CN1709295A - Medicinal formulation for treating prostatitis, and its preparing method and quality control method - Google Patents
Medicinal formulation for treating prostatitis, and its preparing method and quality control method Download PDFInfo
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Abstract
The present invention relates to a Qianlie Antong medicine preparation with the functions of clearing away heat, promoting diuresis, promoting blood circulation and removing toxic material for curing acute and chronic prostatitis. Said medicine preparation is made up by using the Chinese medicinal materials of phellodendron bark, red peony root, salvia root, peach kernel and lycopus or using their extracts. Said invention can obtain obvious therapeutic effect, and also provides its preparation method and quality control method.
Description
Technical field: the present invention is prostatitic medicinal preparation of QIANLIE ANTONG of a kind of treatment and preparation method thereof and method of quality control, belongs to technical field of Chinese medicine.
Technical background: between twenty and fifty period, the incident disease of prostate is mainly acute and chronic prostatitis.Trace it to its cause, between twenty and fifty period is the male's sexual animated period just, and sexual activity is frequent, easily causes prostatic hyperemia repeatedly under the stimulation of sexual excitation, brings out inflammation.Secondly, be the most vigorous period of prostate secretion between twenty and fifty period, for the growth of antibacterial provides good condition.If do not note Personal hygiene, infect at low or other position of Abwehrkraft des Koepers, and pathogen just can enter prostate, forms acute and chronic inflammation.According to domestic statistics, prostatitis is the highest with between twenty and fifty people's prevalence, and the number of going to a doctor because of prostatitis in policlinic accounts for prescription on individual diagnosis patient's male 25%～30%.Nervous and busy city male more should guard against prostatitis, bring inconvenience with exempt from customs examination work, life, study.Long-term clinical practice proves that the prostatitic curative effect of Chinese medicine is definite.Wherein commercially available ANLIETONG PIAN has clearing away heat-damp and promoting diuresis, and blood circulation promoting and blood stasis dispelling is used for syndrome of stagnant dampness-heat, and disease is seen: frequent micturition, and urgent micturition, it is not smooth to urinate, lower abdominal distention pain etc.But this tablet is through extrusion modling, and disintegrate is slow, and drug effect speed is slower; So there is researcher that it should be capsule, as number of patent application is that " 200410023397.2 ", name are called " prostatitis-treating capsule and preparation method thereof ", and number of patent application is that " 200410000135.4 ", name are called the application of " a kind of pure oral preparation of Chinese traditional medicinal for the treatment of prostatosis and preparation method thereof "; But we find in the process of studying: the former has ignored this product is the very strong characteristics of the water extracted immersing paste, hygroscopicity, adopts directly encapsulated straightforward procedure, causes the easy moisture absorption bonding of product, the quality instability; Though the latter extracts the medicine that contains volatile oil, directly sprays into, cause volatile oil to be easy to loss, and big production can only obtain Aromatic water, and not only extraction ratio is low to that is to say our volatile oil, and loss is serious, increase cost, do not increased curative effect; In view of such circumstances, in order to improve stability of drug, need to seek a kind of therapeutic effect ideal, reliable in quality, dosage form reasonably effectively the medicine preparation overcome problem that prior art exists, enrich the dosage form kind, satisfy the needs in market.
Summary of the invention: the objective of the invention is to: prostatitic medicinal preparation of QIANLIE ANTONG of a kind of treatment and preparation method thereof and method of quality control are provided; Comprise coating capsule, coated drop pill and their preparation method and method of quality control with characteristics such as covering bitterness, easy to carry, good mouthfeel, absorption are fast, steady quality.
The present invention constitutes like this: it is mainly by Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g, or the effervescent tablet that is made with their extract of corresponding weight portion, injection, the powder pin, freeze-dried powder, gel, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and membrane.Say accurately: described preparation can be capsule, drop pill.
The preparation method of pharmaceutical preparation of the present invention: it is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, drying under reduced pressure, be ground into fine powder, make different preparations then respectively.
Capsule among the present invention prepares like this: it is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is condensed into thick paste, drying under reduced pressure is ground into fine powder, granulates, coating, coating fluid prescription: 1.2kg HPMC, 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol; Incapsulate, promptly.
