CN103655771A - Traditional Chinese medicine preparation for treating skin ulcers and preparation method thereof - Google Patents
Traditional Chinese medicine preparation for treating skin ulcers and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine preparation for treating skin ulcers. The traditional Chinese medicine preparation comprises the following raw medicines in parts by weight: 1-3 parts of raw astragalus, 0.5-2 parts of Chinese angelica, 1-3 parts of red sage root, 0.5-2 parts of frankincense, 0.5-2 parts of myrrh, 0.5-2 parts of cutch, 0.5-2 parts of cassia twig, 2-4 parts of mirabilitum dehydratum, 0.5-2 parts of coptis and 0.5-2 parts of prepared rhubarb. The traditional Chinese medicine preparation disclosed by the invention can be prepared into tablet, mixture, granula and capsule and has the efficacies of tonifying qi, activating blood, regenerating tissue and healing ulcer when externally applied; and the preparation is mainly used for treating various skin ulcers in later stages and particularly suitable for treating diseases such as lower limb varicose vein type ulcers, traumatic ulcers, infectious ulcers and the like which have the cardinal symptoms that pus and slough at the skin wound are completely dropped, the wound healing speed is slow, the granulation tissue is dark red and the skin surrounding the ulcer is dark. The invention also discloses a preparation method of various dosage forms of the traditional Chinese medicine preparation.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation for the treatment of skin ulcer, the invention still further relates in addition the preparation method of this Chinese medicine preparation.
Background technology
Skin ulcer is a kind of common, multiple surgical diseases.Various epidemiological studies show, the sickness rate of skin ulcer is 3.6%, and along with the increasing of the sickness rate such as the aging trend of population and diabetes, cardiovascular disease, the sickness rate of chronic skin ulcer also rises to some extent, and easily morbidity repeatedly, even there is the possibility of cancerating.
Current conventional skin ulcer Therapeutic Method, focus mostly in improving blood circulation, infection, adopt surgical debridement, skin grafting, local skin flap's musculo cutaneous flap Transfer, closed negative pressure attraction, external somatomedin, multiple dressing and wound-surface cover etc., there is certain curative effect, but for resistant strains, wound surface superinfection, skin ulcer noodles part, be unsuitable for the problems such as debridement skin grafting, have the bottleneck for the treatment of.Therefore, find a kind of convenience and effectively significant for the non-operative treatment in wound healing later stage.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of convenience and the effective Chinese medicine preparation of the treatment skin ulcer of wound healing, and the preparation method of this Chinese medicine preparation is provided.
In order to solve the problems of the technologies described above, the Chinese medicine preparation for the treatment of skin ulcer provided by the invention, this Chinese medicine preparation is prepared from by the crude drug of following weight portion: Radix Astragali 1-3 part, Radix Angelicae Sinensis 0.5-2 part, Radix Salviae Miltiorrhizae 1-3 part, Flos Carthami 0.5-2 part, Olibanum 0.5-2 part, Myrrha 0.5-2 part, catechu 0.5-2 part, Ramulus Cinnamomi 0.5-2 part, 24 parts of Matrii Sulfas Exsiccatus, Rhizoma Coptidis 0.5-2 part, Radix et Rhizoma Rhei (processed) 0.5-2 part.
Preferably, in the Chinese medicine preparation of the above-mentioned treatment skin ulcer of the present invention, the weight portion of crude drug is respectively: 2 parts of Radix Astragali, 1 part of Radix Angelicae Sinensis, 2 parts of Radix Salviae Miltiorrhizaes, 1 part, Flos Carthami, 1 part of Olibanum, 1 part of Myrrha, 1 part, catechu, 1 part of Ramulus Cinnamomi, 3 parts of Matrii Sulfas Exsiccatus, 1 part of Rhizoma Coptidis, 1 part of Radix et Rhizoma Rhei (processed).
Preferably, the Chinese medicine preparation of the above-mentioned treatment skin ulcer of the present invention is tablet, mixture, granule or capsule.
The preparation method of the Chinese medicine preparation tablet of the above-mentioned treatment skin ulcer of the present invention, comprise the following steps processing step: by proportioning, take Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, Olibanum, Myrrha, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 1-5 weight portion adds water and makes slurry; Drop into above-mentioned raw materials medicine part, stir, granulate, dry, roll sheet.
The preparation method of the Chinese medicine preparation mixture of the above-mentioned treatment skin ulcer of the present invention, comprise the following steps processing step: by proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, Olibanum, Myrrha, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settles, filtering insoluble matter, collect filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage.
