CN106511358A - Medicine for treating lupus nephritis and preparation method and application thereof - Google Patents
Medicine for treating lupus nephritis and preparation method and application thereof Download PDFInfo
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- CN106511358A CN106511358A CN201611188885.8A CN201611188885A CN106511358A CN 106511358 A CN106511358 A CN 106511358A CN 201611188885 A CN201611188885 A CN 201611188885A CN 106511358 A CN106511358 A CN 106511358A
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- lupus nephritis
- diflunisal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/695—Silicon compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
Abstract
The invention discloses a medicine for treating lupus nephritis and a preparation method and application thereof. The medicine is prepared from 1-5 parts of hexamethyl disilazane, 11-19 parts of diflunisal, 13-21 parts of monosodium fumarate and 8-16 parts of perillyl alcohol. Diflunisal and monosodium fumarate are mixed and ground, then deionized water is added, the mixture is heated to 75 DEG C and stirred at the temperature, and a mixture A is prepared; hexamethyl disilazane is placed into the mixture A, then the product is sealed and stirred at 88 DEG C, then perillyl alcohol is added, ultrasonic treatment is conducted for 15 min at 63 DEG C, then the product is stirred at 75 DEG C till the product is dry, granulation is conducted, and the medicine is obtained. The medicine is more remarkable in lupus nephritis treating effect, hormone is reduced easily, complications in the treatment process are reduced, the curative effect is enhanced, remarkable, obvious and stable, use is safe and convenient, no toxic and side effects are caused, lupus nephritis does not relapse after healing, the price is low, and the medicine is worthy of clinical popularization.
Description
Technical field
The present invention relates to pharmaceutical technology field, specifically a kind of to treat medicine of lupus nephritis and preparation method thereof and answer
With.
Background technology
Lupus nephritis refer to that systemic lupus erythematosus (sle) (SLE) merges the immunity infringement of double kidney different pathological types, together
When with obvious kidney damage clinical manifestation a kind of disease.Its morbidity and immune complex are formed, immunocyte and cell because
The dysimmunities such as son are relevant.In addition to SLE general manifestations, clinic is mainly shown as hematuria, albuminuria, renal insufficiency etc..Lupus
Property nephritis histological typing for judging state of an illness mobility and prognosis, formulate therapeutic scheme there is important value.Should be according to disease
Feelings light and heavy degree Different Individualization formulates therapeutic scheme.The pathogenesis of lupus nephritis may be relevant with following factor：1. follow
Ring immune complex is in renal deposition；2. immune complex in situ is formed；3. local complement's activation；4. the direct work of autoantibody
With；5. immunoreation of T cell mediation etc..
Glucocorticoid and immunosuppressant are the maximally effective medicines for the treatment of primary disease generally acknowledged both at home and abroad at present, but for a long time should
With can produce more serious side effect, and relapse rate is higher, and after dose is removed and subtracted, the state of an illness is easily repeatedly.Research table in recent years
It is bright, using treatment by Chinese herbs lupus nephritis, curative effect can be improved, side effect is low, but treatment time is long, the relapse rate of disease compared with
It is high.
The content of the invention
It is an object of the invention to provide a kind of treat medicine of lupus nephritis and its preparation method and application, to solve
The problem proposed in above-mentioned background technology.
For achieving the above object, the present invention provides following technical scheme：
A kind of medicine for treating lupus nephritis, is made up of following raw material：HMDS 1-5 parts, difluorobenzene water
Poplar acid 11-19 parts, one sodium 13-21 parts of fumaric acid, perilla alcohol 8-16 parts.
As further scheme of the invention：The medicine of the treatment lupus nephritis, is made up of following raw material：Hexamethyl
Disilazane 2-4 parts, diflunisal 13-17 parts, one sodium 15-19 parts of fumaric acid, perilla alcohol 10-14 parts.
As further scheme of the invention：The medicine of the treatment lupus nephritis, is made up of following raw material：Hexamethyl
3 parts of disilazane, 15 parts of diflunisal, 17 parts of one sodium of fumaric acid, 12 parts of perilla alcohol.
A kind of preparation method of the medicine for treating lupus nephritis, comprises the steps of：
1) by diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding,
It is heated to 75 DEG C and stir process 25-28min at such a temperature, mixture A is obtained；
2) HMDS is inserted in mixture A, then stir process 33- is sealed at a temperature of 88 DEG C
35min, is obtained mixture B；
3) perilla alcohol is added, then supersound process 15min at a temperature of 63 DEG C, ultrasonic power is 900W, Ran Hou
Stir at a temperature of 75 DEG C to dry, pelletize and obtain final product medicine.
Application of the medicine in treatment lupus nephritis medicine is prepared.