Drop pill among the present invention prepares like this: it is standby that Cortex Phellodendri powder is broken into fine powder; Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, the Herba Lycopi, the Radix Linderae, when the Semen Vaccariae and the Radix Angelicae Dahuricae add water and are heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, is substrate with the Macrogol 4000, according to medicine: the part by weight of substrate=1: 2 adds Macrogol 4000, mixing, the employing internal diameter is 3.0mm, external diameter is the dropper of 4.0mm, drips 50 ℃ of system temperature, dripping speed is 20～30d/min, dripping distance is 5cm, splash in the long cooling column of 130cm, be liquid coolant again with the methyl-silicone oil, pill, coating, coating fluid prescription: 1.2kg HPMC, the 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol, promptly.
The method of quality control of the pharmaceutical preparation of product of the present invention, it comprises assay, discriminating etc.; Assay is index with the protocatechualdehyde, differentiates that adopting berberine hydrochloride, peoniflorin is reference substance.
Assay is such: methanol: water: formic acid=9.5: 90: 0.5 is mobile phase; The detection wavelength is 281nm; It is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds methanol and make the solution that every 1ml contains protocatechualdehyde 12 μ g, shakes up, and promptly gets reference substance solution; Get 40 of this product, remove coating, the accurate title, decide, porphyrize is got 6g, and accurate the title decides, put in the conical flask, precision adds water 50ml, claims to decide weight, supersound process 30 minutes is put and is chilled to room temperature, adds water again and supplies the weight that subtracts mistake, shake up, filter, the accurate subsequent filtrate 10ml that draws, regulate pH value to 2 with 10% hydrochloric acid, extract 3 times with the ether jolting, each 10ml merges ether extracted liquid, put in the water-bath and volatilize, residue adds dissolve with methanol, and is diluted to scale, quantitatively is transferred in the 10ml measuring bottle, shake up, promptly get need testing solution; Accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure, promptly.
Discriminating is such:
(1) get 10 of this product, remove coating, porphyrize, the 20ml that adds diethyl ether, supersound process 20 minutes discards ether solution, and medicinal residues volatilize, and add methanol 20ml, and supersound process 20 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene: ethyl acetate: methanol: isopropyl alcohol: strong ammonia solution=4: 3: 2: be developing solvent at 1.5: 0.5, launches, and taking-up is dried; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(2) get 10 of this product, remove coating, porphyrize adds ethanol 25ml, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add ethanol 2ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ 1 of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform: ethyl acetate: methanol: formic acid=40: 5: 12: 0.2 is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Compared with prior art, product provided by the invention has clearing away heat-damp and promoting diuresis, and the effect of blood circulation promoting and blood stasis dispelling is used for syndrome of stagnant dampness-heat, and disease is seen: frequent micturition, and urgent micturition, it is not smooth to urinate, and lower abdominal distention pains etc. have reasonable therapeutic effect for acute and chronic prostatitis; That the preparation of preparation has is easy to carry, cover bitterness, characteristics such as absorbing soon can be good, good anti-moisture ability, and preparation method is rationally feasible, and production cost is suitable, and economic benefit is more satisfactory; Method of quality control can guarantee the quality and the curative effect of product; Overcome the problem that prior art, product exist; Reached the purpose of invention.
The applicant finds that under study for action coating can increase moisture resistance, but also can influence disintegration rate, so the selection of coating material is just very crucial.The coating adjuvant of the most suitable this product and consumption, ratio, process conditions etc. have been found by experiment; Guarantee its science, reasonable, feasible; The preparation that obtains has superperformance and therapeutic effect.
Experimental example 1: art for coating research
(1) volatile oil extracts experiment
1. androlin is caused the outgrowth influence of rat prostate
50 of Wistar rats, male, be divided into five groups at random by body weight: normal control group, model control group, estradiol matched group, drug extract group (not extracting volatile oil), drug extract group (extraction volatile oil).Rat excision bilateral testes begins the subcutaneous injection androlin after 1 week of recuperating, and begins administration simultaneously, continuous 1 month.The last administration was put to death animal after 24 hours, separate to take out prostate, weighed and carried out between each group relatively.The result shows: the model group prostate is heavy apparently higher than the normal control group, and estradiol matched group prostate is heavy significantly to be reduced with model control group.Drug extract group (not extracting volatile oil) does not have marked difference with drug extract group (extraction volatile oil) effect.
