CN105434659A - Injection treating rheumatic or rheumatoid diseases and preparation method thereof - Google Patents
Injection treating rheumatic or rheumatoid diseases and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an injection treating rheumatic or rheumatoid diseases and a preparation method thereof. The injection is prepared from chuanxiong rhizome extract, rhizoma atractylodis extract, radix cyathulae extract, rhizoma corydalis extract, radix angelica sinensis extract, salvia miltiorrhiza extract, safflower carthamus extract, eucommia ulmoides extract, prepared rehmannia root extract, an osmotic pressure regulator, a pH regulator and water, wherein the pH of the injection ranges from 4 to 6.5. The injection can achieve a rapid, effective and good inflammation diminishing and pain stopping effect on arthralgia caused by rheumatic or rheumatoid diseases, and also can improve the immune system of the human body, effectively relieve repeated attacks of inflammation of rheumatic or rheumatoid diseases and treat rheumatic or rheumatoid diseases fundamentally.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine preparation, be specifically related to one and treat rheumatism, rheumatoid injection and preparation method thereof.
Background technology
At present, China's population is gradually in person in middle and old ageization trend development, and rheumatism, rheumatoid arthrosis osteopathia are one of principal diseases of common puzzlement mid-aged population, for a long time without specific treatment.Rheumatism, rheumatoid disease clinically common are a kind ofly changed to main systemic disease with joint, that one contains blood matter disease, its main pathological change has joint to ooze out, lymphocytic infiltration and synovium of joint hypertrophy, it is a kind of chronic inflammation processes of recurrent exerbation, belong to autoimmune disease, may with infection, heredity relevant with the many factors such as disorder of immune mechanism, people's living habit.Rheumatisant's arthralgia unbearably, brings great misery to patient, and impact life and work, what rheumatism was serious may cause valvular heart disease, threat to life.
At present, the treatment of rheumatism patient, the most frequently used Therapeutic Method is extract oral, its safe without toxic side effect, but Chinese medicine ingredients is complicated, and take effect slow, dosing is also large; Also useful western medicine, but its toxic and side effects is large; The also method such as useful acupuncture, traction, operation, although some methods can play an actual curative effect, can not reach the object of radical cure, easy recurrent exerbation, and treatment cost is expensive.
Summary of the invention
One is the object of the present invention is to provide to treat rheumatism, rheumatoid injection and preparation method thereof.
The technical solution used in the present invention is:
One treats rheumatism, rheumatoid injection, in parts by weight of component, every 500 parts of injection are containing, for example lower component: Rhizoma Chuanxiong extracting solution 0.5 ~ 10 part, Rhizoma Atractylodis extracting solution 0.5 ~ 10 part, Radix Cyathulae extracting solution 1 ~ 10 part, Rhizoma Corydalis extracting solution 0.5 ~ 10 part, Radix Angelicae Sinensis extracting solution 1 ~ 10 part, Radix Salviae Miltiorrhizae extract 2 ~ 10 parts, Flos Carthami extract 0.5 ~ 10 part, Cortex Eucommiae extracting solution 1 ~ 10 part, Radix Rehmanniae Preparata extracting solution 2 ~ 10 parts, osmotic pressure regulator 6 ~ 8g/L, pH adjusting agent is appropriate, and surplus is water; Described injection pH is 4 ~ 6.5.
