CN1555831A - Compound formula preparation eontaining glucocorticoid medicine - Google Patents
Compound formula preparation eontaining glucocorticoid medicine Download PDFInfo
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- CN1555831A CN1555831A CNA2003101176120A CN200310117612A CN1555831A CN 1555831 A CN1555831 A CN 1555831A CN A2003101176120 A CNA2003101176120 A CN A2003101176120A CN 200310117612 A CN200310117612 A CN 200310117612A CN 1555831 A CN1555831 A CN 1555831A
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- glucocorticoid
- rhizoma anemarrhenae
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- 239000003862 glucocorticoid Substances 0.000 title claims abstract description 48
- 239000003814 drug Substances 0.000 title claims abstract description 33
- 150000001875 compounds Chemical class 0.000 title claims description 27
- 238000002360 preparation method Methods 0.000 title claims description 26
- 239000000284 extract Substances 0.000 claims abstract description 42
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 17
- 239000000203 mixture Substances 0.000 claims description 15
- 229960004618 prednisone Drugs 0.000 claims description 14
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims description 14
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims description 11
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 9
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- 208000000819 Adrenocortical Hyperfunction Diseases 0.000 description 2
- 241000605445 Anemarrhena asphodeloides Species 0.000 description 2
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- 239000004375 Dextrin Substances 0.000 description 2
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
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- RTMWIZOXNKJHRE-UHFFFAOYSA-N Tigogenin Natural products CC1COC2CC(C)(OC12)C3CCC4C5CCC6CC(O)CCC6(C)C5CCC34C RTMWIZOXNKJHRE-UHFFFAOYSA-N 0.000 description 2
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
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- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
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- IUBSYMUCCVWXPE-UHFFFAOYSA-N metoprolol Chemical compound COCCC1=CC=C(OCC(O)CNC(C)C)C=C1 IUBSYMUCCVWXPE-UHFFFAOYSA-N 0.000 description 1
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Landscapes
- Steroid Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
An orally applied medicine is prepared from glucocorticoid medicine and the extract of anemarrhena rhizome. It can eliminate the untoward reaction caused by glucocorticoid.
Description
Technical field
The present invention relates to a kind of compound preparation that contains glucocorticoid medicine.
Background technology
Glucocorticoid (Glucocorticoids) mainly contains effects such as antiinflammatory, inhibition immunity, and clinical practice is extensive, as is applied to treat the nephrotic syndrome etc.But widely apply glucocorticoid medicine for a long time, can cause many untoward reaction, as iatrogenic adrenocortical hyperfunction, show as myasthenia, moon face, buffalo hump, blood glucose and blood fat rising etc., because glucocorticoid can reduce the body defence capability, and there is not antibiotic effect, so can bring out infection or make hidden focus diffusion in the body, as virus, mycete, tubercule bacillus etc., the prolonged application glucocorticoid can also cause the body internal protein to decompose quickening simultaneously, negative nitrogen balance occurs, become osteogenesis to reduce, cause osteoporosis.
The Rhizoma Anemarrhenae is a tonification medicine commonly used, the Rhizoma Anemarrhenae is the dry rhizome of the liliaceous plant Rhizoma Anemarrhenae (Anemarrhenaasphodeloides Bunge), property plug bitter in the mouth, return lung, stomach, kidney channel, tool is grown the effect that positive pathogenic fire reducing is moisturized laxation, cures mainly cough due to lung-heat, constipation due to dry stool, dysuria etc.
Up to now, there are not the glucocorticoid and the Rhizoma Anemarrhenae to unite and make compound preparation, as the report of glucocorticoid indication medicine.
Summary of the invention
Purpose of the present invention is exactly the compound preparation in order to provide the compound preparation glucocorticoid that contains glucocorticoid medicine and the Rhizoma Anemarrhenae or its extract to make, but this compound preparation life-time service is rare or do not have a glucocorticoid untoward reaction, and can adopt oral formulations, thereby taking convenience.