2. xylol causes the influence of mice ear
Get body weight 18-22g mice, irritate stomach and give pharmaceutical composition of the present invention, every day 1 time, continuous 7 days, be coated with dimethylbenzene 0.1ml in the Mus auris dextra back of the body in 30 minutes after the last administration, mice is put to death in the cervical vertebra dislocation after 2 hours, lays round auricle with card punch in left and right sides ear same area, weighs, ratio with interaural difference and left ear is the swelling degree, compare each group difference, the result shows: drug extract group (not extracting volatile oil) does not have marked difference with drug extract group (extraction volatile oil) effect, sees the following form.
| Group | Number of animals | Contrast | Cause scorching ear weight (%) |
| Matched group aspirin medicine extractum group, (extraction volatile oil) drug extract group, (not extracting volatile oil) | ??10 ??10 ? ??10 ? ? ??10 | ??100.0 ??100.0 ? ??100.0 ? ? ??100.0 | ??189.6±39.7 ??132.9±28.5 ? ??121.1±31.6 ? ? ??120.8±12.5 |
(2) art for coating screening
Coating fluid prescription 1:1.2kg HPMC, 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol
Coating fluid prescription 2:0.8kg HPMC, 200ml tween 80,0.4kgPEG6000,0.6kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol
Coating fluid prescription 3:0.6kg HPMC, 200ml tween 80,0.5kgPEG6000,0.7kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol
The comparison of humidity resistance: take by weighing 5 parts in the capsule 's content sample of coating not, every part of 10g divides in same surface plate, place 25 ℃, the climatic chamber of relative humidity 75%, every day, timing sampling was measured pellet moisture with the moisture titrator, the record average moisture content.Measure the humidity resistance of 3 kinds of coated granules respectively with same method.And mensuration disintegration time.The results are shown in following table.
Sample 0d 10d 30d
Water content % disintegration time min water content % disintegration time min water content % disintegration time min
The coating capsule 5.8 20.1 6.2 20.5 6.9 21.8
Coating capsule 1 2.6 22.6 2.8 22.8 2.9 22.9
Coating capsule 2 3.5 25.9 4.0 27.0 4.1 27.8
Coating capsule 3 2.2 31.4 2.3 32.2 2.5 34.5
The result shows, the granule not capsule moisture absorption of coating is obvious, water content obviously increases in short time, the hydroscopicity height, and coated granule of the present invention has tangible moisture resistance in air, hydroscopicity is low, and we select the coating material of coating solution 1 as this product in conjunction with disintegration time and moisture-resistant test result.
(3) disintegration time is investigated
Disintegration time (min)
Group 123
Coated drop pill 28.5 27.7 27.2
Drop pill 29.3 29.8 29.7 of the present invention
The coating capsule 20.3 20.3 22.9
Capsule 23.6 23.5 23.8 of the present invention
ANLIETONG PIAN 52.3 50.3 49.8
The result as can be known, technology of the present invention is little to disintegration time influence.
(4) study on the stability (accelerated tests)
Average moisture content %
Group March 2 month January
Coated drop pill 5.5 6.3 7.2
Drop pill 3.4 3.5 3.8 of the present invention
The coating capsule 5.8 6.2 6.9
Capsule 2.8 3.7 4.1 of the present invention
The result as can be known, technology of the present invention can effectively increase moisture resistance.
Experimental example 3: pharmacodynamic experiment
1, to the research of prostatitis treating effect
50 of SD rats, anesthesia back routine disinfection cuts about skin 1.5cm.Isolate prostate, 40 rats are wherein caused non-bacterial chronic prostatitis animal model from 2% agar solution 0.1ml of left lobe of prostate, each injection sterilization of lobus dexter, all the other 10 rats are respectively injected sterile saline 0.1ml as the normal control group at left lobe of prostate, lobus dexter.Distinguish suture muscles, skin then, operation back 24h, with the rat random packet, 10 every group.Normal control group: distilled water 1ml/100g body weight; Model control group: distilled water 1ml/100g body weight; Commercially available ANLIETONG PIAN group, Capsules group of the present invention, Capsules group of the present invention: give the relative medicine suspension respectively, the administration volume is the 1ml/100g body weight, and drug dose is equivalent to be grown up clinical plan with 10 times of dosage.Each treated animal gastric infusion every day (or distilled water) 1 time is treated 45d continuously.24h after the last administration behind the title the weight of animals, puts to death the disconnected neck of rat, peels off prostate rapidly, after weighing, puts into the liquid-solid 48h of deciding of FAA, ethanol dehydration step by step, and dimethylbenzene is transparent, waxdip, paraffin embedding, conventional section 4 μ m, HE dyes.Quantity and morphological change situation with matter inflammatory cell and body of gland and lumen of gland between pattern analysis instrument connection computer analysis processing rat prostate.
