CN1836682A - Gadol drop pills and preparation method thereof - Google Patents
Gadol drop pills and preparation method thereof Download PDFInfo
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- CN1836682A CN1836682A CN 200510020567 CN200510020567A CN1836682A CN 1836682 A CN1836682 A CN 1836682A CN 200510020567 CN200510020567 CN 200510020567 CN 200510020567 A CN200510020567 A CN 200510020567A CN 1836682 A CN1836682 A CN 1836682A
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- polyethylene glycol
- gadol
- radix rhodiolae
- drop pills
- water
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Abstract
The rhodiola root dripping pill consists of rhodiola root extract, polyglycol of average molecular weight over 1500 and water. The rhodiola root dripping pill has the features of quick acting, high curative effect, low cost, and other features. The preparation process of the rhodiola root dripping pill is also disclosed.
Description
Technical field
The invention belongs to the pharmaceutical technology field, exactly relating to a kind of is the preparation and preparation method thereof of raw material with the Chinese medicine Radix Rhodiolae.
Background technology
Radix Rhodiolae is the Crassulaceae Rhodida plant, has over one hundred kind in the world, is distributed in the severe cold areas in the Northern Hemisphere more, under most of high mountain flowstones or scrub forest that all are grown in about height above sea level 3500-5000 rice.China has 73 kinds, and wherein Tibet is occupied 32 kinds, 2 mutation, but good development and use are not arranged so far yet.Radix Rhodiolae mainly is used as medicine with root and rhizome, and Herb also can be used as medicine.Mainly contain effective constituent rhodioloside (Salidroside), butyl alcohol (Tyrosot) are arranged, contain starch, protein, fat, tannin, flavone compound, phenolic compound and micro-volatile oil in addition, also contain trace elements iron, aluminum, zinc, silver, cobalt, cadmium, titanium, molybdenum, manganese of biologically active etc., contain a small amount of alkaloid in leaf and the stem.Through the deep pharmacological action and the research of clinical use, the Soviet Union in 1976 Radix Rhodiolae as " adaptogen " sample medicine.Be widely used in resisting fatigue, defying age and aspects such as raising mentality and physical function.
The sixties, the former Soviet Union found Radix Rhodiolae when seeking analeptic, and it is furtherd investigate, and the proposition Radix Rhodiolae has the similar traditional Chinese medical science " strengthening the body resistance " the effect of " adaptogen " sample, and its enhance immunity effect can be better than Radix Ginseng.Professor Sa Lajifu of Si Ke medical university of the former Soviet Union thinks that when tired body can not recover naturally taking Radix Rhodiolae extractum then has remarkable result and nontoxic no addiction.In food industry, can be made into beverage soft but that have the drinks sense of euphoria and can increase work efficiency with Radix Rhodiolae.The former Soviet Union is among the people to be applied to senile heart failure, calmness, sexual impotence and diabetes etc. with Radix Rhodiolae as a kind of analeptic.
The history that Tibetan people utilizes Radix Rhodiolae more early, and is all on the books in " brilliant pearl book on Chinese herbal medicine ", " Tibetan medicine illustrated handbook ".Tibet Radix Rhodiolae more commonly used among the people is treated diseases such as hemoptysis, spitting of blood, pneumonia cough and women leucorrhea.
Contained rhodioloside and Jujubogenin tyrosol have resisting fatigue, anti-hypoxia, anti-microwave radiation, antitoxin and to nervous system and metabolic dual regulation in the Radix Rhodiolae.But also be a kind of environmental adaptation medicine.Before more than thousand year, the Tibetan people of living on the Tibet plateau just is used as medicine with Radix Rhodiolae, in order to the strong body of body-building, the influence of opposing poor environment.Radix Rhodiolae has crucial meaning as a kind of environmental adaptation medicine on military medicine, aerospace medicine.
Existing a lot of for the report of rhodiola rosea formulated product, relate to multiple dosage form, comprise injection, soft capsule, granule, tablet, capsule, oral liquid etc., but all be not the desirable dosage form of Radix Rhodiolae, injection uses inconvenience, needs the patient to arrive medical institutions with good conditionsi and uses; When being used for anti-hypoxia, heart failure, soft capsule, tablet, capsule be because disintegration time is longer, neither desirable dosage form; Granule needs to use with mixing in water for oral taking, uses also inconvenient.
