CN102309705B - Medicine for reducing serum uric acid, preparation method thereof and purpose thereof - Google Patents
Medicine for reducing serum uric acid, preparation method thereof and purpose thereof Download PDFInfo
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Abstract
本发明属于中药领域，公开了一种降低血尿酸的药物及其制备方法和用途。本发明药物由下列重量配比的药材制备而成：光慈姑5-15份、土茯苓10-60份、桑寄生6-30份、生黄芪9-45份、丹参10-30份、米仁10-60份、秦艽9-20份，药材经煎煮、浓缩、除杂、干燥等工艺获得具有降低血尿酸的有效部位，这种有效部位可按常规制成临床接受的不同剂型。本发明药物在制备用于降低血尿酸、降低血脂和肝肾保护的药物中的应用，在制备用于治疗高尿酸血症或并发高脂血症的药物中的应用。本发明药物具有降低血尿酸，且有降低血脂及肝肾保护的作用，用于治疗高尿酸血症或并发高脂血症。The invention belongs to the field of traditional Chinese medicine, and discloses a medicine for reducing blood uric acid, a preparation method and application thereof. The medicine of the present invention is prepared from the following medicinal materials in weight proportions: 5-15 parts of Arthia sativa, 10-60 parts of Smilax smilax, 9-45 parts of raw Astragalus, 10-30 parts of Salvia miltiorrhiza, 10-30 parts of rice kernel 10-60 parts, Gentiana 9-20 parts, the medicinal materials are decocted, concentrated, impurity-removed, dried and other processes to obtain the effective parts that can reduce blood uric acid, and the effective parts can be made into different clinically accepted dosage forms according to routine. The application of the medicament of the present invention in the preparation of medicaments for lowering blood uric acid, lowering blood fat and liver and kidney protection, and in the preparation of medicaments for treating hyperuricemia or complicated hyperlipidemia. The medicine of the invention has the functions of lowering blood uric acid, lowering blood fat and protecting liver and kidney, and is used for treating hyperuricemia or concurrent hyperlipidemia.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate in particular to a kind of medicine that reduces blood uric acid and its production and use.
Background technology
Hyperuricemia (Hyperuricacidemia) is that purine metabolic disturbance or urate excretion reduce caused one group of disease, asymptomatic hyperuricemia is very common clinically, if hyperuricemia can not in time be controlled, the uric acid salt is deposited on tissues such as kidney or joint, cause pathological change, it is gout, diabetes, the risk factor of coronary heart disease and other peripheral vascular diseases, potential risk is very big, have a strong impact on patient's quality of life, increase medical burden, the chemical synthetic drug of clinical great majority treatment hyperuricemia has certain toxicity and side effect, and occurs unusual after the drug withdrawal again.Simultaneously, the sickness rate that high purine, high fat diet cause hyperuricemia and merge hyperlipemia also is obvious ascendant trend, has curative effect preferably though regulate hypolipidemic medicine, exist drug withdrawal after blood fat repeatedly, or side effect in various degree, the expensive deficiency that waits.
Though natural drug particularly Chinese medicine compound with regard to single pathology link; may not obtain the clinical effectiveness that synthetic drug attracts people's attention like that in isolated experiment; but the overall synthetic drug effect of the many compositions of Chinese medicine compound, many target spots, too many levels then be synthetic drug can't be obtained; its in the antimetabolic disorder, alleviate related diseases because of aspects such as effect, protection organ function and injury repairing; original effect is arranged, become the focus of Chinese medicine research just day by day.Treatment by Chinese herbs hyperuricemia, hyperlipemia have that curative effect is sure, lasting, side effect is little, lower-price characteristic.In view of the raising day by day of present hyperuricemia and merging hyperlipemia sickness rate, the Chinese medicine preparation of studying many target spots, effective low toxicity has profound significance.
Summary of the invention
The medicine that the present invention is directed to existing reduction blood uric acid in various degree toxic and side effects and drug withdrawal after defectives such as unusual appear again, medicine of the reduction blood uric acid that a kind of curative effect is sure, lasting, side effect is little and preparation method thereof is provided.Another object of the present invention has provided a kind of purposes that reduces the medicine of blood uric acid.
