CN103656417B - For preventing the Chinese medicine preparation of hip replacement deep vein thrombosis of lower extremity - Google Patents

For preventing the Chinese medicine preparation of hip replacement deep vein thrombosis of lower extremity Download PDF

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CN103656417B
CN103656417B CN201310683732.0A CN201310683732A CN103656417B CN 103656417 B CN103656417 B CN 103656417B CN 201310683732 A CN201310683732 A CN 201310683732A CN 103656417 B CN103656417 B CN 103656417B
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radix
chinese medicine
ethanol
medicine preparation
rhizoma
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CN103656417A (en
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丁飞
王静
牟雪梅
张治成
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Abstract

The invention provides a kind of Chinese medicine preparation preventing hip replacement deep vein thrombosis of lower extremity, its crude drug comprises: Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Poria, Radix Notoginseng, Radix Clematidis, Radix Bupleuri, Ramulus Cinnamomi, Rhizoma Dioscoreae, Radix Pseudostellariae, Radix Campanumoeae, Rhizoma Kaempferiae, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan, Semen Vaccariae and Fructus Corni.This Chinese medicine preparation has effect of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, and preventive effect is obvious, and security performance is high, is a kind of orthopaedics postoperative of clinic promotion and application.

Description

For preventing the Chinese medicine preparation of hip replacement deep vein thrombosis of lower extremity
Technical field
The present invention relates to technical field of Chinese medicine, particularly relating to a kind of for preventing the Chinese medicine preparation of hip replacement deep vein thrombosis of lower extremity.
Background technology
Along with the continuous maturation of hip replacement, it becomes the primary means of the femur diseases such as clinical treatment fracture of femoral neck, femur head necrosis and osteoarthritis day by day, and is accepted by patient and numerous medical personnels gradually and promote.But the formation of Postoperative Lower Deep Venous Thrombosis has a strong impact on the rehabilitation of patient, even jeopardizes the life of patient.At present, the report of hip replacement formation deep vein thrombosis of lower extremity more and more causes the concern of people.
Thrombotic mechanism mainly contains the following aspects: operation itself is a kind of wound, causes the artificial destruction of tissue in operation, and tissue factor discharges, and activates exogenous cruor pathway.The effect of blood vessel injury in venous thrombosis may be the main mechanism of bone surgery venous thrombosis; The hypercoagulability of blood.After operation or wound, the haematogenous mechanism of human body is abnormal, and platelet and thrombin in blood are increased, and blood is in hypercoagulability, makes it to be easy to condensation, for the formation of thrombosis creates condition, becomes the basis that thrombosis occurs; Limb brake, bed, for a long time positive position cause blood flow slow, create condition for thrombosis; Long limbs do not move, and make musculation impel the pumping action of blood quick backflow heart to disappear, and add the chance that thrombosis occurs.For this reason, by Anticoagulation thrombolytic, improve the measure such as microcirculation prevention and improve deep vein thrombosis of lower extremity and seem particularly important.
Tradition prevention hip replacement deep vein thrombosis of lower extremity adopts Low molecular heparin to be formed by depolymerized heparin by enzyme or chemical method, there is good thromboembolism preventing effect, stronger to the preventive effect of deep vein thrombosis of lower extremity, without the need to Laboratory Monitoring, easy to use, but easily cause postoperative hemorrhage to be inclined to, though Low molecular heparin prevention lower limb deep vein thrombosis of lower extremity has the curative effect of affirmative, but it is many to there is contraindication, side effect is large, the shortcomings such as patient compliance difference, especially need to cause the risk of epidural hematoma larger when implementing and operate around the nervous system such as epidural anesthesia to operation.
Chinese medicine is thought, artificial hip joint replacing Post operation deep vein thrombosis of lower extremity by damage body void is qi-blood disharmony, passages through which vital energy circulates blocks, QI and blood is condensed or companion's cold-damp stasis of blood stagnant caused by.Fracture, operation cause limbs injured, and QI and blood is disorderly inverse, stagnation of blood stasis, stagnation of QI and blood may bring about pain, therefore sees suffering limb edema, pain.Most scholars is thought, it is the basic pathogenesis of primary disease that blood stasis hinders in venation, and treatment is when based on blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of for preventing the Chinese medicine preparation of hip replacement deep vein thrombosis of lower extremity, it has effect of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, preventive effect is obvious, and security performance is high, is a kind of orthopaedics postoperative of clinic promotion and application.
For solving the problems of the technologies described above, the invention provides a kind of Chinese medicine preparation preventing hip replacement deep vein thrombosis of lower extremity, its crude drug comprises: Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Poria, Radix Notoginseng, Radix Clematidis, Radix Bupleuri, Ramulus Cinnamomi, Rhizoma Dioscoreae, Radix Pseudostellariae, Radix Campanumoeae, Rhizoma Kaempferiae, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan, Semen Vaccariae and Fructus Corni.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 50g ~ 60g, Fructus Jujubae 35g ~ 45g, Herba Selaginellae 15g ~ 25g, Stigma Croci 20g ~ 30g, Poria 25g ~ 35g, Radix Notoginseng 35g ~ 45g, Radix Clematidis 15g ~ 25g, Radix Bupleuri 20g ~ 30g, Ramulus Cinnamomi 15g ~ 25g, Rhizoma Dioscoreae 30g ~ 40g, Radix Pseudostellariae 45g ~ 55g, Radix Campanumoeae 25g ~ 35g, Rhizoma Kaempferiae 10g ~ 20g, Radix et Rhizoma Rhei Franzenbachii 20g ~ 30g, Radix Flemingiae Philippinensis 25g ~ 35g, Radix Stellariae Yunnanensis 15g ~ 25g, GUANGXIANG rattan 35g ~ 45g, Semen Vaccariae 20g ~ 30g and Fructus Corni 35g ~ 45g.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g ~ 60g, Fructus Jujubae 40g ~ 45g, Herba Selaginellae 20g ~ 25g, Stigma Croci 25g ~ 30g, Poria 25g ~ 30g, Radix Notoginseng 40g ~ 45g, Radix Clematidis 15g ~ 20g, Radix Bupleuri 20g ~ 25g, Ramulus Cinnamomi 15g ~ 20g, Rhizoma Dioscoreae 35g ~ 40g, Radix Pseudostellariae 50g ~ 55g, Radix Campanumoeae 30g ~ 35g, Rhizoma Kaempferiae 10g ~ 15g, Radix et Rhizoma Rhei Franzenbachii 25g ~ 30g, Radix Flemingiae Philippinensis 30g ~ 35g, Radix Stellariae Yunnanensis 20g ~ 25g, GUANGXIANG rattan 40g ~ 45g, Semen Vaccariae 25g ~ 30g and Fructus Corni 40g ~ 45g.