Solid drugs is being made in the process of drop pill, substrate such as solid drugs and Polyethylene Glycol often are difficult for being mixed even, and the uniformity is bad, and medicine is difficult for the system of dripping, and blocking dropping head, has a strong impact on production efficiency.
Summary of the invention
Purpose of the present invention just provides a kind of gadol drop pills, characteristics such as that this drop pill has is rapid-action, good effect, and also cost is low, productivity ratio is high.
Another object of the present invention provides a kind of preparation method of above-mentioned gadol drop pills.
The technical solution adopted for the present invention to solve the technical problems is: a kind of gadol drop pills, it is made up of Radix Rhodiolae extract, Polyethylene Glycol and water, wherein the mean molecule quantity of Polyethylene Glycol is preferably Macrogol 4000 and/or polyethylene glycol 6000 more than 1500.
Above-mentioned gadol drop pills preferably is made up of the component of following weight proportion: 1 part of Radix Rhodiolae extract, 0.7-5 part Polyethylene Glycol and 0.01-0.5 part water.Further the preferred weight proportioning is: 1 part of Radix Rhodiolae extract, 1-3 part Polyethylene Glycol and 0.02-0.25 part water.More preferably weight proportion is: 1 part of Radix Rhodiolae extract, 1.5 parts of Polyethylene Glycol and 0.125 part of water.
Wherein, described Radix Rhodiolae extract extracts the material that makes for adopt water extraction or alcohol extracting method or decoction and alcohol sedimentation technique from the root of Chinese crude drug Crassulaceae Rhodida plant or rhizome or Herb.And, also can adopt organic solvent or column chromatography etc. further refining where necessary.Contain rhodioside (Salidroside) C in extract obtained
14H
20O
7And butyl alcohol (Tyrosot) C
6H
10O
2Deng.
Above-mentioned gadol drop pills can prepare by the method that may further comprise the steps:
(1) get the Radix Rhodiolae extract and the Polyethylene Glycol of described proportioning, mixing, heating makes into molten condition, adds the water of described proportioning again, and mixing obtains waiting the medicinal liquid of the system of dripping;
(2) with liquid paraffin or dimethicone or vegetable oil as coolant, the medicinal liquid of waiting the system of dripping that (1) step is made is made the drop pill of certain specification with dropping-pill machine, gets final product.
Compared with prior art, the invention has the beneficial effects as follows:
(1) compare with capsule, tablet, soft capsule preparation, when guaranteeing curative effect of medication, gadol drop pills is owing to disintegrate rapid (disintegration time only is about 5min), and onset is also faster, is particularly suitable for emergency case medications such as plateau anti-hypoxia, resisting fatigue and cardiovascular and cerebrovascular vessel.
(2) add an amount of water in the gadol drop pills, make Radix Rhodiolae extract and Polyethylene Glycol more easily mix evenly, do not need special installation, simple to operate, more not adding water has extraordinary remarkable result, and makes the system of dripping easily, and blocking dropping head has not improved productivity ratio.
(3) but the administration of gadol drop pills buccal, take than other dosage forms such as granules more convenient, particularly in the open air or the hydropenia environment is down same is suitable for.
(4) gadol drop pills belongs to solid preparation, and is easy to carry than oral liquid, and cracky not, and the shelf-life is longer than oral liquid.
For the effect that confirms that moisture adds in the medicinal dropping ball of the present invention, the inventor has carried out following test to the addition of moisture and has investigated, and method and result are as follows:
Table 1 different in moisture content drips the influence of system effect to drop pill
Radix Rhodiolae extract: Macrogol 4000: water | Drip the system effect observation |
1∶1.5 | Can't mixing, caking can't normally drip system |
1∶1.5∶0.125 | Mix homogeneously, the system of dripping is smooth and easy |
1∶1.5∶0.01 | Elementary mixing is even, and the system of dripping is comparatively smooth and easy |
1∶1.5∶0.05 | Mix homogeneously, the system of dripping is more smooth and easy |
1∶1.5∶0.2 | Mix homogeneously, the system of dripping is smooth and easy, and drop pill is soft slightly |
By above result as can be known, when not moisture, it is relatively poor that gadol drop pills drips the system effect in prescription; In prescription, add a certain proportion of water, can obviously improve its system effect.
