CN100534447C - Medication for treating chronic nephritis and preparation method - Google Patents
Medication for treating chronic nephritis and preparation method Download PDFInfo
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- CN100534447C CN100534447C CNB2004100924190A CN200410092419A CN100534447C CN 100534447 C CN100534447 C CN 100534447C CN B2004100924190 A CNB2004100924190 A CN B2004100924190A CN 200410092419 A CN200410092419 A CN 200410092419A CN 100534447 C CN100534447 C CN 100534447C
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Abstract
A Chinese medicine for treating chronic nephritis is prepared proportionally from Asiatic pennywort herb, astragalus root and Chuan-xiong rhizome through proportional mixing, adding alcohol solution, reflux extracting, collecting the liquid extract, recovering alcohol, adding deionized water, boiling, cooling and laying aside for 10-24 hrs.
Description
Technical field
The present invention relates to medicinal preparation and preparation method thereof, specifically be specially adapted to treat the medicine and the preparation method of chronic nephritis.
Background technology
The one group of immune disease that is primary in glomerule that chronic glomerulonephritis (abbreviation chronic nephritis) is made up of multiple reason, multiple histological type.Clinical characters is onset concealment, and the course of disease is tediously long, and in various degree albuminuria, hematuria and cylinderuria are arranged in the conventional urine examination, and most patient is with in various degree edema, hypertension and renal function injury.Primary disease often is slow progressivity, and treatment is difficult, prognosis is relatively poor, and the state of an illness is developed to chronic nephritis during late period gradually, because nephron is constantly damaged, the strong nephron of depositing is fewer and feweri, and proliferation of fibrous tissue, renal atrophy finally cause renal failure.Chronic nephritis is the main diseases therefore that causes chronic renal failure, and it has become the principal disease that influences health of people.
To the treatment of chronic nephritis, still there is not specific medicament at present.Modern medicine adopts therapies such as blood pressure lowering, anticoagulant, diuresis more, but it mostly is symptomatic treatment, and can not tackle the problem at its root.Chinese medicine thinks that chronic nephritis belongs to the deficiency in origin and excess in superficiality card.In treatment, adopt clearing away heat-damp and promoting diuresis, replenishing QI to invigorate the spleen, activating blood and removing stasis drug to treat usually, but still lack the patent medicine of determined curative effect at present.Now having gone on the market is used for the treatment of the Chinese patent medicine of chronic nephritis, much the problem that all exists some to be difficult to overcome.As Tripterygium glycosides, Colquhounia coccinea Wall. var. mollis (Schlecht.) Prain heel piece, Tripterygium hypoglaucum, the active component of these medicines all belongs to tripterygium plant extract.Studies show that though Radix Tripterygii Wilfordii has antiinflammatory and immunosuppressive action, it can only disease controlling, can not effect a radical cure protopathy.Moreover the side effect of Radix Tripterygii Wilfordii is very big.The report of kidney being poisoned about Radix Tripterygii Wilfordii gets more and more in recent years, has been listed in one of nephrotoxicity medicine.
Summary of the invention
Purpose of the present invention just provides a kind of good effect, the medicine that is used for the treatment of chronic nephritis that toxic and side effects is little, and a kind of preparation method of this medicine is provided simultaneously.
The object of the present invention is achieved like this: the active ingredient of medicine of the present invention is to be made by the raw material of following weight parts ratio: Herba Centellae 20-100 part, Radix Astragali 24-96 part, Rhizoma Chuanxiong 10-40 part.
Its preferred version is that its active ingredient is to be made by the raw material of following weight parts ratio:
Herba Centellae 30-60 part, Radix Astragali 24-48 part, Rhizoma Chuanxiong 20-30 part.
The active ingredient of medicine of the present invention can adopt water extraction process, that is:
Take by weighing the raw material of described weight part ratio, the decocting that adds 8 times of amount volumes boiled 2 hours, filtered, and filtrate is continued to employ, and medicinal residues decoct with water twice, and each 2 hours, to filter, filtrate merges, and concentrating under reduced pressure must contain the thick paste of active component.