Wherein, in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g, Fructus Jujubae 40g, Herba Selaginellae 20g, Stigma Croci 25g, Poria 30g, Radix Notoginseng 40g, Radix Clematidis 20g, Radix Bupleuri 25g, Ramulus Cinnamomi 20g, Rhizoma Dioscoreae 35g, Radix Pseudostellariae 50g, Radix Campanumoeae 30g, Rhizoma Kaempferiae 15g, Radix et Rhizoma Rhei Franzenbachii 25g, Radix Flemingiae Philippinensis 30g, Radix Stellariae Yunnanensis 20g, GUANGXIANG rattan 40g, Semen Vaccariae 25g and Fructus Corni 40g.
Wherein, described Chinese medicine preparation is interior preparation.
Wherein, described Chinese medicine preparation is interior preparation is oral liquid and granule.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine preparation is oral liquid, be specially:
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, the relative density of described clear paste is 1.18 (65 DEG C),
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, in the powder that second step obtains, add the distilled water relative to its quality 3 ~ 4 times amount, the sucrose of 0.05 ~ 0.1 times, the sodium benzoate of 0.01 ~ 0.02 times, stir, boil, cooling, filter, subpackage, namely sterilizing obtains oral liquid.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine preparation is granule, be specially:
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, the relative density of described clear paste is 1.18 (65 DEG C),
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, adds cane sugar powder 1500g by the powder 400g that second step obtains, and mixing, makes dry granule 1600g, be distributed into every bag of 8g.
Beneficial effect of the present invention:
Chinese medicine preparation provided by the invention, it has effect of blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain, and prevention hip replacement deep vein thrombosis of lower extremity successful, security performance is high, is a kind of orthopaedics postoperative of clinic promotion and application.
Detailed description of the invention
Primary disease belongs to the category such as the traditional Chinese medical science " stock swells ", " BI-syndrome involved the blood vessels ", " blood stasis ", " multiple abscess due to blood stasis ", " swelling ".Mainly because the gasification function of blood is lacked of proper care, defended and delay among passages through which vital energy circulates, cause passages through which vital energy circulates stop up hold back obstructed or because of wind-cold damp pathogen, damage through and BI-syndrome involved the blood vessels blood clotting, to block caused by sering, damage or body empty, qi-blood disharmony, passages through which vital energy circulates blocks, and QI and blood is condensed or accompanied the cold-damp stasis of blood stagnant is its cause of disease.The traditional Chinese medical science think this card be because long-term bed or sitting motionless and cause blood stasis and hinder in YIN pulse, numbness obstructed, and nutrient blood is driven in the wrong direction, and backflow obstruction, water Tianjin is excessive and cause.Pathological change based on the stasis of blood, wet, treat based on blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain.
Based on above-mentioned theory of Chinese medical science, the invention provides a kind of Chinese medicine preparation preventing hip replacement deep vein thrombosis of lower extremity, its crude drug comprises: Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Poria, Radix Notoginseng, Radix Clematidis, Radix Bupleuri, Ramulus Cinnamomi, Rhizoma Dioscoreae, Radix Pseudostellariae, Radix Campanumoeae, Rhizoma Kaempferiae, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan, Semen Vaccariae and Fructus Corni.
Further, described Chinese medicine preparation is only made up of above-mentioned raw materials medicine.
Described Chinese medicine preparation is interior preparation, preferably makes oral liquid and granule.
In described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 50g ~ 60g, Fructus Jujubae 35g ~ 45g, Herba Selaginellae 15g ~ 25g, Stigma Croci 20g ~ 30g, Poria 25g ~ 35g, Radix Notoginseng 35g ~ 45g, Radix Clematidis 15g ~ 25g, Radix Bupleuri 20g ~ 30g, Ramulus Cinnamomi 15g ~ 25g, Rhizoma Dioscoreae 30g ~ 40g, Radix Pseudostellariae 45g ~ 55g, Radix Campanumoeae 25g ~ 35g, Rhizoma Kaempferiae 10g ~ 20g, Radix et Rhizoma Rhei Franzenbachii 20g ~ 30g, Radix Flemingiae Philippinensis 25g ~ 35g, Radix Stellariae Yunnanensis 15g ~ 25g, GUANGXIANG rattan 35g ~ 45g, Semen Vaccariae 20g ~ 30g and Fructus Corni 35g ~ 45g.
Further, in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g ~ 60g, Fructus Jujubae 40g ~ 45g, Herba Selaginellae 20g ~ 25g, Stigma Croci 25g ~ 30g, Poria 25g ~ 30g, Radix Notoginseng 40g ~ 45g, Radix Clematidis 15g ~ 20g, Radix Bupleuri 20g ~ 25g, Ramulus Cinnamomi 15g ~ 20g, Rhizoma Dioscoreae 35g ~ 40g, Radix Pseudostellariae 50g ~ 55g, Radix Campanumoeae 30g ~ 35g, Rhizoma Kaempferiae 10g ~ 15g, Radix et Rhizoma Rhei Franzenbachii 25g ~ 30g, Radix Flemingiae Philippinensis 30g ~ 35g, Radix Stellariae Yunnanensis 20g ~ 25g, GUANGXIANG rattan 40g ~ 45g, Semen Vaccariae 25g ~ 30g and Fructus Corni 40g ~ 45g.
