CN104095935A - Chinese herbal preparation for preventing and curing acute mountain sickness and preparation method for Chinese herbal preparation - Google Patents
Chinese herbal preparation for preventing and curing acute mountain sickness and preparation method for Chinese herbal preparation Download PDFInfo
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- CN104095935A CN104095935A CN201410287983.1A CN201410287983A CN104095935A CN 104095935 A CN104095935 A CN 104095935A CN 201410287983 A CN201410287983 A CN 201410287983A CN 104095935 A CN104095935 A CN 104095935A
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Abstract
The invention discloses a Chinese herbal preparation, namely calculus bovis desert cistanche tablets, for preventing and curing acute mountain sickness and a preparation method for the Chinese herbal preparation. The Chinese herbal preparation comprises the following raw materials in parts by weight: 150-350 parts of desertliving cistanche extractive, 50-200 parts of in vitro cultivated calculus bovis and a proper amount of pharmaceutic adjuvants, which are prepared into tablets according to a suitable preparation process. The product is prepared by adopting conventional Chinese medicine theory and scientific research documents as references, and adopting modern pharmacology scientific experiments as foundation; the product has favorable preventing and curing effect for acute mountain sickness, and is stable and reliable in product quality, safe and nontoxic.
Description
Technical field
The invention belongs to Chinese patent medicine preparation field, relate in particular to Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet of a kind of prevention and treatment acute high altitude reaction and preparation method thereof.
Background technology
Acute high altitude reaction (Acute Mountain Sickness, AMS), claim again acute mild altitude sickness, referring to that body is entered into highlands (more than height above sea level 3000m) or occupied for a long time plateau by Plain enters into more high altitude localities, body does not adapt to plateau natural environment and a series of acute anoxias reaction that produces, and morbidity is 1-3 days after arriving at plateau conventionally.Headache is the most typical symptom of AMS.Clinical symptoms comprises headache, dizziness, cardiopalmus, uncomfortable in chest, tachypnea, weak, poor appetite, sleep disorder, and feeling sick appears in severe one, vomiting, cyanosis.The high original area of China is vast, and especially Qinghai-Tibet mean sea level is more than 4000 meters, and AMS is more than 4000 meters different with concrete height above sea level according to the rate of climb, and its sickness rate can reach 50% to 65%.For the crowd of Acute Exposed Altitude, AMS is a major obstacle that affects its live and work.If AMS is not controlled timely and effectively, may make progress as high altitude cerebral adema (high-altitude cerebral edema, HACE) and plateau pneumochysis (high-altitude pulmonary edema, HAPE), threat to life even, the former mortality rate is up to 80%.
In recent years, development along with highland tour's industry and plateau economic construction, crowd's expanding day on turnover plateau, the generation of acute high altitude reaction has caused inconvenience to people's life, work, urgently find short Altitude acclimatization measure effectively, best prevention and therapeutic scheme are still chemoprophylaxis at present.For subjects with acute high-altitude exposure adopt Western medicine or Chinese medicine and western medicine bound drug more remarkable for rapid recovery altitude sickness curative effect, Chinese medicine is improving animal economy hypoxia-bearing capability, alleviates the visceral organ injury aspect that anoxia causes and has unique curative effect.In recent years, along with the limitation of people to the deep understanding of chemicals toxic and side effects and chemical synthetic drug treatment disease, increasing people are enamoured of natural drug, aspect control acute high altitude reaction, Chinese medicine is acknowledged as a kind of effective means, treatment by Chinese herbs has multi-level, many target spots, integrally-regulated advantage.
Summary of the invention
Object of the present invention; be exactly under above-mentioned background; with national Chinese medicine one kind new medicine; national patented product-In vitro cultured Calculus Bovis is primary raw material; use theory of Chinese medical science; and screen in conjunction with modern Chinese medicine pharmaceutical research, with another kind of primary raw material Herba Cistanches extract, be equipped with a kind of new prevention that suitable adjuvant develops and the compound Chinese medicinal preparation for the treatment of acute high altitude reaction.
