CN104116852A - Hemostatic folium callicarpae pedunculalae injection and preparation method thereof - Google Patents

Hemostatic folium callicarpae pedunculalae injection and preparation method thereof Download PDF

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CN104116852A
CN104116852A CN201410394632.0A CN201410394632A CN104116852A CN 104116852 A CN104116852 A CN 104116852A CN 201410394632 A CN201410394632 A CN 201410394632A CN 104116852 A CN104116852 A CN 104116852A
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folium callicarpae
injection
callicarpae formosanae
preparation
hemostasis
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付丽娜
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Abstract

The invention discloses hemostatic folium callicarpae pedunculalae injection. Every 100ml of folium callicarpae pedunculalae injection comprises the main component of 12-20g of folium callicarpae pedunculalae water extract. The hemostatic folium callicarpae pedunculalae injection has the effects of stopping bleeding, reducing swelling, removing stasis, diminishing inflammation and sterilizing, bleeding can be stopped in a short time, and the wound is effectively protected, so that secondary infection of the wound is avoided, and limitation of the wound area is avoided.

Description

Folium Callicarpae Formosanae injection of hemostasis use and preparation method thereof
Technical field
The present invention relates to Chinese medicine field, particularly relate to Folium Callicarpae Formosanae injection of a kind of use of stopping blooding and preparation method thereof.
Background technology
Hemorrhage main finger erythrocyte is overflowed from blood vessel or heart.It is internal hemorrhage that the blood of overflowing enters in body cavity and tissue, and flowing out to external is external haemorrhage.The mechanism of overflowing by blood can hemorrhagely be divided into hemorrhage two kinds of rhexis hemorrhage and spilling property: 1, rhexis hemorrhage be by heart or blood vessel wall, broken due to, break and can betide heart, also can betide tremulous pulse, its origin cause of formation both can be the pathological changes of arterial wall itself, also can corrode arterial wall because of the other pathological changes of tremulous pulse.The hemorrhage reason of phleborrhexis is except wound, and when more common example is hepatitis interstitialis chronica, esophageal varicosis breaks.The rhexis hemorrhage of blood capillary betides the damage of local soft tissue.2, spilling property is hemorrhage is that Vascular Permeability due to blood capillary posterior vein, blood capillary and blood capillary prerolandic artery Rolando increases, and blood spills outside tube chamber by the endotheliocyte gap that expands and impaired basement membrane of blood vessel.
Human body has hemostatic function, slowly a small amount of hemorrhage, how can stop blooding voluntarily, mainly due to Local Damaged blood vessel generation reflexive, shrink, or vascular injury place platelet aggregation forms blood clot through coagulation process, stop continue hemorrhage, local organization or endoceliac blood, can eliminate by absorption or machine, larger absorption of hematoma not exclusively can machine or fibers encapsulation.Amount of bleeding, hemorrhage speed and bleeding part are depended in the hemorrhage impact on body.The hemorrhage process of spilling property is slower, and amount of bleeding is less, can not lead to grave consequences.But as hemorrhage in spilling property when extensive, the spilling property of popularity gastrointestinal mucosa occurring because of portal hypertension during as hepatitis interstitialis chronica is hemorrhage, can be because of the hemorrhage hemorrhagic shock that causes of volume for the moment.The hemorrhage process of rhexis hemorrhage is rapid, when lost at short notice the 20%-25% of circulation volume, hemorrhagic shock can occur.Occur in the hemorrhage of vitals, even if amount of bleeding is few, also can be fatal, as rupture of heart causes pericardium internal hemorrhage, due to pericardial tamponade, can cause acute cardiac insufficiency; Cerebral hemorrhage, especially hemorrhage of brain stem, can be lethal because of important nerve centre pressurized.Local is hemorrhage, can cause corresponding dysfunction, causes contralateral limbs hemiplegia as internal capsule of brain is hemorrhage, and retinal hemorrhage causes visual deterioration or blind.Chronic hemorrhage can cause anemia.