The preparation method of the Chinese medicine preparation granule of the above-mentioned treatment skin ulcer of the present invention, comprises the following steps processing step and takes respectively Olibanum and Myrrha by proportioning, and crushed after being dried is crossed 100 mesh sieves; By proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settles, and filtering insoluble matter is collected filtrate, is condensed into extractum; By proportioning, by the Rhizoma Coptidis of extractum and above-mentioned mistake 100 mesh sieves and Cortex Phellodendri fine powder and appropriate excipient kneading, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate.
The preparation method of the Traditional Chinese medicine preparation capsule agent of the above-mentioned treatment skin ulcer of the present invention, comprises the following steps processing step: by proportioning, take respectively Olibanum and Myrrha, crushed after being dried becomes fine powder; By proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settles, and filtering insoluble matter is collected filtrate, is condensed into extractum; In extractum, add aforementioned Olibanum and Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill.
Test example subsequently will prove, Chinese medicine preparation of the present invention has the effect of benefiting QI for activating blood circulation, promoting tissue regeneration and ulcer healing, cure mainly various skin ulcers, can effectively promote skin ulcer healing, be particularly useful for treating the skin wounds such as varicose ulcer of lower extremity, traumatic ulcer, infective ulcer take wound surface poor growth, pus rotten de-to the greatest extent, the dark red disease as cardinal symptom of granulation color, there is significant QI invigorating, invigorate blood circulation, the effect of granulation promoting.
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.These embodiment are interpreted as only for the present invention is described, is not used in and limits the scope of the invention.After having read the content of the present invention's record, those skilled in the art can make various changes or modifications the present invention, and these equivalences change and modification falls into the scope of the claims in the present invention equally.
The preparation of embodiment 1(Chinese medicine preparation tablet of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 120g adds water and makes slurry; Drop into above-mentioned raw materials medicine part, stir, granulate, dry, roll sheet, obtain.
The preparation of embodiment 2(Chinese medicine preparation mixture of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage, obtains.
The preparation of embodiment 3(Chinese medicine preparation granule of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried, crosses 100 mesh sieves; Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Mediate with above-mentioned Olibanum, Myrrha fine powder and appropriate excipient, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate, obtains.
The preparation of embodiment 4(Traditional Chinese medicine preparation capsule agent of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried becomes fine powder; Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Add Olibanum, Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill, obtain.
The preparation of embodiment 5(Chinese medicine preparation tablet of the present invention)
Get Radix Astragali 90g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 120g adds water and makes slurry; Drop into above-mentioned raw materials medicine part, stir, granulate, dry, roll sheet, obtain.
The preparation of embodiment 6(Chinese medicine preparation mixture of the present invention)
Get Radix Astragali 90g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage, obtains.
The preparation of embodiment 7(Chinese medicine preparation granule of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried, crosses 100 mesh sieves; Get Radix Astragali 90g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Mediate with above-mentioned Olibanum, Myrrha fine powder and appropriate excipient, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate, obtains.
The preparation of embodiment 8(Traditional Chinese medicine preparation capsule agent of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried becomes fine powder; Get Radix Astragali 90g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Add Olibanum, Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill, obtain.
The preparation of embodiment 9(Chinese medicine preparation tablet of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 60g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 60g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 120g adds water and makes slurry; Drop into above-mentioned raw materials medicine part, stir, granulate, dry, roll sheet, obtain.
The preparation of embodiment 10(Chinese medicine preparation mixture of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 60g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 60g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage, obtains.
The preparation of embodiment 11(Chinese medicine preparation granule of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried, crosses 100 mesh sieves; Get Radix Astragali 60g, Radix Angelicae Sinensis 60g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 60g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Mediate with above-mentioned Olibanum, Myrrha fine powder and appropriate excipient, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate, obtains.
The preparation of embodiment 12(Traditional Chinese medicine preparation capsule agent of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried becomes fine powder; Get Radix Astragali 60g, Radix Angelicae Sinensis 60g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 60g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 30g, Radix et Rhizoma Rhei (processed) 30g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Add Olibanum, Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill, obtain.
The preparation of embodiment 13(Chinese medicine preparation tablet of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 60g, Radix et Rhizoma Rhei (processed) 60g, suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 120g adds water and makes slurry; Drop into above-mentioned raw materials medicine part, stir, granulate, dry, roll sheet, obtain.
The preparation of embodiment 14(Chinese medicine preparation mixture of the present invention)
Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, Olibanum 30g, Myrrha 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 60g, Radix et Rhizoma Rhei (processed) 60g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage, obtains.