1. to the influence of chronic prostatitis rat prostate weight coefficient due to the agar, concrete outcome sees the following form:
Influence to chronic prostatitis rat prostate weight coefficient due to the agar
Group n dosage (m/gkg
-1) weight of prostate coefficient (m/mg100g
-1)
Normal control group 10---138.5 ± 26.7
Model control group 10---228.9 ± 36.4
ANLIETONG PIAN group 10 3.2 184.6 ± 45.7
Capsules group 10 3.2 169.1 ± 42.6 of the present invention
Drop pill group 10 3.2 158.7 ± 26.8 of the present invention
From last table as seen, use ANLIETONG PIAN, capsule of the present invention, drop pill of the present invention treatment 45d, its weight of prostate coefficient ratio model control group all reduces, and the effect of capsule of the present invention, drop pill is better than commercially available ANLIETONG PIAN.2. to the influence of matter inflammatory cell quantity and form between prostate, concrete outcome sees the following form:
Influence to matter inflammatory cell quantity and form between prostate
Dosage number of inflammatory cells inflammatory cell area summation area average
Group (m/gkg
-1) (individual) (A/ μ m
2) (A/ μ m
2)
Normal control group---------
Model control group---142.5 ± 59.4 104632.5 ± 28214.1 957.2 ± 432.7
ANLIETONG PIAN group 3.2 148.4 ± 74.5 55624.8 ± 30483.4 486.4 ± 158.8
Capsules group 3.2 146.8 of the present invention ± 26.4 48276.1 ± 25631.5 456.2 ± 125.9
Drop pill group 3.2 148.2 of the present invention ± 62.8 45684.4 ± 15324.6 395.7 ± 265.4
From last table as seen, behind application ANLIETONG PIAN, capsule of the present invention, the drop pill treatment 45d, inflammatory cell area summation, average area reduce.Inflammatory cell quantity and model control group are relatively, do not see minimizing, even slightly increase, this is owing to number of inflammatory cells in the matter between the model control group prostate is more, area is bigger, normal adhesion slabbing, and computer will connect to the reason that flaky a plurality of inflammatory cell identification is calculated as 1 inflammatory cell.
3. to the influence of prostate body of gland quantity and form
Influence to chronic prostatitis rat prostate body of gland quantity due to the agar and form
Area average girth average maximum gauge average minimum diameter average
Group (A/ μ m
2) (A/ μ m
2) (A/ μ m
2) (A/ μ m
2)
Normal control group 11265 ± 4,837 513.8 ± 59.4 359.5 ± 162.4 86.2 ± 26.7
Model control group 12572 ± 2,694 536.4 ± 156.7 137.2 ± 42.6 58.6 ± 16.7
ANLIETONG PIAN group 12893 ± 3,488 548.7 ± 124.1 185.7 ± 36.7 78.4 ± 12.1
Capsules group 13254 of the present invention ± 1,548 567.2 ± 134.8 159.6 ± 59.8 68.5 ± 13.4
Drop pill group 12687 of the present invention ± 2,362 539.1 ± 112.7 165.2 ± 89.1 75.1 ± 19.5
As seen from the above table, after using ANLIETONG PIAN, capsule of the present invention, drop pill treatment 45d, relatively each organizes the therapeutical effect that all has in various degree with model control group, body of gland area average, body of gland maximum gauge average etc. are obviously raise, and the effect of product of the present invention is better than commercially available ANLIETONG PIAN.
Concrete embodiment:
Embodiments of the invention 1: Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g
It is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is condensed into thick paste, drying under reduced pressure is ground into fine powder, granulates, coating, coating fluid prescription: 1.2kg HPMC, 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol; Incapsulate, promptly get capsule, this product oral, three times on the one, each 2.
Embodiments of the invention 2: Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g
It is standby that Cortex Phellodendri powder is broken into fine powder; Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, the Herba Lycopi, the Radix Linderae, when the Semen Vaccariae and the Radix Angelicae Dahuricae add water and are heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, is substrate with the Macrogol 4000, according to medicine: the part by weight of substrate=1: 2 adds Macrogol 4000, mixing, the employing internal diameter is 3.0mm, external diameter is the dropper of 4.0mm, drips 50 ℃ of system temperature, dripping speed is 20～30d/min, dripping distance is 5cm, splash in the long cooling column of 130cm, be liquid coolant again with the methyl-silicone oil, pill, coating, coating fluid prescription: 1.2kg HPMC, the 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol promptly gets drop pill.