The active ingredient of medicine of the present invention also can adopt aqueous extraction-alcohol precipitation technology, that is:
Take by weighing the raw material of described weight part ratio, the water boiling and extraction 3 times that adds 8 times of amount volumes, each 2 hours, filter merging filtrate, be evaporated to 1～2 times of amount volume of medical material, adding ethanol pure and strong to the solution is 70%, the cold preservation standing over night, separate supernatant, decompression recycling ethanol continue to concentrate to such an extent that contain the thick paste of active component.
What best embody medicine excellent results of the present invention is to adopt preparation method provided by the present invention, i.e. resin extraction process, and it may further comprise the steps:
(1) extract active constituents of medicine:
A, take by weighing crude drug: Herba Centellae 20-100 part, Radix Astragali 24-96 part, Rhizoma Chuanxiong 10-40 part by following weight proportion;
B, above-mentioned medical material is added the ethanol of the 40%--60% concentration that 8-10 doubly measures, reflux, extract,, merge extractive liquid, reclaims ethanol;
C, the extracting solution that reclaims behind the ethanol add the deionized water that 3-5 doubly measures, and boil, and put coldly, leave standstill 10-24 hour;
Getting supernatant handles through the low pole macroporous adsorbent resin, first deionized water eluting with 2--3 times of column volume, again with the 20%--30% ethanol elution of 2--3 times of column volume, again with the ethanol elution of the 40%--50% of 1 times of column volume, with the 80%-95% ethanol elution of 2-3 times of column volume, collecting concentration is stream part of the ethanol elution more than 80%, reclaims ethanol under the reduced pressure at last, evaporate to dryness, the active component of crude drug;
Preferred technological parameter is in this step: getting supernatant when the low pole macroporous adsorbent resin is handled, first deionized water eluting with 3 times of column volumes, again with 20% ethanol elution of 3 times of column volumes, again with 40% ethanol elution of 1 times of column volume, with 95% ethanol elution of 3 times of column volumes, the stream part of collecting 95% ethanol elution is reclaimed ethanol under the reduced pressure at last, evaporate to dryness, the active component of crude drug;
(2) above-mentioned active component is added conventional adjuvant, be prepared into pharmaceutical preparation.
The active component of medicine of the present invention can add various adjuvants required when preparing different dosage form, as disintegrating agent, lubricant, binding agent, is prepared into various peroral dosage forms commonly used with Chinese medicine conventional formulation method.As pill, powder, capsule, oral liquid etc.
The present invention has effects such as significant clearing away heat-damp and promoting diuresis, replenishing QI to invigorate the spleen, blood circulation promoting and blood stasis dispelling.Can effectively reduce urine protein, serum creatinine, blood urea nitrogen, improve plasma protein, improve renal function, so can be used for treating chronic nephritis.
Medicine of the present invention is a pure Chinese medicinal preparation, through animal long term toxicity test and clinical practice, does not find toxic and side effects.So safety, reliable when being used for the treatment of chronic nephritis, thereby the harm of effectively having avoided existing self toxicity of medicine to be caused.
Beneficial effect of the present invention has obtained confirmation by following experiment
Medicine of the present invention is to the influence of chronic serum sickness mesangial proliferative nephritis:
Laboratory animal and grouping
85 of the healthy male SD rats of outbreeding system, body weight 150 ± 21 grams, in 10 ages in week, effluent north medical university Experimental Animal Center provides.After animal via normal diet adaptability fed for 1 week, urine protein qualitative results feminine gender, be divided into blank group, model group, resin groups, water at random and put forward group, precipitate with ethanol group, positive controls (wherein resin groups, water are put forward group, the precipitate with ethanol group is referred to as the treatment group), 10 of blank groups, all the other every group 15.
Medication:
The treatment group is all irritated stomach (people's recipe quantity every day is by 79 gram crude drugs) in the medicine of the present invention of 15 times of amounts of human body per kilogram of body weight dosage, and blank group, model group are given and the distilled water of respective amount.
The medicine of the present invention that resin groups is given is (promptly the adopting resin extracting method of the present invention) of adopting preparation method preparation of the present invention.