The preparation of embodiment 15(Chinese medicine preparation granule of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried, crosses 100 mesh sieves; Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 60g, Radix et Rhizoma Rhei (processed) 60g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Mediate with above-mentioned Olibanum, Myrrha fine powder and appropriate excipient, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate, obtains.
The preparation of embodiment 16(Traditional Chinese medicine preparation capsule agent of the present invention)
Get Olibanum 30g, Myrrha 30g, crushed after being dried becomes fine powder; Get Radix Astragali 60g, Radix Angelicae Sinensis 30g, Radix Salviae Miltiorrhizae 60g, Flos Carthami 30g, catechu 36g, Ramulus Cinnamomi 30g, Matrii Sulfas Exsiccatus 90g, Rhizoma Coptidis 60g, Radix et Rhizoma Rhei (processed) 60g, adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, is condensed into extractum; Add Olibanum, Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill, obtain.
By test example, further illustrate the beneficial effect of setting forth Chinese medicine preparation of the present invention below, these test examples have comprised the clinical observation on the therapeutic effect test of Chinese medicine preparation of the present invention.
In the following test example of the present invention, Chinese medicine preparation of the present invention is called benefiting qi and removing blood stasis Chinese medicine, and the test group at its place is called benefiting qi and removing blood stasis Chinese drug-treated group.
Test example: the clinical observation of Chinese medicine preparation treatment skin ulcer of the present invention
1, physical data
Inclusion criteria: allly meet skin ulcer 1 month person that do not belong to syndrome of blood stasis due to qi deficiency in healing person and TCM syndrome diagnostic criteria above.Case derives from surgery of Chinese medicine outpatient service and the ward chronic ulcer of the lower limb patient of Longhua Hospital affiliated Shanghai University Of Chinese Traditional Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medic, Shanghai City Hospital of Combination of Chinese Traditional and Western Medicin, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shanghai University of Chinese Medicine Affiliated Yueyang Integrated Traditional and Western Medicine Hospital, attached Shanghai City institute of traditional Chinese medicine of Shanghai Univ. of Traditional Chinese Medicine, 7 hospitals of Shuguang Hospital, and case acquisition time is in February, 2011 to 2011 year December.In Table 1.1.
Allly enter to organize case and all meet into set condition.According to research approach, enter to organize at random case 200 examples (benefiting qi and removing blood stasis Chinese drug-treated group 100 examples, matched group 100 examples), safety analysis collection (SS) 188 examples (benefiting qi and removing blood stasis Chinese drug-treated group 93 examples, matched group 95 examples), complete analysis collection (FAS) 188 examples (benefiting qi and removing blood stasis Chinese drug-treated group 93 examples, matched group 95 examples), meet scheme collection (PPS) 185 examples (benefiting qi and removing blood stasis Chinese drug-treated group 91 examples, matched group 94 examples).In Table 1.1.
Table 1.1 enters to organize case and safety, efficiency analysis crowd
Enter to organize case load: 200 complete case load: 185 case loads that come off: 15 expulsion rates: 7.5%
Reject case load: 0 rejecting rate: 0.00%
2, diagnostic criteria
(1) Western medicine diagnose standard: skin ulcer 1 month is healing person not above.
(2) TCM syndrome diagnostic criteria: belong to syndrome of blood stasis due to qi deficiency person.
With reference to < < State Standard of the People's Republic of China tcm clinical practice diagnosis and treatment term syndrome > >, the Chinese medicine industry standard traditional Chinese medical science disease Standardization of diagnosis and curative effect > > of the < < People's Republic of China (PRC) and national state-compiled textbook < < Surgery of Chinese Medicine > > (New Century higher institutions of Chinese medicine teaching material).
Primary symptom: wound surface poor growth, granulation color is dark red, and pus is rotten to the greatest extent de-, creates all colour of skin stasis of bloods dark.
Inferior disease: poor appetite, spontaneous perspiration, spiritlessness and weakness, the swollen discomfort of lower limb acid; Tongue is dark red or color is light, and there is indentation on limit, thready pulse.
Possess two of the above-mentioned primary symptoms of syndrome of blood stasis due to qi deficiency and two of inferior diseases and can make diagnosis.