Most preferably, in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g, Fructus Jujubae 40g, Herba Selaginellae 20g, Stigma Croci 25g, Poria 30g, Radix Notoginseng 40g, Radix Clematidis 20g, Radix Bupleuri 25g, Ramulus Cinnamomi 20g, Rhizoma Dioscoreae 35g, Radix Pseudostellariae 50g, Radix Campanumoeae 30g, Rhizoma Kaempferiae 15g, Radix et Rhizoma Rhei Franzenbachii 25g, Radix Flemingiae Philippinensis 30g, Radix Stellariae Yunnanensis 20g, GUANGXIANG rattan 40g, Semen Vaccariae 25g and Fructus Corni 40g.
Fang Zhong, Radix Angelicae Sinensis promoting blood circulation and stopping pain, for damaging rear blood stasis, the key medicine of pain, Fructus Jujubae is enriched blood and is invigorated blood circulation, control all cards of blood deficiency, Herba Selaginellae promoting the circulation of blood blood stasis dispelling, Stigma Croci promoting blood circulation to remove blood stasis, Herba Selaginellae, Stigma Croci all has stronger anticoagulation, anti thrombotic action, Poria is inducing diuresis and reducing edema, Radix Notoginseng has the two-way regulating function of hemostasis and blood circulation promoting and blood stasis dispelling, blood can be improved dense, glutinous, poly-, solidifying state, Radix Clematidis can improve high blood coagulation tendency, inhibition thrombosis, Radix Bupleuri benefiting QI for activating blood circulation, Ramulus Cinnamomi promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, Chinese yam spleen-strengtheningporridge dehumidifying detumescence, Radix Pseudostellariae benefiting qi and raising yang, inducing diuresis to remove edema, dredging collateral granulation promoting, RBC number can be increased, raise hematocrit value, total serum protein and albumin are reduced and has rise effect, vascular endothelial injury can be repaired, Radix Campanumoeae invigorating the spleen and benefiting QI, Rhizoma Kaempferiae pain relieving, Radix et Rhizoma Rhei Franzenbachii blood circulation promoting competent silt, Radix Flemingiae Philippinensis blood stasis dispelling detoxifies, Radix Stellariae Yunnanensis strengthening spleen and nourishing blood, tonifying liver is subsided a swelling, GUANGXIANG rattan blood circulation promoting and blood stasis dispelling, Semen Vaccariae promoting blood circulation to restore menstrual flow, Fructus Corni liver and kidney tonifying, all medicines share, have and improve microcirculation, blood vessel dilating, accelerate blood flow rate, blood viscosity is declined, suppress the effect of platelet aggregation, early postoperation is due to stagnation of QI-blood, venous blood flow slowly and blood be in hypercoagulability, it is the basis causing deep vein thrombosis of lower extremity.Start in 24h after surgery to get involved with Chinese medicine preparation provided by the invention, by blood-activating and qi-promoting, accelerate blood circulation, promote venous blood flow, block the generation due to the slow deep vein thrombosis of lower extremity of venous blood flow.
Each crude drug pharmacology is as follows:
Radix Angelicae Sinensis: latin name angelicaesinensisradix, sweet in the mouth, pungent, warm in nature, enter liver, the heart, spleen channel, enrich blood and invigorate blood circulation, menstruction regulating and pain relieving, the effect of loosening bowel to relieve constipation, be mainly used in having a dizzy spell of deficiency of heart-blood, fatigue and weakness, shortness of breath and palpitation, and other syndrome of deficiency of blood; The sea of blood is hollow, the menoxenia of the cold and deficiency of CHONG and REN meridians or congestion retardance, dysmenorrhoea, produces or suffers from abdominal pain, and other blood stasis are had a pain and the symptom such as the constipation of deficiency of YIN insufficiency of blood dryness of the intestine.
Fructus Jujubae: latin name jujubaefructus, sweet in the mouth, slightly warm in nature, have invigorating the spleen and replenishing QI, effect of nourishing blood to tranquillize the mind, returns spleen, stomach warp, cure mainly weakness of the spleen and stomach, deficiency of QI in middle-JIAO, fatigue and lack of strength, anorexia and loose stool; Blood deficiency fistula is yellow, become thin, or women is dirty dry, and spirit is uneasy waits card.
Herba Selaginellae: latin name SelaginellaeHerba, be the dry herb of Spikemoss plant Herba Selaginellae or Selaginella pulvinata, acrid in the mouth, property is put down, and returns liver, heart channel, has effect of promoting blood circulation to restore menstrual flow.For amenorrhea dysmenorrhea , WEIJIA mass in the abdomen, injury from falling down, spit blood, metrorrhagia, has blood in stool, the cards such as proctoptosis.
Stigma Croci: latin name TamaricisCacumen, the delicate branch and leaf of the drying for Cacumen Tamaricis section plant Cacumen Tamaricis, sweet in the mouth, property is put down, energy blood circulation promoting and blood stasis dispelling, dispersing stagnation and relieving accumulation of pathogens, pain relieving.Be used for the treatment of troubled thoughts pent-up, chest and diaphragm painful abdominal mass is vexed, and spit blood, typhoid fever is gone mad, and frightened fear in a trance, women's amenorrhea, stasis menoxenia, prolonged lochia, blood stasis is had a pain, measles, the cards such as traumatic injury.
Poria: sweet in the mouth, light, property is put down, and enters spleen, lung, bladder, heart channel, has the effect of eliminating dampness and diuresis, spleen invigorating mind calming, be mainly used in the edema of retention of water-damp, dysuria; The pyretic stranguria of damp-heat accumulation, the card such as anorexia and loose stool, phlegm retention stagnation, epilepsy of stagnation of dampness due to deficiency of the spleen.
Radix Notoginseng: latin name NotoginsengRadixetRhizoma, for panax araliaceae plant dry root and rhizome warm in nature, sweet in the mouth, micro-hardship, return liver, stomach warp, there is hemostasis, dissipating blood stasis, detumescence, effect of pain relieving, cure mainly haematemesis, hemoptysis, epistaxis, have blood in stool, dysentery, metrorrhagia, lump in the abdomen, puerperal blood faints, retention of lochia, fall and flutter blood stasis, traumatic hemorrhage, the cards such as carbuncle pain.