Technical solution of the present invention is:
Prevent and treat Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet of acute high altitude reaction, comprise the raw material of following weight component: Herba Cistanches extract 150-350 part, In vitro cultured Calculus Bovis 50-200 part, and the pharmaceutic adjuvant of pharmaceutically license amount.
Described adjuvant is two or more the combination in ethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, magnesium stearate, calcium stearate, Pulvis Talci.
As a kind of preferred technical solution of the present invention, be characterised in that the raw material that comprises following weight component: 150 parts of Herba Cistanches extracts, 50 parts of In vitro cultured Calculus Boviss, microcrystalline Cellulose 50-250 part, carboxymethyl starch sodium 50-100 part, magnesium stearate 1-8 part.
A method of preparing Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet of above-mentioned prevention and treatment acute high altitude reaction, is characterized in that: step is as follows:
(1) each raw material is crossed respectively to 100 mesh sieves, by recipe quantity, take Herba Cistanches extract, In vitro cultured Calculus Bovis, adjuvant a, and mix homogeneously;
(2) with appropriate alcoholic solution, as wetting agent, make soft material, cross 18～24 mesh sieves and make wet granular, wet granular is dried under 50～80 ℃ of conditions; Then use 18～24 mesh sieve granulate, add adjuvant b to mix rear tabletting, obtain Calculus Bovis Herba Cistanches sheet of the present invention;
Described adjuvant a is the mixture of ethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, wherein one or more of polyvinylpolypyrrolidone; Adjuvant b is one or more the mixture in magnesium stearate, calcium stearate, Pulvis Talci.
Product prescription of the present invention be take modern pharmacology scientific experimentation screening as basis; evident in efficacy; the protective effect screening of D-gal macrophage damage is carried out in design by folk prescription and compound recipe; sample comprises Radix Rhodiolae, bezoar capsule, In vitro cultured Calculus Bovis, Herba Cistanches, superfine, Calculus Bovis Herba Cistanches side, the loose parllel screening that carries out of Radix Ginseng Calculus Bovis; experimental design absorbs D-gal for hypercellularity; by " aldose reductase and oxidase ", cause " galactitol accumulation " and " galacturonic acid oxygen free radical injury ".Cell depleting ATP and energy charge, film Na+-K+-ATP enzymatic activity reduces, mitochondrial swelling, cellular metabolism rate is lowered.Compound recipe screening and the protective effects to the damage of D-gal macrophage such as research each folk prescription of screening and Calculus Bovis Herba Cistanches.By screening, in the human macrophage strain model of oxidative of cultivating in vitro, the protective effect of Calculus Bovis and Herba Cistanches extract composition of prescription is more obvious.The clinical trial result of preliminary treatment acute high altitude reaction shows that the effective percentage of Calculus Bovis Herba Cistanches sheet reaches 99%, and wherein cure rate reaches 93%, effective 6%, and wherein 3d cure rate reaches 54%, 5d cure rate and reaches 40%.
Product advantage feature of the present invention is: (1) raw material antioxygenic property is outstanding, and research shows that Herba Cistanches extract and In vitro cultured Calculus Bovis all have good antioxidation.(2) pharmacological evaluation fully verifies that product of the present invention is to action of nervous system effect, anoxia enduring effect and anti-aging effects effect.Product of the present invention can obviously resist caffeine and sodium benzoate and cause mice convulsion, and morphine causes mice straub tail reaction, has assistance syngignoscism with pentobarbital sodium, to central nervous system there is calmness, convulsion, without analgesic activity; Product of the present invention can obviously reduce the blood pressure of rat, but does not affect the electrocardiogram of heart rate, has resisting oxygen lack, can protect brain cell and cardio cerebral function.Product of the present invention can significantly improve body and remove free radical and prevent that free-radical generating from stablize homeostasis, brings into play anti-aging effects.(3) dosage form science, advantage is outstanding, and this product dosage form is tablet, and dosage is accurate, and content is even; The technical maturity of tablet, production mechanization, automaticity are higher, and output is large, and cost is lower; Stability is better; Carry, transport, take all more convenient, be easy to consumer and accept and take.
