CN1559535A - Chinese medicine oral preparaton for treating urinary system infestation and its preparation method - Google Patents
Chinese medicine oral preparaton for treating urinary system infestation and its preparation method Download PDFInfo
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- CN1559535A CN1559535A CNA2004100155776A CN200410015577A CN1559535A CN 1559535 A CN1559535 A CN 1559535A CN A2004100155776 A CNA2004100155776 A CN A2004100155776A CN 200410015577 A CN200410015577 A CN 200410015577A CN 1559535 A CN1559535 A CN 1559535A
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- 239000006228 supernatant Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000006192 thin film tablet Substances 0.000 description 1
- 210000003371 toe Anatomy 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 238000001890 transfection Methods 0.000 description 1
- 208000000143 urethritis Diseases 0.000 description 1
- 238000002562 urinalysis Methods 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
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Abstract
A Chinese medicine in the form of capsule or tablet for treating the infection of urinary system is prepared from 9 Chinese-medicinal materials including bupleurum root, common knot-grass, phellodendron bark, schisandra fruit, etc through extracting, concentrating, drying, mixing with additive, and loading in capsules or tabletting.
Description
Affiliated technical field
The invention belongs to the preparing technical field of pharmaceuticals, be specifically related to a kind of Chinese patent medicine oral formulations for the treatment of urinary system infection and preparation method thereof.
Background technology
Urinary system infection is meant the caused Urinary system inflammation of non-specific bacterial infection of upper and lower urinary tract, comprises pyelonephritis, cystitis, urethritis.Now be called urinary tract infection.The urinary tract infection epidemiologic data shows that this disease is in the majority with the women, and the bachelorette sickness rate is 2%, and married women's sickness rate increases to 5%, and this is relevant with sexual life.Anemia of pregnant woman's urinary tract infection incidence rate is about 7%.Urinary tract infection seldom takes place in the male, just mostly occurs because of prostate hyperplasia after 50 years old.Old women and male's urinary tract infection sickness rate can be up to 10%.Discomfort, lumbago on the common frequent micturition of urinary tract infection person, urgent micturition, dysurea, the pubic arch, very then shiver with cold, generate heat, have a headache, feel sick, vomiting etc., have a strong impact on patient's daily life and work, serious urinary tract infection also can cause complication such as necrosis of renal papillae, perinephric abscess.
In recent years, the research of this disease of Chinese medicine prevention is paid attention to deeply, from therapeutic outcome, Chinese medicine is accumulating rich experience aspect the treatment primary disease, its special advantages and wide prospect have been shown, characteristics with determined curative effect and less toxic and side effects, the Chinese traditional patent formulation preparation of more existing at present treatment primary disease forms.But because the sickness rate height and the pathomechanism complexity of urinary system infection disease, existing pharmaceutical preparation still can not be satisfied clinical and needs market fully.It is the granule of being made by nine flavor Chinese medicines such as Radix Bupleuri, Cortex Phellodendri, the Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis, Radix Glycyrrhizae that " Drug Standard of Ministry of Public Health of the Peoples Republic of China " (17 in Chinese traditional patent formulation preparation) records kind " MINIAONING KELI ", has clearing heat and freeing strangury, promoting urination and stopping pain, the function of reinforcing kidney and strengthening resistance.Be mainly used in pyretic stranguria clinically, treatment of diseases such as hot urination burning pain and urinary system infection.Its preparation method is: above nine flavors decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, collecting decoction staticly settled 24 hours, filter, filtrate is concentrated into the clear paste that relative density is about 1.3 (80 ℃), 1 part of qinghuo reagent, with 4 parts of sucrose, 1 part in dextrin is made granule, drying, packing, promptly.Usage and consumption are: boiled water is taken after mixing it with water, a 12g, 3 times on the one.Above-mentioned preparation technology exists certain defective, put together as all medicines in the prescription and mix to decoct to extract, contained main effective ingredient such as Cortex Phellodendri, the Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis can not be extracted effectively, therefore can not give full play to this formula for treating effect.In addition, situation about from its usage and dosage and clinical practice application process, occurring, owing to be granule, 5 times in preparation process, have been added to the adjuvant-sucrose and the dextrin of clear paste amount, thereby dose is big, and inconvenience etc. is carried in transportation, contains a large amount of sugars simultaneously, diabetics be difficult for to be accepted, and has limited this kind being extensive use of clinically.
Summary of the invention
The object of the present invention is to provide a kind of active constituent content height, steady quality, good effect, the taking dose Chinese patent medicine oral formulations that is used for the treatment of urinary system infection little, easy to use.
Another object of the present invention is to provide the preparation method of this oral preparation of Chinese traditional medicinal, this preparation method is with respectively distinguish the flavor of effective ingredient in the medicine of abundant extraction, and adopts advanced pharmaceutical formulation-capsule, tablet.
The Chinese patent medicine oral formulations that is used for the treatment of urinary system infection provided by the invention, form by the following weight proportion raw material:
Radix Bupleuri 110～130 Fructus Schisandrae Chinensis 90～110 hold 90～110
Cortex Phellodendri 110～130 Radixs Angelicae Dahuricae 90～110 Radix Dipsacis 90～110
Herba Taxilli 90～110 Semen Abutili 110～130 Radix Glycyrrhizaes 90～110.