It is the application of glucocorticoid medicine treatment indication at preparation antiinflammatory, inhibition immune drug that a further object of the invention just is to provide the compound preparation that contains glucocorticoid medicine.
The present invention realizes like this.
The compound preparation that contains glucocorticoid medicine of the present invention is mainly made by following medicine:
Glucocorticoid adopts convenient oral prednisone or other oral glucocorticoid, preferentially selects prednisone at present for use, also can use hydrocortisone, dexamethasone etc.
The Rhizoma Anemarrhenae adopts Common Anemarrhena Rhizome or Rhizoma Anemarrhenae extract, wherein extracting method adopts the technology that present technique field those of ordinary skill is known, and can adopt ethanol water mixture to soak and extract, and decompression recycling ethanol is to adopting paste, be dissolved in water, cold preservation discards precipitation, and the supernatant is evaporated to dried, put and add small amount of methanol or dissolve with ethanol after cold, add acetone and separate out white precipitate, precipitation is used washing with acetone, and drying under reduced pressure promptly.Wherein the alcoholic acid percent by volume of ethanol water mixture is 30～80%, preferred 50%; Wherein to account for the weight rate of Rhizoma Anemarrhenae crude drug be that the extraction ratio of Rhizoma Anemarrhenae extract is about 2～3% to Rhizoma Anemarrhenae extract.This class be dissolved in ethanol water mixed extraction solvent and in acetone sedimentary material, based on the Rhizoma Anemarrhenae total saponins class.
Wherein the weight ratio of oral glucocorticoid and Rhizoma Anemarrhenae extract be preferably 10: 1～200, ratio according to this, comparatively economical comparatively speaking, make oral formulations, include but not limited to oral liquid, capsule, tablet, coated tablet, coated tablet, granule etc.
Its dose of compound preparation of the present invention is weighed with the consumption of glucocorticoid medicine, and is consistent with single clothes glucocorticoid consumption.
The weight ratio of oral glucocorticoid medicine and Rhizoma Anemarrhenae extract preferred 10: 2～50.
The weight ratio of oral glucocorticoid medicine and Rhizoma Anemarrhenae extract more preferably 10: 50.
The production method of oral formulations also can adopt the universal method in present technique field.
Can also add other drug in the compound preparation that contains glucocorticoid of the present invention, as cardiovascular drugs β
-Receptor blocking agent metoprolol, propranolol etc., immunosuppressant such as cyclophosphamide, mercapto azoles purine etc.
The compound preparation that contains glucocorticoid of the present invention can not influence glucocorticoid on the basis of the curative effect of its indication of treatment, alleviate even eliminate the disease such as iatrogenic adrenocortical hyperfunction, osteoporosis of prolonged application glucocorticoid, simultaneously, compound preparation of the present invention is conveniently taken.Through investigating, the compound preparation of glucocorticoid and Rhizoma Anemarrhenae extract compatibility does not influence both stability, is fit to use in conjunction.
The specific embodiment
The invention will be further described below in conjunction with embodiment.
Following embodiment only is to implementing the explanation on the example that feasibility of the present invention does, by no means to any restriction of enforcement of the present invention.
Embodiment 1
Prednisone+Rhizoma Anemarrhenae extract is prepared into compound preparation.
The extracting method of the Rhizoma Anemarrhenae is for adopting ethanol water mixture (alcoholic acid percent by volume 60～80%), and mixture soaks 3 times.Exceed to cover medical material, decompression recycling ethanol merges three times thick paste to the thick paste shape, adds water stirring and dissolving, cold preservation, discards precipitation; The supernatant is evaporated to dried, puts to add small amount of methanol or dissolve with ethanol after cold, adds acetone and separates out white precipitate, and precipitation is used washing with acetone, and drying under reduced pressure promptly gets Rhizoma Anemarrhenae extract.Be this Rhizoma Anemarrhenae extract for being dissolved in ethanol water mixed extraction solvent sedimentary material in acetone, this class material is based on the Rhizoma Anemarrhenae total saponins class.Extraction ratio about 2～3%.