3, inclusive criteria
(1) meet Western medicine diagnose standard person; (2) meet tcm diagnosis standard person; (3) age>=18 one full year of life and≤85 one full year of life, men and women does not limit; (4) knee joint below ulcer of the lower limb wound surface area>=2 ㎝
2and <25 ㎝
2person; (5), as complication with diabetes, glycemic control is stablized (<10.9mmol/L); (6) informed consent, signature Informed Consent Form, and tested voluntarily
4, discharge standard
(1) do not meet diagnostic criteria and inclusive criteria person; (2) be associated with the serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system, psychotic, tumor or HIV sufferers; 1. serum creatinine, blood urea nitrogen > Upper Limit of Normal Value are 1.5 times; 2. ALT > Upper Limit of Normal Value; 3. the arrhythmia that has clinical meaning; (3) gestation or women breast-feeding their children, allergic constitution person; (4) severe infection, state of an illness danger severe one; (5) complication with diabetes, glycemic control unstable (>=10.9mmol/L) person; (6) merge neural malnutrition person; (7) arterial disease ulcer, cancer ulcer or tuberculous ulcer, radiation ulcer, decubital ulcer, leprous ulcer, syphilelcosis; (8) ulcer see tendon, skeleton resurrectionist; (9) knee joint top ulcer of the lower limb, or knee joint below ulcer of the lower limb skin ulcer face area>=25cm
2, or <2 ㎝
2; (10) meet inclusive criteria, but not medication in accordance with regulations cannot judge curative effect, or data is not congruent affects the treatment or safety judgement person; (11) according to researcher judgement, have and reduce into group probability or make, into other complicated medical histories of group, as working environment often changes, easily to cause situation lost to follow-up; (12) participating in the experimenter of other drug clinical research.
5, therapeutic scheme
5.1 trial drug
Test medication: choose at random the Chinese medicine preparation that embodiment 1-16 makes, make Chinese medicine saturated solution if tablet, granule or capsule (removing after capsule) add suitable quantity of water dissolving.
Contrast medication: the multiple agent " b-FGF, bFGF bovine basic fibroblast growth factor externally used solution, is produced by Yisheng Biological Pharmaceutical Co., Ltd., Shuhai, the accurate word S10980077 of traditional Chinese medicines " of external shellfish, at every turn with 150U/cm
2be sprayed at ulcer surface.
5.2 test method
Test group: change dressings+Chinese medicine preparation fumigation treatment of the present invention of conventional surgical.
Matched group: the multiple agent external of change dressings+shellfish of conventional surgical.
Conventional surgical is changed dressings: the cotton ball soaked in alcohol sterilization skin ulcer week skin with 75%, then wipe away gently clean wound secretion with 1:5000 nitrofural cotton balls; After medicament fumigating treatment, gauze lid pastes; Change dressings every day 1 time.
Herb steam therapy: by intelligent Chinese medicine fumigation automatic control therapeutic instrument (Changxing San Zhou electronics science instrument plant, model: XJZA-II) row herbal fumigation.Fumigating method: get Chinese medicine saturated solution 100ml, add water to 1000ml～1100ml heating, steam affected part with medicinal liquid steam fumigating after temperature (40 ℃ of left and right of water temperature), affected part and fumigation instrument puff prot will keep 25cm～30cm distance, and patient can tolerate as degree; Each 30min, every day 1 time.
Respectively at recording wound surface area on same day on-test, 14 ± 3 days, 28 ± 3 days, 42 ± 3 days, 56 ± 3 days.
6, index of assessment of curative effect
6.1 curative effect indexs
Wound healing rate.Wound healing rate=(original wound surface area-wound surface area does not heal)/original wound surface area * 100%.On-test, end, each is surveyed 1 time.
6.2 secondary efficacy indexs
(1) wound healing time: play the complete epithelization required time of wound surface from topical agent.Continue to observe, the date of recording wound healing, observe full 8 weeks, as do not heal, no longer continue to observe.(2) tcm syndrome: adopt syndrome integration to judge.By the symptoms such as wound surface area, the degree of depth, new granulation tissue, newborn epithelial tissue without, light, in, heavy, remember 0,1,2,3,4 minute extremely heavily respectively, each individual event symptom mark accumulative total is integration, after treatment, integration and the front integration contrast for the treatment of, judge by integration drop-out value.Test duration is observed 8 weeks.
6.3 safety indexes
(1) general security index: routine blood test, routine urinalysis, liver function, renal function; (2) untoward reaction is observed.
7. therapeutic evaluation
7.1 curative effect of disease evaluation criterions
With reference to the Chinese medicine industry standard traditional Chinese medical science disease Standardization of diagnosis and curative effect > > of the < < People's Republic of China (PRC), formulate.(1) clinical recovery: wound surface heals completely; (2) effective: wound surface obviously dwindles, >=75%; (3) effective: wound surface dwindles, <75% and >=25%; (4) invalid: wound surface dwindles, <25%, even expands.