Radix Clematidis: latin name clematidisradixetrhizoma is acrid in the mouth, salty, warm in nature, slightly poisonous, enter urinary bladder channel, there is expelling wind and removing dampness, removing obstruction in the collateral to relieve pain, expectorant water, effect of the loose hypochondriac lump, cures mainly gout insensitive impediment, rheumatic arthralgia, numb limbs and tense tendons, chills and pain of the waist and kness, the contracture of muscle arteries and veins, joint stuffiness, beriberi, malaria, lump in the abdomen, tetanus, tonsillitis, all a fishbone or other bone caught in the throat pharynxs.
Radix Bupleuri: latin name bupleuriradix, dry root for umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii.: bitter in the mouth, cold nature, returns liver, gallbladder meridian, there is evacuation bring down a fever, effect of yang invigorating soothing liver-QI, cures mainly cold, fever, alternate attack of chill and fever, malaria, stagnation of QI due to depression of the liver, sternal rib pain, proctoptosis, the cards such as uterus comes off, menoxenia.
Ramulus Cinnamomi: latin name cinnamomiramulus, for the dry twig of canella Cortex Cinnamomi: acrid in the mouth, sweet, warm in nature, GUIXIN, lung, urinary bladder channel, there is diaphoresis expelling pathogenic factors from muscles, warming the meridian and promoting blood circulation, supporing yang activating QI, the effect of dispersing cold for relieving pain, Ramulus Cinnamomi warming the meridian and promoting blood circulation, horizontal logical podomere, for affection of exogenous wind-cold exterior syndrome, no matter have antiperspirant, losslessly all can to apply, also for rheumatic arthralgia, cold syndrome of the stomach stomachache, amenorrhea, dysmenorrhea, rheumatic arthralgia, the cards such as shoulder arm podomere cold type of pain, phlegm retention syndrome and bladder water-retention, heart deficiency of spleen-YANG, retention of water-damp in the body, fullness and distention in the chest and hypochondrium, cough with dyspnea dizziness waits phlegm retention syndrome.
Rhizoma Dioscoreae: latin name dioscoreaerhizoma, sweet in the mouth, property are flat, and enter lung, spleen, stomach warp, have spleen reinforcing nourishing the stomach, lung benefiting reinforces the kidney, and the effect of YIN nourishing and the production of body fluid promoting, cures mainly weakness of the spleen and stomach, the lack of appetite poor appetite of dysfunction of the spleen in transportation, the cards such as the vexed diarrhoea of gastral cavity.
Radix Pseudostellariae: sweet in the mouth, micro-hardship, property is put down, and enters spleen, lung meridian, has air making-up and spleen enlivening, the effect of the lung moistening and production of body fluid promoting, for the lack of appetite asthenia of deficiency-weakness of spleen-QI, deficiency of stomach-Yin, energy strengthening the spleen gas, nourishing stomach-YIN, for deficiency of the lung cough caused by dryness and cardiopalmus sleeplessness, the deficiency-heat hyperhidrosis of deficiency of vital energy Tianjin wound, energy supplementing QI for promoting the production of body fluid, controls deficiency of vital energy xeropulmonary cough, the card such as cardiopalmus sleeplessness, hyperhidrosis of deficiency of both QI and YIN.
Radix Campanumoeae: latin name radixcampanumoeajavanicae, sweet in the mouth, property is put down, return lung, spleen channel, be the root of campanulaceae leopard platymiscium Campanumoea javanica and leopard, there is invigorating the spleen and benefiting QI, tonifying the lung and stopping cough, effect of stimulating milk secretion, cure mainly the empty internal injury of labor, the deficiency of vital energy is weak, cardiopalmus, hyperhidrosis, diarrhea due to hypofunction of the spleen, leucorrhea, milk is rare, the cards such as insufficiency of the spleen cough.
Rhizoma Kaempferiae: latin name kaempferiaerhizoma, be the rhizome of Zingiberaceae Kaempferia plant Rhizoma Kaempferiae, warm in nature, acrid in the mouth, returns stomach warp, has warming middle-JIAO, help digestion, and effect of pain relieving cures mainly trusted subordinate's cold type of pain, stops dyspepsia, traumatic injury, toothache, and diet such as not to disappear at the card.
Radix et Rhizoma Rhei Franzenbachii: latin name RadixetRhizomeRheiFranzenbachii is the root and rhizome of polygonaceae plant rheum rhabarbarum, bitter in the mouth; Cold in nature, return stomach; Large intestine channel, has removing toxic substances of purging heat; Effect of removing heat from blood clots absorbing, cures mainly jaundice due to damp-heat; Dysentery; Amenorrhea is suffered from abdominal pain; Hematemesis and epistaxis; Traumatic injury stasis of blood pain; Carbuncle furunculosis; Aphthous stomatitis; The cards such as burn and scald.
Radix Flemingiae Philippinensis: latin name radixflemingiaeprostratae, for the root of pulse family Moghania plant Flemingia philippinensis, sweet in the mouth, slightly warm in nature, flat, return lung, kidney, urinary bladder channel, have expelling wind and removing dampness, effect of repercussive removing toxic substances, cures mainly rheumatic arthralgia, chronic nephritis, traumatic injury, carbuncle, the cards such as throat moth.
Radix Stellariae Yunnanensis: latin name StellariayunnanensisFranch is the root of pinkwort Yunnan Herba stellariae mediae, sweet in the mouth, and property is put down, and has strengthening spleen and nourishing blood, invigorating the liver and kidney, effect of detumescence, cures mainly anemia, dizzy nervous, tinnitus hectic fever, the soreness of waist, seminal emission, menoxenia, leukorrhagia, fracture, the cards such as mastitis.
GUANGXIANG rattan: be the root of annonaceae Fissistigma plant Radix Fissistigmatis Oldhamii, latin name RadixFissistigmaeOldhamii, acrid in the mouth, warm in nature, there is expelling wind and removing dampness, effect of promoting blood circulation and stopping pain, annotation rheumatic arthralgia, lumbago, stomachache, the cards such as traumatic injury.
Herba Canscorae: latin name HerbaCanscoraeLucidissimmae is the herb of Gentianaceae Canscora plant Herba Canscorae, and micro-sweet, the micro-hardship of taste is cool in nature, there is effect of heat-clearing and toxic substances removing, vital energy regualting and blood circulation-promoting, cure mainly cough due to lung-heat, hepatitis, chest pain, stomachache, traumatic injury, the cards such as venom.