The preparation method of above-mentioned injection, comprises the following steps:
1) by ligusticum wallichii decoction piece, Rhizoma Atractylodis decoction pieces, corydalis tuber decoction pieces, angelica sinensis, salvia piece, Cortex Eucommiae decoction pieces respectively at 60 ~ 80 DEG C, adopt 50 ~ 90% volume fraction ethanol percolate extraction, gained percolate is through removing ethanol, except tannin, filtration, concentrating, obtain Rhizoma Chuanxiong clear paste, Rhizoma Atractylodis clear paste, Rhizoma Corydalis clear paste, Radix Angelicae Sinensis clear paste, Radix Salviae Miltiorrhizae clear paste, Cortex Eucommiae clear paste respectively, again after sterilizing, obtain Rhizoma Chuanxiong extracting solution, Rhizoma Atractylodis extracting solution, Rhizoma Corydalis extracting solution, Radix Angelicae Sinensis extracting solution, Radix Salviae Miltiorrhizae extract, Cortex Eucommiae extracting solution respectively; Wherein, each Chinese medicine clear paste records relative density at 65 DEG C is 0.50 ~ 2.00;
2) Radix Cyathulae decoction pieces, Flos Carthami, Radix Rehmanniae Preparata carry out 70 ~ 95 DEG C of hot water extraction respectively, filter, concentrated, obtain Radix Cyathulae clear paste, Flos Carthami clear paste, Radix Rehmanniae Preparata clear paste, then after sterilizing, obtain Radix Cyathulae extracting solution, Flos Carthami extract, Radix Rehmanniae Preparata extracting solution;
3) by step 1) and 2) extracting solution of gained by proportioning mixing, add suitable quantity of water, add the infiltrations such as osmotic pressure regulator, mixing, filter, add pH adjusting agent and adjust pH to be 4 ~ 6.5, add residue water, sterilizing, obtain injection.
Preferably, in described seepage pressure effects process, control fluid speed 1 ~ 20mL/min.cm
2, controlling liquid outlet quantity is corresponding raw material of Chinese medicine weight 8 ~ 10 times, and unit is w/v.
Preferably, heating is adopted to remove ethanol.
Preferably, employing adds gelatin to remove tannin.
Preferably, membrane filtration sterilizing is adopted.
Preferably, described hot water extraction's time is 1 ~ 4h.
Preferably, step 1) before described Chinese medicine seepage pressure effects, first adopt the soak with ethanol 0 ~ 3h of 50 ~ 90% volume fractions.
Preferably, step 2) described each Chinese medicine adopts hot water extraction three times, relative to each corresponding raw material of Chinese medicine, add the hot water of 5 ~ 20 times amount for the first time, second time adds the hot water of 3 ~ 10 times amount, and third time adds the hot water of 1 ~ 5 times amount, described times amount with unit of weight kg for benchmark.
Preferably, osmotic pressure regulator is sodium chloride.
Chinese medicine injection using method of the present invention is intravenous drip, a 500mL, 1 ~ 2 time on the 1st, and general 12h arthritis pain starts to slow down, and 24h posterior joint pain is obviously alleviated.
The invention has the beneficial effects as follows:
The present invention can effective good result arthralgia caused by rheumatism, rheumatoid being played to anti-inflammatory analgesic fast, can improve human autoimmune's system simultaneously, effectively improve rheumatism, rheumatoid inflammatory episode repeatedly, reach the effect of fundamentally treating.Evident in efficacy, safe and reliable, injection heavy metal of the present invention and Shen Yanda European Union ROSH standard.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is further illustrated, but do not limit to so.
The percentage ratio of ethanol described in embodiment is volume fraction.
Embodiment 1
Get ligusticum wallichii decoction piece 4kg, with 70% medicinal alcohol submergence decoction pieces surface, at 70 DEG C of temperature, soak 2h, load percolator, at 70 DEG C, adopt 70% ethanol percolate extraction, control fluid speed 5mL/min.cm
2when liquid outlet quantity reaches 40L, stop percolation, percolate is transferred to alcohol recycle tank and reclaims ethanol, again percolate is transferred to jacketed pan, be heated to stop without during alcohol taste, add 5% (w/v) gelatin except tannin, filter, filtrate is condensed into clear paste (during 65 DEG C of mensuration, relative density is 1.15) by jacketed pan again, 0.45 μm of micro-pore-film filtration, obtains Rhizoma Chuanxiong extracting solution (about 1.3L), and cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Chinese medicine: Rhizoma Atractylodis decoction pieces 3.5kg, corydalis tuber decoction pieces 3.5kg, angelica sinensis 4kg, salvia piece 4kg, Cortex Eucommiae decoction pieces 3.5kg, respectively as stated above, prepare clear paste separately, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Rhizoma Atractylodis clear paste 1.10, Rhizoma Corydalis clear paste 1.10, Radix Angelicae Sinensis clear paste 1.15, Radix Salviae Miltiorrhizae clear paste 1.15, Cortex Eucommiae clear paste 1.10, then 0.45 μm of micro-pore-film filtration, obtain Rhizoma Atractylodis extracting solution (about 1.4L) respectively, Rhizoma Corydalis extracting solution (about 1.4L), Radix Angelicae Sinensis extracting solution (about 1.5L), Radix Salviae Miltiorrhizae extract (about 1.5L), Cortex Eucommiae extracting solution (about 1.4L).
