CN102309705A - 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
The invention which belongs to the field of traditional Chinese medicines discloses a medicine for reducing serum uric acid, a preparation method thereof and a purpose thereof. The medicine is prepared from the following medicinal materials, by weight, 5-15 parts of edible tulip bulb, 10-60 parts of Smilax glabra, 6-30 parts of parasitic loranthus, 9-45 parts of Radix Astragali, 10-30 parts of Savia miltiorrhiza, 10-60 parts of coix seed, and 9-20 parts of Gentiana macrophylla. The medicinal materials are subjected to technologies of decoction, concentration, impurity removal, drying and the like to obtain effective parts for reducing serum uric acid, and the effective parts can be prepared into different clinically acceptable dosage forms with routine methods. The purpose comprises applications in preparing medicines for reducing serum uric acid, blood fat and protecting livers and kidneys, and applications of medicines for treating hyperuricacidemia or concurrent hyperuricacidemia. The medicine of the present invention which has effects of reducing serum uric acid, blood fat and protecting livers and kidneys can be used for treating hyperuricacidemia or concurrent hyperuricacidemia.
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.
Background technology
Hyperuricemia (Hyperuricacidemia) is that purine metabolic disturbance or urate excretion reduce caused one group of disease, and asymptomatic clinically hyperuricemia is very common, if hyperuricemia can not in time be controlled; The uric acid salt is deposited on tissues such as kidney or joint; Causing pathological change, is the risk factor of gout, diabetes, coronary heart disease and other peripheral vascular diseases, and potential risk property 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 all has certain toxicity and side effect, and occurs unusual after the drug withdrawal once more.Simultaneously; The sickness rate that high purine, high fat diet cause hyperuricemia and merge hyperlipemia also is obvious ascendant trend, though the blood lipid regulation medicine has curative effect preferably, exist drug withdrawal after blood fat repeatedly; Or side effect in various degree, it is not enough to cost an arm and a leg etc.
Though natural drug particularly Chinese medicine compound with regard to single pathology link; May not obtain synthetic drug such clinical effectiveness that attracts people's attention 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; It is disorderly at antimetabolic, alleviate related diseases because of aspects such as effect, protection organ function and injury repairing, and original effect is arranged, and becomes 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 hyperuricemia and merging hyperlipemia sickness rate at present, the Chinese medicine preparation of studying many target spots, effective low toxicity has profound significance.
Summary of the invention
Occur defectives such as unusual once more after the medicine that the present invention is directed to existing reduction blood uric acid toxic and side effects and the drug withdrawal in various degree, 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 able to solve through following technical proposals:
A kind of medicine that reduces blood uric acid is prepared from the medical material of following weight proportion: Bulbus Tulipae 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 the medical material of following weight proportioning: 5 parts of Bulbus Tulipae, 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 Coicis, 10 parts of Radix Gentianae Macrophyllae.
Medicament selection Bulbus Tulipae 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 Bulbus Tulipae 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 kinds of 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 that muscles and bones, sharp joint, stopping leak are rushed down, to remove 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.Gentiana eradicates rheumatism, Shujin network, Qingxudong heat.
The method for preparing of the medicine of reduction blood uric acid according to the invention comprises the steps:
A, to weigh Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae subsequent use;
B, medical material is dropped in the extraction pot, decocte with water, a temperature is reduced to 70 ℃ of mistakes and is filtered the filtrating I in jar; Decocte with water again is by the method for the I that obtains the filtrating II of must filtrating, merging filtrate I and filtrating 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, is concentrated into relative density 1.1 ~ 1.2, 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, process 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, during step B decocte with water, add 8 times of water gagings twice, temperature to 100 a ℃ continued heating decocted 1.5 hours in jar.
As preferably, temperature was 65 ± 3 ℃ when the medicine of step C concentrated, more than vacuum-0.05Mpa.
As preferably, in the step e when dry the control baking temperature at 65 ± 5 ℃, more than vacuum-0.05Mpa.
Medicine of the present invention is used for reducing the application of the medicine of blood uric acid, blood fat reducing and Liver and kidney protection in preparation.
Medicine of the present invention is used for treating the application of the medicine of hyperuricemia or concurrent hyperlipemia in preparation.
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.Experiment in vitro research in early stage shows: pastille serum of the present invention has significant intervention effect to the expression of urate and the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1; Point out it to intervene hyperuricemia and bring out 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
Through embodiment the present invention is described in further detail below.
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
[method for preparing]
A, to weigh Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription subsequent use;
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 reduced to 70 ℃ and is made filtration in jar, and the I of must filtrating is added with 8 times of water gagings and decocted 1.5 hours, by the method for the I that obtains the filtrating II of must filtrating, merging filtrate I and filtrating II, room temperature centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, centrifugation time 20min;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 65 ± 3 ℃, more than vacuum-0.05Mpa, is concentrated into relative density 1.2, concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 40～50 ℃, add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g slowly; The limit edged stirs, and after clarifier adds, continues 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, process granule, dry below 60 ℃, process 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 HPLC (an appendix VI of Chinese Pharmacopoeia version in 2005 D).