Work in daily life, between field, while working and child just practiced step section, collided with unavoidably, knife injury and hemorrhage, hemorrhage just must hemostasis, at present small size hemorrhage most popular be to use adhesive bandage hemostasis, but adhesive bandage area is little, run into area a bit large or hemorrhage slightly more, it just cannot use, and on the other hand, used summer, close airtight, easily cause on the contrary infection.Injured lighter in the situation that, can stop by the natural hemostatic mechanism of health hemorrhagely, described mechanism causes blood coagulation to form the grumeleuse that prevents hemorrhage and auxiliary reparation damaged blood vessels.In some cases, can use basic first aid to stop blood flow auxiliary wound healing, as by wound being applied to continuous pressure to stop the blood flow in patient.This makes thrombin to collect and to form the clot that condenses to stop blood flow in wound site.Yet, the wound that this technology is not suitable for serious wound and has a plurality of petechias.Therefore, hemorrhage one of cause of death that is still.Conventionally, the wound causing in these situations is followed and is bled profusely, and majority causes death.Hemorrhage is conventionally with pressed powder or particle form, or exists with liquid form.All these forms is all flowable, thereby they can realize good hemostasis for the common irregular surface of wound provides good contact.Yet the flowable matter of liquid particulate hemostatic agents also makes them relatively be difficult in use control, and flowable hemorrhage is retained in and need to stops the wound site of blood flow to have certain problem.
At present, treating hemorrhage medicine also has a lot, for the problems referred to above, the patent documentation of publication number 102860852A (application number 201210410531.9) discloses a kind of hemostasis device, the device that relates to surgical hemostasis, be particularly related to a kind of device of hemostasis by compression, comprise fixture and hemostasis part, described hemostasis part is fixedly connected with fixture surface, described fixture is the surperficial resilient sheet-like fabric that is provided with adhesive coating, fixture shape and wound surrounding skin form fit, described hemostasis part is that column is cotton.The patent documentation of publication number 102614048A (application number 201210021539.6) discloses a kind of hemostatic plaster, relates to a kind of method of perform the operation paster and this operation paster of use.Relate in particular to hemostatic plaster.Described operation paster comprise have substrate main body, divide longitudinal slot of at least part of described main body equally and at least one additional slot of the restriction expansible section that extends from described longitudinal slot.Can be by operation paster of the present disclosure for for example providing hemostasis at anastomotic position.The disclosure also provides the external member that comprises this operation paster and model, and described model can make people that described paster is cut out to required size and shape.Publication number 102802683A(application number 201080026527.1) patent discloses a kind of sthptic sponge, a kind of hemostasis cellular sponge is provided, this hemostasis mandruka comprises fibroid biomaterial matrix and adheres to the granule of the granular materials of described host material and fluid-absorbing, and the preparation method and they purposes for wound healing of these sponges are provided.
The prior art that comprises above-mentioned patent documentation also comes with some shortcomings, and much all just tries out hemorrhage on a small quantity in part, and in summer, also easily causes and excite infection as adhesive bandage etc., and hemostatic healing efficacy is undesirable.
Summary of the invention
For the deficiencies in the prior art, one of object of the present invention is to provide a kind of Folium Callicarpae Formosanae injection of the use of stopping blooding, and adopts comparatively common in the localities Chinese crude drug as raw material, with low cost.There is the effect of hemostasis, detumescence, dissipating blood stasis, removing dampness, anti-inflammation and sterilization, can at short notice blood be stopped, effectively protect wound, make the unlikely secondary infection of wound.Another object of the present invention is just to provide the preparation method of above-mentioned Folium Callicarpae Formosanae injection.
Above-mentioned purpose of the present invention is achieved through the following technical solutions:
The Folium Callicarpae Formosanae injection of hemostasis use, the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 12-20g.
The Folium Callicarpae Formosanae injection of hemostasis use, preferably scheme is, the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 14-18g.
The Folium Callicarpae Formosanae injection of hemostasis use, the scheme being more preferably is, the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 16g.
The preparation method of the Folium Callicarpae Formosanae injection of above-mentioned hemostasis use, preparation process is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1-2 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH2-3, refrigerator is placed 1-2 days, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5-7.0, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, and uses glass funnel fine straining, is sub-packed in 2 milliliters or 10 milliliters of ampoules, sterilizing 30 minutes.
According to preparation method recited above: the preferred Callicarpa nudiflora of Folium Callicarpae Formosanae, Callicarpa lobo-apiculata Metc. or the Folium Callicarpae Macrophyllae described in step (1).
According to preparation method recited above: step (1) is concentrated into the thick paste that relative density is 1.2-1.4 (preferably, be concentrated into relative density and be 1.3 thick paste).
According to preparation method recited above: step (1) adds and is equivalent to Folium Callicarpae Formosanae coarse powder quality 4-6 ethanol (preferably, adding the ethanol that is equivalent to 5 times of Folium Callicarpae Formosanae coarse powder quality) doubly.
