CN105535272A - Medicine composition for treating hydronephrosis and preparation thereof - Google Patents
Medicine composition for treating hydronephrosis and preparation thereof Download PDFInfo
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Abstract
The invention provides a medicine composition for treating hydronephrosis and a preparation thereof. The medicine composition is prepared from, by weight, 12-30 parts of semen pharbitidis, 22-30 parts of lignum aquilariae resinatum, 20-25 parts of leaves of longxiancao, 12-15 parts of bunge cherry seeds and 18-20 parts of folium apocyni veneti. The preparation is in the form of capsules comprising the medicine composition for treating hydronephrosis, each capsule is composed of capsule filler and a capsule casing, and the capsule filler comprises the medicine composition and auxiliary materials, wherein the weight ratio of the medicine composition to the auxiliary materials is 1: (0.5-2.5). The medicine composition can effectively treat hydronephrosis, multiple types of constituents are compounded in a synergistic mode to jointly treat hydronephrosis symptoms, the effects of inducing diuresis, removing edema and the like are effectively achieved, meanwhile, a good treatment effect is also achieved on kidney inflammation, in addition, the medicine composition is quick in effectiveness and great in stability ad solubleness, the rate of treating hydronephrosis syndromes is raised, suffering of a patient is alleviated, and the practicability is great.
Description
Technical field
The present invention relates to Chinese medicine composition field, particularly one treats hydronephrotic pharmaceutical composition and preparation thereof.
Background technology
Hydrops disease is because various disease causes fluid accumulation in body cavity, and hydrops is a kind of specific form of edema.Belong to the symptom that critical illness occurs late period more, though be not incurable disease, also really belong to obstinate disease, in general hydrops disease to cure difficulty very large, and easily repeatedly, especially pernicious body cavity hydrops, patient is very painful, more can accelerate the deterioration of the state of an illness.
In hydrops disease patient, hydronephrotic disease is comparatively common, hydronephrosis refers to a kind of disease expanded because of long-pending urine in renal pelvic cavity, during urinary tract obstruction, the urine of renal secretion is discharged and is subject to obstacle, accumulates in kidney, after time is permanent, pyelectasis forms hydronephrosis, and hydronephrosis can cause pressure increase in renal pelvis, renal calices, and result can affect the filtration of glomerule, affect renal function, and excess of the kidney matter also can progressively pressurized atrophy.At present, the hydronephrotic patient numbers of China also has hundreds of thousands of them, and treating all more not effective Therapeutic Method of Chinese and western medicine in hydronephrosis, doctor trained in Western medicine is except adopting diuretic therapy, main employing is drawn water means, and to draw water be a kind of emergent measure, and draws water that to lose albumen more, hydrops is repeatedly fast, more can not effect a radical cure; The traditional Chinese medical science adopts Drug therapy mostly, but therapeutic effect is comparatively slow, and therapeutic effect is also not obvious, cannot thoroughly cure.
For this reason, existing patent publication No. is Chinese patent medicine " diuretic curing capsule " and the preparation method of CN1119112A disclosed treatment hydrops disease, its formula is: Radix Panacis Quinquefolii 6 grams, Cordyceps 2 grams, Radix Notoginseng 2 grams, Calculus Bovis 0.2 gram, Carapax Eretmochelydis 2 grams, Fructus Amomi 2 grams, Lignum Aquilariae Resinatum 2 grams, Semen Lepidii (Semen Descurainiae) 10 grams, Polyporus 10 grams, Semen Pharbitidis 4 grams, Semen Pharbitidis 2 grams, the Chinese patent medicine that this patent provides can treat multiple hydrops disease, but when practical application, for treatment hydronephrotic symptom be not effective especially, and capsule disintegration rate after the later stage uses is slower, drug effect is slower, medicine stability is poor, thus have impact on hydronephrotic therapeutic effect, for this reason, existing hydronephrosis patients is badly in need of a kind of pharmaceutical composition and the preparation thereof that can be specifically designed to treatment hydronephrosis disease.
Summary of the invention
Be not effective especially to solve the hydronephrotic symptom of Chinese patent drugs for treatment of the prior art, and capsule disintegration rate after the later stage uses is slower, drug effect is slower, medicine stability is poor, thus have impact on the problems such as hydronephrotic therapeutic effect, the invention provides one and treat hydronephrotic pharmaceutical composition and preparation thereof.
