CN102000160B - Luodwei dorjie granules and preparation method thereof - Google Patents
Luodwei dorjie granules and preparation method thereof Download PDFInfo
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Abstract
The invention discloses luodwei dorjie granules and a preparation method thereof. The method comprises the following steps of: refluxing codonopsis alpine, tinospora sinensis, costustoot, corydalis impatiens and rhizoma nardostachyos by using ethanol, filtering, combining solution of ethanol, recovering the ethanol and concentrating into cream; drying the cream under reduced pressure and grinding to obtain fine powder; mixing the fine powder with auxiliary materials, preparing into soft materials by using the ethanol, and screening by using a 14-mesh screen to prepare granules; and drying, pelletizing and packaging the prepared granules so as to prepare the luodwei dorjie granules. The composition has the effects of clearing heat and releasing toxin, reducing swelling and easing pain and expelling wind and removing dampness, and is mainly used for treating gout. The decoction is inconvenient to decoct, carry and use; and oral liquid or an oral solid preparation stands for a certain time after high-speed centrifugation and alcohol precipitation, precipitates separate out, and the clarity and appearance of the preparation are influenced. In addition, the product is prepared into oral liquid, the oral liquid is bitter, and has low stability. Therefore, the granules in the oral solid preparations are adopted, the extracted medicaments are rapidly absorbed, and the product is small in volume, stable and is convenient to take.
Description
Technical field
The present invention relates to a kind of preparation of Chinese medicine, be specifically related to a kind of how lucky granule of sieve heap and preparation method thereof with treatment gout function.
Background technology
Gout is a kind of common ciril disease, have uric acid too much more than people's twenty percent of China more than 30 years old, and hyperlithic people's percentage five to 1 12 develops into gout.The human appearance arranged on earth, just have gout to exist.
The medicine of present international and domestic treatment goat is many, but is Western medicine mostly, can only take stopgap measures, and can not effect a permanent cure, and the toxicity of medicine is big, the easily recurrence of treatment back, and the general effect of treatment is not good enough.Tibet is one of district occurred frequently of goat, the Tibetan medicine is with its unique theoretical system, in secular application practice, summed up the better medicine of treatment goat---the how lucky soup of sieve heap, improve after further research, the clinical practice proving effect is apparent in view, can accomplish treating both the principal and secondary aspects of a disease, reduce relapse rate greatly, alleviate patient's misery.
Because this product belongs to antipyretic and antidotal type side's medicine, need to select quick-acting class preparations.This side is used for for many years clinical with decoction, the reflection effect is better.But decoction decocting, carry, use neither convenience.So oral solutions or oral solid formulation are made in plan.When prerun, find, after former side extracts, behind high speed centrifugation processing and precipitate with ethanol, place the regular hour, all have precipitation to separate out, influence the clarity and the outward appearance of preparation.Goods are made the oral liquid bitter in the mouth in addition, and poor stability.
Summary of the invention
The object of the present invention is to provide a kind of how lucky granule of sieve heap for the treatment of gout and preparation method thereof.
For achieving the above object, the how lucky granule of sieve of the present invention heap is made up of principal agent and adjuvant, and wherein principal agent is pressed mass fraction and is made up of the high mountain Radix Codonopsis of 25-35 part, the Herba Lycopodii of 25-35 part, the Radix Aucklandiae of 15-25 part, the Corydalis impatiens (Pall.) Fisch. of 15-25 part and the Radix Et Rhizoma Nardostachyos of 15-25 part.
Described principal agent accounts for the 25-35% of the quality of the pharmaceutical preparations.
Described adjuvant is pressed mass fraction and is made up of the dextrin of 15-25 part, the sucrose of 35-45 part and the soluble starch of 5-15 part.
Preparation method of the present invention is as follows:
1) gets it filled: get the high mountain Radix Codonopsis of 25-35 part, the Herba Lycopodii of 25-35 part, the Radix Aucklandiae of 15-25 part, the Corydalis impatiens (Pall.) Fisch. of 15-25 part and the Radix Et Rhizoma Nardostachyos of 15-25 part by mass fraction;
2) to add the concentration of its 8～12 times of quality be in 55～65% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 0.5～2 hour, filter, merge ethanol liquid, reclaim ethanol, be condensed into the clear paste of the about 1.25～1.40g/ml of density;
3) with step 2) clear paste of gained is at 50～80 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage the 25-35% fine powder being mixed the back with the adjuvant of 65-75% is that 40～60% ethanol are made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made.