According to preparation method recited above: the charcoal treatment (preferably, the charcoal treatment with 0.2%) of 0.1%-0.3% for step (3).
According to preparation method recited above: step (3) sterilizing at 80 ℃-120 ℃ (preferably, sterilizing at 100 ℃).
Using method: intramuscular injection, a 2-4ml; Intravenous drip, a 20-40ml, with application after 5% glucose injection 250-500ml dilution.
The pharmacological effect of each crude drug is respectively:
Folium Callicarpae Formosanae: acrid in the mouth, hardship, property is flat.Return liver, spleen, stomach warp.There is dissipating blood stasis hemostasis, the effect of reducing swelling and alleviating pain.Leaves contains a kind of hemostatic compositions that is referred to as flavonoid condensed tannin, so have the effect of hemostasis, dissipating blood stasis, antiinflammatory.With the formulated injection of Folium Callicarpae Formosanae extract, the hemorrhage and postoperative hemorrhage of otch while can be used for treating gastrointestinal hemorrhage, surgical operation.Leaf is mainly used in spitting blood, spitting of blood, and epistaxis, has blood in stool; External curing traumatic hemorrhage.Root is mainly used in treating swelling and pain by traumatic injury, rheumatic ostalgia.Can astringing to arrest bleeding, again can cooling blood for hemostasis, be applicable to various interior traumatic hemorrhage, be especially used for lung gastrorrhagia.Folium Callicarpae Formosanae, except having anastalsis, still has good anti-anti-infectious function and astriction, tries out in burning, scald texts also better.The acidity of Folium Callicarpae Formosanae aqueous solution is not tolerant is invalid components, therefore pH modulation 2-3 removes it.Liquor callicarpae pH value all has a certain impact to clarity of solution and result of use, regulates according to observations pH value 6.5-7, preserves 1 year left and right haemostatic effect constant.
Water for injection: refer to meet the water of stipulating under Chinese Pharmacopoeia water for injection item.Water for injection is that distilled water or deionization are through the water of distillation gained, therefore the distilled water of weighing again.For colourless clear liquid, odorless, tasteless.PH value should be 5.0-7.0, chloride, sulfate and calcium salt, nitrate and nitrous are vinegar-pepper salt, ammonia, carbon dioxide, readily oxidizable substance, non-volatile matter, heavy metal and bacterial endotoxin.
The stop blooding Folium Callicarpae Formosanae injection of use of the present invention has the effect of hemostasis, detumescence, dissipating blood stasis, removing dampness, anti-inflammation and sterilization, can at short notice blood be stopped, and effectively protects wound, makes the unlikely secondary infection of wound, is not subject to the restriction of wound area size.Be applicable to hemostasis, be especially applicable to stop excessive hemorrhage.The Folium Callicarpae Formosanae injection of hemostasis use can be suitably for application below, such as: have tooth pulled out and pull out molar, the surgical operation of abdominal part, ear, nose or larynx, and operation of opening cranium and the jaw face art of general surgery, local organs excision, tumorectomy, skull.
Technical advantage of the present invention is also embodied in:
1, selected materials is Chinese medicine material, has no side effect;
2, medicine source is easy to get, and medical material is with low cost, can relieve patient ' s burden.
Accompanying drawing explanation
Fig. 1 is used bleeding design sketch after the Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use;
Fig. 2 is used appetite recovery situation design sketch after the Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use.
The specific embodiment
Below in conjunction with embodiment and experimental example, describe technical scheme of the present invention in detail, but protection domain is not by this restriction.
embodiment 1the preparation process of the Folium Callicarpae Formosanae injection of hemostasis use is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH2, refrigerator is placed 1 day, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, the main component of the every 100ml Folium Callicarpae Formosanae of the Folium Callicarpae Formosanae injection injection of the hemostasis use of control gained: Folium Callicarpae Formosanae water extract 12g, use glass funnel fine straining, be sub-packed in 10 milliliters of ampoules, sterilizing 30 minutes.
Using method: intravenous drip, a 20-40ml, with application after 5% glucose injection 250-500ml dilution.
embodiment 2the preparation process of the Folium Callicarpae Formosanae injection of hemostasis use is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH3, refrigerator is placed 2 days, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, the main component of the every 100ml Folium Callicarpae Formosanae of the Folium Callicarpae Formosanae injection injection of the hemostasis use of control gained: Folium Callicarpae Formosanae water extract 20g, use glass funnel fine straining, be sub-packed in 2 milliliters of ampoules, sterilizing 30 minutes.