The concrete technical scheme of the present invention is as follows:
The invention provides one and treat hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 12-30 part, Lignum Aquilariae Resinatum 22-30 part, imperial saliva grass 20-25 part, Semen Pruni 12-15 part, Folium Apocyni Veneti 18-20 part.
The present invention is drawn by great many of experiments, the compositions adopting Semen Pharbitidis, Lignum Aquilariae Resinatum, imperial saliva grass, Semen Pruni, Folium Apocyni Veneti to be formed has good therapeutic effect to hydronephrosis patients, each composition works in coordination with compatibility, complement each other, very fast to hydronephrosis treatment for diseases effect, said composition has good antiinflammatory, analgesic effect to kidney portion inflammation simultaneously, effectively alleviates sufferer painful.
Preferably, this pharmaceutical composition is made up of the raw material of following parts by weight: Semen Pharbitidis 20 parts, Lignum Aquilariae Resinatum 25 parts, imperial saliva grass 22 parts, Semen Pruni 13 parts, Folium Apocyni Veneti 19 parts.Drawn by a large amount of creative experiments, when pharmaceutical composition is made up of the raw material of above-mentioned parts by weight, to hydronephrosis treatment for diseases best results.
Further, this pharmaceutical composition also comprises the raw material of following parts by weight: Herba Sedi 3-5 part, CAOXIE 5-8 part, Fructus rhois chinensis 8-12 part.The present invention, on the basis of existing compositions, further comprises Herba Sedi, CAOXIE and Fructus rhois chinensis, by adding this several composition, further raising is to hydronephrotic therapeutic effect, treatment speed improves, and shortens treatment cycle, has the effect of antiinflammatory, removing toxic substances simultaneously.Herba Sedi has clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling, has the effect of antiinflammatory simultaneously; CAOXIE has dampness removing and goes the effects such as turbid, inducing diuresis to remove edema; Fructus rhois chinensis has the effects such as treatment edema, blood circulation promoting and blood stasis dispelling, anti-inflammatory analgetic, therefore adds Herba Sedi, CAOXIE and Fructus rhois chinensis in raw material of the present invention, effectively improves the hydronephrotic effect for the treatment of, have the effect of anti-inflammation detumescence simultaneously.
Further, this pharmaceutical composition also comprises the raw material of following parts by weight: Radix Phytolaccae 2-5 part, Caulis Akebiae 3-5 part, Herba Artemisiae Scopariae 1-3 part.Also comprise Radix Phytolaccae, Caulis Akebiae and Herba Artemisiae Scopariae in the raw material provided in the present invention, Radix Phytolaccae has relieves oedema or abdominal distension through diuresis or purgation, treats the drug effects such as edema, antiinflammatory, diuresis; Caulis Akebiae has inducing diuresis to remove edema, and lower dampness removing heat, is used for the treatment of the drug effects such as edema; Herba Artemisiae Scopariae has diuresis, detumescence, the effects such as antiinflammatory, and the present invention, by adding Radix Phytolaccae, Caulis Akebiae and Herba Artemisiae Scopariae in the feed, treats hydronephrosis further, has diuresis simultaneously, to effects such as kidney portion antiinflammatory, shorten hydronephrotic treatment time, improve therapeutic efficiency.
Further, this pharmaceutical composition also comprises the raw material of following parts by weight: Folium Pyrrosiae 2-3 part, Herba Cirsii 5-8 part.The present invention adds Folium Pyrrosiae and Herba Cirsii further in the feed, Folium Pyrrosiae has relieving stranguria by diuresis, anti-nephritis, the effects such as alleviating pain, Herba Cirsii is effective to treat acute nephritis, inducing diuresis to remove edema, the drug effects such as treatment hydronephrosis, therefore increase Folium Pyrrosiae and Herba Cirsii not only can be used for treating hydronephrosis, can be used to alleviate nephritis simultaneously, reduce the misery of patient.
In order to carry and instant, present invention also offers the capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 1:0.5-2.5.
Further, described adjuvant comprises the composition of following parts by weight: hydroquinone 2-3 part, polyvidone 6-10 part, cyclohexylsulfamic acid 2-5 part.Mainly use as solubilizing agent by adding hydroquinone, polyvidone and cyclohexylsulfamic acid in capsule, solubilization-aid effect is played to pharmaceutical composition, improve the stability of drug regimen raw material, the effect of slow release can be played simultaneously, make active ingredient fully drug effect occur.