It is (being water extraction process of the present invention) that adopts the water extraction preparation that water is carried the medicine of the present invention that group gives.
The medicine of the present invention that the precipitate with ethanol group is given is (that is: the aqueous extraction-alcohol precipitation technology of the present invention) that adopts the decoction and alcohol sedimentation technique preparation.
Positive controls is irritated stomach (people's recipe quantity every day is by 60 milligrams) in the Radix Tripterygii Wilfordii medicine of 15 times of amounts of human body per kilogram of body weight dosage.
Main agents
Complete Freund's adjuvant and incomplete Freund's adjuvant (GIBCO company), bovine serum albumin (BSA) and escherichia coli endotoxin (SIGMA company).
Rat experiment mesangial proliferative nephritis replication of Model
Adopt the chronic serum sickness MsPGN model [1] of improvement, 40 male SD rats, ketamine intravenous anesthesia is after excision left kidney in back is carried out pre-immunity after 1 week of recuperating.Add BSA3mg at every the subcutaneous branch injection of rat back complete Freund's adjuvant 0.1ml, in 1 weekend, 2 weekend back subcutaneous injection incomplete Freund's adjuvant 0.1ml add BSA3mg, 3 weekends, continuous 4 times of lumbar injection BSA, each 1h at interval, every of injected dose is respectively 0.5,1,1.5,3.0mg; Every of next day is at lumbar injection BSA2mg.Formal immunity: after pre-immunity is finished first day, hocket the next day of tail vein and lumbar injection, every caudal vein is injected BSA dosage from 0.5mg, each 0.5mg that increases, till 2.5mg, continue dosage 0.5mg weekly, till every day consumption 5mg.The lumbar injection amount is 1 times of tail vein injection amount, till every day consumption 10mg.2 week of immunity back tail vein injection escherichia coli endotoxin 100 μ g/ only.All rat is put to death with formal immunity 8 all backs and gets nephridial tissue.
Formal immune 4 weekends, measure blank group and model group urine albumen amount, see table 1 for details.
Table 1: blank group and the proteic comparison of model group twenty-four-hour urine of formal immune 4 weekends
Annotate ﹠amp; Compare P＜0.01 with blank
The result shows blank the group and the proteic comparison of model group twenty-four-hour urine at formal immune 4 weekends, and significant difference is arranged, and illustrates that pathology damage has appearred in model group.
Biochemistry and pathological examination
Biochemical analysis: (1) twenty-four-hour urine protein quantification; (2) blood urea nitrogen, creatinine; (3) total serum protein, albumin.Semi-automatic biochemical analyzer detects
The morphologic inspection of renal tissue.
Experimental result
The present invention is to the influence of MsPGN rat urine protein
When experiment finished, the twenty-four-hour urine protein quantification of model group was compared obvious rising with normal group, and each group of treatment all has albuminuria in various degree, significantly reduces but compare each treatment group with model group.Wherein the twenty-four-hour urine protein quantification with resin groups is minimum, and resin groups can obviously alleviate the albuminuria of MsPGN rat.See table 2 for details.
Table 2 is respectively organized 24h urine protein quantitation situation of change (mg/24h)
▲ compare P＜0.01 with normal group
# compares P＜0.01 with model group
The present invention is to the influence of MsPGN rat serum creatinine, blood urea nitrogen and plasma protein
When experiment finished, blood CRE, the BUN of model group were all apparently higher than normal group p＜0.01, and the BUN of treatment group and positive controls compares obvious reduction p＜0.01 with model group.The CRE of treatment group, positive controls compares obvious reduction with model group, p＜0.01 or p＜0.05 is wherein better with resin groups and positive controls curative effect.
During the tenth weekend, the plasma protein of model group is compared obvious reduction p＜0.01 with normal group, and the total protein of resin groups is compared obvious rising p＜0.05 with model group, and other each groups are compared no significant difference with model group.Resin groups, water are carried the albumin of group, positive controls and are compared obvious rising, p＜0.01 or p＜0.05 with model group.But it is better with the resin groups curative effect.See table 3 for details.