Above-mentioned technical problem, the present invention is solved by following technical proposals:
A kind of medicine that reduces blood uric acid is prepared from by the medical material of following weight proportion: Pseudobulbus Cremastrae Seu Pleiones 5-15 part, Rhizoma Smilacis Glabrae 10-60 part, Herba Taxilli 6-30 part, Radix Astragali 9-45 part, Radix Salviae Miltiorrhizae 10-30 part, Semen Coicis 10-60 part, Radix Gentianae Macrophyllae 9-20 part.
As preferably, be prepared from by the medical material of following weight proportioning: 5 parts of Pseudobulbus Cremastrae Seu Pleioness, 30 parts of Rhizoma Smilacis Glabraes, 15 parts of Herba Taxillis, 15 parts of Radix Astragali, 15 parts of Radix Salviae Miltiorrhizaes, 30 parts of Semen Coiciss, 10 parts of Radix Gentianae Macrophyllae.
Medicament selection Pseudobulbus Cremastrae Seu Pleiones of the present invention, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis and Radix Gentianae Macrophyllae make up, and these drug combinations make each efficacy of drugs produce synergism, reach the purpose that reduces blood uric acid, blood fat, protection Liver and kidney.The Pseudobulbus Cremastrae Seu Pleiones detoxicating and resolving stagnation of pathogens, the promoting the circulation of blood blood stasis dispelling.Rhizoma Smilacis Glabrae (also make Rhizoma Smilacis Glabrae and use in the minority area, dark-coloured Rhizoma Smilacis Chinensis produces Sichuan, claims Smilax lanceaefolia Roxb. Var.opaca A.DC. again by following several congener rhizome.Stingless Rhizoma Smilacis Chinensis Smairei Levl., its rhizome is made Rhizoma Smilacis Glabrae usefulness in Tibet, then be Rhizoma Smilacis in Yunnan, referring to " Rhizoma Smilacis " bar.Radix Stephaniae Tetrandrae leaf Rhizoma Smilacis Chinensis Smenispermoidea DC produces Tibet) strengthening the spleen and stomach, open muscles and bones, sharp joint, stopping leak rush down, except four coldness of the body wet, detoxicating and resolving stagnation of pathogens, dispelling wind and removing obstruction in the collateral, dampness removing is let out turbid.The Herba Taxilli invigorating the liver and kidney, bone and muscle strengthening, wind-damp dispelling, antiabortive unit.Radix Astragali (being the root of leguminous plant Radix Astagali or Radix Astragali) strengthening superficial resistance to stop perspiration, evacuation of pus granulation promoting, inducing diuresis to remove edema, antiabortive beneficial blood.The Radix Salviae Miltiorrhizae promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, the relieving restlessness that clears away heart-fire, nourishing blood to tranquillize the mind.Semen Coicis spleen invigorating eliminating dampness by diuresis, eliminating impediment antidiarrheal can be treated dysuria, edema, beriberi, diarrhea due to hypofunction of the spleen also can be used for sick treatment such as lung abscess, acute appendicitis.Radix Gentianae Macrophyllae Eradicates rheumatism, Shujin network, clearind deficient heat.
The preparation method of the medicine of reduction blood uric acid of the present invention comprises the steps:
A, to take by weighing Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae standby;
B, medical material is dropped in the extraction pot, decoct with water, a temperature is down to 70 ℃ of I that filter to get filtrate in jar, decoct with water again, get the filtrate II by the method that obtains the filtrate I, merging filtrate I and filtrate II, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, be concentrated into relative density 1.1～1.2, get concentrated solution;
D, get concentrated solution and put in the settling tank, heat 40～50 ℃, add chitosan clarifier, the limit edged stirs, and after clarifier adds, continues insulated and stirred 20～30 minutes, it is centrifugal to be chilled to room temperature after 2 hours (back embodiment places to spend the night), centrifugal rotational speed 3000rpm, centrifugation time 20min, centrifugal liquid is according to concentrating the clear paste that condition is concentrated into relative density 1.32～1.44 among the step C.
As preferably, qinghuo reagent is sub-packed in the drip pan, and is dry in vacuum drying oven, after the oven dry dry extract.