Get Radix Cyathulae decoction pieces 3kg, Flos Carthami 3kg, Radix Rehmanniae Preparata 3kg, respectively by following operation: with 90 DEG C of hot water extraction three times, each 2h, first time adds 20L water, second time adds 15L water, third time adds 10L water, three filtrates are merged after filter, dress jacketed pan, filtrate is condensed into clear paste, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Radix Cyathulae clear paste 1.10, Flos Carthami clear paste 1.10, Radix Rehmanniae Preparata clear paste 1.10, 0.45 μm of micro-pore-film filtration, divide and obtain Radix Cyathulae extracting solution (about 0.6L), Flos Carthami extract (about 0.5L), Radix Rehmanniae Preparata extracting solution (about 0.6L), cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Rhizoma Chuanxiong extracting solution 5mL, Rhizoma Atractylodis extracting solution 4.5mL, Radix Cyathulae extracting solution 5mL, Rhizoma Corydalis extracting solution 5mL, Radix Angelicae Sinensis extracting solution 6mL, Radix Salviae Miltiorrhizae extract 7.5mL, Flos Carthami extract 5mL, Cortex Eucommiae extracting solution 5mL, Radix Rehmanniae Preparata extracting solution 7.5mL mix and blend 0.5h, filling jetting is to 400mL, add sodium chloride 3.5g, mixing, filter, adjust pH value to 5, injecting water to mixed liquor is 500mL, adopts 0.45 μm of micro-pore-film filtration, fill, sterilizing 30min, obtains injection.
Embodiment 2
Get ligusticum wallichii decoction piece 4kg, with 80% medicinal alcohol submergence decoction pieces surface, at 75 DEG C of temperature, soak 2h, load percolator, at 75 DEG C, adopt 80% ethanol percolate extraction, control fluid speed 4mL/min.cm
2when liquid outlet quantity reaches 45L, stop percolation, percolate is transferred to alcohol recycle tank and reclaims ethanol, again percolate is transferred to jacketed pan, be heated to stop without during alcohol taste, add 5% (w/v) gelatin except tannin, filter, filtrate is condensed into clear paste (during 65 DEG C of mensuration, relative density is 1.15) by jacketed pan again, 0.45 μm of micro-pore-film filtration, obtains Rhizoma Chuanxiong extracting solution (about 1.3L), and cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Chinese medicine: Rhizoma Atractylodis decoction pieces 3.5kg, corydalis tuber decoction pieces 3.5kg, angelica sinensis 4kg, salvia piece 4kg, Cortex Eucommiae decoction pieces 3.5kg, respectively as stated above, prepare clear paste separately, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Rhizoma Atractylodis clear paste 1.10, Rhizoma Corydalis clear paste 1.10, Radix Angelicae Sinensis clear paste 1.15, Radix Salviae Miltiorrhizae clear paste 1.15, Cortex Eucommiae clear paste 1.10, then 0.45 μm of micro-pore-film filtration, obtain Rhizoma Atractylodis extracting solution (about 1.4L) respectively, Rhizoma Corydalis extracting solution (about 1.4L), Radix Angelicae Sinensis extracting solution (about 1.5L), Radix Salviae Miltiorrhizae extract (about 1.5L), Cortex Eucommiae extracting solution (about 1.4L).
