CN115120657B

CN115120657B - Traditional Chinese medicine composition and pharmaceutical preparation for impervious capacity expansion in burn shock period and preparation method

Info

Publication number: CN115120657B
Application number: CN202210926816.1A
Authority: CN
Inventors: 赵杰; 孔昭遐; 孙业祥
Original assignee: First Affiliated Hospital of Anhui Medical University
Current assignee: First Affiliated Hospital of Anhui Medical University
Priority date: 2022-08-03
Filing date: 2022-08-03
Publication date: 2023-05-09
Anticipated expiration: 2042-08-03
Also published as: CN115120657A

Abstract

The invention provides a traditional Chinese medicine composition, a pharmaceutical preparation and a preparation method for impervious capacity expansion in burn shock period, which relate to the technical field of traditional Chinese medicines and are composed of specific parts by weight of raw astragalus, radix codonopsis pilosulae, raw white atractylodes rhizome, whole angelica, radix rehmanniae, white peony root, red sage root, rhizoma alismatis, plantain seed, polyporus, poria cocos and schisandra chinensis. The traditional Chinese medicine compound is a prescription for teaching experience of the first name of the old traditional Chinese medicine Kong Zhaoxia nationwide, is clinically applied with sixty carriers, has firm classical theory support of traditional Chinese medicine, has reasonable component proportion, excellent medicine compatibility, low cost and easy quality control, is proved by animal and clinical experiments, has definite curative effect, no toxic or side effect and safe administration, and can be applied to preparing the traditional Chinese medicine composition for expanding capacity and resisting exudation in the burn shock exudation period.

Description

Traditional Chinese medicine composition and pharmaceutical preparation for impervious capacity expansion in burn shock period and preparation method

Technical Field

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for impervious dilatation in burn shock period, a pharmaceutical preparation and a preparation method thereof.

Background

Burn shock is a pathophysiological process and clinical syndrome which are presented early after severe burn and affect the whole-course disease development and treatment result, is one of the earliest complications after burn patients, and is initially manifested by increased peripheral vascular resistance, reduced cardiac output, reduced urine volume and blood concentration, serious patients can cause multiple organ failure to endanger life, the shock period is not stable, and systemic infection and visceral complications are easy to occur in the later period. Therefore, the treatment of burn shock period is of great importance. However, the clinical burn shock treatment is passive due to the unclear occurrence and development mechanism of the burn shock, heart failure is caused by excessive heart load due to excessive fluid infusion, and tissue perfusion and oxygen supply cannot be ensured due to insufficient fluid infusion. Therefore, the traditional Chinese medicine capable of resisting exudation and expanding volume is searched, the passive fluid infusion is changed into the passive fluid infusion to resist shock, the active decrease of exudation and the shock prevention are especially necessary, and the traditional Chinese medicine composition has certain advantages in the aspect of resisting exudation and expanding volume in the burn shock period.

Skin and hair are not stored after severe burn, striae and skin are not firm, channels and collaterals are burned, body fluid is excreted, qi is removed along with body fluid, and meanwhile, heart is hurt, frightened and frightened, heart qi is suddenly deficiency, drum is less in movement, qi deficiency causes blood stagnation, palpitation and pulse number, indifferent feeling or dysphoria, dry mouth and urine are little, and the symptoms such as unconsciousness and adverse reaction are caused. The dysfunction of nerve fluid and cardiovascular system is caused, just like the "frightening heart is not dependent on the mind and not dependent on the spirit" in Huangdi's internal channel, so qi is not enough because of the undetermined mind. The skin barrier is destroyed after serious burn in modern medicine, so that the peripheral circulation is blood circulation disorder, tissue metabolism disorder, capillary permeability increase, nerve body fluid and cardiovascular system dysfunction are caused, and skin and hair are not stored in burn parts, skin and skin striae are not dense, the channels and collaterals are burned, collaterals are directly damaged, so that local superficial and defensive loss and consolidation of burn are formed, nutrient and blood stasis stagnates, body fluid is extravasated, and qi is separated along with body fluid, so that shock is caused. The preparation is especially important for invigorating qi, promoting blood circulation, and resisting seepage and expanding the volume in early burn.

In view of this, the present invention has been made.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for impervious dilatation in burn shock stage, which at least solves one of the technical problems in the prior art.

It is a further object of the present invention to provide a pharmaceutical formulation.

The present invention also provides a method for preparing the pharmaceutical preparation.

In order to achieve the above object of the present invention, the following technical solutions are specifically adopted:

the invention provides a traditional Chinese medicine composition for impervious capacity expansion in burn shock period, which is prepared from the following raw materials: 400-600 parts of raw astragalus, 200-300 parts of radix codonopsis pilosulae, 100-200 parts of raw bighead atractylodes rhizome, 200-300 parts of whole angelica, 200-300 parts of radix rehmanniae, 200-300 parts of white peony root, 200-300 parts of red sage root, 200-300 parts of rhizoma alismatis, 200-300 parts of plantain seed, 200-300 parts of Polyporus, 200-300 parts of poria cocos and 100-200 parts of schisandra chinensis.

Further, the material consists of the following raw materials: 450 to 550 parts of raw astragalus root, 220 to 280 parts of radix codonopsis pilosulae, 120 to 180 parts of raw white atractylodes rhizome, 220 to 280 parts of whole angelica, 220 to 280 parts of dried rehmannia root, 220 to 280 parts of white peony root, 220 to 280 parts of red sage root, 220 to 280 parts of rhizoma alismatis, 220 to 280 parts of plantain seed, 220 to 280 parts of polyporus umbellatus, 220 to 280 parts of poria cocos and 120 to 180 parts of schisandra chinensis.