Table 3 serum creatinine at the tenth weekend, blood urea nitrogen and plasma protein situation of change
Annotate ﹠amp; Compare P＜0.01 with model group
# compares P＜0.05 with model group
▲ compare P＞0.05 with model group
@ compares P＜0.01 with the precipitate with ethanol group
The nephridial tissue light microscopy checking
Below in conjunction with accompanying drawing, its check result is described.
Fig. 1 is the pathology HE colored graph of normal group.
Fig. 2 is the pathology HE colored graph of model group.
Fig. 3 is the pathology HE colored graph of resin groups.
Fig. 4 carries the pathology HE colored graph of group for water.
Fig. 5 is the pathology HE colored graph of precipitate with ethanol group.
The pathology HE colored graph of the positive matched group of Fig. 6.
Fig. 7 is the pathological staining PAS figure of normal group.
Fig. 8 is the pathology PAS colored graph of model group.
Fig. 9 is the pathology PAS colored graph of resin groups.
Figure 10 carries the pathology PAS colored graph of group for water.
Figure 11 is the pathology PAS colored graph of precipitate with ethanol group.
The pathology PAS colored graph of the positive matched group of Figure 12.
Can find out that from Fig. 1, Fig. 7 and Fig. 2-Figure 12 contrast model group part glomerulus increases, the glomerulus hair Thin blood vessel is obviously expanded endotheliocytic swelling, cell infiltration, mesangial cell focal segmental hyperplasia, section Divide the capsula glomeruli adhesion, majority presents the mesenteric tissue hyperplasia that the weight that fills the air does not wait, and the major part zone is moderate Hyperplasia shows as mesangial region broadening, and mesangial cell and extracellular matrix all have hyperplasia in the mesangial region of broadening, and be individual The severe hyperplasia does not appear in the zone, and capillary lumen is narrow and small, and discrete structure destroys, and blood vessel disappears. Treatment group reaches The slight hyperplasia of mesangial cell, the slight broadening of extracellular matrix, tube chamber does not have the extruding phenomenon, wherein with resin Group and positive controls pathological change are lighter.
Above-mentioned experiment shows that the present invention can effectively prevent and treat chronic nephritis.
The specific embodiment
Embodiment 1 capsule
Extract active constituents of medicine: take by weighing crude drug by following weight proportion: Herba Centellae 100kg, Radix Astragali 96kg, Rhizoma Chuanxiong 40kg; Above-mentioned medical material is added the ethanol of 8 times 40% concentration, reflux, extract,, merge extractive liquid, reclaims ethanol; Reclaim the deionized water that extracting solution behind the ethanol adds 3 times, boil, put coldly, left standstill 24 hours; Getting supernatant handles through the low pole macroporous adsorbent resin, first deionized water eluting with 3 times of column volumes, again with 20% ethanol elution of 3 times of column volumes, again with 40% ethanol elution of 1 times of column volume, with 95% ethanol elution of 3 times of column volumes, the stream part of collecting 95% ethanol elution is reclaimed ethanol under the reduced pressure at last, evaporate to dryness, the active component dry extract of crude drug; Dry extract is broken into fine powder, the snap fit capsule of packing into, 0.25 gram/grain, every day three times, each 4-6 grain.
Embodiment 2 tablets
Extract active constituents of medicine: take by weighing crude drug by following weight proportion: Herba Centellae 20kg, Radix Astragali 24kg, Rhizoma Chuanxiong 10kg;
With the ethanol of 10 times of 60% concentration of above-mentioned medical material adding, reflux, extract,, merge extractive liquid, reclaims ethanol; Reclaim the deionized water that extracting solution behind the ethanol adds 5 times, boil, put coldly, left standstill 10 hours; Getting supernatant handles through the low pole macroporous adsorbent resin, first deionized water eluting with 2 times of column volumes, again with 30% ethanol elution of 2 times of column volumes, again with 40%% ethanol elution of 1 times of column volume, with 80% ethanol elution of 2 times of column volumes, the stream part of collecting 80% ethanol elution is reclaimed ethanol under the reduced pressure at last, evaporate to dryness must contain the dry extract of crude drug active component; Dry extract is broken into fine powder, adds adjuvant, compacting is in blocks, 0.5 gram/sheet.Every day three times, each 2-5 sheet.