Wherein adjuvant is pressed mass fraction and is made up of the dextrin of 15-25 part, the sucrose of 35-45 part and the soluble starch of 5-15 part.
Compositions of the present invention has the effect of heat-clearing and toxic substances removing, reducing swelling and alleviating pain, expelling wind and removing dampness.Be mainly used in the treatment of goat.Owing to decoction decocting, carry, use neither convenience.And oral solutions or oral solid formulation are placed the regular hour behind high speed centrifugation processing and precipitate with ethanol, all have precipitation to separate out, and influence the clarity and the outward appearance of preparation.Goods are made the oral liquid bitter in the mouth in addition, and poor stability.So the present invention adopts the granule in the oral dosage form, fast through extracting post-absorption because of medicine of the present invention, and product volume is little, and is stable, taking convenience.
The specific embodiment
Embodiment 1:
1) gets it filled: get 30 parts high mountain Radix Codonopsis, 30 parts Herba Lycopodii, 20 parts the Radix Aucklandiae, 18 parts Corydalis impatiens (Pall.) Fisch. and 20 parts Radix Et Rhizoma Nardostachyos by mass fraction;
2) to add the concentration of its 10 times of quality be in 60% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 1 hour, filters, and merges ethanol liquid, reclaims ethanol, is condensed into the clear paste of the about 1.25g/ml of density;
3) with step 2) clear paste of gained is at 60 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage 30% fine powder being mixed the back with 70% adjuvant is that 50% ethanol is made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made;
Adjuvant is pressed mass fraction and is made up of 20 parts dextrin, 40 parts sucrose and 10 parts soluble starch.
Embodiment 2:
1) gets it filled: get 25 parts high mountain Radix Codonopsis, 27 parts Herba Lycopodii, 15 parts the Radix Aucklandiae, 15 parts Corydalis impatiens (Pall.) Fisch. and 15 parts Radix Et Rhizoma Nardostachyos by mass fraction;
2) to add the concentration of its 8 times of quality be in 55% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 0.5 hour, filters, and merges ethanol liquid, reclaims ethanol, is condensed into the clear paste of the about 1.35g/ml of density;
3) with step 2) clear paste of gained is at 80 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage 25% fine powder being mixed the back with 75% adjuvant is that 60% ethanol is made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made;
Adjuvant is pressed mass fraction and is made up of 15 parts dextrin, 35 parts sucrose and 5 parts soluble starch.
Embodiment 3:
1) gets it filled: get 35 parts high mountain Radix Codonopsis, 27 parts Herba Lycopodii, 25 parts the Radix Aucklandiae, 23 parts Corydalis impatiens (Pall.) Fisch. and 25 parts Radix Et Rhizoma Nardostachyos by mass fraction;
2) to add the concentration of its 12 times of quality be in 65% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 1 hour, filters, and merges ethanol liquid, reclaims ethanol, is condensed into the clear paste of the about 1.3g/ml of density;
3) with step 2) clear paste of gained is at 50 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage 35% fine powder being mixed the back with 65% adjuvant is that 40% ethanol is made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made;
Adjuvant is pressed mass fraction and is made up of 25 parts dextrin, 45 parts sucrose and 15 parts soluble starch.
Embodiment 4:
1) gets it filled: get 28 parts high mountain Radix Codonopsis, 25 parts Herba Lycopodii, 18 parts the Radix Aucklandiae, 20 parts Corydalis impatiens (Pall.) Fisch. and 18 parts Radix Et Rhizoma Nardostachyos by mass fraction;
2) to add the concentration of its 9 times of quality be in 58% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 1.5 hours, filters, and merges ethanol liquid, reclaims ethanol, is condensed into the clear paste of the about 1.40g/ml of density;
3) with step 2) clear paste of gained is at 70 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage 28% fine powder being mixed the back with 72% adjuvant is that 55% ethanol is made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made;
Adjuvant is pressed mass fraction and is made up of 18 parts dextrin, 38 parts sucrose and 8 parts soluble starch.