Using method: intramuscular injection, a 2-4ml.
model case one:horse XX, man, 38 years old, people from Dongguan City, Guangdong Province.The horse master worker of 43 years old has driven a taxi 9 years, has for a long time the defect of constipation, finds again just middle band blood the year before last, obtains hemorrhoid, and during outbreak, blood stasis is deviate from, the swollen Fructus Vitis viniferae of picture that to obtain.Dare not dare not sit on foot, sleep all obtains on all fours and sleeps, and has said nothing of out car.Go to toilet especially as putting to torture, original hemorrhoid are pain just, constipation for many years, and more than 20 minute, last lavatory, the image-stone head of hard stool, not only dry but also slow, from hemorrhoid, streak, as lancinate, ache get Ma master worker and directly tremble.Listen friend to say that hemorrhoid operation is very painful, even and if also slice off and can recur, also may there is the sequela such as anal stenosis, fecal incontinence, so do not dare to go to the hospital always.Oneself bought many ointment, medicine is fastened, and is all much to get better at that time, drive several overhead traveling cranes and just violated again.Final or in hospital of anorectal section, done hemorrhoid and eradicated art, perform the operation very successful, just with excessive hemorrhage.
Hospital is used the Folium Callicarpae Formosanae injection of embodiment 2 gained hemostasis use to Mr. Ma, operation intramuscular injection on the same day 2 times, and each 4ml, the same day, bleeding obviously alleviated.For prevent continue hemorrhage may, doctor selects to continue the Folium Callicarpae Formosanae injection 1 day of intramuscular injection embodiment 2 gained hemostasis use, each 2ml, one day 2 times.Bleeding is inhibited, and does not find bleeding again, and so far, Mr. Ma also can leave hospital smoothly.
embodiment 3the preparation process of the Folium Callicarpae Formosanae injection of hemostasis use is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH2, refrigerator is placed 1 day, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, the main component of the every 100ml Folium Callicarpae Formosanae of the Folium Callicarpae Formosanae injection injection of the hemostasis use of control gained: Folium Callicarpae Formosanae water extract 14g, use glass funnel fine straining, be sub-packed in 2 milliliters of ampoules, sterilizing 30 minutes.
Using method: intramuscular injection, a 2-4ml.
embodiment 4the preparation process of the Folium Callicarpae Formosanae injection of hemostasis use is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH3, refrigerator is placed 2 days, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, the main component of the every 100ml Folium Callicarpae Formosanae of the Folium Callicarpae Formosanae injection injection of the hemostasis use of control gained: Folium Callicarpae Formosanae water extract 18g, use glass funnel fine straining, be sub-packed in 10 milliliters of ampoules, sterilizing 30 minutes.
Using method: intravenous drip, a 20-40ml, with application after 5% glucose injection 250-500ml dilution.
model case two:high XX, female, 48 years old, people from Guangzhou, Guangdong.The stumble on enclosed mass of the outside upper quadrant one 2cm*1cm size of left breast of patient, does not give attention.After one week, get hospital admission, mammary gland B ultrasonic shows: the outside upper quadrant one 2.3cm*1.2cm low echo area of left breast, and border is clear, form rule, galactocele possibility, fibroadenoma is not got rid of.Suggestion excision.Bilateral body of gland is medium cotton-shaped echo, thick about 1.7cm, and hierarchical structure is owed clearly, the outside upper spy of left breast and a tubulose liquid dark space, the about 3mm of caliber, and the outside upper spy of left breast and the low echo of a 2.1cm*1.4cm, be inside shown in part liquid dark space, border motif rule, remaining feminine gender.Mammary gland is infrared to be shown: bilateral breast hypertrophy; The outside upper real property lump companion cystis degeneration's (mostly being optimum) of left breast.Training checks: two breasts are symmetrical, have no red swelling of the skin, and the outside upper quadrant of left breast can touch the enclosed mass of a 2.0cm*1.0cm, in matter, and clear border, mobility can.Bilateral nipple has no on discharge bilateral axillary regions and clavicle and does not touch enlarged lymph node.After making a definite diagnosis, Mrs Gao determines operation.