Get Radix Cyathulae decoction pieces 3kg, Flos Carthami 3kg, Radix Rehmanniae Preparata 3kg, respectively by following operation: with 95 DEG C of hot water extraction three times, each 2h, first time adds 20L water, second time adds 15L water, third time adds 10L water, three filtrates are merged after filter, dress jacketed pan, filtrate is condensed into clear paste, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Radix Cyathulae clear paste 1.10, Flos Carthami clear paste 1.10, Radix Rehmanniae Preparata clear paste 1.10, 0.45 μm of micro-pore-film filtration, divide and obtain Radix Cyathulae extracting solution (about 0.6L), Flos Carthami extract (about 0.5L), Radix Rehmanniae Preparata extracting solution (about 0.5L), cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Rhizoma Chuanxiong extracting solution 7mL, Rhizoma Atractylodis extracting solution 6mL, Radix Cyathulae extracting solution 7mL, Rhizoma Corydalis extracting solution 8mL, Radix Angelicae Sinensis extracting solution 4mL, Radix Salviae Miltiorrhizae extract 8mL, Flos Carthami extract 6mL, Cortex Eucommiae extracting solution 10mL, Radix Rehmanniae Preparata extracting solution 8mL mix and blend 0.5h, filling jetting is to 400mL, add sodium chloride 3.5g, mixing, filter, adjust pH value to 5, injecting water to mixed liquor is 500mL, adopts 0.45 μm of micro-pore-film filtration, fill, sterilizing 30min, obtains injection.
Embodiment 3
Get ligusticum wallichii decoction piece 4kg, with 60% medicinal alcohol submergence decoction pieces surface, at 65 DEG C of temperature, soak 2h, load percolator, at 60 DEG C, adopt 65% ethanol percolate extraction, control fluid speed 6mL/min.cm
2when liquid outlet quantity reaches 35L, stop percolation, percolate is transferred to alcohol recycle tank and reclaims ethanol, again percolate is transferred to jacketed pan, be heated to stop without during alcohol taste, add 5% (w/v) gelatin except tannin, filter, filtrate is condensed into clear paste (during 65 DEG C of mensuration, relative density is 1.15) by jacketed pan again, 0.45 μm of micro-pore-film filtration, obtains Rhizoma Chuanxiong extracting solution (about 1.3L), and cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Chinese medicine: Rhizoma Atractylodis decoction pieces 3.5kg, corydalis tuber decoction pieces 3.5kg, angelica sinensis 4kg, salvia piece 4kg, Cortex Eucommiae decoction pieces 3.5kg, respectively as stated above, prepare clear paste separately, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Rhizoma Atractylodis clear paste 1.10, Rhizoma Corydalis clear paste 1.10, Radix Angelicae Sinensis clear paste 1.15, Radix Salviae Miltiorrhizae clear paste 1.15, Cortex Eucommiae clear paste 1.10, then 0.45 μm of micro-pore-film filtration, obtain Rhizoma Atractylodis extracting solution (about 1.4L) respectively, Rhizoma Corydalis extracting solution (about 1.4L), Radix Angelicae Sinensis extracting solution (about 1.5L), Radix Salviae Miltiorrhizae extract (about 1.5L), Cortex Eucommiae extracting solution (about 1.4L).
Get Radix Cyathulae decoction pieces 3kg, Flos Carthami 3kg, Radix Rehmanniae Preparata 3kg, respectively by following operation: with 85 DEG C of hot water extraction three times, each 2h, first time adds 20L water, second time adds 15L water, third time adds 10L water, three filtrates are merged after filter, dress jacketed pan, filtrate is condensed into clear paste, wherein, at 65 DEG C, the clear paste density measuring each Chinese medicine corresponding is as follows: Radix Cyathulae clear paste 1.10, Flos Carthami clear paste 1.10, Radix Rehmanniae Preparata clear paste 1.10, 0.45 μm of micro-pore-film filtration, divide and obtain Radix Cyathulae extracting solution (about 0.7L), Flos Carthami extract (about 0.7L), Radix Rehmanniae Preparata extracting solution (about 0.7L), cold preservation is for subsequent use 0 ~ 5 DEG C of storage.