Through demonstrations such as pharmacodynamics for many years, toxicology tests, steady quality of the present invention, safe and reliable:
1. pharmacodynamic study:
Atmospheric closed animal model test shows that Calculus Bovis Herba Cistanches sheet can extend the normobaric hypoxia mouse survival time; the test of hypobaric hypoxia animal pattern shows that Calculus Bovis Herba Cistanches sheet can effectively extend the swimming time of hypobaric hypoxia model mice, comprehensively shows that Calculus Bovis Herba Cistanches sheet has good anti-hypoxia and resisting fatigue effect.
2. stability experiment:
Three batch samples of centering trial production of the present invention are carried out 0-24 month observation, investigate result and show that the indexs such as its character, discriminating, hardness, disintegration, assay, microbial limit have no significant change.Therefore, steady quality of the present invention.
3. toxicologic study:
The acute toxicity tests shows that Calculus Bovis Herba Cistanches sheet has no obvious poisoning symptom with the sample of the dosage of 22 g/kg after the Kunming mouse gavage to female, male two kinds of sexes, observes 14 d without death.Put to death animal subject to dissect the main organs such as inspection, liver,spleen,kidney, stomach, intestinal, the heart, lung at test end, shows no obvious abnormalities change.Under 10.00g g/kg body weight dosage, PCEMNR micronucleus test, mouse sperm deformity result of the test are all negative.30 days feeding trials of SD rat; result shows with the Calculus Bovis Herba Cistanches sheet of 1 g/kg body weight, 2 g/kg body weight, 4 g/kg body weight dosage to SD rat oral gavage 30 days; duration of test; animal growth is good; each dosage group body weight, weightening finish, food utilization, routine blood test index, blood biochemistry index, organ weights and internal organs/body weight ratio and matched group comparison, there was no significant difference (P > 0.05).Gross anatomy has no the abnormal change relevant with sample with tissue pathology checking.This prompting is fed rat is had no to obvious toxic-side effects for 30 days.
Composition principle of the present invention: Herba Cistanches kidney-replenishing in prescription, benefiting essence-blood, with the prosperous blood of the two compatibility gas of Calculus Bovis, does not stop up QI invigorating stagnant, invigorates blood circulation and does not just hinder.Motherland's medical science think " vital qi person; suffered in sky; with essence derived from food and and the person that fills body also " (< < Ling Shu Miraculous Pivot or Divine Axis Ci Jiezhen pathogen opinion > >, gas is the base substance that forms human body and sustain life.Plateau is due to factors such as unique geography, weathers, and environment is in the not enough state of clearing heat in QI system.Clearing heat in QI system is not enough, pectoral qi is weak, lung governing qi function reduces, be difficult to department's breathing and pass through heart arteries and veins, the gas of human body is in the state of relative deficiency, form again on this basis the pathological products such as blood stasis, phlegm retention, water be wet, finally form a series of pathological changes of deficiency in origin and excess in superficiality, so prevention with Chinese medicine treatment acute high altitude reaction should be take benefiting QI for activating blood circulation as basic principle.Herba Cistanches sweet-salty is warm in nature, returns kidney, large intestine channel, homework kidney-replenishing, and benefiting essence-blood, loosening bowel to relieve constipation, infertile for sexual impotence, soreness of the waist and knees, muscles and bones is unable, dryness of the intestine constipation.In the > > of < < Sheng Nong's herbal classic, Herba Cistanches is classified as top grade; " main five kinds of strain and seven kinds of impairment, invigorating middle warmer, except stem invasion by pathogenic cold burning pain, supports the five internal organs, reinforcing YIN-essence, benefiting