Embodiment 5:
1) gets it filled: get 32 parts high mountain Radix Codonopsis, 35 parts Herba Lycopodii, 23 parts the Radix Aucklandiae, 25 parts Corydalis impatiens (Pall.) Fisch. and 23 parts Radix Et Rhizoma Nardostachyos by mass fraction;
2) to add the concentration of its 11 times of quality be in 62% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 1 hour, filters, and merges ethanol liquid, reclaims ethanol, is condensed into the clear paste of the about 1.32g/ml of density;
3) with step 2) clear paste of gained is at 60 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage 32% fine powder being mixed the back with 68% adjuvant is that 45% ethanol is made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made;
Adjuvant is pressed mass fraction and is made up of 23 parts dextrin, 42 parts sucrose and 12 parts soluble starch.
One, function and the function of each raw material in compositions cures mainly
According to ancient prescription " five tastes sieve heap is how lucky " is main, is that important evidence employing modern science pharmaceutical technology is elaborated a kind of sick pure Tibetan medicine that ventilates for the treatment of that forms with the Tibetan medicine and pharmacology monumental work Four-Volume Medical Code, " ten million Buddhist relics " etc.
In the side function of high mountain Radix Codonopsis with cure mainly into: bitter, hot, puckery, cold.Yellow fluid reducing, detumescence.Cure mainly rheumatic arthritis, furuncle is swollen bitterly, leprosy.
In the side function of Radix Aucklandiae (Radix Vladimiriae) with cure mainly into: hot, bitter, temperature.Return spleen, stomach, large intestine, three warmers, gallbladder meridian.Stomach warming, circulation of qi promoting, pain relieving, broken painful abdominal mass knot, granulation promoting.Cure mainly flatulence pain, " dragon is sick ", disorders of blood, diphtheria, pneumonopathy, " Baconic " is poly-to stagnate, diarrhea of heat type, the open sore part is not held back etc.
In the side function of Radix Et Rhizoma Nardostachyos with cure mainly into: hot, sweet, temperature.Return spleen, stomach warp.Heat-clearing and toxic substances removing, the cold relieving detumescence.Control pestilence disease, for a long time heat symptom-complex.
The function of Corydalis impatiens (Pall.) Fisch. is hardship, cold with curing mainly in the side.Heat-clearing and toxic substances removing, anti-inflammatory analgetic.Cure mainly the xerostomia that heat in blood causes, giddy, back pain, liver, gallbladder-heat disease, granulation promoting is wound more, the furuncle carbuncle.
In the side function of Herba Lycopodii with cure mainly into: sweet, bitter, puckery, cold.Heat clearing away is dispeled the wind.Cure mainly wind heat and do not conform to disease, heat symptom-complex due to " dragon ", " red crust ", " Baconic " three polymerization.To deficiency-heat and control goat good effect is arranged.
According to the Tibetan medicine and pharmacology theory, the present invention is that to close the cold both sexes disease of heat, Repercusion analgesia, the expelling wind and removing dampness that disease causes be monarch for blood circulation promoting and blood stasis dispelling, mediation " ' dragon ', ' red crust ', ' Baconic ' " three with high mountain Radix Codonopsis, Herba Lycopodii; With the Radix Aucklandiae (Radix Vladimiriae) is minister, strengthens the effect of blood circulation promoting and blood stasis dispelling, dredging collateral to stop pain; With the Corydalis impatiens (Pall.) Fisch. is assistant, and principal drug assistance is with expelling wind and removing dampness, blood circulation promoting and blood stasis dispelling, Repercusion analgesia; For making, the channels sootheing and network vessel quickening guide drugs works with Radix Et Rhizoma Nardostachyos.
To sum up state; It is that prescription of the present invention meets the Tibetan medicine and pharmacology theory that five tastes sieve is piled many Jis, and particularly proof five tastes sieve is piled many Jis and had the airy effect of significant treatment in the middle of secular clinical practice.Five tastes sieve is piled many Jis and can effectively be treated the ventilation disease and can curative effect preferably be arranged to rheumatism again.
Two, toxicity test
According to the specification requirement of new Chinese medicine toxicologic study, experimental study the acute toxicity of the how lucky preparation of sieve heap.The result shows, after the administration of the how lucky preparation mouse stomach of sieve heap, does not find obvious acute toxicity, and mice maximum dosage-feeding on the one is 130.4g crude drug/kg, is equivalent to clinical adult and intends 136 times of consumptions every day.