As preferably, get dry extract and add conventional adjuvant, according to common process, make the dosage form of clinical acceptance.
The dosage form of medicine of the present invention is oral liquid, tablet, capsule, pill, granule or drop pill.
As preferably, when step B decocts with water, add 8 times of water gagings twice, continue heating after the temperature to 100 ℃ in jar and decocted 1.5 hours.
As preferably, temperature was 65 ± 3 ℃ when the medicine of step C concentrated, more than vacuum-0.05Mpa.
As preferably, control baking temperature at 65 ± 5 ℃, more than vacuum-0.05Mpa when dry in the step e.
The application of medicine of the present invention in the medicine of protecting for the preparation of reduction blood uric acid, blood fat reducing and Liver and kidney.
Medicine of the present invention is for the preparation of the application in the medicine for the treatment of hyperuricemia or concurrent hyperlipemia.
Medicine of the present invention as hospital agreement side clinical practice for many years, obtain clinical efficacy preferably, in the treatment hyperuricemia, comparatively significantly lipid-lowering effect is arranged, prescription invigorating the spleen and benefiting QI, clearing away heat-damp and promoting diuresis, dissipating stasis and purging turbidity also meet the pathological characteristic that hyperlipemia is seen insufficiency of the spleen phlegm-turbidity and blood stasis resistance more.Early stage, experiment in vitro studies show that: pastille serum of the present invention has significant intervention effect to the expression of human vascular endothelial ICAM-1, VCAM-1 that urate and TNF-α induce, point out it to intervene hyperuricemia and bring out the inflammatory reaction of arteriosclerosis initial stage and arteriosclerosis, to the protective effect mechanism of endothelial injury; Medicine of the present invention has regulating action to hyperlipidemia rats blood fat and the metabolism disorder of liver inner lipid, can protect hepatocyte to suppress steatosis, and prompting the present invention has significant blood fat reducing, liver-protective effect; Drug therapy hyperuricemia of the present invention or merging hyperlipemia have clinical efficacy preferably.
The specific embodiment
Describe in further detail below by the present invention of embodiment.
Embodiment 1
The preparation of medicinal granule of the present invention.
[prescription] Pseudobulbus Cremastrae Seu Pleiones 167g Rhizoma Smilacis Glabrae 1000g Herba Taxilli 500g Radix Salviae Miltiorrhizae 500g
Radix Astragali 500g Semen Coicis 1000g Radix Gentianae Macrophyllae 333g
[preparation method]
A, to take by weighing Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription standby;
B, crude drug is dropped in the extraction pot, add 8 times of water gagings, heating decocted 1.5 hours, and temperature to 100 ℃ picks up counting in jar; Temperature is down to 70 ℃ and is made filtration in jar, gets the filtrate I, is added with 8 times of water gagings and decocts 1.5 hours, gets the filtrate II by the method that obtains the filtrate I, merging filtrate I and filtrate II, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 65 ± 3 ℃, is concentrated into relative density 1.2 more than vacuum-0.05Mpa, gets concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 40～50 ℃, slowly add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g, the limit edged stirs, after clarifier adds, continue insulated and stirred 30min, be chilled to place after the room temperature and spend the night, centrifugal, centrifugal rotational speed 3000rpm, centrifugation time 20min, centrifugal liquid is according to concentrating the clear paste that condition is concentrated into relative density 1.32～1.44 among the step C;
E, qinghuo reagent are sub-packed in the drip pan, and the control baking temperature is at 65 ± 5 ℃, and is dry in the vacuum drying oven more than vacuum-0.05Mpa, gets extract powder after the oven dry;
F, get that dry extract adds lactose and stevioside is an amount of, make granule, dry below 60 ℃, make 1000g.
[usage and consumption] boiled water is taken after mixing it with water.A 10g, 3 times on the one.
[specification] every packed 10g.
[storage] sealing.
[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: be filler with the octadecylsilane chemically bonded silica; Be mobile phase with acetonitrile-water (35:65); The detection wavelength is 203nm; Number of theoretical plate is pressed the astragaloside peak and is calculated, and should be not less than 3000.
The preparation of reference substance solution: get the astragaloside reference substance, the accurate title, decide, and adds methanol and make the solution that every 1ml contains 1mg, namely.