Above-mentioned Chinese medicine raw materials by weight proportion is made the preparation method of oral preparation of Chinese traditional medicinal of the present invention, may further comprise the steps:
(1) gets the Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis and add 6～10 times of amount 65～90% ethanol, reflux, extract, 2～4 times, each 1～3h.Merge ethanol extract, decompression recycling ethanol; Be condensed into thick paste, cold drying is ground into fine powder, and is standby;
(2) get Cortex Phellodendri and add 8～12 times of water gagings immersion 1～6h, decoct each 1～3h 2～3 times, filter, merging filtrate, being evaporated to relative density is 1.05-1.12 (60 ℃ of surveys), add ethanol to determining alcohol and reach 45～60%, stir, leave standstill, filter, residue is extremely closely colourless with 45～60% washing with alcohol, merging filtrate and washing liquid, decompression recycling ethanol is condensed into thick paste, cold drying, be ground into fine powder, standby;
(3) get that Radix Bupleuri, hold, Radix Dipsaci, Herba Taxilli, Semen Abutili, glycyrrhizic liuwei drug, add 8～12 times of water gagings and soak 1～6h, decoct 2-4 time, each 1～3h filters merging filtrate, being evaporated to relative density is 1.15-1.25 (60 ℃ of surveys), adds ethanol to determining alcohol and reaches 45～60%, stirs, leave standstill, filter decompression filtrate recycling ethanol, be condensed into thick paste, cold drying is ground into fine powder, and is standby;
(4) get above-mentioned (1), (2), (3) item fine powder down, merge, add carboxymethyl starch sodium, microcrystalline Cellulose, fully mix homogeneously, the system soft material is granulated drying, granulate, add an amount of magnesium stearate mixing, encapsulated or tabletting, coating promptly make capsule of the present invention or tablet.
Raw material used in the present invention requires to meet respectively " relevant every regulation under each Chinese medicine item of Chinese pharmacopoeia version in 2000.Coating adopts film coating, and its adjuvant Opadry (opadry AMB) requires to meet the USP standard.
The principle of foundation of the present invention and beneficial effect:
1. the extraction of the Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis: the main effective ingredient of the Radix Angelicae Dahuricae is a coumarin kind compound, and imperatorin is represented composition for it.Pharmacological experiments shows that the coumarin kind compound in the Radix Angelicae Dahuricae has pharmacological actions such as anti-inflammation, antipyretic-antalgic, but coumarin kind compound is water insoluble, is soluble in organic solvent; Fructus Schisandrae Chinensis mainly contains lignan component, and specific examples of such components is soluble in organic solvent, has strong antioxidation, immunoregulation effect, anti-stress effect, and the ethanol immersion of Fructus Schisandrae Chinensis has antibacterial and anti-inflammation functions.Therefore can select for the extraction of the Radix Angelicae Dahuricae and Fructus Schisandrae Chinensis that economy is easy to get, the ethanol of environmentally safe extracts as extracting solvent for use.
The Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis are compared test by mixing the decocting extraction with alcohol reflux, and the utilization high performance liquid chromatography is measured the content of its effective ingredient imperatorin and deoxyschizandrin respectively, the results are shown in Table one:
The comparative test of table one Radix Angelicae Dahuricae and Fructus Schisandrae Chinensis decocting and ethanol extraction
Extracting method imperatorin (mg/g) deoxyschizandrin (mg/g)
8 times of water gagings decoct and extract, 2 times, 2h/ time 0.0132 0.0133
8 times the amount 80% ethanol extraction, 2 times, 2h/ time 0.7756 0.3114
As seen from the above table, the alcohol reflux extracting process of the Radix Angelicae Dahuricae of the present invention and Fructus Schisandrae Chinensis is compared with the decocting extraction process, can improve extraction ratio of effective constituents greatly, thereby improves drug effect.
2, the extraction of Cortex Phellodendri: Cortex Phellodendri mainly contains quaternary ammonium type alkaloids chemical constituents such as berberine, coptisine, jateorhizine, palmatine, have resisting pathogenic microbes, calmness, analgesic, improve multiple pharmacological effect such as immunologic function, antiulcer, be the medicinal main effective ingredient of Cortex Phellodendri, these compositions dissolubility in hot water is better, and the available water decocting method extracts.In order to determine rational extracting method, Cortex Phellodendri decoction separately, Cortex Phellodendri and Radix Glycyrrhizae closed fry in shallow oil, 8 herbal medicines such as Cortex Phellodendri and Radix Glycyrrhizae, Herba Taxilli close and fry in shallow oil that (three groups are and add 10 times of water gagings at every turn, decoct 2 times, each 1.5h, collecting decoction, filtration) after, the utilization high performance liquid chromatography is measured content of berberine in its extracting solution respectively, the results are shown in Table two:
Table two Cortex Phellodendri and Radix Glycyrrhizae are fried in shallow oil the influence to content of berberine altogether
The processing method Cortex Phellodendri adds Radix Glycyrrhizae and closes and fry in shallow oil Cortex Phellodendri and singly fry in shallow oil Cortex Phellodendri and add 8 flavors such as Radix Glycyrrhizae and close and fry in shallow oil
Content of berberine (%) 0.364 0.777 0.204
By table two as seen, Cortex Phellodendri and Radix Glycyrrhizae or with 8 herbal medicines such as Radix Glycyrrhizae, Herba Taxilli close fry in shallow oil after, content of berberine significantly reduces in the extracting solution, singly fries in shallow oil with Cortex Phellodendri to differ more than 1 times or 2 times.Therefore, the present invention adopts the method for independent decocting extraction to extract Cortex Phellodendri.In addition, after extracting solution concentrated, the ethanol with 45～60% carried out the precipitate with ethanol remove impurity, is used for tabletting after making extract powder again, both can reduce dose, can significantly improve the content of effective ingredient berberine again.
3, Radix Bupleuri, hold, the extraction of Radix Dipsaci, Herba Taxilli, Semen Abutili, glycyrrhizic liuwei drug: Radix Bupleuri and Radix Dipsaci all contain compositions such as saponin, flavonoid, pharmacological evaluation show have antiinflammatory, analgesic, analgesia, diuresis, antioxidation, antitumor and immunological enhancement.Herba Taxilli, hold, Semen Abutili contains and holds flavones ingredients such as glycosides and Quercitroside, and its decocting liquid all has diuresis, antibiotic, antivirus action.Radix Glycyrrhizae mainly contains glycyrrhizic acid and licoflavone constituents, has antiviral, antioxidation, antiulcer, endocrine regulation and immunoregulation effect.Therefore the contained main effective ingredient of above Six-element medicine all is dissolvable in water water, can merge together to extract with decocting, not only can reduce production cost, but also meet the actual needs of the clinical and big production of Chinese medicine.Therefore but decocting liquid contains non-active ingredients such as a large amount of starch, protein, phlegmatic temperament, has increased dose, selects for use 45～60% ethanol to carry out the precipitate with ethanol remove impurity, discards the dross and selects the essential, reduces the purpose of dose to reach.