Semen Vaccariae: latin name Vaccariasegetalis is the dry mature seed of pinkwort Vaccaria segetalis, bitter in the mouth, and property is put down, and enter liver, stomach warp, has promoting blood circulation to restore menstrual flow, stimulating milk secretion eliminating carbuncle, and the effect of inducing diuresis for treating stranguria syndrome cures mainly blood stasis amenorrhea, dysmenorrhea, difficult labour; Lack of lactation after delivery, acute mastitis swells and ache; Pyretic stranguria, stranguria with blood, the cards such as stranguria caused by urinary stone.
Fructus Corni: latin name cornifructus, sour in the mouth, puckery, slightly warm in nature, returns liver, kidney channel, has liver and kidney tonifying, effect of essence astringing and desertion stemming.For vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating is collapsed.Interior-heat such as to be quenched one's thirst at the card.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine preparation is oral liquid, be specially:
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, the relative density of described clear paste is 1.18 (65 DEG C),
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, in the powder that second step obtains, add the distilled water relative to its quality 3 ~ 4 times amount, the sucrose of 0.05 ~ 0.1 times, the sodium benzoate of 0.01 ~ 0.02 times, stir, boil, cooling, filter, subpackage, namely sterilizing obtains oral liquid.
Present invention also offers the preparation method of above-mentioned Chinese medicine preparation, when the dosage form of described Chinese medicine preparation is granule, be specially:
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, the relative density of described clear paste is 1.18 (65 DEG C),
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, adds cane sugar powder 1500g by the powder 400g that second step obtains, and mixing, makes dry granule 1600g, be distributed into every bag of 8g.
Below adopt embodiment to describe embodiments of the present invention in detail, to the present invention, how application technology means solve technical problem whereby, and the implementation procedure reaching technique effect can fully understand and implement according to this.
The preparation of embodiment 1 oral liquid 1
By Radix Angelicae Sinensis 55g, Fructus Jujubae 40g, Herba Selaginellae 20g, Stigma Croci 25g, Radix Notoginseng 40g, Radix et Rhizoma Rhei Franzenbachii 25g, Radix Flemingiae Philippinensis 30g, Radix Stellariae Yunnanensis 20g, GUANGXIANG rattan 40g and Semen Vaccariae 25g pulverizes respectively, mixing, be in the ethanol 2kg of 70% in determining alcohol by mixed powder dissolution, flood 24 hours, adopt percolation with the speed of 4ml per minute slowly percolation, collect percolate, be evaporated to 1/10 of original volume, centrifugal, obtain supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of 1kg, then graded ethanol eluting, first time uses 1.3kg determining alcohol 50% ethanol elution, use 2.2kg determining alcohol 80% ethanol elution again, merge graded ethanol eluent, decompression recycling ethanol, obtains clear paste, the relative density of described clear paste is 1.18 (65 DEG C), by Poria 30g, Radix Clematidis 20g, Radix Bupleuri 25g, Ramulus Cinnamomi 20g, Rhizoma Dioscoreae 35g, Radix Pseudostellariae 50g, Radix Campanumoeae 30g, Rhizoma Kaempferiae 15g, Fructus Corni 40g pulverizes respectively, and mixing, adds 1.8kg soak by water twice by mixed powder, each 3 hours, collecting decoction, left standstill, filter, filtrate merges with clear paste above, stirs, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1, lets cool, and adds ethanol and carries out precipitate with ethanol 24 hours, the volume content of the ethanol added is 55%, filters, and filtrate is concentrated and obtains dry mastic, be ground into powder, the distilled water relative to its quality 3 times amount is added, the sucrose of 0.05 times, the sodium benzoate of 0.01 times in the powder obtained, stir, boil, cooling, filter, subpackage, namely sterilizing obtains oral liquid 1.
The preparation of embodiment 2 oral liquid 2
By Radix Angelicae Sinensis 60g, Fructus Jujubae 45g, Herba Selaginellae 25g, Stigma Croci 30g, Radix Notoginseng 45g, Radix et Rhizoma Rhei Franzenbachii 30g, Radix Flemingiae Philippinensis 35g, Radix Stellariae Yunnanensis 25g, GUANGXIANG rattan 45g and Semen Vaccariae 30g pulverizes respectively, mixing, be in the ethanol 2.5kg of 70% in determining alcohol by mixed powder dissolution, flood 24 hours, adopt percolation with the speed of 4ml per minute slowly percolation, collect percolate, be evaporated to 1/10 of original volume, centrifugal, obtain supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of 1.5kg, then graded ethanol eluting, first time uses 1.8kg determining alcohol 50% ethanol elution, use 2.5kg determining alcohol 80% ethanol elution again, merge graded ethanol eluent, decompression recycling ethanol, obtains clear paste, the relative density of described clear paste is 1.18 (65 DEG C), by Poria 25g, Radix Clematidis 15g, Radix Bupleuri 20g, Ramulus Cinnamomi 15g, Rhizoma Dioscoreae 40g, Radix Pseudostellariae 55g, Radix Campanumoeae 35g, Rhizoma Kaempferiae 10g, Fructus Corni 45g pulverizes respectively, and mixing, adds 2kg soak by water twice by mixed powder, each 3 hours, collecting decoction, left standstill, filter, filtrate merges with clear paste above, stirs, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1, lets cool, and adds ethanol and carries out precipitate with ethanol 24 hours, the volume content of the ethanol added is 55%, filters, and filtrate is concentrated and obtains dry mastic, be ground into powder, the distilled water relative to its quality 3 times amount is added, the sucrose of 0.05 times, the sodium benzoate of 0.01 times in the powder obtained, stir, boil, cooling, filter, subpackage, namely sterilizing obtains oral liquid 2.