The preparation of need testing solution: get this product under the content uniformity item, porphyrize is got about 5g, precision steelyard is fixed, adds the ultrasonic 30min of methanol 50ml, filters, discard filtrate just, accurately measure subsequent filtrate 25ml, water bath method, residue adds water 20ml dissolving, and with extracted with diethyl ether 3 times, 30ml at every turn, discard ether, combining water layer, with water saturated n-butanol extraction 3 times, each 20ml, merge n-butanol extracting liquid, with 1% sodium hydroxide solution washing 3 times, each 20ml discards water layer, n-butyl alcohol liquid evaporate to dryness, add dissolve with methanol behind the evaporate to dryness and be settled to 1ml, cross 0.45 μ m aqueous filter membrane, namely.
Embodiment 2
The preparation of medicinal tablet of the present invention.
[prescription] Pseudobulbus Cremastrae Seu Pleiones 167g Rhizoma Smilacis Glabrae 1000g Herba Taxilli 500g Radix Salviae Miltiorrhizae 500g
Radix Astragali 500g Semen Coicis 1000g Radix Gentianae Macrophyllae 333g
[preparation method]
A, to take by weighing Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription standby;
B, crude drug is dropped in the extraction pot, add 8 times of water gagings, heating decocted 1.5 hours, and temperature to 100 ℃ picks up counting in jar; Temperature is down to 70 ℃ and is made filtration in jar, gets the filtrate I, is added with 8 times of water gagings and decocts 1.5 hours, gets the filtrate II by the method that obtains the filtrate I, merging filtrate I and filtrate II, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 65 ℃, is concentrated into relative density 1.2 more than vacuum-0.05Mpa, gets concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 50 ℃, slowly add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g, the limit edged stirs, after clarifier adds, continue insulated and stirred 30min, be chilled to place after the room temperature and spend the night, centrifugal, centrifugal rotational speed 3000rpm, centrifugation time 20min, centrifugal liquid is according to concentrating the thick paste that condition is concentrated into relative density 1.44 among the step C;
E, get thick paste and be sub-packed in the drip pan, the control baking temperature is at 65 ℃, and is dry in the above vacuum drying oven of vacuum-0.05Mpa, after the oven dry extract powder;
F, an amount of Icing Sugar, the dextrin of adding, mixing is made granule, drying, compacting is (coating) in flakes.
Embodiment 3
The preparation of medicine capsule of the present invention
[prescription] Pseudobulbus Cremastrae Seu Pleiones 167g Rhizoma Smilacis Glabrae 1000g Herba Taxilli 500g Radix Salviae Miltiorrhizae 500g
Radix Astragali 500g Semen Coicis 1000g Radix Gentianae Macrophyllae 333g
[preparation method]
A, to take by weighing Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription standby;
B, crude drug is dropped in the extraction pot, add 8 times of water gagings, heating decocted 1.5 hours, and temperature to 100 ℃ picks up counting in jar; Temperature is down to 70 ℃ and is made filtration in jar, gets the filtrate I, is added with 8 times of water gagings and decocts 1.5 hours, gets the filtrate II by the method that obtains the filtrate I, merging filtrate I and filtrate II, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 68 ℃, is concentrated into relative density 1.2 more than vacuum-0.05Mpa, gets concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 40 ℃, slowly add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g, the limit edged stirs, after clarifier adds, continue insulated and stirred 30min, be chilled to place after the room temperature and spend the night, centrifugal, centrifugal rotational speed 3000rpm, centrifugation time 20min, centrifugal liquid is according to concentrating the thick paste that condition is concentrated into relative density 1.32 among the step C;
E, an amount of starch of adding, mixing, cold drying is ground into fine powder, sieves, and mixing incapsulates, namely.
Embodiment 4
The preparation of medicine oral liquid of the present invention.