4, dosage form of the present invention is thin film tablet and capsule, and trimmed size is 0.35～0.5 gram/sheet.Usage and dosage is: oral, and 3 times on the one, one time 3～5 (grain).Once take 12 grams with former " MINIAONING KELI " and compare, taking dose reduces greatly, thereby has taking convenience, is easy to transport the advantage of storing and carrying.
5, measure content of berberine in the present invention and commercially available " MINIAONING KELI " respectively by the utilization high performance liquid chromatography, the result shows, per 1 (grain) content of berberine of the present invention is more than the 1.5mg, promptly once minimum dose is 1.5mg/ grain * 3/time=4.5mg, and " MINIAONING KELI " every bag of (12 grams, ampoule) content of berberine only is 1.5mg, this shows that one of oral formulations effective ingredient of the present invention content of berberine is higher than more than 2 times of " MINIAONING KELI ", thereby improved drug effect.
6, tablet of the present invention has advantages such as disintegrate is rapid, mechanical performance is strong, humidity resistance is good with full water damp-proof Opadry (Opadry AMB) coating, has improved stability of formulation and effectiveness.
7, the present invention has clearing heat and freeing strangury, promoting urination and stopping pain, the effect of reinforcing kidney and strengthening resistance.Be used for diseases such as pyretic stranguria, hot urination burning pain and urinary system infection, have advantages such as steady quality, determined curative effect.Show that through pharmacodynamics test that the present invention has is analgesic, antibiotic, antiinflammatory, diuresis, analgesic effect, drug effect obviously is better than " MINIAONING KELI ".
The present invention is further illustrated below in conjunction with the report of embodiment and Pharmacodynamic test of active extract.
Embodiment 1
(1) gets Radix Angelicae Dahuricae 100g, Fructus Schisandrae Chinensis 100g, mix, add 8 times of amount 80% ethanol, reflux, extract, 2 times, each 1.5h.Merge ethanol extract, decompression recycling ethanol is condensed into thick paste, and cold drying is ground into fine powder, and is standby;
(2) get Cortex Phellodendri 120g and add 10 times of water gagings immersion 1h, decoct each 1.5h 2 times, filter, merging filtrate, being evaporated to relative density is 1.05-1.08 (60 ℃ of surveys), add ethanol to determining alcohol and reach 50%, stir, leave standstill 24h, filter, residue is extremely closely colourless with 50% washing with alcohol, merging filtrate and washing liquid, decompression recycling ethanol is concentrated into thick paste, low-temperature vacuum drying, be ground into fine powder, standby;
(3) get Radix Bupleuri 120g, and hold 100g, Radix Dipsaci 100g, Herba Taxilli 100g, Semen Abutili 120g, Radix Glycyrrhizae 100g, mix, add 10 times of water gagings and soak 1h, decoct 3 times, each 1.5h filters, merging filtrate, being evaporated to relative density is 1.15-1.25 (60 ℃ of surveys), adds ethanol to determining alcohol and reaches 50%, stir, leave standstill 24h, filter, decompression filtrate recycling ethanol is condensed into thick paste, cold drying, be ground into fine powder, standby;
(4) get above-mentioned (1), (2), (3) item fine powder down, merge, add carboxymethyl starch sodium, microcrystalline Cellulose, fully mix homogeneously is made soft material, granulate, and drying, granulate adds an amount of magnesium stearate mixing, and is encapsulated, promptly makes capsule of the present invention.
Embodiment 2
(1) gets Radix Angelicae Dahuricae 400g, Fructus Schisandrae Chinensis 400g, mix, add 10 times of amount 70% ethanol, reflux, extract, 3 times, each 1h.Merge ethanol extract, decompression recycling ethanol is condensed into thick paste, and cold drying is ground into fine powder, and is standby;
(2) get Cortex Phellodendri 480g and add 12 times of water gagings immersion 3h, decoct each 2h 2 times, filter, merging filtrate, being evaporated to relative density is 1.12 (60 ℃ of surveys), add ethanol to determining alcohol and reach 60%, stir, leave standstill 18h, filter, residue is extremely closely colourless with 60% washing with alcohol, merging filtrate and washing liquid, decompression recycling ethanol is concentrated into thick paste, low-temperature vacuum drying, be ground into fine powder, standby;
(3) get Radix Bupleuri 480g, and hold 400g, Radix Dipsaci 400g, Herba Taxilli 400g, Semen Abutili 480g, Radix Glycyrrhizae 400g, mix, add 12 times of water gagings and soak 4h, decoct 3 times, each 1.5h filters, merging filtrate, being evaporated to relative density is 1.20 (60 ℃ of surveys), adds ethanol to determining alcohol and reaches 60%, stir, leave standstill 20h, filter, decompression filtrate recycling ethanol is condensed into thick paste, cold drying, be ground into fine powder, standby;
(4) get above-mentioned (1), (2), (3) item fine powder down, merge, add carboxymethyl starch sodium, microcrystalline Cellulose, abundant mix homogeneously, with an amount of ethanol system soft material, 16 mesh sieve system granules, 50 ℃ of dryings, granulate, add an amount of magnesium stearate, mixing, tabletting, with Opadry (opadry AMB) bag film-coat, promptly make 1000 in tablet of the present invention.