Get Rhizoma Chuanxiong extracting solution 3mL, Rhizoma Atractylodis extracting solution 5mL, Radix Cyathulae extracting solution 5mL, Rhizoma Corydalis extracting solution 4mL, Radix Angelicae Sinensis extracting solution 3mL, Radix Salviae Miltiorrhizae extract 8mL, Flos Carthami extract 4mL, Cortex Eucommiae extracting solution 9mL, Radix Rehmanniae Preparata extracting solution 5mL mix and blend 0.5h, filling jetting is to 400mL, add sodium chloride 3.5g, mixing, filter, adjust pH value to 5, injecting water to mixed liquor is 500mL, adopts 0.45 μm of micro-pore-film filtration, fill, sterilizing 30min, obtains injection.
The effective constituent determination of each Chinese medicine extraction liquid of gained in each embodiment, measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VID).
Rhizoma Chuanxiong extracting solution effective ingredient---the mensuration of ferulic acid:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-1% acetum (30:70) for mobile phase; Determined wavelength 321nm.Reason plate number calculates should be not less than 4000 by ferulic acid.
The preparation of reference substance solution: get ferulic acid reference substance appropriate, accurately weighed, put brown measuring bottle, add 70% methanol and make the solution of every lml containing 20 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. four sieves) about 0.5g, accurately weighed, put in tool plug conical flask, precision adds people 70% methanol 50ml, close plug, weighed weight, reflux 30 minutes, lets cool, more weighed weight, supply the weight of less loss with 70% methanol, shake up, leave standstill, get supernatant, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Rhizoma Atractylodis extracting solution effective ingredient---atisine chloride atractydin measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-water (79:21) for mobile phase; Determined wavelength 340nm.Reason plate number calculates should be not less than 5000 by atisine chloride atractydin peak.
The preparation of reference substance solution: get atisine chloride atractydin reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing 20 μ l, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.2g, accurately weighed, put in tool plug conical flask, precision adds methanol 50ml, close plug, weighed weight, supersound process (power 250W, frequency 40kHz) 1 hour, lets cool, weighed weight again, supply the weight of less loss with methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Radix Cyathulae extracting solution effective ingredient---cyasterone measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; Being mobile phase A with methanol, take water as Mobile phase B, and according to the form below regulation carries out gradient elution; Determined wavelength 243nm.Reason plate number calculates should be not less than 3000 by cyasterone peak.
Table 1 gradient elution table
The preparation of reference substance solution: get cyasterone reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing 25 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 1g, accurately weighed, put in tool plug conical flask, precision adds methanol 20ml, close plug, weighed weight, reflux 1 hour, let cool, more weighed weight, the weight of less loss is supplied with methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Rhizoma Corydalis extracting solution effective ingredient---tetrahydropalmatine measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-0.1% phosphoric acid solution (pH value to 6.0 adjusted by triethylamine) (55:45) for mobile phase; Determined wavelength 280nm.Reason plate number calculates should be not less than 3000 by tetrahydropalmatine.
The preparation of reference substance solution: get tetrahydropalmatine reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing 46 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.5g, accurately weighed, put in boiling flask, precision adds dense ammonia-methanol (1:20) mixed solution 50ml, weighed weight, merceration 1 hour post-heating refluxes 1 hour, let cool, more weighed weight, the weight of less loss is supplied with dense ammonia-methanol (1:20) mixed solution, shake up, filter.Precision gets subsequent filtrate 25ml, evaporate to dryness, and residue adds dissolve with methanol, is transferred in 5ml measuring bottle, and is diluted to scale, shake up, and filters, gets subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Radix Angelicae Sinensis extracting solution effective ingredient---ferulic acid measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With acetonitrile-0.085% phosphoric acid solution (17:83) for mobile phase; Determined wavelength 316nm; Column temperature 35 DEG C.Reason plate number calculates should be not less than 5000 by ferulic acid.