After making a definite diagnosis, implement operation under the state of general anesthesia, operation must mean can be hemorrhage, in implementing the process of operation, doctor selects the Folium Callicarpae Formosanae injection 40ml of intravenous drip embodiment 4 gained hemostasis use, and with using after 5% glucose injection 300ml dilution, in operation process, amount of bleeding is few.After operation, continued to use the Folium Callicarpae Formosanae injection 40ml of embodiment 4 gained hemostasis use the same day, with using after 5% glucose injection 400ml dilution, substantially there is no obvious bleeding.
embodiment 5the preparation process of the Folium Callicarpae Formosanae injection of hemostasis use is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH3, refrigerator is placed 2 days, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, the main component of the every 100ml Folium Callicarpae Formosanae of the Folium Callicarpae Formosanae injection injection of the hemostasis use of control gained: Folium Callicarpae Formosanae water extract 16g, use glass funnel fine straining, be sub-packed in 10 milliliters of ampoules, sterilizing 30 minutes.
Using method: intravenous drip, a 20-40ml, with application after 5% glucose injection 250-500ml dilution.
test example:in order to verify the Folium Callicarpae Formosanae injection of the hemostasis use of embodiment 5 gained, we have carried out contrast test.Patient 200 people (wherein puerpera 100 people, other patient with operation 100 people) are selected in experiment, and every type is divided into matched group and experimental group randomly, and every group number is identical, is respectively 100 people (being respectively puerpera 50 people, other patient with operation 50 people).With observation post administration, record patient's health bleeding.Experimental group: the Folium Callicarpae Formosanae injection of intravenous drip embodiment 5 gained hemostasis use, a 40ml, with 5% glucose injection 300ml dilution.Matched group: adopt other treatment scheme, such as the mode with apparatus hemostasis.Criterion of therapeutical effect wherein: cure: operation bleeding on the same day is well controlled; Effective: operation bleeding on the same day obviously alleviates, but also has certain bleeding; Invalid: operation bleeding on the same day does not have controlled substantially, there is again the phenomenon of bleeding profusely in large or later stage of amount of bleeding.Wherein effectively comprise healing and effective.
Observe 15 days time limits, observed content is as follows:
1, postoperative 1-15 days, adheres to observing and recording patient's amount of bleeding every day, counts average bleeding, and result is as accompanying drawing 1:
Analyze: from accompanying drawing 1, can find out, the haemostatic effect of the Folium Callicarpae Formosanae injection of use embodiment 5 gained hemostasis use is better, and anthemorrhagic speed is faster, in 1 day, substantially can stop blooding completely.And during 10-15 days, using the average bleeding of the Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use is 0, and adopt the average bleeding of the matched group of other treatment scheme, be 50ml, can obviously find out, the Folium Callicarpae Formosanae injection later stage of using embodiment 5 gained hemostasis use, hemorrhage probability was minimum again.
2, observe postoperative appetite situation in each group every day, in 15 days after surgery, get 3 with meal (being respectively the 5th day lunch, the 10th day lunch, and the lunch of the 15th day) to them postoperative appetite recovery situation statistics record, result is as accompanying drawing 2:
Analyze: from accompanying drawing 2, can find out, the Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use can anorexigenic patient recover its appetite within the shorter time of taking medicine, for patient's continuation rehabilitation and the absorption of nutrition are laid a good foundation.
3, the Comparison of therapeutic that adopts the experimental group of the matched group of other treatment scheme and the Folium Callicarpae Formosanae injection of use embodiment 5 gained hemostasis use, result is as shown in table 1:
Table 1
efficacy analysis:as can be seen from Table 1, use the embodiment of the present invention 5 gained hemostasis use Folium Callicarpae Formosanae injection there is no an invalid example, and adopt the matched group of other treatment scheme to have 3 people invalid, bleeding, especially bleed profusely and be easy to cause shock or even loss of life, so 3% inefficiency exists certain risk.And using the cure rate of Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use up to 94%, total effective rate has reached 100%, and adopts the cure rate of the matched group of other treatment scheme only to reach 72%.Experiment shows to use the experimental group of the Folium Callicarpae Formosanae injection of embodiment 5 gained hemostasis use to compare with adopting the matched group of other treatment scheme, its better efficacy, and cure rate is higher, and inefficiency is low, has reduced potential risks.