[prescription] Pseudobulbus Cremastrae Seu Pleiones 167g Rhizoma Smilacis Glabrae 1000g Herba Taxilli 500g Radix Salviae Miltiorrhizae 500g
Radix Astragali 500g Semen Coicis 1000g Radix Gentianae Macrophyllae 333g
[preparation method]
A, to take by weighing Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription standby;
B, crude drug is dropped in the extraction pot, add 8 times of water gagings, heating decocted 1.5 hours, and temperature to 100 ℃ picks up counting in jar; Temperature is down to 70 ℃ and is made filtration in jar, gets the filtrate I, is added with 8 times of water gagings and decocts 1.5 hours, gets the filtrate II by the method that obtains the filtrate I, merging filtrate I and filtrate II, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 62 ℃, is concentrated into relative density 1.2 more than vacuum-0.05Mpa, gets concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 45 ℃, add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g slowly, the limit edged stirs, after clarifier adds, continue insulated and stirred 30min, be chilled to place after the room temperature and spend the night, centrifugal, centrifugal rotational speed 3000rpm, centrifugation time 20min, filtrate is concentrated into every ml and contains crude drug 2g approximately, and cold preservation is placed;
E, filtration add water to 2000ml, add an amount of Sugarless type sweeting agent and antiseptic, filter, stir, and fill, sterilization namely gets oral liquid.
Test example 5
The influence of the expression of human vascular endothelial ICAM-1, VCAM-1 that pastille serum of the present invention is induced urate and TNF-α
1, medicine pastille serum of the present invention human vascular endothelial ICAM-1 that TNF-α is induced, the influence of VCAM-1 gene expression.
Table 1: the human vascular endothelial ICAM-1 that medicine pastille serum of the present invention is induced TNF-α, the influence of VCAM-1 gene expression
Compare ▲ P≤0.01 with the blank group; Compare ☆ P≤0.05, ★ P≤0.01 with TNF-α stimulating group.
2, medicine pastille serum of the present invention human vascular endothelial ICAM-1 that urate is induced, the influence of VCAM-1 gene expression.
Table 2: the human vascular endothelial ICAM-1 that medicine pastille serum of the present invention is induced TNF-α, the influence of VCAM-1 gene expression
Compare △ P≤0.05, ▲ P≤0.01 with the blank group; Compare ☆ P≤0.05, ★ P≤0.01 with the urate stimulating group.
Conclusion: 1, under this medicine pastille serum intervention of middle concentration (5%), the mRNA of the ICAM-1 that urate and TNF-α induce expresses remarkable reduction, and the urate stimulating group of the more corresponding serum-concentration of protein expression significantly descends.2, under the intervention of basic, normal, high concentration (2.5%, 5%, 10%) medicine pastille serum of the present invention, the mRNA of the human vascular endothelial VCAM-1 that urate and TNF-α induce expresses all remarkable reduction (P≤0.05, P≤0.01).This medicine pastille serum has significant intervention effect to the expression of human vascular endothelial ICAM-1, VCAM-1 that urate and TNF-α induce; point out it to intervene hyperuricemia and bring out the inflammatory reaction of arteriosclerosis initial stage and arteriosclerosis, to the protective effect mechanism of endothelial injury.
Test example 6
Medicine of the present invention is to the research of hyperlipidemia rats blood fat and liver inner lipid metabolism disorder adjusting
Table 3 medicine of the present invention is to the result that influences of the TC of hyperlipidemia rats serum and liver
Compare with normal group
*P＜0.05,
*P＜0.01; Compare ☆ P＜0.05, ☆ ☆: P＜0.01 with model group;
Compare ★: P＜0.05, ★ ★: P＜0.01 with the Xuezhikang group
Table 4 medicine of the present invention is to the result that influences of the TG of hyperlipidemia rats serum and liver
Compare with normal group
*P＜0.05,
*P＜0.01; Compare ☆ P＜0.05, ☆ ☆: P＜0.01 with model group;
3, hepatic tissue pathology result
(1) perusal result:
1. normal liver: Hepatic is scarlet, and matter is soft, smooth surface.
2. pathological liver: 1. model group: Hepatic is yellowish, and matter crust slightly owes smooth, is graininess.2. Chinese medicine intervention group: relatively Hepatic is light red partially with normal group, and matter is soft, smooth surface.3. Xuezhikang group: Hepatic is dark red partially, and matter is soft, smooth surface.