Take by weighing above-mentioned Rhizoma Anemarrhenae extract 50 grams, other takes by weighing prednisone 10 grams, adds auxiliary shape agent such as dextrin, starch, Icing Sugar is an amount of, mix homogeneously adds 95% ethanol and makes binding agent, moistening granulation, 45～60 ℃ of dryings add Pulvis Talci, magnesium sulfate, and tabletting is made 2000 altogether.Wherein every contains prednisone 5mg.
Embodiment 2
Prednisone+Rhizoma Anemarrhenae extract is made the compound granular agent.
The Rhizoma Anemarrhenae extract extracting method be 40～50% with alcoholic acid volume hundred powder of ethanol water mixture than being somebody's turn to do with embodiment 1.
Take by weighing above-mentioned Rhizoma Anemarrhenae extract 200 grams, other takes by weighing prednisone 10 grams, adds auxiliary shape agent, and is an amount of as dextrin, starch, Icing Sugar, mix homogeneously adds 80% ethanol wet method system soft material, crosses sieve series grain on the 20th, 70 ℃ be dried to water content 4% ±, be distributed into 2000 the bag, make granule.
Embodiment 3
Prednisone+Rhizoma Anemarrhenae extracting solution is made oral liquid.
The Rhizoma Anemarrhenae extract extracting method changes alcoholic acid volume hundred powder of ethanol water mixture ratio into 30～40% with embodiment 1.
Take by weighing above-mentioned Rhizoma Anemarrhenae extract 100 grams, other takes by weighing prednisone 1000 grams, adds a little sugar flavoring, and adds water to 200,000 milliliters, is distributed into every 100ml or 10ml, and embedding is prepared into oral liquid.
Embodiment 4
Rhizoma Anemarrhenae extract is to the influence experiment of glucocorticoid model plasma corticosterone and hydrocortisone.
1, experimental technique
Experiment is divided into three groups, and matched group only pours into normal saline, continuous 5 days; Processed group: Rhizoma Anemarrhenae extract+dexamethasone, extracted rabbit ear hematometry corticosterone earlier as the radix value 8 o'clock mornings before the moulding, begin to irritate hello Rhizoma Anemarrhenae extract 10mg/kg then, for three days on end, get rabbit ear hematometry corticosterone content morning on the 4th, observe the influence of Rhizoma Anemarrhenae extract to the rabbit plasma corticosterone, about at 5 o'clock in the afternoon same day, poured into dexamethasone 50ug/kg then, continuous 2 days, got the rabbit ear in the 6th day at 8 o'clock in the morning then and survey plasma corticosterone content, to observe Rhizoma Anemarrhenae extract the inhibiting influence of dexamethasone.Dexamethasone group: pour into normal saline every day, the same processed group of perfusion dexamethasone.