Further, described adjuvant also comprises the polyethylene oxide azo ketone that parts by weight are 1-3 part.By increasing polyethylene oxide azo ketone in capsule, mainly use as disintegrating agent, the capsule that raw mixture can be made to be formed by polyethylene oxide azo ketone can whole disintegrate in 10 minutes, improves disintegration, shortens the therapeutic effect of Chinese medicine.
Further, described capsule shells comprises the composition of following parts by weight: POLY-karaya 5-10 part, calcium alginate 2-5 part, acetyl group Pullulan 1-2 part and water 5-10 part.By the capsule shells selecting above material to make, there is good sun-proof, thermal protective performance, further ensure quality and the stability of capsule filling, further increase the stability of capsule, drug effect can be played fully.
Preferably, the application of described pharmaceutical composition in the hydronephrotic medicine of preparation treatment is defined in the present invention.
Beneficial effect of the present invention is as follows: the invention provides pharmaceutical composition and effectively treat hydronephrosis, pass through Semen Pharbitidis, Lignum Aquilariae Resinatum, dragon saliva grass, Semen Pruni, the compositions such as Folium Apocyni Veneti work in coordination with compatibility, co-therapy hydronephrosis disease, effectively reach the drug effects such as inducing diuresis to remove edema, there is again good therapeutic effect for kidney portion inflammation simultaneously, in terms of existing technologies, capsule provided by the invention can improve disintegration, pharmaceutical composition is made to realize drug effect fast, stability and the dissolubility of this pharmaceutical composition are strong, improve the treatment rate to hydronephrosis disease, alleviate the slight illness of patient, practical.
Detailed description of the invention
Below in conjunction with following examples, the present invention is described in further detail.
Embodiment 1
One treats hydronephrotic pharmaceutical composition, and this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 12 grams, Lignum Aquilariae Resinatum 22 grams, imperial saliva grass 20 grams, Semen Pruni 12 grams, Folium Apocyni Veneti 18 grams.
Embodiment 2
One treats hydronephrotic pharmaceutical composition, and this pharmaceutical composition is made up of the raw material of following parts by weight: Semen Pharbitidis 20 grams, Lignum Aquilariae Resinatum 25 grams, imperial saliva grass 22 grams, Semen Pruni 13 grams, Folium Apocyni Veneti 19 grams.
Embodiment 3
One treats hydronephrotic pharmaceutical composition, and this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 30 grams, Lignum Aquilariae Resinatum 30 grams, imperial saliva grass 25 grams, Semen Pruni 15 grams, Folium Apocyni Veneti 20 grams.
Embodiment 4
The basis of embodiment 1 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 12 grams, Lignum Aquilariae Resinatum 22 grams, imperial saliva grass 20 grams, Semen Pruni 12 grams, Folium Apocyni Veneti 18 grams, Herba Sedi 3 grams of, CAOXIE 5 grams, Fructus rhois chinensis 8 grams.
Embodiment 5
The basis of embodiment 2 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 20 grams, Lignum Aquilariae Resinatum 25 grams, imperial saliva grass 22 grams, Semen Pruni 13 grams, Folium Apocyni Veneti 19 grams, Herba Sedi 4 grams of, CAOXIE 6.5 grams, Fructus rhois chinensis 10 grams.
Embodiment 6
The basis of embodiment 3 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 30 grams, Lignum Aquilariae Resinatum 30 grams, imperial saliva grass 25 grams, Semen Pruni 15 grams, Folium Apocyni Veneti 20 grams, Herba Sedi 5 grams of, CAOXIE 8 grams, Fructus rhois chinensis 12 grams.
Embodiment 7
The basis of embodiment 4 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition also comprises the raw material of following parts by weight: Semen Pharbitidis 12 grams, Lignum Aquilariae Resinatum 22 grams, imperial saliva grass 20 grams, Semen Pruni 12 grams, Folium Apocyni Veneti 18 grams, Herba Sedi 3 grams of, CAOXIE 5 grams, Fructus rhois chinensis 8 grams, Radix Phytolaccae 2 grams, Caulis Akebiae 3 grams, Herba Artemisiae Scopariae 1 gram.