essence-blood ", be reinforcing the kidney and supporting YANG, sperm adding and marrow healthing; blood enriching and dryness moistening, the famous and precious Chinese crude drug that happy color is prolonged life.Modern study shows, it has many-sided pharmacological actions such as the renal function of raising, defying age, antioxidation, adjusting immunologic function.The pharmaceutical research of relevant Herba Cistanches extract alleviating physical fatigue and clinical practice report is as follows: it is model that Gao Zhanyou be take large intensity endurance training rat, the impact of research Herba Cistanches on rat resisting kinetic fatigue ability and brain free radical, this result of study shows, taking Herba Cistanches extract contributes to rat power to exhaust the prolongation of time, can do and improve its motor capacity, the generation of delay fatigue.Wang Zhiqiangs etc. are given mice Herba Cistanches water decoction gavage 7d, and result Herba Cistanches water decoction group mice anoxia enduring time-to-live and mice burden swimming persistent period are obviously longer than matched group; Lumbar injection Herba Cistanches water decoction has also obviously extended the time-to-live of nitrite poisoning mice.Result demonstration, Herba Cistanches can increase mice anti-hypoxia and tired tolerance.Modern pharmacology experiment shows; In vitro cultured Calculus Bovis can effectively extend the life span of atmospheric closed hypoxia mice; it has resisting oxygen lack; and this effect is active and reduce MDA content, improve body and remove the ability of free radical, alleviate the infringement of lipid peroxidation to brain, the heart, tissue with its raising SOD, the protection heart, brain cell are relevant.In a word, the two compatibility science, had both met Traditional Chinese medical theory, realized significant benefiting QI for activating blood circulation effect, had again good modern pharmacology scientific research basis.
Product of the present invention has good prevention and therapeutic effect, stable and reliable product quality, safety non-toxic to acute high altitude reaction.
The specific embodiment
Embodiment 1
Supplementary material is pulverized respectively and to cross 100 mesh sieves standby; by recipe quantity, take Herba Cistanches extract 150g, In vitro cultured Calculus Bovis 50g, microcrystalline Cellulose 100g; carboxymethyl starch sodium 50g; mix homogeneously, adds appropriate alcoholic solution to make wetting agent soft material processed, crosses 18～24 mesh sieves and granulates; wet granular is dried under 40～90 ℃ of conditions; with 18～24 mesh sieve granulate, add tabletting after the abundant mix homogeneously of magnesium stearate 1g, obtain 1000 of Calculus Bovis Herba Cistanches sheets of the present invention.
Embodiment 2
Supplementary material is pulverized respectively and to cross 100 mesh sieves standby; by recipe quantity, take Herba Cistanches extract 350g, In vitro cultured Calculus Bovis 200g, microcrystalline Cellulose 200g; carboxymethyl starch sodium 80g; mix homogeneously, adds appropriate alcoholic solution to make wetting agent soft material processed, crosses 18～24 mesh sieves and granulates; wet granular is dried under 40～90 ℃ of conditions; with 18～24 mesh sieve granulate, add tabletting after the abundant mix homogeneously of magnesium stearate 1g, obtain 1000 of Calculus Bovis Herba Cistanches sheets of the present invention.
Embodiment 3
Supplementary material is pulverized respectively and to cross 100 mesh sieves standby; by recipe quantity, take Herba Cistanches extract 150g, In vitro cultured Calculus Bovis 50g, microcrystalline Cellulose 50g; carboxymethyl starch sodium 50g; mix homogeneously, adds appropriate alcoholic solution to make wetting agent soft material processed, crosses 18～24 mesh sieves and granulates; wet granular is dried under 40～90 ℃ of conditions; with 18～24 mesh sieve granulate, add tabletting after the abundant mix homogeneously of magnesium stearate 1g, obtain 1000 of Calculus Bovis Herba Cistanches sheets of the present invention.