Embodiment 3～6 Chinese medicine extraction of active ingredients are carried out according to embodiment 1 described method, and just the consumption proportion of raw material is different, and make different dosage forms according to the corresponding preparation routine, but all can reach effect of the present invention.
Claims (2)
1, a kind of preparation method that is used for the treatment of the medicine of chronic nephritis: it is characterized in that it may further comprise the steps:
(1) extract active constituents of medicine:
A) take by weighing crude drug by following weight proportion: Herba Centellae 20-100 part, Radix Astragali 24-96 part, Rhizoma Chuanxiong 10-40 part;
B) above-mentioned medical material is added the ethanol of 8-10 40%--60% concentration doubly, reflux, extract,, merge extractive liquid, reclaims ethanol;
C) extracting solution that reclaims behind the ethanol adds 3-5 deionized water doubly, boils, and puts coldly, leaves standstill 10-24 hour;
D) getting supernatant handles through the low pole macroporous adsorbent resin, first deionized water eluting with 2--3 times of column volume, again with the 20%--30% ethanol elution of 2--3 times of column volume, again with the ethanol elution of the 40%--50% of 1 times of column volume, with the 80%-95% ethanol elution of 2-3 times of column volume, collecting concentration is stream part of the ethanol elution more than 80%, reclaims ethanol under the reduced pressure at last, evaporate to dryness, the active component of crude drug;
(2) above-mentioned active component is added conventional adjuvant, be prepared into pharmaceutical preparation.
2, process for preparing medicine according to claim 1, it is characterized in that described d step is: get supernatant and handle through the low pole macroporous adsorbent resin, first deionized water eluting with 3 times of column volumes, again with 20% ethanol elution of 3 times of column volumes, again with 40% ethanol elution of 1 times of column volume, at last with 95% ethanol elution of 3 times of column volumes, collect stream part of 95% ethanol elution, reclaim ethanol under the reduced pressure, evaporate to dryness, the active component of crude drug.
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| CNB2004100924190A CN100534447C (en) | 2004-12-22 | 2004-12-22 | Medication for treating chronic nephritis and preparation method |
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| CNB2004100924190A CN100534447C (en) | 2004-12-22 | 2004-12-22 | Medication for treating chronic nephritis and preparation method |
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| CN100534447C true CN100534447C (en) | 2009-09-02 |
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| CN105031603A (en) * | 2015-09-08 | 2015-11-11 | 宋晓梅 | Polygonum aviculare Chinese medicine decoction for treating nephritis and preparation method thereof |
| CN113041300B (en) * | 2021-05-20 | 2022-05-10 | 广东省中医院（广州中医药大学第二附属医院、广州中医药大学第二临床医学院、广东省中医药科学院） | Prescription for treating diabetes and its application |
| CN114432411B (en) * | 2022-02-22 | 2022-12-20 | 黑龙江省济仁药业有限公司 | Traditional Chinese medicine composition for treating chronic nephrosis proteinuria and preparation method and application thereof |
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Owner name: SHINEWAY PHARMACEUTICAL (ZHANGJIAKOU) CO., LTD. Free format text: FORMER OWNER: SHINEWAY PHARMACEUTICAL CO., LTD. Effective date: 20111011 |
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Free format text: CORRECT: ADDRESS; FROM: 051430 SHIJIAZHUANG, HEBEI PROVINCE TO: 075000 ZHANGJIAKOU, HEBEI PROVINCE |
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Effective date of registration: 20111011 Address after: High tech Zone, Hebei province Zhangjiakou City Road 075000 No. 4 Patentee after: Shineway Pharmaceutical (Zhangjiakou) Co., Ltd. Address before: 051430 Hebei city of Shijiazhuang province Luancheng County South Pharmaceutical Company Limited Patentee before: Shineway Pharmaceutical Co., Ltd. |