Embodiment 8
The basis of embodiment 5 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 20 grams, Lignum Aquilariae Resinatum 25 grams, imperial saliva grass 22 grams, Semen Pruni 13 grams, Folium Apocyni Veneti 19 grams, Herba Sedi 4 grams of, CAOXIE 6.5 grams, Fructus rhois chinensis 10 grams, Radix Phytolaccae 3.5 grams, Caulis Akebiae 4 grams, Herba Artemisiae Scopariae 2 grams.
Embodiment 9
The basis of embodiment 6 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 30 grams, Lignum Aquilariae Resinatum 30 grams, imperial saliva grass 25 grams, Semen Pruni 15 grams, Folium Apocyni Veneti 20 grams, Herba Sedi 5 grams of, CAOXIE 8 grams, Fructus rhois chinensis 12 grams, Radix Phytolaccae 5 grams, Caulis Akebiae 5 grams, Herba Artemisiae Scopariae 3 grams.
Embodiment 10
The basis of embodiment 7 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition also comprises the raw material of following parts by weight: Semen Pharbitidis 12 grams, Lignum Aquilariae Resinatum 22 grams, imperial saliva grass 20 grams, Semen Pruni 12 grams, Folium Apocyni Veneti 18 grams, Herba Sedi 3 grams of, CAOXIE 5 grams, Fructus rhois chinensis 8 grams, Radix Phytolaccae 2 grams, Caulis Akebiae 3 grams, Herba Artemisiae Scopariae 1 gram, Folium Pyrrosiae 2 grams, Herba Cirsii 5 grams.
Embodiment 11
The basis of embodiment 8 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 20 grams, Lignum Aquilariae Resinatum 25 grams, imperial saliva grass 22 grams, Semen Pruni 13 grams, Folium Apocyni Veneti 19 grams, Herba Sedi 4 grams of, CAOXIE 6.5 grams, Fructus rhois chinensis 10 grams, Radix Phytolaccae 3.5 grams, Caulis Akebiae 4 grams, Herba Artemisiae Scopariae 2 grams, Folium Pyrrosiae 2.5 grams, Herba Cirsii 6.5 grams.
Embodiment 12
The basis of embodiment 9 provides one and treats hydronephrotic pharmaceutical composition, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 30 grams, Lignum Aquilariae Resinatum 30 grams, imperial saliva grass 25 grams, Semen Pruni 15 grams, Folium Apocyni Veneti 20 grams, Herba Sedi 5 grams of, CAOXIE 8 grams, Fructus rhois chinensis 12 grams, Radix Phytolaccae 5 grams, Caulis Akebiae 5 grams, Herba Artemisiae Scopariae 3 grams, Folium Pyrrosiae 3 grams, Herba Cirsii 8 grams.
Embodiment 13
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:1.
When described pharmaceutical composition is 20 grams, described adjuvant is 10, then it comprises the composition of following parts by weight: hydroquinone 2 grams, polyvidone 6 grams, cyclohexylsulfamic acid 2 grams.
Embodiment 14
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:3.
When described pharmaceutical composition is 9.3 grams, described adjuvant is 14 grams, then it comprises the composition of following parts by weight: hydroquinone 2.5 grams, polyvidone 8 grams, cyclohexylsulfamic acid 3.5 grams.
Embodiment 15
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:5.
When described pharmaceutical composition is 7.2 grams, described adjuvant is 18 grams, then it comprises the composition of following parts by weight: hydroquinone 3 grams, polyvidone 10 grams, cyclohexylsulfamic acid 5 grams.
Embodiment 16
On the basis of embodiment 13, the invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:1.
When described pharmaceutical composition is 22 grams, described adjuvant is 11, then it comprises the composition of following parts by weight: hydroquinone 2 grams, polyvidone 6 grams, cyclohexylsulfamic acid 2 grams, polyethylene oxide azo ketone 1 gram.
Embodiment 17
On the basis of embodiment 14, the invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:3.
When described pharmaceutical composition is 10.7 grams, described adjuvant is 16 grams, then it comprises the composition of following parts by weight: hydroquinone 2.5 grams, polyvidone 8 grams, cyclohexylsulfamic acid 3.5 grams, polyethylene oxide azo ketone 2 grams.
Embodiment 18
On the basis of embodiment 15, the invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:5.
When described pharmaceutical composition is 8.4 grams, described adjuvant is 21 grams, then it comprises the composition of following parts by weight: hydroquinone 3 grams, polyvidone 10 grams, cyclohexylsulfamic acid 5 grams, polyethylene oxide azo ketone 3 grams.