Definite for showing curative effect of medication of the present invention, toxicity is little, and the inventor has carried out part pharmacodynamics test and acute toxicity test research.The research method and the result of the test that are adopted are as follows:
(1) pharmacodynamics test research
1, test material
(1), medicine and reagent:
(component by following weight proportion makes medicinal dropping ball of the present invention: the water of 1 part of Radix Rhodiolae extract, 1.5 parts of Macrogol 4000s and 0.125 part; Dosage group (0.4g/kg), medicinal dropping ball high dose group of the present invention (0.8g/kg) in low dose group (0.2g/kg), the medicinal dropping ball of the present invention down together).
Drugs compared (the Radix Rhodiolae extract that does not contain Polyethylene Glycol; 0.2g/kg).
SHENGMAI YIN is Gejiu City Pharmaceutical Industry Co., Ld., Yunnan Prov.'s product.
Homemade CY-2 type oxygen analyser.
(2), animal: Kunming mouse is provided by institute of antibiotics, Sichuan Experimental Animal Center.
2, test method and result
(1). to the influence of mice anoxia enduring and oxygen consumption
Choose 60 Kunming mouses, male and female half and half, body weight 18~22g is divided into 6 groups at random by sex and body weight, 10 every group.Press the listed dosage of table 2, administration group lumbar injection relative medicine, capacity normal saline such as matched group lumbar injection, after 30 minutes each treated animal is placed airtight vial respectively, each one, with the variation of oxygen content in the homemade CY-2 type oxygen analyser measurement bottle, until dead mouse.The record mice time-to-live, the surplus oxygen amount when keto consumpting speed in the time of 30 minutes and death in the bottle.The results are shown in Table 1.
The influence of table 2 pair mice anoxia enduring and oxygen consumption (x ± SD)
Group | Dosage (g/kg) | Mus number (only) | Time-to-live | 30 minutes oxygen consumption |
Dosage medicine group of the present invention low dosage does not contain the drugs compared SHENGMAI YIN of Polyethylene Glycol in the matched group medicine group of the present invention high dose medicine group of the present invention | ---- 0.8 0.4 0.2 0.2 1.5 | 10 10 10 10 10 10 | 53.1±2.2 98.3±3.1 ** 88.2±3.1 ** 73.7±3.8 ** 62.9±3.2 * 62.1±2.9 * | 12.4±0.4 8.4±0.5 ** 9.3±0.4 * 9.7±0.5 * 10.7±0.6 10.1±0.4 |
Annotate: each administration group and matched group are relatively
*P<0.05;
*P<0.01.
Table 2 shows that medicinal dropping ball of the present invention can significantly improve the ability of mice anoxia enduring, show as the mice time-to-live than matched group and the drugs compared, the SHENGMAI YIN that do not contain Polyethylene Glycol obviously prolong.And 30 minutes oxygen consumption more do not contain the drugs compared of Polyethylene Glycol and SHENGMAI YIN few (* * P<0.01) significantly.
(2). to the influence of mice cold resistant
Choose 120 Kunming mouses, male and female half and half, body weight 18~22g is divided into 6 groups at random by sex and body weight, 20 every group.Press the listed dosage of table 3, administration group lumbar injection relative medicine, capacity normal saline such as matched group lumbar injection, after 30 minutes each group mice is mixed in the ferrum cage, place the subzero 12 ℃ cold environment of subzero 11-, when control group mice death half, death toll (the results are shown in Table 3) of each group of record.
The influence of table 3 pair mice cold resistant (x ± SD)
Group | Dosage (g/kg) | Mus number (only) | Death toll | Mortality rate (%) |
Dosage medicine group of the present invention low dosage does not contain the drugs compared SHENGMAI YIN of Polyethylene Glycol in the matched group medicine group of the present invention high dose medicine group of the present invention | ---- 0.8 0.4 0.2 0.2 1.5 | 20 20 20 20 20 20 | 15 7 8 10 13 11 | 75.0 35.0** 40.0** 50.0** 65.0 55.0* |
Annotate: each administration group and matched group be * P<0.05 relatively; * P<0.01.
Table 3 shows that medicinal dropping ball of the present invention can significantly improve the tolerance to cold of mice, makes mortality rate reduce to 35.0-50.0% respectively by 75.0% of matched group, does not more contain the drugs compared and the SHENGMAI YIN effective (* * P<0.01) of Polyethylene Glycol.
(2) acute toxicity test research
The inventor has carried out the acute toxicity test investigation with mice to medicinal dropping ball of the present invention, the result: the maximum dosage-feeding of medicine mouse stomach of the present invention administration is 180g biology/kg/24h, and maximum administration multiple is intended clinical oral administration day dosage (1200 times of 0.15g crude drug/kg) for 60kg body weight adult.The result shows that medicinal dropping ball safe dose scope of the present invention is bigger.