Embodiment 3
(1) gets Radix Angelicae Dahuricae 110g, Fructus Schisandrae Chinensis 90g, mix, add 7 times of amount 60% ethanol, reflux, extract, 2 times, each 2.5h.Merge ethanol extract, decompression recycling ethanol is condensed into thick paste, and cold drying is ground into fine powder, and is standby;
(2) get Cortex Phellodendri 130g and add 10 times of water gagings immersion 3h, decoct each 1h 4 times, filter, merging filtrate, being evaporated to relative density is 1.07 (60 ℃ of surveys), add ethanol to determining alcohol and reach 50%, stir, leave standstill 22h, filter, residue is extremely closely colourless with 50% washing with alcohol, merging filtrate and washing liquid, decompression recycling ethanol is concentrated into thick paste, low-temperature vacuum drying, be ground into fine powder, standby;
(3) get Radix Bupleuri 110g, and hold 110g, Radix Dipsaci 90g, Herba Taxilli 110g, Semen Abutili 130g, Radix Glycyrrhizae 100g, mix, add 9 times of water gagings and soak 2h, decoct 3 times, each 1.2h filters, merging filtrate, being evaporated to relative density is 1.18 (60 ℃ of surveys), adds ethanol to determining alcohol and reaches 53%, stir, leave standstill 20h, filter, decompression filtrate recycling ethanol is condensed into thick paste, low-temperature vacuum drying, be ground into fine powder, standby;
(4) get above-mentioned (1), (2), (3) item fine powder down, merge, add carboxymethyl starch sodium, microcrystalline Cellulose, abundant mix homogeneously, with an amount of ethanol system soft material, 16 mesh sieve system granules, 45 ℃ of dryings, 12 mesh sieve granulate, add an amount of magnesium stearate, mixing, tabletting, the bag film-coat promptly makes tablet of the present invention.
For proving that the present invention treats the effect and the safety of urinary system infection, carried out toxicity and pharmacodynamics test, result of study is as follows:
One, acute toxicity test
Studies on acute toxicity result shows that behind the gastric infusion of the present invention, mice is movable obviously to be reduced, and diarrhoea partly occurs, and basic the recovery normally do not found other toxic reaction after 24 hours.Mice maximum dosage-feeding on the one is 179.2g crude drug/kg, is equivalent to 344.6 times of clinical adult's consumptions every day.
Two, long term toxicity test
The long term toxicity result of study shows, with large, medium and small three dosage of the present invention (40.16,20.8,10.4g crude drug/kg, 80,40,20 times of consumption are equivalent to respectively to be grown up) give rat continuous irrigation stomach three months, general situation, hematology, blood biochemical, routine urinalysis, electrocardiogram, system's dissection, organ coefficient and histopathology to rat all do not have obvious influence, do not find toxic reaction, convalescent period does not also have the retardance toxic reaction, and it is 40.16g crude drug/kg/ day that rat non-toxic reaction dosage is provided.
Three, Pharmacodynamic test of active extract
[test material]
Trial drug: Film coated tablets of the present invention, the 0.46g/ sheet, every gram experiment medicine is equivalent to crude drug 5.6g, is made into the solution of desired concn with distilled water.Contrast medicine, main agents and antibacterial: MINIAONING KELI; SANJIN PIAN; Reference culture is identified institute, Chinese medicine antibacterial preservation center available from the Chinese Academy of Medical Sciences, Beijing pharmaceutical biological product, and the clinical isolates strain is provided by first hospital of Xi'an Communications University etc., all identifies through the full-automatic digital Bacteria Identification instrument of TAXK-II.
[test method and result]
(1) analgesic test
50 of mices, male and female half and half are divided into 5 groups at random, 10 every group.First group of negative matched group given the isometric(al) normal saline; Second group of positive matched group given MINIAONING KELI 28g crude drug/kg; Third and fourth, five groups for Film coated tablets group of the present invention, gives Film coated tablets 7,14 of the present invention, 28g crude drug/kg respectively.Each organizes all gastric infusions, 0.2ml/10g, and every day 1 time, for three days on end.1 hour pneumoretroperitoneum of last administration is injected 0.6% acetum 0.1ml/10g, and mouse writhing reaction (mouse web portion pastes ground, indent, stretching, extension hind leg, distortion) number of times the results are shown in Table 1 in the observed and recorded 15min.
The influence that table 1 the present invention reacts mouse writhing (x ± s)
Group dosage number of animals writhing response
G crude drug/kg) (only) (inferior/15min)
Negative control group 10 14.9 ± 6.9
MINIAONING KELI 28 10 9.2 ± 5.0*
The present invention low dose of 7 10 13.5 ± 6.7
Dosage 14 10 9.2 ± 5.5 among the present invention
The heavy dose of 28 10 8.5 ± 5.6* of the present invention
Compare * P＜0.05 with negative control group
By table 1 as seen, Film coated tablets of the present invention can suppress the mouse writhing reaction that acetic acid stimulates, and compares with negative control group, and heavy dose of group has significant difference (P＜0.05), and the pain that the peaceful film-coat Dichlorodiphenyl Acetate of prompting urinary system stimulates has analgesic activity.The positive control drug MINIAONING KELI also can suppress the mouse writhing reaction that acetic acid stimulates, but effect is weaker than Film coated tablets of the present invention slightly.
(2) antiinflammatory test
(1) acute abdominal cavity exudative inflammation test
50 of mices, male and female half and half are divided into 5 groups at random, 10 every group.First group of negative matched group given the isometric(al) normal saline; Second group of positive matched group given MINIAONING KELI 28g crude drug/kg; Third and fourth, five groups for Film coated tablets group of the present invention, gives Film coated tablets 7,14 of the present invention, 28g crude drug/kg respectively.Each organizes all gastric infusions, 0.2ml/10g, and every day 1 time, for three days on end.After the last administration 1 hour, every Mus intravenous injection 0.5% azovan blue solution 0.1ml/10g, lumbar injection 0.6% acetic acid 0.2ml/ only then, the cervical vertebra dislocation is put to death behind the 20min, cut off the abdominal cavity, with 6ml normal saline gradation flushing abdominal cavity, collect cleaning mixture and add normal saline to l0ml, the centrifugal 15min of 3000rpm.Get supernatant in the 590nm colorimetric, calculate azovan blue content by standard curve.The results are shown in Table 2.