Embodiment 19
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment; described capsule is made up of capsule filling and capsule shells; described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:1, and described capsule shells comprises the composition of following parts by weight: POLY-karaya 5 grams, calcium alginate 2 grams, acetyl group Pullulan 1 gram and 5 grams, water.
Embodiment 20
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment; described capsule is made up of capsule filling and capsule shells; described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:3, and described capsule shells comprises the composition of following parts by weight: POLY-karaya 8 grams, calcium alginate 3.5 grams, acetyl group Pullulan 1.5 grams and 8 grams, water.
Embodiment 21
The invention provides a kind of capsule comprising the hydronephrotic pharmaceutical composition of described treatment; described capsule is made up of capsule filling and capsule shells; described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 2:5, and described capsule shells comprises the composition of following parts by weight: POLY-karaya 10 grams, calcium alginate 5 grams, acetyl group Pullulan 2 grams and 10 grams, water.
Embodiment 22
On the basis of embodiment 13-21, in the present invention, define the application of described pharmaceutical composition in the hydronephrotic medicine of preparation treatment.
Experiment 1, pharmaceutical composition provided by the invention are to hydronephrotic therapeutic effect
500 routine patients are filtered out in hospital's urology department and Nephrology outpatient service, wherein women occupies 233 examples, male occupies 267 examples, mean age is 52.6 years old, all patients are all diagnosed as hydronephrosis through B ultrasonic and CT examination, wherein mild hydronephrotic kidney is 216 examples, and moderate hydronephrosis is 186 examples, and severe hydronephrosis is 98 examples.
Patient is divided into 5 groups at random, often organize 100 routine patients, 5 groups in sex, age, the course of disease, the state of an illness etc. without significant difference (P>0.05), there is comparability.The wherein capsule made of first group of pharmaceutical composition taken the embodiment of the present invention 2 and provide, the capsule that second group of pharmaceutical composition taken the embodiment of the present invention 5 and provide is made, the capsule that the 3rd group of pharmaceutical composition taken the embodiment of the present invention 8 and provide is made, the capsule that the 4th group of pharmaceutical composition taken the embodiment of the present invention 11 and provide is made, 5th group as a control group, it takes the hydronephrotic Chinese patent medicine for the treatment of " diuretic curing capsule " that patent document publication number provides for CN1119112A, patient in each group takes corresponding medicine twice equal every day, 30 days courses for the treatment of, take period and Continuous Observation is carried out to 5 groups of patients, record symptom and change.
The criterion of curative effect situation:
Cure: clinical symptom disappearance, B ultrasonic.Renal phlebography, CT check hydronephrosis and disappear or substantially disappear;
Effective: clinical symptoms obviously alleviates, B ultrasonic, renal phlebography, CT check hydronephrosis and reduce 30%-80%;
Invalid: symptom is improved not obvious or do not improved, and hydronephrosis reduces less than 30%.
After three courses for the treatment of, 5 groups of patient outcomes are as follows:
Embodiment 2 | Embodiment 5 | Embodiment 8 | Embodiment 11 | Existing patent | |
Cure | 60 | 70 | 80 | 97 | 2 |
Effectively | 22 | 18 | 15 | 2 | 50 |
Invalid | 18 | 12 | 5 | 1 | 48 |
In sum, as can be seen from data, the pharmaceutical composition that first group to the 4th group is taken the embodiment of the present invention 2 successively, embodiment 5, embodiment 8, embodiment 11 provide, for the 5th group, the medicine of first four groups is better to hydronephrotic therapeutic effect, the pharmaceutical composition that even embodiment 11 provides reaches 97% to hydronephrotic therapeutic effect, therefore, 1 demonstrates pharmaceutical composition provided by the invention and has good therapeutic effect to hydronephrosis by experiment.
Experiment 2, the vitro release determination test comprising the capsule of pharmaceutical composition provided by the invention
The release of pharmaceutical composition detects: check with reference to 2010 editions version " Chinese Pharmacopoeia " annex XIXD vitro drug release degree.
Get above embodiment 13 respectively, capsule that embodiment 14, embodiment 15 provide and the hydronephrotic Chinese patent medicine for the treatment of " diuretic curing capsule " that patent document publication number provides for CN1119112A, and the capsule of taking-up is inserted in digestion instrument respectively, sample respectively in 1h, 2h, 4h, 6h, 12h, 16h, 24h, and the sample high performance liquid chromatography of taking out is detected stripping percentage rate, and calculate the cumulative release percentage rate of medicine.