7.2 therapeutic effect of syndrome criterion
With reference to < < new Chinese medicine guideline of clinical investigations (trying), 2002 > > formulate.(1) clinical recovery: tcm clinical practice symptom, sign disappear or substantially disappear, and syndrome integration reduces >=95%; (2) effective: tcm clinical practice symptom, sign are obviously improved, syndrome integration reduces >=70%; (3) effective: tcm clinical practice symptom, sign all take a favorable turn, syndrome integration reduces >=30%; (4) invalid: tcm clinical practice symptom, sign are all not improved, even increase the weight of, syndrome integration reduces less than 30%.Note: computing formula (nimodipine method) is: [integration before (the rear integration of integration-treatment before treatment)/treatment] * 100%.
The evaluation of 7.3 safeties
1 grade: safety, without any untoward reaction, safety indexes checks without abnormal; 2 grades: safer, there is mild adverse effects, do not need to do any processing and can continue administration, safety indexes checks without abnormal; 3 grades: have safety issue, have moderate untoward reaction, or safety indexes inspection has mile abnormality, after processing, can continue administration; 4 grades: because serious adverse reaction is ended test, or safety indexes inspection is obviously abnormal.
8. statistical analysis technique
Curative effect of disease index adopts FAS and two kinds of data sets of PPS; Other curative effect index FAS set analysis.Safety indexes adopts SS set analysis.The harmonious analysis of baseline also will adopt FAS set analysis.Statistical analysis content comprises actual two groups of subject enrollment quantity, comes off and rejects case situation, demography and other baseline characteristic, compliance, efficacy analysis and safety analysis.Cure rate represents with %, the evaluation employing CMH check of curative effect; Healing time indices adopts the multifactor analysis of variance and two sample average t check; Syndrome is observed the variance analysis that table adopts repeated measurement data, uses SAS statistical package.
9, therapeutic outcome (in Table 9.1～9.5)
9.1 Wound healing rate
Two groups of Wound healing rate comparisons: matched group healing rate 14th ± 3 days is (53.86 ± 38.75) %, 28th ± 3 days is (67.24 ± 40.31) %, 42nd ± 3 days is (76.48 ± 37.59) %, 56th ± 3 days is (81.98 ± 33.08) %.Benefiting qi and removing blood stasis Chinese drug-treated group healing rate 14th ± 3 days is (47.10 ± 40.64) %, within 28th ± 3 days, is (65.68 ± 39.54) %, within 42nd ± 3 days, is (74.93 ± 42.73) %, within 56th ± 3 days, is (83.11 ± 32.98) %.
Learn by statistics check, 28th ± 3 days, 42nd ± 3 days, 56th ± 3 days Wound healing rates of benefiting qi and removing blood stasis Chinese drug-treated group respectively with the Wound healing rate comparison in 14th ± 3 days of benefiting qi and removing blood stasis Chinese drug-treated group, difference all has significant (P<0.05); 28th ± 3 days, 42nd ± 3 days, 56th ± 3 days Wound healing rates of matched group respectively with matched group Wound healing rate comparison in 14th ± 3 days, difference all has significant (P<0.05); And benefiting qi and removing blood stasis Chinese drug-treated group and matched group Wound healing rate 14th ± 3 days, 28th ± 3 days, 42nd ± 3 days, 56th ± 3 days, there was no significant difference (P>0.05) relatively between group.Prompting benefiting qi and removing blood stasis treatment by Chinese herbs chronic ulcer of the lower limb is evident in efficacy; It is evident in efficacy that chronic ulcer of the lower limb is treated in Bfgf-ESSEX external ruling by law; And benefiting qi and removing blood stasis Chinese medicine is compared with the outer usage of Bfgf-ESSEX, the effect no significant difference for the treatment of chronic ulcer of the lower limb wound surface.FAS collection is consistent with the statistical result of PPS collection.In Table 9.1.
Table 9.1 liang group Wound healing rate comparison (
)
Note: with matched group comparison in 14th ± 3 days,
■represent P<0.05; With the comparison in 14th ± 3 days of benefiting qi and removing blood stasis Chinese drug-treated group,
▲represent P<0.05
9.2 wound healing time
Observe matched group 65 examples that heal, the average healing days of wound surface (27.74 ± 14.59) day 8 weeks.Benefiting qi and removing blood stasis Chinese drug-treated group 58 examples that heal, the average healing days of wound surface (29.31 ± 14.38) day.