Table 2 Film coated tablets of the present invention is to the influence of chmice acute abdominal cavity exudative inflammation (x ± s)
Group dosage number of animals azovan blue amount suppression ratio
(the g crude drug/kg) (only) (μ g/ml) (%)
Negative control group 10 2.6 ± 1.4
MINIAONING KELI 28 10 1.3 ± 0.8* 47.54
The present invention low dose of 7 10 1.7 ± 0.8 34.62
Dosage 14 10 1.4 ± 1.0* 46.15 among the present invention
The heavy dose of 28 10 1.1 ± 0.6** 57.69 of the present invention
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 2 as seen, Film coated tablets of the present invention can make mouse peritoneal azovan blue seepage discharge reduce, with negative control group relatively, in, heavy dose of group all has significant difference (P＜0.05 or P＜0.01), the chmice acute exudative inflammation that point out Film coated tablets of the present invention can suppress acetic acid stimulates reacts.The positive control drug MINIAONING KELI also can suppress the chmice acute exudative inflammation reaction that acetic acid stimulates, but effect is weaker than tablet of the present invention.
(2) rat paw edema method
50 of rats are divided into 5 groups at random, 10 every group.First group of negative matched group given the isometric(al) distilled water; Second group of positive matched group given MINIAONING KELI 20g crude drug/kg; Third and fourth, five groups little for Film coated tablets of the present invention, in, heavy dose of group, give Film coated tablets 5,10 of the present invention, 20g crude drug/kg respectively.Each organizes gastric infusion, every day 1 time, and 0.2ml/100g, for three days on end.Behind the last administration 60min, the right back sufficient sole of the foot intradermal injection 10% Ovum Gallus domesticus album 0.1ml of every Mus causes inflammation.Cause scorching before and cause scorching back 30min, 1h, 2h, 4h measure the right back sufficient pawl volume of rat with rat toes volume determination instrument so that the difference of sufficient pawl volume the results are shown in Table 3 as the swelling degree before and after scorching.
Table 3 Film coated tablets of the present invention to the influence of rat acute inflammation (x ± s, n=10)
Group dosage swelling degree (mm)
(the 30min 1h 2h 4h of g crude drug/kg)
Negative control group 0.40 ± 0.24 0.73 ± 0.32 0.66 ± 0.14 0.40 ± 0.12
MINIAONING KELI 20 0.34 ± 0.16 0.47 ± 0.23*, 0.27 ± 0.13* 0.17 ± 0.13
Low dose of 5 0.34 ± 0.24 0.62 ± 0.24 0.46 ± 0.18* 0.37 ± 0.17 of the present invention
Dosage 10 0.32 among the present invention ± 0.21 0.61 ± 0.33 0.46 ± 0.24* 0.32 ± 0.12
Heavy dose of 20 0.32 ± 0.20 0.45 ± 0.12*, 0.44 ± 0.23*, the 0.27 ± 0.15* of the present invention
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 3 as seen, Film coated tablets of the present invention can suppress the generation and the development of the rat acute inflammation that Ovum Gallus domesticus album brings out, compare with negative control group, 2h has significant difference (P＜0.05) behind little, the middle dosed administration, and 1h, 2h, 4h have significant difference (P＜0.05) after the administration of heavy dose of group.Illustrate that thin film farming sheet of the present invention has Chinese People's Anti-Japanese Military and Political College's Mus acute exudative inflammation effect.The positive control drug MINIAONING KELI also can suppress the rat acute exudative inflammation reaction that Ovum Gallus domesticus album brings out, and effect is weaker than Film coated tablets of the present invention when 4h.
(3) to the diuresis of normal rabbits
40 of healthy rabbits are divided into 5 groups at random, 8 every group.First group of negative matched group given normal saline; Second group of positive matched group, give MINIAONING KELI 10.4g crude drug/kg, third and fourth, five groups be Film coated tablets group of the present invention, give Film coated tablets 2.6,5.2 of the present invention, 10.4g crude drug/kg respectively.Load at first for rabbit with water, 30ml/kg, intravenous injection 3% pentobarbital sodium 1ml/kg anesthesia is then lain on the back and is fixed in operating-table, cuts off the hypogastric region hair, does being about the 5cm otch above pubic symphysis along median line, opens the abdominal cavity, exposes bladder.Cut bladder then, insert, fixedly the bladder funnel is with the collection urine.Operation finishes the back and stops 20min, collects 30min urine amount then.Gastric infusion, 5ml/kg.Begin to collect the urine amount after the administration, totally 4 times (the 1st 0～30min, 30～60min for the second time, 60～90min for the third time, the 4th time 90～120min), each 30min.The results are shown in Table 4.
Table 4 the present invention is to the diuresis of normal rabbits (x ± s)
Group dosage number of animals urine amount (ml)
(30min 60min 90min 120min after the administration before (only) administration of g crude drug/kg)
Negative control group 8 1.73 ± 0.79 1.26 ± 1.19 1.79 ± 1.24 2.25 ± 0.79 2.10 ± 0.98
MINIAONING KELI 10.4 8 1.56 ± 0.49 2.66 ± 4.45 3.24 ± 2.63 5.09 ± 3.83* 3.58 ± 2.15
The present invention low dose of 2.6 8 1.73 ± 2.11 2.84 ± 3.25 3.04 ± 2.92 2.43 ± 1.85 1.54 ± 0.52
Dosage 5.2 8 1.90 among the present invention ± 0.68 3.05 ± 2.33 3.01 ± 1.82 3.63 ± 1.65* 3.03 ± 1.92
Heavy dose of 10.4 8 1.71 ± 0.89 3.09 ± 2.74 5.36 ± 4.63*, 6.49 ± 5.1*, the 4.89 ± 3.57* of the present invention
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 4 as seen, Film coated tablets of the present invention can increase the urine amount of normal rabbits, compare with negative control group, 90min has significant difference (P＜0.05) after the middle dosage group administration, 60min, 90min, 120min all have significant difference (P＜0.05) after the administration of heavy dose of group, point out Film coated tablets of the present invention that rabbit is had diuresis.The positive control drug MINIAONING KELI also has diuresis to rabbit, but effect is weaker than Film coated tablets of the present invention.