Dissolution (%) result of the test of inventive samples
The pharmaceutical composition of embodiment 13 slow releasing in 24h as can be seen from the table, the pharmaceutical composition of embodiment 14 all discharges in 12h, and the pharmaceutical composition of embodiment 15 all discharges in 4h, and there is serious peak valley phenomenon, the capsule that existing patent publication No. provides for CN1119112A only released 75% within 24 hours, therefore, the pharmaceutical composition provided in embodiment of the present invention 13-15 is at interpolation hydroquinone, after polyvidone and Cyclohexylamino sulphur, the stability of drug regimen raw material can be significantly improved, play slow release effect, promote the absorption of active component in Chinese medicine major ingredient, preferably, along with hydroquinone, the content of polyvidone and Cyclohexylamino sulphur increases, releasing effect is more obviously good.
Experiment 3, effect measuring disintegration comprising the capsule of pharmaceutical composition provided by the invention
According to the regulation in Chinese Pharmacopoeia, survey and survey disintegration of capsule its emulsifying effectiveness to pharmaceutical composition.
Get above embodiment 16 respectively, capsule that embodiment 17, embodiment 18 provide and the hydronephrotic Chinese patent medicine for the treatment of " diuretic curing capsule " that patent document publication number provides for CN1119112A, test disintegration respectively, test data result is as follows:
Different auxiliary material is on the impact of capsule disintegration
As can be seen from the table, the present invention is compared with existing patent document, and the present invention contains the polyethylene oxide azo ketone that parts by weight are 1-3 part, effectively can improve the disintegration of pharmaceutical composition in capsule.
Test example 4 stability test comprising the capsule of pharmaceutical composition provided by the invention
1. accelerated test
Get capsule that above embodiment 19 provides and the hydronephrotic Chinese patent medicine for the treatment of " diuretic curing capsule " that patent document publication number provides for CN1119112A respectively, all at temperature 40 DEG C ± 2 DEG C, relative humidity is place 6 months under the condition of 75% ± 5%, sample respectively once 1 month, 2 months, 3 months, 6 the end of month at duration of test, detect character, color and luster, abnormal smells from the patient, main constituent content (labelled amount %), the moisture of capsule, found that, the indices of embodiment 19 has no significant change; And the capsule color that patent document publication number provides for CN1119112A obviously deepens, the labelled amount of main constituent significantly reduces, and moisture increases.
2. long term test
Get capsule that above embodiment 19 provides and the hydronephrotic Chinese patent medicine for the treatment of " diuretic curing capsule " that patent document publication number provides for CN1119112A respectively, all at temperature 25 DEG C ± 2 DEG C, relative humidity is place 12 months under the condition of 60% ± 10%, sample respectively once 0 month, 3 months, 6 months, 9 months, 12 the end of month at duration of test, detect character, color and luster, main constituent content (labelled amount %), the moisture of capsule, found that, the indices of embodiment 19 has no significant change; And the capsule color that patent document publication number provides for CN1119112A obviously deepens, the labelled amount of main constituent significantly reduces, and moisture increases.
As can be seen from accelerated test and long term test, the mixture of POLY-karaya, calcium alginate and acetyl group Pullulan can significantly improve the stability of capsule, and the capsule shells be simultaneously made up of heterogeneity also has certain contribution to the stability of capsule.
Clinical trial, the clinical observation on the therapeutic effect of capsule provided by the invention:
Lin, man 40 years old, office working clan, suffered from chronic nephritis in 2010, show as albuminuria, hematuria, hypertension, hydronephrosis, hurt like hell, adhere to taking capsule that pharmaceutical composition provided by the invention makes after one month, hydronephrosis disappears, pain symptom is alleviated, the clinical symptom disappearance such as albuminuria, hematuria, hydronephrosis, graft function, without recurrence.
Field, female 53 years old, retired employees, suffer from nephritis, cause hydronephrosis, kiney edema, occur hematuria once in a while, hurt like hell, and take capsule that pharmaceutical composition provided by the invention makes after 3 weeks, kiney edema disappears, pain relief, without repeatedly.
Liu, man 50 years old, hydronephrosis is serious, and swelling, cannot carry out normal diuresis, urination inconvenience, hematuria, and through kidney water suction inefficacy, take capsule that pharmaceutical composition provided by the invention makes after 4 weeks, graft function, without obvious pain symptom, edema disappears.