The specific embodiment
The present invention is described in further detail below in conjunction with the specific embodiment.
Embodiment one forms to very other component by listed each embodiment weight proportion in the table 4.
Table 4 embodiment one to ten each composition weight proportioning
The preparation method of embodiment one to three may further comprise the steps:
(1) according to each composition weight proportioning among listed each embodiment in the table 4, get the Radix Rhodiolae extract and the Polyethylene Glycol of described proportioning, mixing, heating makes into molten condition, adds the water of described proportioning again, and mixing obtains waiting to drip the medicinal liquid of making;
(2) with about 15 ℃ liquid paraffin as coolant, the medicinal liquid of waiting the system of dripping that (1) step is made is made the drop pill of certain specification with dropping-pill machine, gets final product.
The preparation method of embodiment four to six may further comprise the steps:
(1) according to each composition weight proportioning among listed each embodiment in the table 4, get the Radix Rhodiolae extract and the Polyethylene Glycol of described proportioning, mixing, heating makes into molten condition, adds the water of described proportioning again, and mixing obtains waiting to drip the medicinal liquid of making;
(2) with about 8 ℃ dimethicone as coolant, the medicinal liquid of waiting the system of dripping that (1) step is made is made the drop pill of certain specification with dropping-pill machine, gets final product.
The preparation method of embodiment seven to ten may further comprise the steps:
(1) according to each composition weight proportioning among listed each embodiment in the table 4, get the Radix Rhodiolae extract and the Polyethylene Glycol of described proportioning, mixing, heating makes into molten condition, adds the water of described proportioning again, and mixing obtains waiting to drip the medicinal liquid of making;
(2) with about 5 ℃ vegetable oil as coolant, the medicinal liquid of waiting the system of dripping that (1) step is made is made the drop pill of certain specification with dropping-pill machine, gets final product.
Claims (7)
1, a kind of gadol drop pills, it is made up of Radix Rhodiolae extract, Polyethylene Glycol and water, and wherein the mean molecule quantity of Polyethylene Glycol is more than 1500.
2, gadol drop pills according to claim 1 is characterized in that: the weight proportion of described each component is: 1 part of Radix Rhodiolae extract, 0.7-5 part Polyethylene Glycol and 0.01-0.5 part water.
3, gadol drop pills according to claim 2 is characterized in that: the weight proportion of described each component is: 1 part of Radix Rhodiolae extract, 1-3 part Polyethylene Glycol and 0.02-0.25 part water.
4, gadol drop pills according to claim 3 is characterized in that: the weight proportion of described each component is: 1 part of Radix Rhodiolae extract, 1.5 parts of Polyethylene Glycol and 0.125 part of water.
5, gadol drop pills according to claim 1 is characterized in that: described Polyethylene Glycol is Macrogol 4000 and/or polyethylene glycol 6000.
6, gadol drop pills according to claim 1 is characterized in that: described Radix Rhodiolae extract extracts the material that makes for adopt water extraction or alcohol extracting method or decoction and alcohol sedimentation technique from the Chinese crude drug Radix Rhodiolae.
7, the preparation method of the described gadol drop pills of a kind of claim 1 may further comprise the steps:
(1) get the Radix Rhodiolae extract and the Polyethylene Glycol of described proportioning, mixing, heating makes into molten condition, adds the water of described proportioning again, and mixing obtains waiting the medicinal liquid of the system of dripping;
(2) with liquid paraffin or dimethicone or vegetable oil as coolant, the medicinal liquid of waiting the system of dripping that (1) step is made is made the drop pill of certain specification with dropping-pill machine, gets final product.
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CN 200510020567 CN1836682A (en) | 2005-03-24 | 2005-03-24 | Gadol drop pills and preparation method thereof |
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CN 200510020567 CN1836682A (en) | 2005-03-24 | 2005-03-24 | Gadol drop pills and preparation method thereof |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101234136B (en) * | 2008-02-04 | 2011-06-22 | 赵红姝 | Medicament for curing diabetes retina affection |
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2005
- 2005-03-24 CN CN 200510020567 patent/CN1836682A/en active Pending
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101234136B (en) * | 2008-02-04 | 2011-06-22 | 赵红姝 | Medicament for curing diabetes retina affection |
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