Compared with prior art, the invention has the beneficial effects as follows：
The Drug therapy lupus nephritis curative effect of the present invention is more notable, while being conducive to the decrement of hormone, reduces treatment
During complication, and efficacy consolidation is evident in efficacy, determined curative effect, stable curative effect, safe and convenient to use, and without any poison
Side effect, can not be relapsed after the healing, and prevent Relapse rate, cheap, and clinic is promoted, and is suitable to industrialized production.
Specific embodiment
Below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described,
Obviously, described embodiment is only a part of embodiment of the invention, rather than the embodiment of whole.Based in the present invention
Embodiment, the every other embodiment obtained under the premise of creative work is not made by those of ordinary skill in the art, all
Belong to the scope of protection of the invention.
Embodiment 1
In the embodiment of the present invention, a kind of medicine for treating lupus nephritis is made up of following raw material：HMDS
1 part, 11 parts of diflunisal, 13 parts of one sodium of fumaric acid, 8 parts of perilla alcohol.
By diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, plus
Heat to 75 DEG C and at such a temperature stir process 25min, prepared mixture A.HMDS is inserted in mixture A,
Then stir process 33min is sealed at a temperature of 88 DEG C, mixture B is obtained.Perilla alcohol is added, then in 63 DEG C of temperature
Lower supersound process 15min, ultrasonic power is 900W, then stirs to dry at a temperature of 75 DEG C, pelletizes and obtain final product medicine.
Embodiment 2
In the embodiment of the present invention, a kind of medicine for treating lupus nephritis is made up of following raw material：HMDS
5 parts, 19 parts of diflunisal, 21 parts of one sodium of fumaric acid, 16 parts of perilla alcohol.
By diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, plus
Heat to 75 DEG C and at such a temperature stir process 28min, prepared mixture A.HMDS is inserted in mixture A,
Then stir process 35min is sealed at a temperature of 88 DEG C, mixture B is obtained.Perilla alcohol is added, then in 63 DEG C of temperature
Lower supersound process 15min, ultrasonic power is 900W, then stirs to dry at a temperature of 75 DEG C, pelletizes and obtain final product medicine.
Embodiment 3
In the embodiment of the present invention, a kind of medicine for treating lupus nephritis is made up of following raw material：HMDS
2 parts, 13 parts of diflunisal, 15 parts of one sodium of fumaric acid, 10 parts of perilla alcohol.
By diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, plus
Heat to 75 DEG C and at such a temperature stir process 26min, prepared mixture A.HMDS is inserted in mixture A,
Then stir process 34min is sealed at a temperature of 88 DEG C, mixture B is obtained.Perilla alcohol is added, then in 63 DEG C of temperature
Lower supersound process 15min, ultrasonic power is 900W, then stirs to dry at a temperature of 75 DEG C, pelletizes and obtain final product medicine.
Embodiment 4
In the embodiment of the present invention, a kind of medicine for treating lupus nephritis is made up of following raw material：HMDS
4 parts, 17 parts of diflunisal, 19 parts of one sodium of fumaric acid, 14 parts of perilla alcohol.
By diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, plus
Heat to 75 DEG C and at such a temperature stir process 26min, prepared mixture A.HMDS is inserted in mixture A,
Then stir process 34min is sealed at a temperature of 88 DEG C, mixture B is obtained.Perilla alcohol is added, then in 63 DEG C of temperature
Lower supersound process 15min, ultrasonic power is 900W, then stirs to dry at a temperature of 75 DEG C, pelletizes and obtain final product medicine.
Embodiment 5
In the embodiment of the present invention, a kind of medicine for treating lupus nephritis is made up of following raw material：HMDS
3 parts, 15 parts of diflunisal, 17 parts of one sodium of fumaric acid, 12 parts of perilla alcohol.
By diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, plus
Heat to 75 DEG C and at such a temperature stir process 26min, prepared mixture A.HMDS is inserted in mixture A,
Then stir process 34min is sealed at a temperature of 88 DEG C, mixture B is obtained.Perilla alcohol is added, then in 63 DEG C of temperature
Lower supersound process 15min, ultrasonic power is 900W, then stirs to dry at a temperature of 75 DEG C, pelletizes and obtain final product medicine.
Comparative example 1
In addition to one sodium of fumaric acid is not contained, its formula and preparation process are consistent with embodiment 5.
Comparative example 2
Only contain one sodium of fumaric acid, its preparation process is consistent with embodiment 5.