Zheng, man, 40 years old, company worker, there is hematuria once in a while in early stage kidney portion inflammation, there is kiney edema in the later stage, hurt like hell, and western medicines in treatment repeatedly, equal inefficacy, take capsule that Pharmaceutical composition provided by the invention makes after 3 weeks, pain disappears, kiney edema disappears, hematuria disappearance, after continuing to take 2 weeks, thoroughly fully recovers.
The present invention is not limited to above-mentioned preferred forms; anyone can draw other various forms of products under enlightenment of the present invention; no matter but any change is done in its shape or structure; every have identical with the application or akin technical scheme, all drops within protection scope of the present invention.
Claims (10)
1. treat a hydronephrotic pharmaceutical composition, it is characterized in that, this pharmaceutical composition comprises the raw material of following parts by weight: Semen Pharbitidis 12-30 part, Lignum Aquilariae Resinatum 22-30 part, imperial saliva grass 20-25 part, Semen Pruni 12-15 part, Folium Apocyni Veneti 18-20 part.
2. the hydronephrotic pharmaceutical composition for the treatment of as claimed in claim 1, it is characterized in that, this pharmaceutical composition is made up of the raw material of following parts by weight: Semen Pharbitidis 20 parts, Lignum Aquilariae Resinatum 25 parts, imperial saliva grass 22 parts, Semen Pruni 13 parts, Folium Apocyni Veneti 19 parts.
3. the hydronephrotic pharmaceutical composition for the treatment of as claimed in claim 1, it is characterized in that, this pharmaceutical composition also comprises the raw material of following parts by weight: Herba Sedi 3-5 part, CAOXIE 5-8 part, Fructus rhois chinensis 8-12 part.
4. the hydronephrotic pharmaceutical composition for the treatment of as claimed in claim 3, it is characterized in that, this pharmaceutical composition also comprises the raw material of following parts by weight: Radix Phytolaccae 2-5 part, Caulis Akebiae 3-5 part, Herba Artemisiae Scopariae 1-3 part.
5. the hydronephrotic pharmaceutical composition for the treatment of as claimed in claim 4, it is characterized in that, this pharmaceutical composition also comprises the raw material of following parts by weight: Folium Pyrrosiae 2-3 part, Herba Cirsii 5-8 part.
6. comprise the capsule of the hydronephrotic pharmaceutical composition for the treatment of described in any one of claim 1-5, it is characterized in that, described capsule is made up of capsule filling and capsule shells, and described capsule filling comprises the pharmaceutical composition and adjuvant that weight part ratio is 1:0.5-2.5.
7. capsule as claimed in claim 6, it is characterized in that, described adjuvant comprises the composition of following parts by weight: hydroquinone 2-3 part, polyvidone 6-10 part, cyclohexylsulfamic acid 2-5 part.
8. capsule as claimed in claim 7, it is characterized in that, described adjuvant also comprises the polyethylene oxide azo ketone that parts by weight are 1-3 part.
9. capsule as claimed in claim 6, it is characterized in that, described capsule shells comprises the composition of following parts by weight: POLY-karaya 5-10 part, calcium alginate 2-5 part, acetyl group Pullulan 1-2 part and water 5-10 part.
10. the application of the pharmaceutical composition as described in any one of claim 1-5 in the hydronephrotic medicine of preparation treatment.
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101683438A (en) * | 2008-09-24 | 2010-03-31 | 张希学 | Morning glory formulation for treating nephritic dropsy |
CN101879288A (en) * | 2010-07-02 | 2010-11-10 | 李志强 | Chinese medicinal formula for treating hydronephrosis |
CN104623437A (en) * | 2015-01-19 | 2015-05-20 | 王春东 | Traditional Chinese medicine composition for treating hydronephrosis and preparation method |
-
2016
- 2016-01-12 CN CN201610018281.2A patent/CN105535272A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101683438A (en) * | 2008-09-24 | 2010-03-31 | 张希学 | Morning glory formulation for treating nephritic dropsy |
CN101879288A (en) * | 2010-07-02 | 2010-11-10 | 李志强 | Chinese medicinal formula for treating hydronephrosis |
CN104623437A (en) * | 2015-01-19 | 2015-05-20 | 王春东 | Traditional Chinese medicine composition for treating hydronephrosis and preparation method |
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Application publication date: 20160504 |