(4) separate heat test
40 of healthy rabbits are divided into 5 groups at random, 8 every group.First group of negative matched group given normal saline; Second group of positive matched group, give MINIAONING KELI 10.4g crude drug/kg, third and fourth, five groups be the peaceful Film coated tablets group of urinary system, give the peaceful Film coated tablets 2.6,5.2 of urinary system, 10.4g crude drug/kg respectively.Each group is with behind the 5ml/kg gastric infusion, at every rabbit quadriceps femoris place injection autoclaving and with the escherichia coli liquid 2ml of cultured solution of broth 10 times of dilutions, measures every rabbit anus temperature during 1,2,3,5,8,12 h behind the dead bacterium liquid of injection.The difference of each administration treated animal body temperature and basal body temperature and the difference of model group body temperature are compared.The results are shown in Table 5.
The peaceful Film coated tablets of table 5 urinary system to dead escherichia coli cause the rabbit fervescence influence (x ± s, n=8)
Body temperature after the medication of group dosage
(1h 2h 3h 5h 8h 12h after the normal pyrogenicity of g crude drug/kg)
Negative control group 39.04 ± 0.10 41.61 ± 0.29 41.86 ± 0.19 41.80 ± 0.17 41.76 ± 0.13 41.53 ± 0.18 40.64 ± 0.22 39.90 ± 0.26
MINIAONING KELI 10.4 39.04 ± 0.09 41.43 ± 0.29 41.63 ± 0.20*, 41.48 ± 0.29*, 41.38 ± 0.25**40.89 ± 0.32**40.29 ± 0.34* 39.95 ± 0.33
The present invention 26 38.95 ± 0.09 41.55 ± 0.23 41.77 ± 0.17 41.70 ± 0.17 41.69 ± 0.25 41.34 ± 0.14* 40.64 ± 0.19 40.08 ± 0.30
The present invention 5.2 39.04 ± 0.11 41.68 ± 0.24 41.64 ± 0.17*, 41.57 ± 0.20*, 41.43 ± 0.25**41.03 ± 036** 40.13 ± 0.17**39.63 ± 0.24*
The present invention 10.4 39.06 ± 0.09 41.50 ± 0.35 41.64 ± 0.19*, 41.49 ± 0.21**41.28 ± 0.19**40.31 ± 0.22**40.10 ± 0.24**39.45 ± 0.16*
Compare * P＜0.05, * * P＜0.01 with negative control group
By table 5 as seen, the peaceful Film coated tablets of urinary system can reduce escherichia coli and cause the rabbit fervescence, compares with negative control group, and 5h has significant difference (P＜0.05) after the small dose group administration; 1h, 2h, 3h, 5h, 8h, 12h have significant difference (P＜0.05, P＜0.01) after the middle dosage group administration; 1h, 2h, 3h, 5h, 8h, 12h all have significant difference (P＜0.05, P＜0.01) after the administration of heavy dose of group, and the peaceful Film coated tablets of prompting urinary system causes that to escherichia coli the rabbit fervescence has inhibitory action.The positive control drug MINIAONING KELI causes that to escherichia coli the rabbit fervescence also has inhibitory action, but effect is weaker than the peaceful Film coated tablets of urinary system.
(5) in-vitro antibacterial test
1. the mensuration of Film coated tablets MIC of the present invention and MBC
1.1 the mensuration to colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, acinetobacter calcoaceticus, Bacillus proteus, Salmonella enteritidis type strain and clinical separation strain MIC and MBC: (560mg crude drug/ml) carries out continuous two times of gradient dilutions by 10% with MH meat soup with Film coated tablets of the present invention, each concentration liquid is added to 96 well culture plates respectively, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate the 24h observed result for 37 ℃ in common incubator.Contained minimum drug level is MIC in the no bacterial growth hole.To not see successively that again the culture in bacterial growth hole draws the 0.1ml dibbling respectively in the MH flat board, and put common incubator and cultivate 24h for 37 ℃ that the minimum drug level of no bacterial growth inoculation zone correspondence is MBC, the results are shown in Table 6～7.
1.2 the mensuration to streptococcus pyogenes, streptococcus faecalis, gonococcus type strain MIC and MBC: (560mg crude drug/ml) carries out continuous two times of gradient dilutions by 10% with the MH meat soup that contains 0.5% calf serum with Film coated tablets of the present invention, each concentration liquid is added to 96 well culture plates respectively, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, in 5%CO
2Incubator is cultivated the 48h observed result for 37 ℃.Contained minimum drug level is MIC in the no bacterial growth hole.Culture that to not see each hole of bacterial growth is more successively drawn the 0.1ml transfection respectively to nutrition flat board (streptococcus pyogenes, streptococcus faecalis inoculation blood plate, gonococcus inoculation chocolate flat board), puts 5%CO
2Incubator is cultivated 48h for 37 ℃, and the corresponding minimum drug level in no bacterial growth inoculation zone is MBC, the results are shown in Table 5～6.
1.3 to the mensuration of Candida albicans type strain: Film coated tablets of the present invention is protected Ruo Shi (SB) meat soup (560mg crude drug/ml) is carried out continuous two times of gradient dilutions by 10% with husky with clinical MIC of separation and MBC, each concentration liquid is added to 96 well culture plates respectively, the 0.2ml/ hole.Adding concentration more successively is 10
6The test organisms liquid 10 μ l/ holes of CFU/ml are set up antibacterial contrast and culture medium contrast simultaneously.Put room temperature effect 12h, cultivate the 48h observed result for 37 ℃ in common incubator.Contained minimum drug level is MIC in the no bacterial growth hole.To not see successively that again the culture in each hole of bacterial growth draws the 0.1ml dibbling respectively in the SB flat board, and put common incubator and cultivate 48h for 37 ℃ that no bacterial growth inoculation area relative minimum drug level is MBC, the results are shown in Table 6～7.