The preparation of reference substance solution: get ferulic acid reference substance appropriate, accurately weighed, put brown measuring bottle, add 70% methanol and make the solution of every lml containing 12 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.2g, accurately weighed, put in tool plug conical flask, precision adds people 70% methanol 20ml, close plug, weighed weight, reflux 30 minutes, lets cool, more weighed weight, supply the weight of less loss with 70% methanol, shake up, leave standstill, get supernatant, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Radix Salviae Miltiorrhizae extract effectively becomes---Tanshinone II
amensuration is divided with salvianolic acid B:
Tanshinone II
a, measure according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VID).
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-water (75:25) for mobile phase; Determined wavelength 270nm.Reason plate number presses Tanshinone II
acalculating should be not less than 2000.
The preparation of reference substance solution: get Tanshinone II
areference substance is appropriate, accurately weighed, puts brown measuring bottle, adds methanol and makes every lml containing Tanshinone II
athe solution of 16 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.3g, accurately weighed, put in tool plug conical flask, precision adds people's methanol 50ml, close plug, weighed weight, reflux 1 hour, let cool, more weighed weight, the weight of less loss is supplied with methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 5 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Salvianolic acid B, measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VID).
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-acetonitrile-formic acid-water (30:10:1:59) for mobile phase; Determined wavelength 286nm.Reason plate number calculates should be not less than 2000 by salvianolic acid B.
The preparation of reference substance solution: get salvianolic acid B reference substance appropriate, accurately weighed, add 75% methanol and make the solution of every lml containing salvianolic acid B 0.14mg, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.2g, accurately weighed, put in tool plug conical flask, precision adds people 75% methanol 50ml, close plug, weighed weight, reflux 1 hour, let cool, more weighed weight, the weight of less loss is supplied with 75% methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Flos Carthami extract effective ingredient---S-A Hydroxysafflor yellow A and kaempferol measure:
S-A Hydroxysafflor yellow A, measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VID).
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-acetonitrile-0.7% phosphoric acid solution (26:2:72) for mobile phase; Determined wavelength 403nm.Reason plate number calculates should be not less than 3000 by S-A Hydroxysafflor yellow A.
The preparation of reference substance solution: get S-A Hydroxysafflor yellow A reference substance appropriate, accurately weighed, add the solution that 25% methanol makes every lml hydroxyl carthamin yellow A-containing 0.13mg, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.4g, accurately weighed, put in tool plug conical flask, precision adds people 25% methanol 50ml, weighed weight, supersound process (power 300W, frequency 550kHz) 40 minutes, let cool, more weighed weight, the weight of less loss is supplied with 25% methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Kaempferol, measures according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VID).
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-0.4% phosphoric acid solution (52:48) for mobile phase; Determined wavelength 367nm.Reason plate number calculates should be not less than 3000 by kaempferol.
The preparation of reference substance solution: get kaempferol reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing kaempferol 9 μ g, to obtain final product.
The preparation of need testing solution: get this product powder (crossing No. three sieves) about 0.5g, accurately weighed, put in tool plug conical flask, precision adds methanol 25ml, close plug, weighed weight, reflux 3 hours, lets cool, more weighed weight, supply the weight of less loss with methanol, shake up, filter, precision measures subsequent filtrate 15ml, put in boiling flask, add hydrochloric acid solution (15 → 37) 5ml, shake up, to put in water-bath heating hydrolysis 30 minutes, cool immediately, be transferred in 25ml measuring bottle, with methanol dilution to scale, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Cortex Eucommiae extracting solution effective ingredient---pinoresinol diglucoside measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-water (25:75) for mobile phase; Determined wavelength 277nm.Reason plate number calculates should be not less than 1000 by pinoresinol diglucoside peak.