By accompanying drawing 1-2, can be found out, use the experimental group of Folium Callicarpae Formosanae injection and the matched group of employing other treatment scheme of embodiment 5 gained hemostasis use in 15 days of observation period, all can reach the object of stopping blooding and improving appetite, but the haemostatic effect of experimental group is better faster, and appetite recovery is also faster.Through clinical trial, prove; the stop blooding Folium Callicarpae Formosanae injection of use of the present invention has the effect of hemostasis, detumescence, dissipating blood stasis, removing dampness, anti-inflammation and sterilization, can at short notice blood be stopped, and effectively protects wound; make the unlikely secondary infection of wound, be not subject to the restriction of wound area size.Be applicable to hemostasis, be especially applicable to stop excessive hemorrhage.The stop blooding Folium Callicarpae Formosanae injection of use of the present invention adopts Chinese medicinal material simple and easy to get as raw material, and instant effect, and without any side effects reaches the effect of quick-acting haemostatic powder.
Finally it should be noted that, embodiment is the specific embodiment of optimum of the present invention, be not limited to the present invention, although the present invention is had been described in detail with reference to previous embodiment, for a person skilled in the art, its technical scheme that still can record aforementioned each embodiment is modified, or part technical characterictic is wherein equal to replacement.Within the spirit and principles in the present invention all, any modification of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.

Claims (10)

1. the Folium Callicarpae Formosanae injection of hemostasis use, is characterized in that the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 12-20g.
2. Folium Callicarpae Formosanae injection according to claim 1, is characterized in that, the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 14-18g.
3. Folium Callicarpae Formosanae injection according to claim 1, is characterized in that, the main component of every 100ml Folium Callicarpae Formosanae injection: Folium Callicarpae Formosanae water extract 16g.
4. according to the preparation method of the arbitrary described Folium Callicarpae Formosanae injection of claim 1-3, it is characterized in that, step is as follows:
(1) get Folium Callicarpae Formosanae coarse powder, water extraction twice is boiled 1-2 hour at every turn, and twice filtrate merges, and is concentrated into thick paste shape, add ethanol, fully stir, washing, puts on cloth formula funnel separated, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtains rough water extract dry powder;
(2) get the rough dry powder of step (1) gained, add a small amount of water for injection and dissolve, the hydrochloric acid that adds 2N is adjusted pH2-3, refrigerator is placed 1-2 days, makes its precipitation coarse filtration, removes precipitate, filtrate is used after active carbon layer filtering again, adds the sodium hydroxide of 2N, adjusts pH6.5-7.0, be condensed into thick paste shape, add 4 times of amount ethanol fully to wash, discard ethanol mother solution, precipitation, 60 ℃ of following being dried, obtain light brown powder stand-by;
(3) get the powder after refining, by recipe quantity, add water for injection to dissolve, adjust pH to 6.5, by charcoal treatment once, suction strainer, adds to the full amount of water for injection, and uses glass funnel fine straining, is sub-packed in 2 milliliters or 10 milliliters of ampoules, sterilizing 30 minutes.
5. the preparation method of Folium Callicarpae Formosanae injection according to claim 4, is characterized in that: the preferred Callicarpa nudiflora of Folium Callicarpae Formosanae, Callicarpa lobo-apiculata Metc. or the Folium Callicarpae Macrophyllae described in step (1).
6. the preparation method of Folium Callicarpae Formosanae injection according to claim 4, is characterized in that: step (1) is concentrated into the thick paste that relative density is 1.2-1.4 (preferably, be concentrated into relative density and be 1.3 thick paste).
7. the preparation method of Folium Callicarpae Formosanae injection according to claim 4, is characterized in that: step (1) adds and is equivalent to Folium Callicarpae Formosanae coarse powder quality 4-6 ethanol (preferably, adding the ethanol that is equivalent to 5 times of Folium Callicarpae Formosanae coarse powder quality) doubly.
8. the preparation method of Folium Callicarpae Formosanae injection according to claim 4, is characterized in that: the charcoal treatment (preferably, the charcoal treatment with 0.2%) of 0.1%-0.3% for step (3).
9. the preparation method of Folium Callicarpae Formosanae injection according to claim 4, is characterized in that: step (3) sterilizing at 80 ℃-120 ℃ (preferably, sterilizing at 100 ℃).
10. the application of the Folium Callicarpae Formosanae injection as described in as arbitrary in claim 1-3 when the medicine for the preparation of hemostasis.
CN201410394632.0A 2014-08-13 2014-08-13 Hemostatic folium callicarpae pedunculalae injection and preparation method thereof Pending CN104116852A (en)

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