Chromatographic condition and system suitability test: with the octadecylsilane chemically bonded silica is filler; With acetonitrile-water (35:65) is mobile phase; 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 process the solution that every 1ml contains 1mg, promptly gets.
The preparation of need testing solution: get these article under the content uniformity item, porphyrize is got about 5g, and precision steelyard is fixed, adds the ultrasonic 30min of methanol 50ml; Filter, discard filtrating just, accurately measure subsequent filtrate 25ml, water bath method, residue add water 20ml dissolving; And with extracted with diethyl ether 3 times, each 30ml discards ether, and combining water layer is with water saturated n-butanol extraction 3 times; Each 20ml merges n-butanol extracting liquid, and with 1% sodium hydroxide solution washing 3 times, each 20ml discards water layer; N-butyl alcohol liquid evaporate to dryness adds dissolve with methanol and is settled to 1ml behind the evaporate to dryness, cross 0.45 μ m aqueous filter membrane, promptly gets.
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
[method for preparing]
A, to weigh Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription subsequent use;
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 reduced to 70 ℃ and is made filtration in jar, and the I of must filtrating is added with 8 times of water gagings and decocted 1.5 hours, by the method for the I that obtains the filtrating II of must filtrating, merging filtrate I and filtrating II, room temperature centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, centrifugation time 20min;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 65 ℃, more than vacuum-0.05Mpa, be concentrated into to relative density 1.2, concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 50 ℃, add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g slowly; The limit edged stirs, and after clarifier adds, continues 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 processed 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
[method for preparing]
A, to weigh Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription subsequent use;
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 reduced to 70 ℃ and is made filtration in jar, and the I of must filtrating is added with 8 times of water gagings and decocted 1.5 hours, by the method for the I that obtains the filtrating II of must filtrating, merging filtrate I and filtrating II, room temperature centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, centrifugation time 20min;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 68 ℃, more than vacuum-0.05Mpa, be concentrated into to relative density 1.2, concentrated solution;
D, get concentrated solution and put in the settling tank, be heated to 40 ℃, add chitosan clarifier (be mixed with 2% acetum 1% chitosan gum liquid solution) 10g slowly; The limit edged stirs, and after clarifier adds, continues 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, and promptly gets.
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
[method for preparing]
A, to weigh Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis, Radix Gentianae Macrophyllae by prescription subsequent use;
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 reduced to 70 ℃ and is made filtration in jar, and the I of must filtrating is added with 8 times of water gagings and decocted 1.5 hours, by the method for the I that obtains the filtrating II of must filtrating, merging filtrate I and filtrating II, room temperature centrifugal centrifugal liquid, centrifugal rotational speed 3000rpm, centrifugation time 20min;
C, centrifugal liquid is imported in the concentrator, temperature is controlled at 62 ℃, more than vacuum-0.05Mpa, be concentrated into to relative density 1.2, 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, and after clarifier adds, continues insulated and stirred 30min; Be chilled to place after the room temperature and spend the night, centrifugal, centrifugal rotational speed 3000rpm; Centrifugation time 20min, filtrating 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 promptly gets oral liquid.
Test Example 5
Pastille serum of the present invention is to the influence of the expression of urate and the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1
1, medicine pastille serum of the present invention is to the influence of the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1 gene expression.
Table 1: medicine pastille serum of the present invention is to the influence of the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1 gene expression
| Group | N | ICAM-1/ β-actin | VCAM-1/ β-actin |
| The blank group | 3 | 0.444 ± 0.036 | 0.082 ± 0.019 |
| TNF-α stimulating group | 3 | 0.868 ± 0.027 ▲ | 0.353 ± 0.038 ▲ |
| The low concentration intervention group | 3 | 0.632 ± 0.030 ▲ ★ | 0.205 ± 0.027 ▲ ★ |
| Middle concentration intervention group | 3 | 0.373 ± 0.023 ★ | 0.272 ± 0.039 ▲ ☆ |
| The high concentration intervention group | 3 | 0.690 ± 0.073 ▲ ★ | 0.241 ± 0.032 ▲ ★ |
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 is to the influence of the inductive human vascular endothelial ICAM-1 of urate, VCAM-1 gene expression.