Table 6 Film coated tablets of the present invention is to the MIC and the MBC of reference culture
Bacterial strain MIC (MBC of mg crude drug/ml) (the mg crude drug/ml)
Colon bacillus ATCC25922 strain 70 140
Staphylococcus aureus ATCC25925 strain 2.185 8.75
Pseudomonas aeruginosa ATCC27853 strain 70 140
Staphylococcus epidermidis ATCC26069 strain 4.375 7.75
Streptococcus pyogenes 32300 strains 4.375 17.5
Acinetobacter calcoaceticus 25003 strains 17.5 70
Streptococcus faecalis ATCC10541 strain 8.75 17.5
Gonococcus 20106 strains 1.0938 4.375
Bacillus proteus 49010 strains 35 70
Salmonella enteritidis 50040 strains 17.5 35
Candida albicans 85021 strains 2.1875 8.75
Table 7 the present invention is to MIC, the MIC of 473 strain clinical isolates strains
50, MIC
90And MBC (the mg crude drug/ml)
MIC MIC is counted in the bacterial strain strain
50MIC
90MBC
Escherichia coli 155 35～140 64.5806 81.5126 70～280
Golden yellow Portugal bacterium 115 1.0938～8.75 3.8794 4.0514 4.375～17.5
Epidermis Portugal bacterium 50 2.185～8.75 3.9804 4.1038 4.375～17.5
Acinetobacter calcoaceticus 38 8.75～70 20.7237 24.5717 17.5～140
Bacillus proteus 85 17.5～70 34.5882 48.3146 35～140
Read coccus 30 0.5469～4.375 1.6401 1.9306 2.185～8.75 in vain
By table 6 as seen, Film coated tablets of the present invention all has than obvious suppression and deactivation the type strain of testing selected colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, streptococcus pyogenes, acinetobacter calcoaceticus, streptococcus faecalis, gonococcus, Bacillus proteus, Salmonella enteritidis, saccharomyces albicans, and its MBC is 2～4 times of MIC.By table 7 as seen, Film coated tablets of the present invention all has certain inhibition and deactivation to testing 473 selected strain clinical isolates strains, and its MBC is 2～4 times of MIC.
2. condition of culture is to the influence of Film coated tablets MIC of the present invention
Choose colon bacillus ATCC25922 strain and staphylococcus epidermidis ATCC26069 strain, change condition of culture, measure Film coated tablets of the present invention respectively being tried the MIC of antibacterial.
2.1pH influence: with reference to test 1MIC assay method, the pH of culture fluid is transferred to 5.7,7.2,8.5 respectively, measures MIC separately respectively, the results are shown in Table 8.
Table 8pH is to the influence of thin film farming sheet MIC of the present invention
MIC (the mg crude drug/ml)
PH colon bacillus staphylococcus epidermidis
ATCC25922 strain ATCC26069 strain
5.7 70 4.375
7.2 70 4.375
8.5 70 4.375
By table 8 as seen, change the pH of culture fluid, do not influence the MIC of Film coated tablets of the present invention colon bacillus ATCC25922 strain and staphylococcus epidermidis ATCC26069 strain.
2.2 the influence of bacterial load:, will test bacterial concentration and change into 10 successively with reference to test 1MIC assay method
6, 10
8, 10
10CFU/ml, 10 μ l are inoculated in every hole, carry out MIC and measure, and the results are shown in Table 9.
Table 9 bacterial load is to the influence of Film coated tablets MIC of the present invention
Bacterial load MIC (the mg crude drug/ml)
(CFU/ml) colon bacillus staphylococcus epidermidis
ATCC25922 strain ATCC26069 strain
10
6 70 4.375
10
8 70 4.375
10
10 70 4.37
By table 9 as seen, change bacterial load, do not influence the MIC of Film coated tablets of the present invention colon bacillus ATCC25922 strain and staphylococcus epidermidis ATCC26069 strain.
(6) antibacterial tests in the body
1. the mensuration of test organisms minimum lethal dose
With ICR mice random packet, 10 every group, male and female half and half.Test organisms liquid is diluted with 10 times of continuous gradients of the normal saline that contains 5% gastric Mucin, infect one group of mice with each dilution bacterium liquid lumbar injection, infective dose 0.2ml/10g, with 5% gastric Mucin normal saline is contrast, observed 7 days, the dead mouse situation respectively organized in record, so that the whole dead Cmin amount of bacteria of mice are as minimum lethal dose (MLD).The result shows, the minimum lethal dose 2 * 10 of Bacillus proteus 49010 strains
7CFU/kg.
2. Film coated tablets of the present invention is to infecting mouse 0% (ED
0) and 100% (ED
100) mensuration of protective number
ICR mice random packet, 10 every group, male and female half and half.With test organisms 100%MLD lumbar injection infecting mouse.Film coated tablets of the present invention is begun to do 5 times of continuous gradient dilutions with normal saline by 20%, one group of mice of each dilution factor medicinal liquid gastric infusion, 0.2ml/10g (initial dosage 22.4g crude drug/kg), every day 1 time, continuous 7 days, set up simultaneously and infect contrast and normal control group, observe dead mouse situation in 7 days.The all dead maximum dosage-feeding of mice is 0% protective number, and the mice all minimum dosage of survival is 100% protective number.The result shows that thin film farming sheet of the present invention is to the ED of Bacillus proteus 49010 strain infecting mouses
100Be 22.4g ecological balance medicine/kg, ED
0Be 0.35g crude drug/kg.
3. Film coated tablets of the present invention pastes Bacillus proteus 49010 strain infecting mouses 50% (ED
50) mensuration of protective number
ICR mice random packet, 10 every group, male and female half and half.With Bacillus proteus 49010 strain 100%MLD bacterium liquid lumbar injection infecting mouses.Film coated tablets of the present invention is begun to do 1: 2 continuous 5 gradient dilution with normal saline by 20%, one group of mice of each gradient medicinal liquid gastric infusion.Dosage 0.2ml/10g (initial dosage 22.4g crude drug/kg), every day 1 time, continuous 7 days.Infect matched group and normal control group and give the isometric(al) normal saline with method, positive control is established two groups, gives SANJIN PIAN and MINIAONING KELI respectively.Observe dead mouse situation in 7 days, calculate the ED of Film coated tablets of the present invention Bacillus proteus 49010 strain infecting mouses
50And 95% fiducial limit, the results are shown in Table 10.