The preparation of reference substance solution: get pinoresinol diglucoside reference substance appropriate, accurately weighed, add methanol and make the solution of every lml containing 0.5mg, to obtain final product.
The preparation of need testing solution: get this product and be about 3g, be cut into fragment, is kneaded into cotton-shaped, gets about 2g, accurately weighed, put in apparatus,Soxhlet's, add chloroform in right amount, reflux 6 hours, discard chloroform liquid, chloroform flung to by medicinal residues, then puts in apparatus,Soxhlet's, add methanol appropriate, reflux 6 hours, extracting solution reclaims methanol to appropriate, be transferred in 10ml measuring bottle, add methanol to scale, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 10 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Radix Rehmanniae Preparata extracting solution effective ingredient---verbascoside measures:
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With acetonitrile-0.1% acetum (16:84) for mobile phase; Determined wavelength 334nm.Reason plate number calculates should be not less than 5000 by verbascoside peak.
The preparation of reference substance solution: get verbascoside reference substance appropriate, accurately weighed, add mobile phase and make the solution of every lml containing 10 μ g, to obtain final product.
The preparation of need testing solution: get the most coarse powder of this product and be about 2g, accurately weighed, put in the flask of original place, precision adds methanol 100ml, weighed weight, reflux 30 minutes, lets cool, more weighed weight, supply the weight of less loss with methanol, shake up, filter, precision measures subsequent filtrate 50ml, and decompression and solvent recovery is closely dry, and residue mobile phase dissolves, be transferred in 10ml measuring bottle, add mobile phase to scale, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 20 μ l. of need testing solution note people's chromatograph of liquid respectively, measure, to obtain final product.
Each embodiment active constituent content measuring result sees table 2.
The active ingredient of table 2 each embodiment Chinese medicine extraction liquid measures
Embodiment records containing 3 ~ 8mg ferulic acid, 4.5 ~ 14mg atisine chloride atractydin, 0.5 ~ 1.5mg cyasterone, 0.5 ~ 2.5mg tetrahydropalmatine, 15 ~ 50mg S-A Hydroxysafflor yellow A, 0.5 ~ 2.5mg wood a kind of apple element, 3 ~ 5mg pinoresinol diglucoside, 0.9 ~ 2mg verbascoside, 10 ~ 15mg tanshinone IIA, 100 ~ 230mg salvianolic acid B, sodium chloride 7g/L in every 500mL injection, and the pH of described injection is 4 ~ 6.5.
Clinical observation treatment is carried out to 600 routine rheumatoid arthritis patients, wherein man 340 example, female 260 example, the existing finger pain of patient's multilist, or knee pain, or finger, lower limb, wrist swell and ache, or trick is unable.
The present invention adopts intravenous drip mode, each 500mL, 1 time on the every 3rd, within 15th, is a course for the treatment of.
Curative effect determinate standard: " healing ": Clinical symptom and sign disappears, recovers normal, more than half a year without recidivist; " effective ": the basic or major part of Clinical symptom and sign disappears, without recurrence in three months; " effectively ": clinical symptoms is clearly better, without recurrence in one month; Engineering noise: Clinical symptom and sign is without improvement or drug allergy.
Therapeutic effect: clinical cure 134 example, accounts for 22.3%; Effective 327 examples, account for 54.5%; Effective 113 examples, account for 18.8%; Invalid 26 examples, account for 4.3%.Injection of the present invention is evident in efficacy, is conducive to patient and alleviates condition of illness in time, safe and reliable, injection heavy metal of the present invention and Shen Yanda European Union ROSH standard.