2, experimental result
(1) Rhizoma Anemarrhenae total saponins reaches the inhibiting influence of dexamethasone the influence of plasma corticosterone:
Pouring into simple dexamethasone adrenal cortex function obviously is suppressed, plasma corticosterone drops to 2.62 ± 0.39 by 10.09 ± 0.53, suppression ratio reaches 74.03%, and add with Rhizoma Anemarrhenae extract group plasma corticosterone lowering of concentration amplitude less, adrenocortical suppression ratio is 22.04%, the prompting Rhizoma Anemarrhenae extract can resist the inhibitory action of dexamethasone to hypophysis cerebri-interrenal system, and single do not have significant change with the Rhizoma Anemarrhenae extract plasma corticosterone, sees Table 1
Table 1: Rhizoma Anemarrhenae extract is to the influence of plasma corticosterone and to the inhibiting influence of dexamethasone
The 6th day on the 4th suppression ratio (%) of radix value
Matched group 10.31 ± 0.46 9.86 ± 0.60
Processed group 9.98 ± 0.42 10.23+0.58 7.78 ± 0.51 22.04
Dexamethasone 10.09 ± 0.53 2.62 ± 0.39 74.03
(2) to the influence of blood plasma cortisol content
Basic plasma corticosterone determining alcohol is 128.09 ± 20.6mol/L before the rabbit moulding, (before the treatment) is that 238.7 ± 45.2mol/L. adds with the still higher 236.9 ± 42.2nmo/L of Rhizoma Anemarrhenae extract treatment back hydrocortisone after the moulding, wherein there are 8 examples to reduce, 6 examples raise, average decline 4.8nmo/L, with no significant difference before the treatment, the prompting Rhizoma Anemarrhenae total saponins does not influence the catabolism of hydrocortisone.Matched group is 236.4 ± 24.8nmo/L, and wherein 6 examples, 3 examples that descend raise, and does not also have significant difference with comparing after the moulding, sees Table 2:
Table 2: Rhizoma Anemarrhenae extract is to the influence of blood plasma cortisol content
After (before the treatment) treats after the moulding before the moulding
Treatment group 128.09 ± 20.6 238.7 ± 45.2 236.9 ± 42.2
Matched group 236.4 ± 24.8
Experimental result shows that Rhizoma Anemarrhenae extract does not influence the concentration of plasma corticosterone substantially, and the not influence of concentration to blood plasma cortisol does not cause hyposuprarenalism, or causes atrophy of adrenal gland.The prompting Rhizoma Anemarrhenae extract has only alleviated the caused side effect of glucocorticoid.
Embodiment 5
The untoward reaction of embodiment 1 treatment primary nephrotic syndrome relatively
1. case is selected 1～December adult with primary nephrotic syndrome, 30 examples in 2002, confirm that through the kidney biopsy its histological type is: the IgAN7 example, membranous nephropathy 2 examples, film productive nephritis 6 examples, mesangial proliferative nephritis 6 examples, focal hardening nephritis 3 examples, IgNM 1 example, slight pathotype 3 examples, minute lesion 2 examples.With the same period case 30 examples compare.Its histological type distributes similar to the treatment group.
2. the oral prednisone 1mgkg of Therapeutic Method matched group
-1d
-1, begin decrement to maintenance dose after serveing on for 8 weeks.Keep 3 months to half a year.Oral embodiment 1 is organized in treatment, serve on 8 weeks beginning decrement to maintenance dose, observes respectively and many indexs such as recorded heart rate, blood pressure, perspiration and insomnia degree before and after the treatment.
2 the results are shown in Table 3
When table 3:60 example kidney primary nephrotic syndrome patient treats with hormone and embodiment 1, bad
The reaction comparison sheet
| Group | Heart rate is accelerated | Hypertension | Hyperhidrosis | Insomnia and dreamful sleep | Acne | Stomachache | Infect |
| 30 examples are single with prednisone group (matched group) | 18 | 3 | 13 | 18 | 10 | 4 | 4 |
| 1 group of 30 routine embodiment | 6 | 2 | 3 | 8 | 5 | 2 | 1 |
The result shows, with hormone compound recipes such as Rhizoma Anemarrhenae extract of the present invention and prednisones, and the side effect that can significantly alleviate glucocorticoid and produced.
Embodiment 2, embodiment 3 show through clinical trial, possesses the effect that alleviate untoward reaction similar with embodiment 1 equally.
Embodiment 6
The study on the stability of embodiment 1, embodiment 2, embodiment 3.
Place The effects through room temperature, with prednisone, Rhizoma Anemarrhenae Sarsasapogenin (sarsasapogenin, C
27H
45O
3) be evaluation index, embodiment 1, embodiment 2, embodiment placed 2 years, all can keep steady quality.
Show that the compound recipe that contains the compound preparation of glucocorticoid medicine of the present invention does not influence the stability of prednisone, Rhizoma Anemarrhenae extract.
Embodiment 7
The oral liquid that prednisone+Rhizoma Anemarrhenae extracting solution+propranolol is made, wherein propranolol concentration is 1mg/ml.