6 toxicity test of embodiment
1) acute toxicity testing：
Using NIH mices 60, SPF levels, male and female half and half, 18～22g of body weight carry out acute toxicity test.Mice is random
It is divided into two groups, 30 per group, i.e. matched group and administration group, fasting 12 hours before experiment；Medicine prepared by embodiments of the invention 1
Thing is dissolved in water, (concentration be 6.58g crude drugs/ml, maximum concentration) gavage, and gavage volume is 5ml/kg (i.e. single-dose agent
Measure as 32.9 crude drugs/kg), matched group gives normal saline, is administered 2 times within one day, and delivery time 6 hours, after administration
Continuous Observation 14 days, and record toxic reaction and the death toll of mice.Test result indicate that：Compare with matched group, after administration
Mice has no notable difference, tests Continuous Observation 14 days, and mouse systemic situation, diet, drinking-water, body weight increase are normal.Mice
Medicine LD50 32.9 crude drugs of the ＞/kg of the oral administration gavage present invention, daily maximum dosage-feeding are 65.8 crude drugs/kg/ days.The present invention's
Chinese medicine clinical application amount is 1.5g crude drugs/day/people, and in terms of 60kg, average dosage is 0.025g crude drugs/kg/ to adult's body weight
Day.By weighing machine：The dosis tolerata of the medicine of mice (average weight is counted with 20g) the oral administration gavage present invention as quantity 1316
Times.Therefore the Acute toxicity of the present invention is low, clinical application safety.
2) long term toxicity test：
The medicine of the embodiment of the present invention 1 presses 10.78,20.35 and 33.48g crude drugs/kg continuous uses 15 weeks to mice
After (1.0ml/100g body weight, daily 2 times) and drug withdrawal 3 weeks, as a result show：Medicine of the present invention is to the hair of rat, behavior, size
Just, the index such as body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat has no significant effect, and internal organs naked eyes do not find different
Sample changes and histological indications show, medication 15 weeks and after being discontinued 3 weeks, and each internal organs of rat are without substantially changing.Illustrate this
, to small toxicity after rat long-term prescription, also no abnormal reaction after drug withdrawal, using safety for invention medicine.
7 clinical trial of embodiment
By the criteria for classification (11 standards meet more than 4) that American society of rheumatism nineteen eighty-two revises, while there is difference
Renal damage performance (edema, albuminuria, cylinderuria, hematuria etc.) of degree makes a definite diagnosis Lupus Nephritis Patients 50.All patients with
Machine is divided into treatment group and matched group.Wherein test group 25, male 2, female 23；Age l8～55 year old, mean age 37.3 ±
2.8 year；The course of disease 5 months～6 years, average 2.6 ± 1.1 years；Renal function is slightly impaired 16, and moderate is impaired 7, severe impaired 2
Example.Matched group 25, man 2, female 23；17～55 years old age, 36.6 ± 2.6 years old mean age；The course of disease 4 months～6 years, puts down
Equal 2.5 ± 1.3 years；Renal function is slightly impaired 15, and moderate is impaired 7, and severe is impaired 2.The state of an illness and the course of disease of two groups of patients
It is similar, with comparability.
The active situation of main detection Lupus Nephritis Patients, renal function and urine protein level before and after treatment.LN activities refer to
Mark：(1) clinical manifestations such as heating, erythra, arthritis, myositis, vasculitises are whether there is；(2) urine examination whether there is urine protein, erythrocyte, white
The increase of cell and cylinderuria；(3) renal function has unchanged；(4) (Anti-ds-DNA antibodies are titrated for SLE Serum inspection
The dynamic observation of degree, C3, C4).
Test group adopts 5 Drug therapy of the embodiment of the present invention, daily 2.5g medicines to take in three times, is within 1 month 1 course for the treatment of.
Using using the treatment of hormone standard course for the treatment of, prednisone initial dose is daily lmg/kg to matched group, and 1 decoction being taken at a draught of morning takes 8 weeks
Gradually decrement, subtracts weekly the 10% of commercial weight afterwards, reduces to 5～l0mg/ days, maintains 1 year.Ring phosphinylidyne is given while using hormone
Amine flooding, i.e., add human physiology saline 100ml angular veins to instil with 8～12mg/kg of cyclophosphamide, and the time of instiling is no less than 1
Hour, per 2 weeks 1 time, add up accumulated dose<150mg/kg.Per March intravenous infusion 1 time is changed to later, and 1 year after stable disease, side stops making
Use Cyclophosphamide.Two groups are treated three months, follow-up more than 1 year.
Criterion of therapeutical effect is as follows：
Complete incidence graph：Clinical symptoms disappear, and lab testing normally and maintains more than 3 months；
Significantly alleviate：Clinical symptoms disappear or alleviate, and urine protein is reduced>50%, serological index is normal or is close to normal；
Alleviate part：Clinical symptoms disappear or alleviate, and urine protein is reduced<50%, serological index makes moderate progress；
It is invalid：Treatment more than 3 months, above-mentioned indices without improvement or deteriorate.