(2) light microscopic result (seeing accompanying drawing 1～6)
1. normal group: the low power mirror, normal hepatocytes lobule and portal area, hepatic tissue is made up of numerous lobules of liver, and lobule central authorities are central vein, centered by central vein, liver cell plate becomes radial arrangement, and hepatocyte is oval, eosinophilic cytoplasmic, nuclear is circular, is positioned at central authorities.High power mirror normal hepatocytes lobule, the portal area.
2. model group: the low power mirror, fatty degeneration of liver is outstanding to involve whole lobules of liver, and lobules of liver liver plate structure is destroyed; The high power mirror has fat to drip merge to form netted in the cytoplasm of liver, have fat to drip in the hepatic tissue to form the sky that differs in size and dye vesicle.The subregion hydropic degeneration becomes the balloon sample to become, the portal area proliferation of fibrous tissue, and karyolysis appears in indivedual hepatocyte.
3. high dose group: with model group comparison lesion degree alleviate the most obvious, the cell cavity obviously diminishes and number obviously reduces, the fibroplasia of part portal area reduces the most obvious.
4. middle dosage group: the bigger fat that as seen is dispersed in drips the vesicle of formation, and edema is arranged in the part of hepatocytes.
5. low dose group: the fat in the visible larger area cytoplasm of liver drips the sky combustion vesicle of formation, alleviates to some extent with model group comparison portal area fibroplasia.
6. Xuezhikang group: have fat to drip the sky combustion vesicle of formation in the lobules of liver, portal area fibroplasia alleviates obviously than model group.
Conclusion: 1. compare with model group, medicine of the present invention significantly reduces TC, TG, the LDL-c level (P＜0.05 or P＜0.01) of hyperlipidemia rats serum, the HDL-c level of the serum that significantly raises (P＜0.01); Aspect the reduction serum TC, with its high dose group of Xuezhikang group comparison significant difference (P＜0.05) is arranged; Aspect reduction liver TC, with its high and low dose group of Xuezhikang group comparison significant difference (P＜0.05) is arranged.2. compare with model group, medicine of the present invention is to antioxidation P＞0.05 no difference of science of statistics of hyperlipidemia rats; It respectively organizes no difference of science of statistics (P＞0.05) with the comparison of Xuezhikang group.3. medicine of the present invention can protect hepatocyte to suppress steatosis, the metabolism disorder of scalable hyperlipidemia rats liver inner lipid.Point out medicine of the present invention to have significant blood fat reducing, liver-protective effect.To prevention coronary heart disease, cardiovascular disease such as atherosclerosis have certain research using value.
Test example 7
The clinical observation of Drug therapy hyperuricemia of the present invention
1, clinical data
Adopt at random, double blinding, placebo clinical trial design.Select age 18-65 year hyperuricemia 60 examples, wherein merge gouty arthritis 25 examples, merge hyperlipemia 28 examples.
2, case choice criteria
1. tcm diagnosis standard [with reference to Chinese Medicine science and technology publishing house " new Chinese medicine clinical research guideline " May in 2002 the 1st edition]
Insufficiency of the spleen or press from both sides damp and hot stasis of blood knot card: primary symptom: lassitude and weak, diarrhea with loose stool, redness and swelling of joints or pain; Inferior disease: spiritlessness and sparing of words, limbs are stranded heavy, tastelessness and no thirst, lack of appetite is indigestion and loss of appetite, and gastral cavity abdomen painful abdominal mass is vexed, the nausea of feeling sick, limbs edema or urine amount are few.The tongue arteries and veins: pale tongue or red, indentation arranged, thin fur or yellow greasy, moderate pulse or moisten thin.
Possess 3 of main symptoms (tongue fur indispensability); Or 2 of main symptoms, it is namely diagnosable to add time card 2 (tongue fur indispensabilities).
2. Western medicine diagnose standard
The gout diagnostic criteria is with reference to 11 editions " practical internal medicine " gout diagnostic criterias of chief editor such as Chen Haozhu and chief editors' such as " new Chinese medicine clinical research guideline " and Wang Haiyan the 2nd edition " nephrology ")
The asymptomatic hyperuricemia of a is clinical asymptomatic, blood uric acid concentration: male UA〉420 μ mmol/L, women UA〉360 μ mmol/L.