Take by weighing Rhizoma Anemarrhenae extract 100 grams as extracting among the embodiment 3, other takes by weighing propranolol 1000 grams, and prednisone 1000 grams add a little sugar flavoring, are dissolved in water, and add water to 200,000 milliliters, are distributed into every 100ml or 10ml, and embedding is prepared into oral liquid.
Embodiment 7 needing to can be used for the indication of life-time service corticosteroids medicine equally.
Claims (8)
1, a kind of compound preparation that contains glucocorticoid medicine, mainly make by following medicine:
Oral glucocorticoid medicine, Rhizoma Anemarrhenae extract, wherein Rhizoma Anemarrhenae extract extracts solvent sedimentary material in acetone for being dissolved in ethanol water mixture, the extraction ratio of the Rhizoma Anemarrhenae is 2～3%, and the weight ratio of glucocorticoid and Rhizoma Anemarrhenae extract is 10: 1～200, makes peroral dosage form.
2, the compound preparation that contains glucocorticoid medicine according to claim 1 is characterized in that: the oral glucocorticoid medicine is a prednisone.
3, the compound preparation that contains glucocorticoid medicine according to claim 1, the extracting method that it is characterized in that Rhizoma Anemarrhenae extract is to adopt ethanol water mixture to soak to extract, and decompression recycling ethanol is dissolved in water to the thick paste shape, cold preservation, discard precipitation, the supernatant is evaporated to dried, puts to add small amount of methanol or dissolve with ethanol after cold, add acetone and separate out white precipitate, precipitation is used washing with acetone, drying under reduced pressure promptly, wherein the alcoholic acid percent by volume of ethanol water mixture is 30～80%.
4, according to claim 1 or the 3 described compound preparations that contain glucocorticoid medicine, it is characterized in that alcoholic acid percentage ratio is 50% in the ethanol water mixture.
5, the compound preparation that contains glucocorticoid medicine according to claim 1, it is characterized in that peroral dosage form be oral liquid, capsule, tablet, granule one of them.
6, the compound preparation that contains glucocorticoid medicine according to claim 1, the weight ratio that it is characterized in that glucocorticoid and Rhizoma Anemarrhenae extract is 10: 2～50.
7, according to claim 1 or the 6 described compound preparations that contain glucocorticoid medicine, the weight ratio that it is characterized in that glucocorticoid and Rhizoma Anemarrhenae extract is 10: 50.
8, the described application that contains the compound preparation of glucocorticoid medicine at the medicine of preparation glucocorticoid indication of claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310117612 CN1279958C (en) | 2003-12-31 | 2003-12-31 | Compound formula preparation eontaining glucocorticoid medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200310117612 CN1279958C (en) | 2003-12-31 | 2003-12-31 | Compound formula preparation eontaining glucocorticoid medicine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1555831A true CN1555831A (en) | 2004-12-22 |
| CN1279958C CN1279958C (en) | 2006-10-18 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200310117612 Expired - Lifetime CN1279958C (en) | 2003-12-31 | 2003-12-31 | Compound formula preparation eontaining glucocorticoid medicine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1279958C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102134286A (en) * | 2011-05-11 | 2011-07-27 | 天津大学 | Method for extracting rhizoma anemarrhenae polysaccharide from rhizoma anemarrhenae decoction pieces |
-
2003
- 2003-12-31 CN CN 200310117612 patent/CN1279958C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102134286A (en) * | 2011-05-11 | 2011-07-27 | 天津大学 | Method for extracting rhizoma anemarrhenae polysaccharide from rhizoma anemarrhenae decoction pieces |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1279958C (en) | 2006-10-18 |
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Address after: No. 6 Hongda Middle Road, 100920 Beijing Economic and Technological Development Zone Patentee after: Yuekang Pharmaceutical Group Co.,Ltd. Address before: No. 6 Hongda Middle Road, 100920 Beijing Economic and Technological Development Zone Patentee before: YOUCARE PHARMACEUTICAL GROUP Co.,Ltd. |
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Granted publication date: 20061018 |