Embodiment 4
Supplementary material is pulverized respectively and to cross 100 mesh sieves standby; by recipe quantity, take Herba Cistanches extract 350g, In vitro cultured Calculus Bovis 200g, microcrystalline Cellulose 250g; carboxymethyl starch sodium 100g; mix homogeneously, adds appropriate alcoholic solution to make wetting agent soft material processed, crosses 18～24 mesh sieves and granulates; wet granular is dried under 40～90 ℃ of conditions; with 18～24 mesh sieve granulate, add tabletting after the abundant mix homogeneously of magnesium stearate 8g, obtain 1000 of Calculus Bovis Herba Cistanches sheets of the present invention.
Claims (4)
1. Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet of prevention and treatment acute high altitude reaction, is characterized in that: the raw material that comprises following weight component: Herba Cistanches extract 150-350 part, In vitro cultured Calculus Bovis 50-200 part, and the pharmaceutic adjuvant of pharmaceutically license amount.
2. Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet of prevention as claimed in claim 1 and treatment acute high altitude reaction, is characterized in that: described adjuvant is two or more the combination in ethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, polyvinylpolypyrrolidone, magnesium stearate, calcium stearate, Pulvis Talci.
Prevention as claimed in claim 1 and treatment acute high altitude reaction Chinese medicine preparation-Calculus Bovis Herba Cistanches sheet; it is characterized in that: the raw material that comprises following weight component: 150 parts of Herba Cistanches extracts; 50 parts of In vitro cultured Calculus Boviss; microcrystalline Cellulose 50-250 part; carboxymethyl starch sodium 50-100 part, magnesium stearate 1-8 part.
4. according to the medicine described in claim 1 or 3, its concrete preparation technology is as follows
(1) each raw material was pulverized respectively to 100 mesh sieves, by recipe quantity, took Herba Cistanches extract, In vitro cultured Calculus Bovis, adjuvant a, and mix homogeneously;
(2) with appropriate alcoholic solution, as wetting agent, make soft material, cross 18～24 mesh sieves and make wet granular, wet granular is dried under 40～90 ℃ of conditions; Then use 18～24 mesh sieve granulate, add adjuvant b to mix rear tabletting, obtain Calculus Bovis Herba Cistanches sheet of the present invention;
Described adjuvant a is the mixture of ethyl cellulose, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl cellulose, carboxymethyl starch sodium, wherein one or more of polyvinylpolypyrrolidone; Adjuvant b is one or more the mixture in magnesium stearate, calcium stearate, Pulvis Talci.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112603956A (en) * | 2021-01-11 | 2021-04-06 | 贵州中医药大学 | Traditional Chinese medicine compound preparation for preventing acute altitude stress |
Citations (3)
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|---|---|---|---|---|
| CN1257722A (en) * | 1998-12-24 | 2000-06-28 | 赵徕淋 | Medicinal oil for dredging channels and collaterals of heart and brain and its preparing process |
| CN1452875A (en) * | 2002-04-26 | 2003-11-05 | 章浩 | Health tea with rhodiola root and glossy ganoderma as main material and its making process |
| CN102210838A (en) * | 2010-04-09 | 2011-10-12 | 肖嘉惠 | Medicinal composition for strengthening immunity and improving human body condition |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1257722A (en) * | 1998-12-24 | 2000-06-28 | 赵徕淋 | Medicinal oil for dredging channels and collaterals of heart and brain and its preparing process |
| CN1452875A (en) * | 2002-04-26 | 2003-11-05 | 章浩 | Health tea with rhodiola root and glossy ganoderma as main material and its making process |
| CN102210838A (en) * | 2010-04-09 | 2011-10-12 | 肖嘉惠 | Medicinal composition for strengthening immunity and improving human body condition |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112603956A (en) * | 2021-01-11 | 2021-04-06 | 贵州中医药大学 | Traditional Chinese medicine compound preparation for preventing acute altitude stress |
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