According to the clinical course of treatment of the how lucky preparation of sieve heap, according to the specification requirement of new Chinese medicine toxicologic study, this experimental study sieve pile how lucky granule to 6 months of rat (clinical course of treatment 6 times) long term toxicities.The result shows, with large, medium and small three dosage of the how lucky preparation of sieve heap (16,32,64g crude drug/kg, 20,40,80 times of consumption are equivalent to respectively to be grown up) give rat continuous irrigation stomach six months, general situation, hematology, blood biochemical, routine urinalysis, electrocardiogram, system's dissection, organ coefficient and histopathology to rat do not have obvious influence, do not find the overt toxicity reaction, convalescent period does not also have the retardance toxic reaction, and it is 64g crude drug/kg/ day that rat non-toxic reaction dosage is provided.But long-term heavy dose of medication notes the influence possible to female body weight, white blood count and differential and hepatic and renal function.
By toxicological test research, prove that the how lucky preparation of sieve heap do not find obvious acute toxicity, long term toxicity test proves drug safety, avirulence.
Three, pharmacodynamics confirmatory experiment
Sieve heap how lucky preparation has been carried out analgesia, antiinflammatory, the influence of rat hyperuricemia model and urate nephropathy etc. has been cured mainly relevant Pharmacodynamic test of active extract research with function.The result is as follows:
1, the how lucky preparation of sieve heap presses 9.71,19.42,38.86g crude drug/kg is to the mouse stomach administration, improve the threshold of pain of mice thermostimulation, compare with negative control group, 60min and 120min have significant difference (P＜0.05 or P＜0.01) after the middle dosage group administration, 30min, 60min and 120min have significant difference (P＜0.05 or P＜0.01) after the administration of heavy dose of group, and the pain that the how lucky granule of prompting sieve heap causes the mice thermostimulation has stronger analgesic activity; Obviously suppress the mouse writhing reaction that acetic acid stimulates, with negative control group relatively, in, heavy dose of group has significant difference (P＜0.01), the pain of the how lucky granule Dichlorodiphenyl Acetate stimulation of prompting sieve heap also has stronger analgesic activity.
2, the how lucky preparation of sieve heap presses 9.71,19.42,38.86g crude drug/kg is to the mouse stomach administration, suppress the acute exudative inflammation reaction that dimethylbenzene stimulates mice ear to bring out, the swelling degree is reduced, compare with negative control group, in, heavy dose of group has significant difference (P＜0.05), the how lucky granule of prompting sieve heap has the effect of anti-chmice acute exudative inflammation.The how lucky granule of sieve heap presses 6.79,13.58,27.16g crude drug/kg is to the rat oral gavage administration, the generation and the development of the rat acute inflammation that inhibition micro-crystal type uric acid sodium brings out, compare with negative control group, 30min, 2h have significant difference (P＜0.01) after the middle dosage group administration, 30min, 1h, 2h have significant difference (P＜0.05 or P＜0.01) after the administration of heavy dose of group, the rat acute exudative inflammation effect that the how lucky granule of prompting sieve heap has anti-micro-crystal type uric acid sodium to bring out.The how lucky granule of sieve heap by 3.62,7.24,14.48g crude drug/kg is to the rabbit gastric infusion, reduces leukocytic quantity in the gouty arthritis rabbit arthroedema, with model control group relatively, in, the heavy dose of group have significant difference (P＜0.05); The inflammation that alleviates gouty arthritis model rabbit synovium of joint changes, and the how lucky granule of prompting sieve heap has antiinflammatory action to the rabbit gouty arthritis.
3, the how lucky preparation of sieve heap presses 6.79,13.58,27.16g crude drug/kg is to the rat oral gavage administration, obviously reduce uric acid level in hyperuricemia and the urate nephropathy rat model blood, compare with model control group, each dosage group all has significant difference (P＜0.05 or P＜0.01); Slight reduce creatinine level in the blood, with model control group relatively, in, heavy dose of group has significant difference (P＜0.05); Slight reduction blood urea nitrogen level, but statistics there was no significant difference (P＞0.05); Protein in the blood is not had obvious influence, but can reduce T-CHOL and triglyceride in the blood.Common pathology inspection shows that the how lucky granule of sieve heap can reduce the deposition of hyperuricemia and urate nephropathy rat model kidney urate crystal, and the acute injury sexually transmitted disease (STD) that alleviates urate nephropathy becomes.The how lucky granule of results suggest sieve heap has uric acid in the blood of reduction, alleviates urate crystal and deposit at kidney hyperuricemia and urate nephropathy rat model, alleviate urate nephropathy the change of acute injury sexually transmitted disease (STD), improve the effect of renal function.