Learn by statistics check, two groups of wound healing time there was no significant differences (P>0.05), benefiting qi and removing blood stasis Chinese medicine is compared with the outer usage of Bfgf-ESSEX, the effect no significant difference for the treatment of chronic ulcer of the lower limb wound surface.FAS collection is consistent with the statistical result of PPS collection.In Table 9.2.
Table 9.2 liang group wound healing time comparison (my god
)
9.3 curative effect of disease evaluations
Observe matched group fully recover 65 examples, effective 9 examples, effective 9 examples, invalid 11 examples, total effective rate 88.30%, cure rate 69.15%, recovery from illness obvious effective rate 78.72% 8 weeks.Benefiting qi and removing blood stasis Chinese drug-treated group fully recover 59 examples, effective 9 examples, effective 13 examples, invalid 6 examples, total effective rate 93.10%, cure rate 67.82%, recovery from illness obvious effective rate 78.16%.
Learn by statistics check, two groups of curative effect of disease there was no significant differences (P>0.05), the outer usage of benefiting qi and removing blood stasis Chinese medicine and Bfgf-ESSEX all can promote chronic ulcer of the lower limb healing, and the therapeutic effect there was no significant difference of two kinds of therapies.FAS collection is consistent with the statistical result of PPS collection.In Table 9.3.
Table 9.3 liang group curative effect of disease comparison
9.4 tcm syndrome therapeutic evaluatioies
Observe matched group fully recover 51 examples, effective 14 examples, effective 15 examples, invalid 13 examples, total effective rate 86.02%, cure rate 54.84%, recovery from illness obvious effective rate 69.89% 8 weeks.Benefiting qi and removing blood stasis Chinese drug-treated group fully recover 55 examples, effective 10 examples, effective 19 examples, invalid 3 examples, total effective rate 96.55%, cure rate 63.22%, recovery from illness obvious effective rate 74.71%.
Learn by statistics check, two groups of tcm syndrome recovery from illness obvious effective rate there was no significant differences (P>0.05), and benefiting qi and removing blood stasis Chinese drug-treated group total effective rate is obviously better than matched group (P<0.05).Be that the outer usage of benefiting qi and removing blood stasis Chinese medicine and Bfgf-ESSEX all can be improved chronic ulcer of the lower limb tcm syndrome, and improving aspect tcm symptom, the therapeutical effect of benefiting qi and removing blood stasis Chinese medicine is obviously better than matched group.FAS collection is consistent with the statistical result of PPS collection.In Table 9.4.
Table 9.4 liang group tcm syndrome curative effect comparison
Note: with matched group comparison,
▲represent P<0.05
9.5 tcm syndrome integrations
Before benefiting qi and removing blood stasis Chinese drug-treated group and treatment, relatively, at 14th ± 3 days, 28th ± 3 days, 42nd ± 3 days, 56th ± 3 days, improve wound surface form (area, the degree of depth, edge of wound move under water), wound surface cambium (granulation color and luster, new granulation tissue, newborn epithelial tissue), create all skin vitalities, lower limbs edema (position, form quality, degree), wound surface microbial load, create aspect the syndromes such as all skin temperatures, skin color, pain (degree, frequency) and all there is significant difference (P<0.05).FAS collection is consistent with the statistical result of PPS collection.
Before matched group and treatment, relatively, at 14th ± 3 days, 28th ± 3 days, 42nd ± 3 days, 56th ± 3 days, improve wound surface form (area, the degree of depth, edge of wound move under water), wound surface cambium (granulation color and luster, new granulation tissue, newborn epithelial tissue), create all skin vitalities, lower limbs edema (position, form quality, degree), wound surface microbial load, create aspect the syndromes such as all skin temperatures, skin color, pain (degree, frequency) and all there is significant difference (P<0.05).FAS collection is consistent with the statistical result of PPS collection.
Benefiting qi and removing blood stasis Chinese drug-treated group and matched group comparison, benefiting qi and removing blood stasis Chinese drug-treated group is created aspect the syndromes such as all vigor, wound week skin temperature and is obviously better than matched group within 28th ± 3 days, improving lower limbs edema (position, character), pain (frequency), skin, and difference has statistical significance (P<0.05).Benefiting qi and removing blood stasis Chinese drug-treated group was improved lower limbs edema (position, character), pain (degree), creates all skin temperatures, aspect the syndromes such as impact of quality of life, is obviously better than matched group at 42nd ± 3 days, difference has statistical significance (P<0.05).Benefiting qi and removing blood stasis Chinese drug-treated group is improved wound surface cambium (newborn epithelial tissue) for 56th ± 3 days, improve lower limbs edema (position, character, degree), pain (frequency, degree), skin and create all vigor, wound week skin temperature, the syndrome aspects such as impact of quality of life are obviously better than to matched group, difference has statistical significance (P<0.05).FAS collection is consistent with the statistical result of PPS collection.