Claims (10)
1. a treatment rheumatism, rheumatoid injection, in parts by weight of component, every 500 parts of injection are containing, for example lower component: Rhizoma Chuanxiong extracting solution 0.5 ~ 10 part, Rhizoma Atractylodis extracting solution 0.5 ~ 10 part, Radix Cyathulae extracting solution 1 ~ 10 part, Rhizoma Corydalis extracting solution 0.5 ~ 10 part, Radix Angelicae Sinensis extracting solution 1 ~ 10 part, Radix Salviae Miltiorrhizae extract 2 ~ 10 parts, Flos Carthami extract 0.5 ~ 10 part, Cortex Eucommiae extracting solution 1 ~ 10 part, Radix Rehmanniae Preparata extracting solution 2 ~ 10 parts, osmotic pressure regulator 6 ~ 8g/L, pH adjusting agent is appropriate, and surplus is water; Described injection pH is 4 ~ 6.5.
2. the preparation method of injection according to claim 1, comprises the following steps:
1) by ligusticum wallichii decoction piece, Rhizoma Atractylodis decoction pieces, corydalis tuber decoction pieces, angelica sinensis, salvia piece, Cortex Eucommiae decoction pieces respectively at 60 ~ 80 DEG C, adopt 50 ~ 90% volume fraction ethanol percolate extraction, gained percolate is through removing ethanol, except tannin, filtration, concentrating, obtain Rhizoma Chuanxiong clear paste, Rhizoma Atractylodis clear paste, Rhizoma Corydalis clear paste, Radix Angelicae Sinensis clear paste, Radix Salviae Miltiorrhizae clear paste, Cortex Eucommiae clear paste respectively, again after sterilizing, obtain Rhizoma Chuanxiong extracting solution, Rhizoma Atractylodis extracting solution, Rhizoma Corydalis extracting solution, Radix Angelicae Sinensis extracting solution, Radix Salviae Miltiorrhizae extract, Cortex Eucommiae extracting solution respectively; Wherein, each Chinese medicine clear paste records relative density at 65 DEG C is 0.50 ~ 2.00;
2) Radix Cyathulae decoction pieces, Flos Carthami, Radix Rehmanniae Preparata carry out 70 ~ 95 DEG C of hot water extraction respectively, filter, concentrated, obtain Radix Cyathulae clear paste, Flos Carthami clear paste, Radix Rehmanniae Preparata clear paste, then after sterilizing, obtain Radix Cyathulae extracting solution, Flos Carthami extract, Radix Rehmanniae Preparata extracting solution;
3) by step 1) and 2) extracting solution of gained by proportioning mixing, add suitable quantity of water, add the infiltrations such as osmotic pressure regulator, mixing, filter, add pH adjusting agent and adjust pH to be 4 ~ 6.5, add residue water, sterilizing, obtain injection.
3. the preparation method of injection according to claim 2, is characterized in that: in described seepage pressure effects process, controls fluid speed 1 ~ 20mL/min.cm
2, controlling liquid outlet quantity is corresponding raw material of Chinese medicine weight 8 ~ 10 times, and unit is w/v.
4. the preparation method of injection according to claim 2, is characterized in that: adopt heating to remove ethanol.
5. the preparation method of injection according to claim 2, is characterized in that: adopt and add gelatin to remove tannin.
6. the preparation method of injection according to claim 2, is characterized in that: adopt membrane filtration sterilizing.
7. the preparation method of injection according to claim 2, is characterized in that: described hot water extraction's time is 1 ~ 4h.
8. the preparation method of injection according to claim 2, is characterized in that: step 1) before described Chinese medicine seepage pressure effects, first adopt the soak with ethanol 0 ~ 3h of 50 ~ 90% volume fractions.
9. the preparation method of injection according to claim 2, it is characterized in that: step 2) described each Chinese medicine adopts hot water extraction three times, relative to each corresponding raw material of Chinese medicine, add the hot water of 5 ~ 20 times amount for the first time, second time adds the hot water of 3 ~ 10 times amount, third time adds the hot water of 1 ~ 5 times amount, described times amount with unit of weight kg for benchmark.
10. the preparation method of injection according to claim 1 and 2, is characterized in that: osmotic pressure regulator is sodium chloride.
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CN101002828A (en) * | 2007-01-10 | 2007-07-25 | 厦门国宇知识产权研究有限公司 | Method for preparing Danhong injection, and products thereof |
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