Table 10 Film coated tablets of the present invention is to the protective effect of Bacillus proteus 49010 strain infecting mouses
Group dosage log10 dose number of animals death toll survival rate
((only) (only) of g crude drug/kg) (%)
Blank group 10 0 100
Infect matched group 10 10 0
SANJIN PIAN 7.8 0.8921 10 3 70
MINIAONING KELI 11.2 1.0492 10 3 70
Sheet 11.2 1.0492 10 1 90 of the present invention
Sheet 5.6 0.7482 10 4 60 of the present invention
Sheet 2.8 0.4472 10 7 30 of the present invention
Sheet 1.4 0.1462 10 9 10 of the present invention
Sheet 0.7 0.1549 10 10 0 of the present invention
The result shows that Film coated tablets of the present invention is to the ED of Bacillus proteus 49010 strain infecting mouses
50Be 6.0062g crude drug/kg, 95% credible 4.1957～8.6038g crude drug/kg that is limited to.
[conclusion (of pressure testing)]
Film coated tablets of the present invention is external to be had than obvious suppression and deactivation urinary tract infection common bacteria colon bacillus, staphylococcus aureus, Pseudomonas aeruginosa, staphylococcus epidermidis, streptococcus pyogenes, acinetobacter calcoaceticus, streptococcus faecalis, gonococcus, Bacillus proteus, Salmonella enteritidis, saccharomyces albicans, and changing pH and bacterial load does not influence the antibacterial action of Film coated tablets of the present invention to colon bacillus and staphylococcus epidermidis; In the gastric infusion, body the Bacillus proteus infecting mouse there is protective effect; Can suppress the rat acute inflammatory reaction that the chmice acute exudative inflammation reacts and Ovum Gallus domesticus album brings out that acetic acid stimulates; Suppress the mouse writhing reaction that acetic acid stimulates; Rabbit had diuresis.To the rabbit gastric infusion, can suppress the rabbit fervescence that dead escherichia coli cause.That presentation of results, Film coated tablets of the present invention have is antibiotic, antiinflammatory, diuresis, analgesic, analgesic activity, and effect is better than MINIAONING KELI.
Claims (3)
1, a kind of oral preparation of Chinese traditional medicinal for the treatment of urinary system infection is characterized in that the composition of raw material and weight proportion are:
Radix Bupleuri 110～130 Fructus Schisandrae Chinensis 90～110 Herba Polygoni Avicularis 90～110
Cortex Phellodendri 110～130 Radixs Angelicae Dahuricae 90～110 Radix Dipsacis 90～110
Herba Taxilli 90～110 Semen Abutili 110～130 Radix Glycyrrhizaes 90～110.
2, the oral preparation of Chinese traditional medicinal of treatment urinary system infection according to claim 1 is characterized in that described oral formulations is capsule and tablet.
3, the preparation method of the oral preparation of Chinese traditional medicinal of the described treatment urinary system infection of claim 2 may further comprise the steps:
(1) gets the Radix Angelicae Dahuricae, Fructus Schisandrae Chinensis and add 6～10 times of amount 65～90% ethanol, reflux, extract, 2～4 times, each 1～3h.Merge ethanol extract, decompression recycling ethanol is condensed into thick paste, and cold drying is ground into fine powder, and is standby;
(2) get Cortex Phellodendri and add 8～12 times of water gagings immersion 1～6h, decoct each 1～3h 2～3 times, filter, merging filtrate, being evaporated to relative density is 1.05-1.12 (60 ℃ of surveys), add ethanol to determining alcohol and reach 45～60%, stir, leave standstill, filter, residue is extremely closely colourless with 45～60% washing with alcohol, merging filtrate and washing liquid, decompression recycling ethanol is condensed into thick paste, cold drying, be ground into fine powder, standby;
(3) get Radix Bupleuri, Herba Polygoni Avicularis, Radix Dipsaci, Herba Taxilli, Semen Abutili, glycyrrhizic liuwei drug, add 8～12 times of water gagings and soak 1～6h, decoct 2～4 times, each 1～3h filters merging filtrate, being evaporated to relative density is 1.15-1.25 (60 ℃ of surveys), adds ethanol to determining alcohol and reaches 45～60%, stirs, leave standstill, filter decompression filtrate recycling ethanol, be condensed into thick paste, cold drying is ground into fine powder, and is standby;
(4) get above-mentioned (1), (2), (3) item fine powder down, merge, add carboxymethyl starch sodium, microcrystalline Cellulose, fully mix homogeneously, the system soft material is granulated drying, granulate, add the magnesium stearate mixing, encapsulated or tabletting, coating promptly make capsule of the present invention or tablet.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101244165B (en) * | 2007-02-14 | 2012-04-25 | 深圳市卓海科技文化实业有限公司 | Tablet for treating damp-heat stranguria syndrome and preparation method thereof |
| CN104189199A (en) * | 2014-09-25 | 2014-12-10 | 合肥平光制药有限公司 | Pharmaceutical composition for treating urinary tract infection, and preparation method |
| CN104383053A (en) * | 2014-11-29 | 2015-03-04 | 江志强 | Traditional Chinese medicine preparation for treating urinary tract infection and production method of traditional Chinese medicine preparation |
| CN112057519A (en) * | 2020-10-19 | 2020-12-11 | 中南大学湘雅医院 | Preparation method of medicament for treating urinary system infection |
-
2004
- 2004-03-09 CN CN 200410015577 patent/CN1298351C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101244165B (en) * | 2007-02-14 | 2012-04-25 | 深圳市卓海科技文化实业有限公司 | Tablet for treating damp-heat stranguria syndrome and preparation method thereof |
| CN104189199A (en) * | 2014-09-25 | 2014-12-10 | 合肥平光制药有限公司 | Pharmaceutical composition for treating urinary tract infection, and preparation method |
| CN104383053A (en) * | 2014-11-29 | 2015-03-04 | 江志强 | Traditional Chinese medicine preparation for treating urinary tract infection and production method of traditional Chinese medicine preparation |
| CN104383053B (en) * | 2014-11-29 | 2015-05-27 | 江志强 | Traditional Chinese medicine preparation for treating urinary tract infection and production method of traditional Chinese medicine preparation |
| CN112057519A (en) * | 2020-10-19 | 2020-12-11 | 中南大学湘雅医院 | Preparation method of medicament for treating urinary system infection |
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