B gouty arthritis sole of the foot toe, tarsometatarsus, ankle, knee joint etc. are located the simple joint red and swollen heat pain, blood uric acid concentration UA〉420 μ mmol/L, the acid of urinating〉4.17mmol/d, the synovial bursa fluid inspection finds urate crystal, the x line is taken the photograph the sclerotin that sheet checks that the cartilage edge closes on the joint irregular sample round defect of giving a farfetched interpretation, and there is proliferation response at the edge.
3 Therapeutic Method
Diet Therapy (scheme slightly), two groups of patients all avoid high purine class diet, alleviating alcohol addiction.Every day, amount of drinking water was no less than 2000ml.
Drug therapy and the course for the treatment of:
1. treatment group: the present invention forms granule, and 2 times on the one, one time 1 bag, oral, treated for 4 weeks continuously.
2. matched group: simulation granule (placebo), 2 times on the one, one time 1 bag, oral, treated for 4 weeks continuously.
4, observation index
1. doing well,improving situation: the light and heavy degree to each symptom adopts sxemiquantitative integration method record, at treatment beginning, 2 weekends, record respectively when finish the course for the treatment of.
2. laboratory detects:
Blood plasma uric acid, blood glucose, blood fat (TG, TCH, LDL-c), liver, renal function, blood electrolyte, blood, urine, stool routine examination, EKG, before the treatment and treatment back 4 weekly checks record 1 time.
5, efficacy determination
1. comprehensive therapeutic effect is judged (with reference to the clinical research guideline of new Chinese medicine treatment gout)
Clinical recovery: treatment back cardinal symptom, sign disappear, and symptom integral reduces 〉=95%, and it is normal that blood uric acid recovers;
Produce effects: treatment back cardinal symptom, sign are obviously improved, and symptom integral reduces 〉=70%, and blood uric acid is normal or approach normal;
Effectively: treatment back cardinal symptom, sign all take a favorable turn, and symptom integral reduces 〉=30%, and blood uric acid has improvement;
Invalid: treatment back cardinal symptom, sign all do not have improvement, and symptom integral reduces＜30%, and blood uric acid does not have improvement.
Computing formula (nimodipine method) is: ［ integration before (integration before the treatment-treatment back integration) ÷ treatment ］ * 100%.
6, result
1. tcm symptom integration and the every index situation of laboratory are relatively learned by statistics and are handled before two groups age, sex, the treatment, all do not have significant difference, have comparability (P＞0.05).
2. two groups of comprehensive therapeutic effects relatively
Two groups of comprehensive therapeutic effects relatively have significant differences (P＜0.01) through the X2 check.
Table 5 test group and matched group comprehensive therapeutic effect are relatively
7, conclusion
Test group clinical recovery rate 20%, obvious effective rate 26.67%, effective percentage 40%, total effective rate 80%, matched group clinical recovery rate 3.33%, obvious effective rate 6.67%, effective percentage 23.33%, total effective rate 33.33%.Show: the present invention treats the hyperuricemia placebo group that obviously is better than evident in efficacy.
Test example 8
The clinical observation of Drug therapy hyperlipemia of the present invention
With the present invention 15 routine hyperuricemias being merged hyperlipemia treats, all there is remarkable decline (P＜0.01) blood TG, TCH, LDL-c treatment back before the treatment, difference and matched group (13 example) before and after the treatment compare, and highly significant difference (P＜0.01) is arranged.Show that the present invention treats the hyperlipemia placebo group that obviously is better than evident in efficacy.
In a word, the above only is preferred embodiment of the present invention and test example, and all equalizations of doing according to the present patent application claim change and modify, and all should belong to the covering scope of training of the present invention.
Claims (9)
1. medicine that reduces blood uric acid, it is characterized in that: the medical material by following weight proportion is prepared from: 5 parts of Pseudobulbus cremastrae seu pleiones, 30 parts of Rhizoma Smilacis Glabraes, 15 parts of Herba Taxillis, 15 parts of Radix Astragali, 15 parts of Radix Salviae Miltiorrhizaes, 30 parts of Semen Coiciss, 10 parts of Radix Gentianae Macrophyllae.