Visible, Yiqi Huoxue TCM sustainable improvement chronic ulcer of the lower limb tcm syndrome, and improving wound surface cambium (newborn epithelial tissue), improving lower limbs edema (position, character, degree), pain (frequency, degree), skin and create all vigor, wound week skin temperature, the syndrome aspects such as impact of quality of life are all better than to the outer usage of Bfgf-ESSEX.FAS collection consistent with the statistical result of PPS collection (in Table the comparison of 9.5 liang of group tcm syndrome integrations).
The comparison of table 9.5 liang group tcm syndrome integration
9.6 safety evaluatio
During observing 8 weeks, benefiting qi and removing blood stasis Chinese drug-treated group I level 87 examples (97.75%), II level 1 example (1.12%), III level 0 example (0.00%), IV level 1 example (1.13%); Matched group I level 89 examples (100.00%), II level 0 example (0.00%), III level 0 example (0.00%), IV level 0 example (0.00%); Comparing difference not statistically significant (P>0.05) between group (safety analysis collection SS).Visible, benefiting qi and removing blood stasis treatment by Chinese herbs chronic ulcer of the lower limb is safe.In Table 9.6.
Table 9.6 liang group safety evaluatio comparison
Table 9.1～9.6 are visible: two groups aspect Wound healing rate, wound healing time, curative effect of disease, tcm syndrome curative effect, the improvement before and after indices treatment all has significant statistical significance (P<0.05).And observe curative effect of disease 8 weeks, matched group fully recover 65 examples, effective 9 examples, effective 9 examples, invalid 11 examples, total effective rate 88.30%, cure rate 69.15%, recovery from illness obvious effective rate 78.72%; Benefiting qi and removing blood stasis Chinese drug-treated group fully recover 59 examples, effective 9 examples, effective 13 examples, invalid 6 examples, total effective rate 93.10%, cure rate 67.82%, recovery from illness obvious effective rate 78.16%; Compare difference not statistically significant (P>0.05) with matched group.Observe tcm syndrome curative effect 8 weeks, matched group fully recover 51 examples, effective 14 examples, effective 15 examples, invalid 13 examples, total effective rate 86.02%, cure rate 54.84%, recovery from illness obvious effective rate 69.89%.Benefiting qi and removing blood stasis Chinese drug-treated group fully recover 55 examples, effective 10 examples, effective 19 examples, invalid 3 examples, total effective rate 96.55%, cure rate 63.22%, recovery from illness obvious effective rate 74.71%.Compare with matched group, total effective rate benefiting qi and removing blood stasis Chinese drug-treated group is better than matched group, and difference has statistical significance (P<0.05).Benefiting qi and removing blood stasis Chinese medicine sustainable improvement chronic ulcer of the lower limb tcm syndrome, and improving the newborn epithelial tissue of wound surface, improve lower limbs edema (position, character, degree), pain (frequency, degree), skin create all vigor, wound week skin temperature, on the equal outer usage of excellent Bfgf-ESSEX in the syndrome aspects such as impact of quality of life.And benefiting qi and removing blood stasis treatment by Chinese herbs chronic ulcer of the lower limb is safe.Illustrate that benefiting qi and removing blood stasis Chinese medicine for external application treatment skin ulcer of the present invention has good clinical effectiveness, and the effect of its wound healing is compared there was no significant difference with the multiple agent of shellfish, is better than usage outside the multiple agent of shellfish aspect improving the tcm symptoms such as lower limbs edema, pain.
Claims (7)
1. a Chinese medicine preparation for the treatment of skin ulcer, it is characterized in that, this Chinese medicine preparation is prepared from by the crude drug of following weight portion: Radix Astragali 1-3 part, Radix Angelicae Sinensis 0.5-2 part, Radix Salviae Miltiorrhizae 1-3 part, Flos Carthami 0.5-2 part, Olibanum 0.5-2 part, Myrrha 0.5-2 part, catechu 0.5-2 part, Ramulus Cinnamomi 0.5-2 part, Matrii Sulfas Exsiccatus 2-4 part, Rhizoma Coptidis 0.5-2 part, Radix et Rhizoma Rhei (processed) 0.5-2 part.