The preparation of embodiment 3 granule
By Radix Angelicae Sinensis 55g, Fructus Jujubae 40g, Herba Selaginellae 20g, Stigma Croci 25g, Radix Notoginseng 40g, Radix et Rhizoma Rhei Franzenbachii 25g, Radix Flemingiae Philippinensis 30g, Radix Stellariae Yunnanensis 20g, GUANGXIANG rattan 40g and Semen Vaccariae 25g pulverizes respectively, mixing, be in the ethanol 2kg of 70% in determining alcohol by mixed powder dissolution, flood 24 hours, adopt percolation with the speed of 4ml per minute slowly percolation, collect percolate, be evaporated to 1/10 of original volume, centrifugal, obtain supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of 1kg, then graded ethanol eluting, first time uses 1.3kg determining alcohol 50% ethanol elution, use 2.2kg determining alcohol 80% ethanol elution again, merge graded ethanol eluent, decompression recycling ethanol, obtains clear paste, the relative density of described clear paste is 1.18 (65 DEG C), by Poria 30g, Radix Clematidis 20g, Radix Bupleuri 25g, Ramulus Cinnamomi 20g, Rhizoma Dioscoreae 35g, Radix Pseudostellariae 50g, Radix Campanumoeae 30g, Rhizoma Kaempferiae 15g, Fructus Corni 40g pulverizes respectively, mixing, adds 1.8kg soak by water twice by mixed powder, each 3 hours, collecting decoction, leave standstill, filter, filtrate merges with clear paste above, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1, lets cool, and adds ethanol and carries out precipitate with ethanol 24 hours, the volume content of the ethanol added is 55%, filter, filtrate is concentrated and obtains dry mastic, be ground into powder, get this powder 400g and add cane sugar powder 1500g part, mixing, makes dry granule 1600g, is distributed into every bag of 8g.
Embodiment 4 toxicity test
Acute toxicity test:
Choose NIH kind mice 20, male and female half and half, body weight is 23.52 ± 2.20g (X ± S), by the dosage gastric infusion of 40ml/kg, one day twice, observe seven, phenomenon without exception, without dead, body weight increases to 27.57 ± 2.61g (X ± S), comparatively weightening finish 17.22% before administration.
The oral liquid clinical medicine dose of Chinese medicine composition of the present invention is 5ml × 2=10ml every day, adult's body weight is by 60kg, the oral dose of being then grown up is 10ml/60kg=0.167ml/kg, and it is 40 × 2=80ml/kg that mice is daily measured, and the 80/0.167=480 of suitable people's consumption doubly.
The oral liquid formulations of Chinese medicine composition of the present invention is oral ampulla, selects NIH kind mice 10, and with the every dosage tail vein injection only of 0.5mL, 8-10 at the uniform velocity injects second, observes 72 hours, phenomenon without exception, without dead.
Result of the test shows: the oral liquid toxicity of Chinese medicine composition of the present invention is less.
Long term toxicity test:
The Wistar rat 60 of experimental animal: 7-8 health in age in week, male and female half and half.Observe one week before test, adopt randomized blocks that rat is divided into three groups, often organize 20, male and female half and half, sub-cage rearing.Periodic logging rats eating amount, freely drinks water.Claim a body weight weekly.
Tested material and dosage: oral liquid 1 prepared by embodiment 1
Dosage group is the requirement by acute toxicity testing result and new Chinese medicine toxicologic study guide, if height two dosage groups and a matched group.High dose is 1200g/kg, and be equivalent to 70 times of clinical application amount, low dose group is 500g/kg, is equivalent to 30 times of clinical application amount.Route of administration and method: adopt administration by gavage.Gavage volume presses the not even depth administration such as capacity such as grade of 1% of body weight.Every day 1 time, 6 days weekly, amount to 8 weeks.Body weight change adjustment dosage is pressed weekly during administration.
Observation index:
Ordinary circumstance: observe outward appearance sign every day, behavioral activity, urine excrement situation, food-intake.Weigh weekly and observe change.
Hematological examination: often organize and get 10 rats (male and female half and half) at random, before administration, after administration the 4th week and the 8th week, at tail venous blood sampling, the indexs such as erythrocyte, leukocyte classification, platelet, reticulocyte and content of hemoglobin are tested by " national Clinical Laboratory rule of operation " requirement.
Rat is dissected and histopathologic examination: experiment terminates, often organize and get 10 rats (male and female half and half), thigh blood vessel sacrificed by exsanguination, conventional dissection, observe the mode of appearance of each internal organs, color etc., and the internal organs such as the heart, liver, spleen, lung, kidney, brain are weighed, calculate the percentage ratio of itself and body weight, i.e. organ coefficient.Then pathology method process routinely, does the histopathologic examination of the heart, liver, spleen, lung, kidney, brain and femur.
Result:
General state and body weight change: during administration, each treated animal general state, movable normal, no abnormality seen reacts.Administration group is substantially close with matched group food-intake.Administration group and matched group body weight growth trend basically identical, illustrate that long term administration has no significant effect growth of animal.Male Mus or female Mus each administration group weight gain value compared with matched group, no significant difference (P > 0.05).
Hematological indices: height, end dosage group erythrocyte, platelet, platelet and content of hemoglobin before administration, after administration 4 weeks and 8 weeks, compared with matched group, P > 0.05, illustrates that medicine has no significant effect above-mentioned each index.
Histopathologic examination: off-test, rat is dissected, and does not find the obvious change of the organs such as the heart, liver, spleen, lung, kidney, brain.Histopathologic examination does not also find that there is pathological change, shows long term administration to each organs and tissues without obvious damage.
Brief summary:
Within continuous 8 weeks, pour into the oral liquid 1 of embodiment 1 preparation to rat oral, dosage is 70 times and 30 times of quantity, and rat general state is good, performance without exception, and each group bodyweight difference, without significance, has no significant effect rat normal growth.
Administration in continuous 8 weeks, blood index is not remarkable, illustrates that oral liquid 1 long term toxicity test result prepared by embodiment 1 shows, finds no pathological change.
Above result of the test shows, oral liquid 1 life-time service provided by the invention, without overt toxicity, is safer Chinese medicine preparation.