1 two groups of part Experiment room Indexes Comparisons of table
Can be seen that in addition to erythrocyte sedimentation rate speeds index by the result of table 1, test group recovery situation in other respects is bright
It is aobvious to be better than matched group.
The comparitive study of 2 two groups of Lupus Nephritis Patients of table
| Group | n | Complete incidence graph | Significantly alleviate | Alleviate part | It is invalid | Total effective rate |
| Matched group | 25 | 4 | 8 | 3 | 10 | 60 |
| Test group | 25 | 13 | 11 | 1 | 0 | 100 |
Test group curative effect can be seen that by the result of table 2 and be substantially better than matched group, the Drug therapy of this explanation present invention
Lupus nephritis curative effect is more notable, while being conducive to the decrement of hormone, reduces the complication in therapeutic process, and curative effect is consolidated
Gu, prevent Relapse rate, clinic from promoting.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of spirit or essential attributes without departing substantially from the present invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the present invention is by appended power
Profit is required rather than described above is limited, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although this specification is been described by according to embodiment, not each embodiment is only wrapped
Containing an independent technical scheme, this narrating mode of description is only that those skilled in the art should for clarity
Using description as an entirety, the technical scheme in each embodiment can also Jing it is appropriately combined, form those skilled in the art
Understandable other embodiment.
Claims (5)
1. a kind of medicine for treating lupus nephritis, it is characterised in that be made up of following raw material：HMDS 1-5 parts,
Diflunisal 11-19 parts, one sodium 13-21 parts of fumaric acid, perilla alcohol 8-16 parts.
2. it is according to claim 1 treatment lupus nephritis medicine, it is characterised in that be made up of following raw material：Pregnancy
Base disilazane 2-4 parts, diflunisal 13-17 parts, one sodium 15-19 parts of fumaric acid, perilla alcohol 10-14 parts.
3. it is according to claim 1 treatment lupus nephritis medicine, it is characterised in that be made up of following raw material：Pregnancy
3 parts of base disilazane, 15 parts of diflunisal, 17 parts of one sodium of fumaric acid, 12 parts of perilla alcohol.
4. it is a kind of as described in claim 1-3 is arbitrary treatment lupus nephritis medicine preparation method, it is characterised in that by
Following steps are constituted：
1) by diflunisal and one sodium mixed grinding of fumaric acid, the deionized water of 4.5 times of the two quality is subsequently adding, is heated
To 75 DEG C and at such a temperature stir process 25-28min, is obtained mixture A；
2) HMDS is inserted in mixture A, then stir process 33-35min is sealed at a temperature of 88 DEG C, made
Obtain mixture B；
3) perilla alcohol is added, then supersound process 15min at a temperature of 63 DEG C, ultrasonic power is 900W, then at 75 DEG C
At a temperature of stir to dry, granulation obtains final product medicine.
5. application of the medicine as described in claim 1-3 is arbitrary in treatment lupus nephritis medicine is prepared.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611188885.8A CN106511358A (en) | 2016-12-21 | 2016-12-21 | Medicine for treating lupus nephritis and preparation method and application thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201611188885.8A CN106511358A (en) | 2016-12-21 | 2016-12-21 | Medicine for treating lupus nephritis and preparation method and application thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106511358A true CN106511358A (en) | 2017-03-22 |
Family
ID=58341200
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201611188885.8A Withdrawn CN106511358A (en) | 2016-12-21 | 2016-12-21 | Medicine for treating lupus nephritis and preparation method and application thereof |
Country Status (1)
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101466368A (en) * | 2006-06-15 | 2009-06-24 | 诺瓦提斯公司 | Compositions comprising tegaserod alone or in combination with a proton pump inhibitor for treating or preventing gastric injury |
| CN101854925A (en) * | 2007-09-26 | 2010-10-06 | Aisa治疗公司 | Use of a monoterpene to increase tissue repair |
-
2016
- 2016-12-21 CN CN201611188885.8A patent/CN106511358A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101466368A (en) * | 2006-06-15 | 2009-06-24 | 诺瓦提斯公司 | Compositions comprising tegaserod alone or in combination with a proton pump inhibitor for treating or preventing gastric injury |
| CN101854925A (en) * | 2007-09-26 | 2010-10-06 | Aisa治疗公司 | Use of a monoterpene to increase tissue repair |
Non-Patent Citations (3)
| Title |
|---|
| （日）谷村显雄等: "《食品添加剂公定书 注释·解说 第6版》", 30 September 1997 * |
| 叶志中等: "《解读红斑狼疮》", 31 August 2003, 沈阳：辽宁科学技术出版社 * |
| 马世昌: "《化学物质辞典》", 30 April 1999, 西安：陕西科学技术出版社 * |
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