Embodiments of the invention 3: Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g
It is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, adds distilled water, promptly gets oral liquid.
Embodiments of the invention 4: Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g
It is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, adds carbomer, makes gel.
Embodiments of the invention 5: Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g
It is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, adds sodium carboxymethyl cellulose, tabletting is made dispersible tablet.
Embodiments of the invention 6: assay
Methanol: water: formic acid=9.5: 90: 0.5 is mobile phase; The detection wavelength is 281nm; It is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds methanol and make the solution that every 1ml contains protocatechualdehyde 12 μ g, shakes up, and promptly gets reference substance solution; Get 40 of this product, remove coating, the accurate title, decide, porphyrize is got 6g, and accurate the title decides, put in the conical flask, precision adds water 50ml, claims to decide weight, supersound process 30 minutes is put and is chilled to room temperature, adds water again and supplies the weight that subtracts mistake, shake up, filter, the accurate subsequent filtrate 10ml that draws, regulate pH value to 2 with 10% hydrochloric acid, extract 3 times with the ether jolting, each 10ml merges ether extracted liquid, put in the water-bath and volatilize, residue adds dissolve with methanol, and is diluted to scale, quantitatively is transferred in the 10ml measuring bottle, shake up, promptly get need testing solution; Accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure, promptly.
Embodiments of the invention 7: differentiate
(1) get 10 of this product, remove coating, porphyrize, the 20ml that adds diethyl ether, supersound process 20 minutes discards ether solution, and medicinal residues volatilize, and add methanol 20ml, and supersound process 20 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene: ethyl acetate: methanol: isopropyl alcohol: strong ammonia solution=4: 3: 2: be developing solvent at 1.5: 0.5, launches, and taking-up is dried; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(2) get 10 of this product, remove coating, porphyrize adds ethanol 25ml, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add ethanol 2ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform: ethyl acetate: methanol: formic acid=40: 5: 12: 0.2 is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Claims (8)
1, the prostatitic pharmaceutical preparation of a kind of treatment is characterized in that: it is mainly by Cortex Phellodendri 200g, Radix Paeoniae Rubra 200g, Radix Salviae Miltiorrhizae 100g, Semen Persicae 140g, Herba Lycopi 120g, Radix Linderae 120g, Semen Vaccariae 80g, Radix Angelicae Dahuricae 80g or the effervescent tablet that is made with their extract of corresponding weight portion, injection, powder pin, freeze-dried powder, gel, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and membrane.
2, according to the prostatitic pharmaceutical preparation of the described treatment of claim 1, it is characterized in that: described preparation is capsule or drop pill.
3, the preparation method of the prostatitic pharmaceutical preparation of treatment as claimed in claim 1 or 2, it is characterized in that: it is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, drying under reduced pressure, be ground into fine powder, make different preparations then respectively.
4, according to the preparation method of the prostatitic pharmaceutical preparation of the described treatment of claim 3, it is characterized in that: the capsule in the described preparation prepares like this: it is standby that Cortex Phellodendri powder is broken into fine powder; When Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Herba Lycopi, the Radix Linderae, Semen Vaccariae and the Radix Angelicae Dahuricae add water and be heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate is condensed into thick paste, drying under reduced pressure is ground into fine powder, granulates, coating, coating fluid prescription: 1.2kg HPMC, 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol; Incapsulate, promptly.
5, according to the preparation method of the prostatitic pharmaceutical preparation of the described treatment of claim 4, it is characterized in that: the drop pill in the described preparation prepares like this: it is standby that Cortex Phellodendri powder is broken into fine powder; Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, the Herba Lycopi, the Radix Linderae, when the Semen Vaccariae and the Radix Angelicae Dahuricae add water and are heated to 80 ℃, add Semen Persicae again, continue heating, decoct three times, 2 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction, filter, filtrate is condensed into thick paste, is substrate with the Macrogol 4000, according to medicine: the part by weight of substrate=1: 2 adds Macrogol 4000, mixing, the employing internal diameter is 3.0mm, external diameter is the dropper of 4.0mm, drips 50 ℃ of system temperature, dripping speed is 20～30d/min, dripping distance is 5cm, splash in the long cooling column of 130cm, be liquid coolant again with the methyl-silicone oil, pill, coating, coating fluid prescription: 1.2kg HPMC, the 200ml tween 80,0.3kgPEG6000,0.5kg titanium dioxide, 0.1kg Pulvis Talci, 20kg ethanol, promptly.