2. the Chinese medicine preparation for the treatment of skin ulcer according to claim 1, it is characterized in that, the weight portion of crude drug is respectively: 2 parts of Radix Astragali, 1 part of Radix Angelicae Sinensis, 2 parts of Radix Salviae Miltiorrhizaes, 1 part, Flos Carthami, 1 part of Olibanum, 1 part of Myrrha, 1 part, catechu, 1 part of Ramulus Cinnamomi, 3 parts of Matrii Sulfas Exsiccatus, 1 part of Rhizoma Coptidis, 1 part of Radix et Rhizoma Rhei (processed).
3. the Chinese medicine preparation for the treatment of skin ulcer according to claim 1 and 2, is characterized in that, this Chinese medicine preparation is tablet, mixture, granule or capsule.
4. the preparation method of the Chinese medicine preparation tablet for the treatment of skin ulcer claimed in claim 3, it is characterized in that, comprise following processing step: by proportioning, take Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, Olibanum, Myrrha, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), suitably crushed after being dried, crosses 100 mesh sieves; Taking starch 1-5 weight portion adds water and makes slurry; Drop into above-mentioned raw materials medicine, stir, granulate, dry, roll sheet.
5. the preparation method of the Chinese medicine preparation mixture for the treatment of skin ulcer claimed in claim 3, it is characterized in that, comprise following processing step: by proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, Olibanum, Myrrha, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settle, filtering insoluble matter, collects filtrate, concentrated, add appropriate antiseptic, correctives and antibacterial, subpackage.
6. the preparation method of the Chinese medicine preparation granule for the treatment of skin ulcer claimed in claim 3, is characterized in that, comprises following processing step: by proportioning, take respectively Olibanum and Myrrha, crushed after being dried, crosses 100 mesh sieves; By proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settles, and filtering insoluble matter is collected filtrate, is condensed into extractum; By proportioning, by the Olibanum of extractum and above-mentioned mistake 100 mesh sieves and Myrrha fine powder and appropriate excipient kneading, add appropriate wetting agent or adhesive, make soft material, granulate, dry, granulate.
7. the preparation method of the Traditional Chinese medicine preparation capsule agent for the treatment of skin ulcer claimed in claim 3, is characterized in that, comprises following processing step: by proportioning, take respectively Olibanum and Myrrha, crushed after being dried becomes fine powder; By proportioning, take respectively Radix Astragali, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae, Flos Carthami, catechu, Ramulus Cinnamomi, Matrii Sulfas Exsiccatus, Rhizoma Coptidis and Radix et Rhizoma Rhei (processed), adopt the conventional method decocting of Chinese medicine preparation to extract, collecting decoction, staticly settles, and filtering insoluble matter is collected filtrate, is condensed into extractum; In extractum, add aforementioned Olibanum and Myrrha fine powder and appropriate amount of auxiliary materials, mix, dry, pulverize, sieve, fill.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105796677A (en) * | 2016-05-23 | 2016-07-27 | 四川省中医药科学院 | Application of paliurus ramosissimus (Lour.) poir or extract thereof in preparing medicine for treating infectious ulcer |
| CN105832909A (en) * | 2016-06-02 | 2016-08-10 | 徐永华 | Traditional Chinese medicine preparation for treating necrotic ulcer of skin |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102091203A (en) * | 2011-01-19 | 2011-06-15 | 李惠斌 | External traditional Chinese medicine preparation for treating chronic wounds and preparation method thereof |
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| CN102091203A (en) * | 2011-01-19 | 2011-06-15 | 李惠斌 | External traditional Chinese medicine preparation for treating chronic wounds and preparation method thereof |
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| 王粤湘等: "慢性皮肤溃疡中药辨证换药及辨证施护效果观察", 《护理学杂志》 * |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105796677A (en) * | 2016-05-23 | 2016-07-27 | 四川省中医药科学院 | Application of paliurus ramosissimus (Lour.) poir or extract thereof in preparing medicine for treating infectious ulcer |
| CN105796677B (en) * | 2016-05-23 | 2020-03-31 | 四川省中医药科学院 | Application of paliurus ramosissimus or extract thereof in preparation of medicine for treating infectious ulcer |
| CN105832909A (en) * | 2016-06-02 | 2016-08-10 | 徐永华 | Traditional Chinese medicine preparation for treating necrotic ulcer of skin |
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