By the pharmacodynamics test research of novel formulation, prove that the how lucky preparation of sieve heap has analgesia, antiinflammatory action and uric acid reducing effect, has therapeutical effect to goat.Influence of rat hyperuricemia model and urate nephropathy etc. is cured mainly the effectiveness that relevant test has also illustrated preparation with function.
Claims (5)
1. sieve with treatment gout function is piled how lucky granule, it is characterized in that: said preparation is made up of principal agent and adjuvant, and wherein principal agent is pressed mass fraction and is made up of the high mountain Radix Codonopsis of 25-35 part, the Herba Lycopodii of 25-35 part, the Radix Aucklandiae of 15-25 part, the Corydalis impatiens (Pall.) Fisch. of 15-25 part and the Radix Et Rhizoma Nardostachyos of 15-25 part.
2. the how lucky granule of sieve heap with treatment gout function according to claim 1, it is characterized in that: described principal agent accounts for the 25-35% of the quality of the pharmaceutical preparations.
3. the how lucky granule of sieve heap with treatment gout function according to claim 1, it is characterized in that: described adjuvant is pressed mass fraction and is made up of the dextrin of 15-25 part, the sucrose of 35-45 part and the soluble starch of 5-15 part.
4. preparation method with how lucky granule of sieve heap of treatment gout function is characterized in that:
1) gets it filled: get the high mountain Radix Codonopsis of 25-35 part, the Herba Lycopodii of 25-35 part, the Radix Aucklandiae of 15-25 part, the Corydalis impatiens (Pall.) Fisch. of 15-25 part and the Radix Et Rhizoma Nardostachyos of 15-25 part by mass fraction;
2) to add the concentration of its 8～12 times of quality be in 55～65% the alcoholic solution to the medical material that step 1) is got, reflux, extract, 2 times, and each return time is 0.5～2 hour, filter, merge ethanol liquid, reclaim ethanol, be condensed into the clear paste of density 1.25～1.40g/ml;
3) with step 2) clear paste of gained is at 50～80 ℃ of drying under reduced pressure, and pulverize the back and cross into 100 mesh sieves and get fine powder;
4) by mass percentage the 25-35% fine powder being mixed the back with the adjuvant of 65-75% is that 40～60% ethanol are made into behind the soft material after 14 mesh sieve system granules with mass concentration, and 50～80 ℃ of dryings, granulate is packed, promptly with the granule made.
5. the preparation method with how lucky granule of sieve heap of treatment gout function according to claim 4, it is characterized in that: described adjuvant is pressed mass fraction and is made up of the dextrin of 15-25 part, the sucrose of 35-45 part and the soluble starch of 5-15 part.
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| CN201010548181A CN102000160B (en) | 2010-11-17 | 2010-11-17 | Luodwei dorjie granules and preparation method thereof |
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| CN103623066B (en) * | 2013-12-12 | 2015-07-01 | 山东金诃药物研究开发有限公司 | Corydalis impatiens total alkaloid extractive for preparing anti-cancer drugs and application thereof |
| CN104771442B (en) * | 2015-02-15 | 2019-04-30 | 广西卫生职业技术学院 | A kind of Herba Lycopodii extract and its extracting method and application |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1106291A (en) * | 1994-02-04 | 1995-08-09 | 白玛加措 | Tibetan drug and its prepn. |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1106291A (en) * | 1994-02-04 | 1995-08-09 | 白玛加措 | Tibetan drug and its prepn. |
Non-Patent Citations (3)
| Title |
|---|
| 刘忠等.藏药七味罗堆多吉颗粒剂对大鼠高尿酸血症和尿酸性肾病的影响.《江苏中医药》.2009,第41卷(第01期),72-73. * |
| 刘忠等.藏药七味罗堆多吉颗粒剂镇痛、抗炎作用的实验研究.《江苏中医药》.2009,第41卷(第08期),74-76. * |
| 王聚乐等.藏药七味罗堆多吉颗粒剂工艺研究.《西藏大学学报(汉文版)》.2007,第22卷(第03期),115-117. * |
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