Embodiment 5 clinical data
With the patient of in March, 2009 ~ 2012 row artificial hip joint replacing in year June for object of study, meet case totally 218 examples of research standard, male 99 examples (45.41%), female 119 example (54.59%).Age is minimum is 45 years old, and the oldest is 85 years old, average 62.3 years old.Femur head necrosis 45 example (20.64%), fracture of femoral neck 147 example (67.43%), Hip osteoarthritis 26 example (11.93%).One-side operation 192 example (88.07%), bilateral 26 example (11.93%).Be divided into 2 groups at random, Chinese drug-treated group 108 example, man 50 example, female 58 example; One-sided displacement 93 example, bilateral substitution 15 example.Western medicine group 110 example, man 49 example, female 61 example; One-sided displacement 99 example, bilateral substitution 11 example.All cases all adopt seriality combined spinal-epidural anesthesia, perform the operation through hip joint lateral approach.The Fundamentals comparing difference not statistically significants (P>0.05) such as 2 groups of ages, sex, primary disease, operative sites (one-sided or bilateral), have comparability.
Method
Within after Chinese drug-treated group Replacement of Hip Joint the 1st day, namely give oral liquid 1 prepared by embodiment 1, every day 2 times, sooner or later each 1 time, each 5ml, western medicine group gives low molecular heparin calcium (Hainan pharmaceutical Co. Ltd of general alliance, low molecular heparin calcium injection: specification: 1mL:5000IU, the accurate word of traditional Chinese medicines: H20010300), preoperative 2h, subcutaneous injection 2500IU, Post operation subcutaneous injection every day 2500IU, is used in conjunction 14d.Each object of study is respectively at the inspection carrying out lower limb color Doppler, hemorheology, plasma D-dimer content (D-dimer, DD), platelet, prothrombin time (PT) and partial thromboplastin time (APTT) index in preoperative 1d, postoperative 14d.Functional exercise is identical with rehabilitation two groups.
Statistical method
Compare the change of DD, APTT, PT, PLT and drainage volume difference before and after 2 groups of Postoperative Lower Deep Venous Thrombosis incidence rates, medication.Data measured SPSS13.0 statistical software analyzes.Adopt χ 2and t inspection, P<0.05 is that difference has statistical significance.
Result
2 groups of deep vein thrombosis of lower extremity sickness rate compare
There is deep vein thrombosis of lower extremity 58 example in 218 routine patients, the total incidence rate of deep vein thrombosis of lower extremity is 26.61%.Wherein Chinese drug-treated group 32 example, incidence of deep vein thrombosis 29.63%; Western medicine group 26 example, incidence of deep vein thrombosis 23.64%.Row deep veins of lower limb is ultrasonic makes a definite diagnosis deep vein thrombosis of lower extremity.The comparison that 2 groups of patient's Postoperative Lower Deep Venous Thrombosis occur, P>0.05, no significant difference.Chinese medicine preparation prevention of deep vein thrombosis provided by the invention is pointed out to be formed effectively.
2 groups of every coagulation indexes compare, and the results are shown in Table 1 to table 3.
Table 12 group Activated partial thromboplastic time (APTT) compares
Group Number of cases Preoperative Postoperative 1d Postoperative 14d
Chinese drug-treated group 108 22.62±2.12 26.10±3.38 32.21±2.38
Western medicine group 110 22.84±2.23 24.13±3.15 30.50±3.46
Table 22 group prothrombin time (PT) compares
Group Number of cases Preoperative Postoperative 1d Postoperative 14d
Chinese drug-treated group 108 10.60±0.41 12.59±0.49 14.31±0.69
Western medicine group 110 10.62±0.47 10.93±0.50 12.15±0.73
Table 32 group platelet count compares × and 10 9l -1
Group Number of cases Preoperative Postoperative 1d Postoperative 14d
Chinese drug-treated group 108 210.54±13.49 192.78±19.67 216.50±21.65
Western medicine group 110 218.31±15.58 192.57±15.76 216.08±25.31
From table 1 ~ 3, 2 groups of patient APTT and PT Indexes Comparison no significant difference (P>0.05) before medication, 2 groups of patients before the treatment after self APTT and PT Indexes Comparison difference have statistical significance (P<0.01 or P<0.05), postoperative 14d2 group patient APTT and PT Indexes Comparison difference have statistical significance (P<0.01 or P<0.05), prothrombin time (PT) and partial thromboplastin time (APTT) significantly can be extended from the known Chinese medicine preparation of statistical result and low molecular heparin calcium, but Chinese medicine preparation effect is better than low molecular heparin calcium.2 groups of PLT compare, no significant difference.
The change of DDi before and after western medicines in treatment, in table 4.
The change (μ g/ml) of DDi before and after table 4 western medicines in treatment
Time Chinese drug-treated group Western medicine group
Preoperative 1.17±0.76 1.14±0.56
Postoperative 1d 3.26±0.57 1.92±0.61
Postoperative 7d 1.09±0.46 0.82±0.30
Postoperative 10d 0.71±0.31 0.48±0.19
Postoperative 14d 0.34±0.05 0.29±0.05
Before treatment, DDi content all (detects its plasma D-dimer content result with Liatest standard measure higher than normal value, with content >0.5 μ g/mL for sun), within postoperative 1st day, DDi obviously increases, and has significance (P<0.05) with admission examination comparing difference.Postoperative 7 ~ 10d is in declining (P<0.05) gradually, and treatment terminates rear DDi content all within normal range.Chinese medicine preparation prevention of deep vein thrombosis provided by the invention is pointed out to be formed effectively.
The comparison of 2 groups of case postoperative wound drainage flows, in table 5.
The comparison (ml) of table 52 group case postoperative wound drainage flow
Group Number of cases Postoperative wound drainage flow
Chinese drug-treated group 108 304±29
Western medicine group 110 417±69
From table 5,2 groups of case postoperative wound drainage flow comparing differences have statistical significance (P<0.01), point out postoperative application Chinese medicine preparation provided by the invention to cause less amount of bleeding than low molecular heparin calcium, have better safety.
All above-mentioned this intellectual properties of primary enforcement, not setting restriction this new product of other forms of enforcement and/or new method.Those skilled in the art will utilize this important information, and foregoing is revised, to realize similar implementation status.But all modifications or transformation belong to the right of reservation based on new product of the present invention.