Table 2: medicine pastille serum of the present invention is to the influence of the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1 gene expression
| Group | N | ICAM-1/ β-actin | VCAM-1/ β-actin |
| The blank group | 3 | 0.435 ± 0.015 | 0.030 ± 0.013 |
| The urate stimulating group | 3 | 0.608 ± 0.097 △ | 0.256 ± 0.044 ▲ |
| The low concentration intervention group | 3 | 0.511 ± 0.045 | 0.212 ± 0.040 ▲ ☆ |
| Middle concentration intervention group | 3 | 0.307 ± 0.025 △ ★ | 0.214 ± 0.038 ▲ ☆ |
| The high concentration intervention group | 3 | 0.848 ± 0.140 ▲ ★ | 0.196 ± 0.017 ▲ ★ |
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 urate and the inductive ICAM-1 of TNF-α expresses has 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 urate and the inductive human vascular endothelial VCAM-1 of TNF-α expresses all has remarkable reduction (P≤0.05, P≤0.01).This medicine pastille serum has significant intervention effect to the expression of urate and the inductive human vascular endothelial ICAM-1 of TNF-α, VCAM-1; Point out it to intervene hyperuricemia and bring out 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 * P＜0.05, * * P＜0.01 with normal group; 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 * P＜0.05, * * P＜0.01 with normal group; 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. herbs 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
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 balloon appearance 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 dose groups: the visible bigger fat that 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, significant difference (P＜0.05) is arranged with its high dose group of Xuezhikang group comparison; Aspect reduction liver TC, significant difference (P＜0.05) is arranged with its high and low dose group of Xuezhikang group comparison.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 Application Research and are worth.
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 is indispensable); Or 2 of main symptoms, it is promptly diagnosable to add 2 of time cards (tongue fur is indispensable).
2. Western medicine diagnose standard
The gout diagnostic criteria is with reference to chief editor's such as Chen Haozhu 11 editions " practical internal medicine " gout diagnostic criterias 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, and the x line is taken the photograph the sclerotin that sheet inspection cartilage edge closes on the joint has irregular kind 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.
The Drug therapy and the course of treatment:
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 of treatment.
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 approaching 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 < 30%, blood uric acid does not have improvement in the symptom integral minimizing.
Computing formula (nimodipine method) is: ［ integration before (integration before the treatment-treatment back integration) ÷ treatment ］ * 100%.
6, result
1. tcm symptom integration and laboratory each item index situation relatively through statistical procedures, all do not have significant difference before two groups age, sex, the treatment, 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 superior to 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; Blood TG, TCH, LDL-c treat all has remarkable decline before treat the back (P 0.01); 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 superior to evident in efficacy.
In a word, the above is merely preferred embodiment of the present invention and Test Example, and all equalizations of doing according to claim of the present invention change and modify, and all should belong to the covering scope of training of the present invention.
Claims (10)
1. medicine that reduces blood uric acid, it is characterized in that: the medical material following weight proportion is prepared from: Bulbus Tulipae 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.
2. a kind of medicine that reduces blood uric acid according to claim 1, it is characterized in that: the medical material following weight proportion is prepared from: 5 parts of Bulbus Tulipae, 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 Coicis, 10 parts of Radix Gentianae Macrophyllae.
3. method for preparing that reduces the medicine of blood uric acid, its step comprises:
A, weigh medical material: Bulbus Tulipae, Rhizoma Smilacis Glabrae, Herba Taxilli, Radix Astragali, Radix Salviae Miltiorrhizae, Semen Coicis and Radix Gentianae Macrophyllae, subsequent use;
B, medical material is dropped in the extraction pot, decocte with water, a temperature is reduced to 70 ℃ of mistakes and is filtered the filtrating I in jar; Decocte with water again, temperature is reduced to 70 ℃ of mistakes and is filtered the filtrating II in jar, merging filtrate I and filtrating 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, is concentrated into relative density 1.1 ~ 1.2, 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.
4. a kind of method for preparing that reduces the medicine of blood uric acid according to claim 3 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.
5. a kind of method for preparing that reduces the medicine of blood uric acid according to claim 3 is characterized in that, also comprises step F: get dry extract and add adjuvant, process oral liquid, tablet, capsule, pill, granule or drop pill.
6. a kind of method for preparing that reduces the medicine of blood uric acid according to claim 3 is characterized in that: during step B decocte with water, add 8 times of water gagings twice, temperature to 100 a ℃ continued heating decocted 1.5 hours in jar.
7. a kind of method for preparing that reduces the medicine of blood uric acid according to claim 3 is characterized in that: temperature was 65 ± 3 ℃ when the medicine of step C concentrated, more than vacuum-0.05Mpa.
8. a kind of method for preparing that reduces the medicine of blood uric acid according to claim 3 is characterized in that: in the step e when dry the control baking temperature at 65 ± 5 ℃, more than vacuum-0.05Mpa.
9. medicine according to claim 1 and 2 is used for reducing the application of the medicine of blood uric acid, blood fat reducing and Liver and kidney protection in preparation.
10. medicine according to claim 1 and 2 is used for treating the application of the medicine of hyperuricemia or concurrent hyperlipemia in preparation.
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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 |
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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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| 周德杰: "高尿酸血症的治疗进展", 《吉林医药学院学报》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| Publication number | Publication date |
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| CN102309705B (en) | 2013-08-28 |
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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 |