formulating by the skin infection cooperative groups meeting of national dermasurgery association (1. recovery from illness: ulceration heals fully behind the external treatment, around it with red, swollen, hot, pain inflammatory show disappearance thereupon; 2. take a turn for the better: ulcer surface dwindles more than 2/3 behind the external treatment, around it with red, swollen, hot, pain is basic disappears or portion's disappearance greatly; 3. invalid: ulcer surface dwindles below 1/3 behind the external treatment, and red, swollen, hot, pain does not have obvious changer.) judge therapeutic effect, local topical health recovery from illness 41 examples (accounting for 62%) behind the film cream that heal, 23 examples that take a turn for the better (accounting for 35%), invalid 2 examples (accounting for 3%).The course of treatment is the shortest 14 days, and is the longest 98 days, average 44 days.

Zoopery: 54 of cleaning level ccv rats, male and female half and half, be divided into three groups at random, make the model of animal body surface wound surface according to the method for Shen Shi, each is organized the rat wound surface and is coated with chitosan Chinese medicine compound herbal membrane (medication group), Shengji Yuhong Gao (positive controls) and vaseline (blank group) respectively.Respectively at getting the wound surface granulation tissue after the administration in the 4th day, 7 days, 11 days, observe pathological change and VEGF (VEGF), proliferating cell nuclear antigen (PCNA) and phagocyte (ED1) are carried out quantitative analysis with the SABC method.The constituent ratio that the result shows after medication group (the chitosan Chinese medicine compound herbal membrane) medication 4 days, 7 days, 11 days inflammatory exudation layer thicknesses, soak into the ED1 in the inflammatory cell is starkly lower than positive controls and blank group (p＜0.01); The VEGF (VEGF) of the group of medication simultaneously, proliferating cell nuclear antigen (PCNA) are apparently higher than positive controls and blank group (p＜0.01).

Claims (1)

1. the prescription of a chitosan Chinese medicine compound herbal membrane is characterized in that: following each compositions in weight percentage:

Radix Arnebiae (Radix Lithospermi): 15%

Radix Angelicae Sinensis: 15%

The Radix Angelicae Dahuricae: 10%

Sanguis Draxonis: 10%

Margarita: 10%

Chitosan: 40%