The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (7)

1. prevent a Chinese medicine preparation for hip replacement deep vein thrombosis of lower extremity, it is characterized in that: crude drug is made up of Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Poria, Radix Notoginseng, Radix Clematidis, Radix Bupleuri, Ramulus Cinnamomi, Rhizoma Dioscoreae, Radix Pseudostellariae, Radix Campanumoeae, Rhizoma Kaempferiae, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan, Semen Vaccariae and Fructus Corni;
In described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 50g ~ 60g, Fructus Jujubae 35g ~ 45g, Herba Selaginellae 15g ~ 25g, Stigma Croci 20g ~ 30g, Poria 25g ~ 35g, Radix Notoginseng 35g ~ 45g, Radix Clematidis 15g ~ 25g, Radix Bupleuri 20g ~ 30g, Ramulus Cinnamomi 15g ~ 25g, Rhizoma Dioscoreae 30g ~ 40g, Radix Pseudostellariae 45g ~ 55g, Radix Campanumoeae 25g ~ 35g, Rhizoma Kaempferiae 10g ~ 20g, Radix et Rhizoma Rhei Franzenbachii 20g ~ 30g, Radix Flemingiae Philippinensis 25g ~ 35g, Radix Stellariae Yunnanensis 15g ~ 25g, GUANGXIANG rattan 35g ~ 45g, Semen Vaccariae 20g ~ 30g and Fructus Corni 35g ~ 45g.
2. Chinese medicine preparation as claimed in claim 1, it is characterized in that: in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g ~ 60g, Fructus Jujubae 40g ~ 45g, Herba Selaginellae 20g ~ 25g, Stigma Croci 25g ~ 30g, Poria 25g ~ 30g, Radix Notoginseng 40g ~ 45g, Radix Clematidis 15g ~ 20g, Radix Bupleuri 20g ~ 25g, Ramulus Cinnamomi 15g ~ 20g, Rhizoma Dioscoreae 35g ~ 40g, Radix Pseudostellariae 50g ~ 55g, Radix Campanumoeae 30g ~ 35g, Rhizoma Kaempferiae 10g ~ 15g, Radix et Rhizoma Rhei Franzenbachii 25g ~ 30g, Radix Flemingiae Philippinensis 30g ~ 35g, Radix Stellariae Yunnanensis 20g ~ 25g, GUANGXIANG rattan 40g ~ 45g, Semen Vaccariae 25g ~ 30g and Fructus Corni 40g ~ 45g.
3. Chinese medicine preparation as claimed in claim 1 or 2, is characterized in that: in described Chinese medicine preparation, the weight of each crude drug is respectively Radix Angelicae Sinensis 55g, Fructus Jujubae 40g, Herba Selaginellae 20g, Stigma Croci 25g, Poria 30g, Radix Notoginseng 40g, Radix Clematidis 20g, Radix Bupleuri 25g, Ramulus Cinnamomi 20g, Rhizoma Dioscoreae 35g, Radix Pseudostellariae 50g, Radix Campanumoeae 30g, Rhizoma Kaempferiae 15g, Radix et Rhizoma Rhei Franzenbachii 25g, Radix Flemingiae Philippinensis 30g, Radix Stellariae Yunnanensis 20g, GUANGXIANG rattan 40g, Semen Vaccariae 25g and Fructus Corni 40g.
4. Chinese medicine preparation as claimed in claim 1 or 2, is characterized in that: described Chinese medicine preparation is interior preparation.
5. Chinese medicine preparation as claimed in claim 1 or 2, is characterized in that: described Chinese medicine preparation is interior preparation is oral liquid and granule.
6. the preparation method of Chinese medicine preparation described in claim 1 or 2, is characterized in that: when the dosage form of described Chinese medicine preparation is oral liquid, be specially,
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, relative density during described clear paste 65 DEG C is 1.18,
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, in the powder that second step obtains, add the distilled water relative to its quality 3 ~ 4 times amount, the sucrose of 0.05 ~ 0.1 times, the sodium benzoate of 0.01 ~ 0.02 times, stir, boil, cooling, filter, subpackage, namely sterilizing obtains oral liquid.
7. the preparation method of Chinese medicine preparation described in claim 1 or 2, is characterized in that: when the dosage form of described Chinese medicine preparation is granule, be specially,
The first step, by Radix Angelicae Sinensis, Fructus Jujubae, Herba Selaginellae, Stigma Croci, Radix Notoginseng, Radix et Rhizoma Rhei Franzenbachii, Radix Flemingiae Philippinensis, Radix Stellariae Yunnanensis, GUANGXIANG rattan and Semen Vaccariae are pulverized respectively, mix by weight, be in the ethanol of 70% ~ 80% in determining alcohol by mixed powder dissolution, flood 24 hours ~ 36 hours, adopt percolation with the speed of 2 ~ 4ml per minute slowly percolation, collect percolate, the quality of the ethanol added is 5 ~ 8 times of mixed-powder quality, be evaporated to 1/10 of original volume, centrifugal, obtain centrifuged supernatant, supernatant crosses macroporous resin column absorption, first discard with the water elution of the mixture quality obtained relative to the first step 2 ~ 4 times, then graded ethanol eluting, for the first time with the mixture quality obtained relative to the first step 3 ~ 5 times of determining alcohol 50% ~ 60% ethanol elutions, again with the mixture quality obtained relative to the first step 6 ~ 8 times of determining alcohol 80% ~ 90% ethanol elutions, merge graded ethanol eluent, decompression recycling ethanol, obtain clear paste, relative density during described clear paste 65 DEG C is 1.18,
Second step, pulverizes respectively by remaining components, mixes by weight, mixed powder is added up common phase for its quality 6 ~ 8 times of soak by water twice, each 2 ~ 4 hours, collecting decoction, leave standstill, filter, clear paste prepared by filtrate and the first step merges, stir, being concentrated into the raw dose ratio of Chinese medicine preparation is 0.5 ~ 1: 1, lets cool, add ethanol and carry out precipitate with ethanol 24 hours, the volume content of the ethanol added is 45% ~ 55%, filters, filtrate is concentrated and obtains dry mastic, be ground into powder;
3rd step, adds cane sugar powder 1500g by the powder 400g that second step obtains, and mixing, makes dry granule 1600g, be distributed into every bag of 8g.
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