6, the method for quality control of the prostatitic pharmaceutical preparation of treatment as claimed in claim 1 or 2, it comprises assay, discriminating etc.; It is characterized in that: assay is index with the protocatechualdehyde, differentiates that adopting berberine hydrochloride, peoniflorin is reference substance.
7, according to the method for quality control of the prostatitic pharmaceutical preparation of the described treatment of claim 6, it is characterized in that: assay is such: methanol: water: formic acid=9.5: 90: 0.5 is mobile phase; The detection wavelength is 281nm; It is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds methanol and make the solution that every 1ml contains protocatechualdehyde 12 μ g, shakes up, and promptly gets reference substance solution; Get 40 of this product, remove coating, the accurate title, decide, porphyrize is got 6g, and accurate the title decides, put in the conical flask, precision adds water 50ml, claims to decide weight, supersound process 30 minutes is put and is chilled to room temperature, adds water again and supplies the weight that subtracts mistake, shake up, filter, the accurate subsequent filtrate 10ml that draws, regulate pH value to 2 with 10% hydrochloric acid, extract 3 times with the ether jolting, each 10ml merges ether extracted liquid, put in the water-bath and volatilize, residue adds dissolve with methanol, and is diluted to scale, quantitatively is transferred in the 10ml measuring bottle, shake up, promptly get need testing solution; Accurate respectively reference substance solution and each 10 μ l of need testing solution of drawing inject chromatograph of liquid, measure, promptly.
8, according to the method for quality control of the prostatitic pharmaceutical preparation of the described treatment of claim 6, it is characterized in that: discriminating is such:
(1) get 10 of this product, remove coating, porphyrize, the 20ml that adds diethyl ether, supersound process 20 minutes discards ether solution, and medicinal residues volatilize, and add methanol 20ml, and supersound process 20 minutes filters, and filtrate is concentrated into 2ml, as need testing solution; Other gets the berberine hydrochloride reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; According to thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene: ethyl acetate: methanol: isopropyl alcohol: strong ammonia solution=4: 3: 2: be developing solvent at 1.5: 0.5, launches, and taking-up is dried; Put under the ultra-violet lamp 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(2) get 10 of this product, remove coating, porphyrize adds ethanol 25ml, and supersound process 20 minutes filters, and filtrate evaporate to dryness, residue add ethanol 2ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds ethanol and makes the solution that every 1ml contains 2mg, in contrast product solution; Test according to thin layer chromatography, draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform: ethyl acetate: methanol: formic acid=40: 5: 12: 0.2 is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510003094 CN1709295A (en) | 2005-06-03 | 2005-06-03 | Medicinal formulation for treating prostatitis, and its preparing method and quality control method |
| CN200610200511A CN100582774C (en) | 2005-06-03 | 2006-06-02 | Detection method of treating prostatitis formulation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510003094 CN1709295A (en) | 2005-06-03 | 2005-06-03 | Medicinal formulation for treating prostatitis, and its preparing method and quality control method |
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| Publication Number | Publication Date |
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| CN1709295A true CN1709295A (en) | 2005-12-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510003094 Pending CN1709295A (en) | 2005-06-03 | 2005-06-03 | Medicinal formulation for treating prostatitis, and its preparing method and quality control method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370740A (en) * | 2011-10-16 | 2012-03-14 | 广东养美医药投资有限公司 | Self-heating Chinese medicinal adhesive plaster for treating prostatitis |
| CN105012994A (en) * | 2015-08-25 | 2015-11-04 | 东莞市达庆医疗器械有限公司 | Medical, functional and biological hydrogel dressing for urinary system and preparation method of hydrogel dressing |
-
2005
- 2005-06-03 CN CN 200510003094 patent/CN1709295A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102370740A (en) * | 2011-10-16 | 2012-03-14 | 广东养美医药投资有限公司 | Self-heating Chinese medicinal adhesive plaster for treating prostatitis |
| CN105012994A (en) * | 2015-08-25 | 2015-11-04 | 东莞市达庆医疗器械有限公司 | Medical, functional and biological hydrogel dressing for urinary system and preparation method of hydrogel dressing |
| CN105012994B (en) * | 2015-08-25 | 2018-02-16 | 东莞市达庆医疗器械有限公司 | A kind of medical bio uropoiesis hydrogel functional dressings and preparation method thereof |
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