2. a kind of preparation method that reduces the medicine of blood uric acid according to claim 1, its step comprises:
A, weigh medical material: Pseudobulbus cremastrae seu pleiones, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis and Radix Gentianae Macrophyllae, standby;
B, medical material is dropped in the extraction pot, decoct with water, a temperature is down to 70 ℃ of I that filter to get filtrate in jar, decoct with water, temperature is down to 70 ℃ of II that filter to get filtrate, merging filtrate I and filtrate II in jar again, centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, the centrifugation time 20min of getting of room temperature;
C, centrifugal liquid is imported in the concentrator, be concentrated into relative density 1.1 ~ 1.2, get concentrated solution;
D, get concentrated solution and put in the settling tank, heat 40～50 ℃, add chitosan clarifier, the limit edged stirs, and after clarifier adds, continues insulated and stirred 20 ~ 30 minutes, it is centrifugal after 2 hours to be chilled to room temperature, centrifugal rotational speed 3000rpm, centrifugation time 20min, centrifugal liquid is according to concentrating the clear paste that condition is concentrated into relative density 1.32 ~ 1.44 among the step C.
3. a kind of preparation method that reduces the medicine of blood uric acid according to claim 2 is characterized in that, also comprise step e: qinghuo reagent is sub-packed in the drip pan, and is dry in vacuum drying oven, gets dry extract after the oven dry.
4. a kind of preparation method that reduces the medicine of blood uric acid according to claim 2 is characterized in that, also comprises step F: get dry extract and add adjuvant, make oral liquid, tablet, capsule, pill, granule or drop pill.
5. a kind of preparation method that reduces the medicine of blood uric acid according to claim 2 is characterized in that: when step B decocts with water, add 8 times of water gagings twice, continue heating after the temperature to 100 ℃ in jar and decocted 1.5 hours.
6. a kind of preparation method that reduces the medicine of blood uric acid according to claim 2 is characterized in that: temperature was 65 ± 3 ℃ when the medicine of step C concentrated, more than vacuum-0.05Mpa.
7. a kind of preparation method that reduces the medicine of blood uric acid according to claim 3 is characterized in that: control baking temperature at 65 ± 5 ℃, more than vacuum-0.05Mpa when dry in the step e.
8. the application of medicine according to claim 1 in the medicine of protecting for the preparation of reduction blood uric acid, blood fat reducing and Liver and kidney.
9. medicine according to claim 1 is for the preparation of the application in the medicine for the treatment of hyperuricemia or concurrent hyperlipemia.
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| CN105687901A (en) * | 2016-03-08 | 2016-06-22 | 青岛市中心医院 | Traditional Chinese medicine for treating hyperuricemia |
| CN105726809A (en) * | 2016-03-28 | 2016-07-06 | 张艳娟 | Medicine composition for treating primary hyperuricemia |
| CN107875266A (en) * | 2017-11-28 | 2018-04-06 | 高大朋 | For treating the oral traditional Chinese medicine of gout and tophus |
| CN119405816A (en) * | 2025-01-02 | 2025-02-11 | 正大青春宝药业有限公司 | A uric acid-lowering pharmaceutical composition and its preparation method, application and product |
| CN119405759A (en) * | 2025-01-09 | 2025-02-11 | 正大青春宝药业有限公司 | Composition for reducing uric acid and improving renal function, and preparation method, application and product thereof |
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| CN101185730A (en) * | 2006-11-21 | 2008-05-28 | 申海莉 | Pain-relieving mixture for treating gouty arthritis |
| CN101837093A (en) * | 2006-10-13 | 2010-09-22 | 吴洵邦 | Chinese medicinal composition for curing gout |
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| CN101837093A (en) * | 2006-10-13 | 2010-09-22 | 吴洵邦 | Chinese medicinal composition for curing gout |
| CN101185730A (en) * | 2006-11-21 | 2008-05-28 | 申海莉 | Pain-relieving mixture for treating gouty arthritis |
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Effective date of registration: 20191202 Address after: 310023 No. 551, Xixi Road, Hangzhou, Zhejiang, Xihu District Patentee after: Zhengda Qingchunbao Pharmaceutical Co., Ltd. Address before: 310007 No. 453, Stadium Road, Hangzhou, Zhejiang, Xihu District Patentee before: Hangzhou Chinese Medicinal Hospital |