Further, the material consists of the following raw materials: 500 parts of raw astragalus, 250 parts of radix codonopsis pilosulae, 150 parts of raw bighead atractylodes rhizome, 250 parts of whole angelica, 250 parts of dried rehmannia root, 250 parts of white peony root, 250 parts of red sage root, 250 parts of rhizoma alismatis, 250 parts of plantain seed, 250 parts of Polyporus, 250 parts of poria cocos and 150 parts of schisandra chinensis.

The invention also provides application of the traditional Chinese medicine composition in preparing a pharmaceutical preparation for impervious dilatation in burn shock period.

The invention also provides a pharmaceutical preparation, which comprises an active ingredient and pharmaceutically acceptable auxiliary materials;

the active ingredients comprise the traditional Chinese medicine composition.

Further, the dosage forms of the pharmaceutical preparation comprise tablets, capsules, granules, powder, pills or syrup.

The invention also provides a preparation method of the medicinal preparation, which comprises the steps of adding ethanol into each component in the formula amount for reflux extraction for 2 times, concentrating the extracting solution to the relative density of the liquid medicine of 1.05, combining the centrifugate and the ethanol extract after centrifugal impurity removal, concentrating the centrifugate and the ethanol extract under reduced pressure to the relative density of the liquid medicine of 1.15, and preparing extract powder from the obtained concentrated solution.

Furthermore, the pharmaceutical preparation is a granule, the preparation method further comprises the step of wetting and granulating the extract powder after adding dextrin and sugar powder, and the granule is obtained after drying.

Further, the pharmaceutical preparation is a tablet, and the preparation method further comprises the steps of mixing the extract powder with lactose, proteoglycan and ethanol, granulating, drying, adding magnesium stearate, uniformly mixing, and tabletting to obtain the tablet.

Further, the pharmaceutical preparation is a capsule, and the preparation method further comprises the step of filling the extract powder into a capsule to obtain the capsule.

Compared with the prior art, the invention has the following beneficial effects:

(1) The pharmaceutical composition has firm classical theory support of traditional Chinese medicine, accords with the principle of monarch, minister and assistant components of the traditional Chinese medicine, forms a complete principle and prescription system for burn shock patients for the first time, and fills the theoretical gap of treating burn by the traditional Chinese medicine at home and abroad;

(2) The clinical application of the theory guides the formation of the medicine combination, the clinical treatment of sixty carriers, the curative effect is safe and reliable, no toxic or side effect exists, the administration is safe, and the medicine combination can be applied to the preparation of the traditional Chinese medicine combination for expansion and seepage resistance in the burn shock period;

(3) The traditional Chinese medicine composition has the advantages of excellent compatibility, reasonable proportion, low cost, and good popularization and application prospect, and reduces the economic and mental burden of patients.

Detailed Description

Unless defined otherwise herein, scientific and technical terms used in connection with the present invention shall have the meanings commonly understood by one of ordinary skill in the art. The meaning and scope of terms should be clear, however, in the event of any potential ambiguity, the definitions provided herein take precedence over any dictionary or extraneous definition. In this application, the use of "or" means "and/or" unless stated otherwise. Furthermore, the use of the term "include" and other forms is not limiting.

The technical solutions of the present invention will be clearly and completely described in connection with the embodiments, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

According to one aspect of the invention, a traditional Chinese medicine composition for impervious dilatation in burn shock period is provided, which consists of the following raw materials: 400-600 parts of raw astragalus, 200-300 parts of radix codonopsis pilosulae, 100-200 parts of raw bighead atractylodes rhizome, 200-300 parts of whole angelica, 200-300 parts of radix rehmanniae, 200-300 parts of white peony root, 200-300 parts of red sage root, 200-300 parts of rhizoma alismatis, 200-300 parts of plantain seed, 200-300 parts of Polyporus, 200-300 parts of poria cocos and 100-200 parts of schisandra chinensis.

The invention is a complete system of traditional Chinese medicine treatment shock period management method prescription according to clinical experience summary of the traditional Chinese medicine, the prescription principle is matched according to the monarch, minister, assistant and guide rules, and the prescription of the composition is optimized and determined, so that the purposes of strict compatibility, fine prescription and treatment of both principal and secondary aspect of disease are achieved. The method comprises the following steps:

in the formula, three medicines of radix codonopsis pilosulae, radix astragali and radix rehmanniae are used as monarch drugs for reinforcing primordial qi, relieving depletion of body fluid, and cutting middle-jiao qi and yin deficiency, chinese magnoliavine fruit, whole Chinese angelica, red sage root and white paeony root are used as auxiliary monarch drugs for nourishing yin, promoting blood circulation and removing blood stasis, raw atractylodes macrocephala, rhizoma alismatis, poria cocos and semen plantaginis are used as auxiliary drugs for nourishing yin, clearing heat and promoting diuresis, spleen and stomach are used as acquired sources, and paddy essence is miniaturized, so raw atractylodes macrocephala is used for leading the drugs to enter meridians due to the drugs.

The component medicine mechanism in the formula of the invention is as follows:

radix codonopsis pilosulae: strengthening spleen, supplementing qi, nourishing blood and promoting the production of body fluid. Modern pharmacological researches show that the radix codonopsis pilosulae can enrich blood, resist high temperature, strengthen immune cell functions, effectively improve high temperature tolerance of human body to burn and improve shock ischemia and anoxia state.

Radix astragali: tonify qi, strengthen superficies, arrest sweating, arrest spontaneous emission, promote tissue regeneration and induce diuresis. Modern pharmacological research shows that astragalus root can raise immunity, dilate blood vessel, resist anoxia, protect burn and kidney function damage and promote skin healing.

Radix rehmanniae: clear heat and cool blood, nourish yin and promote the production of body fluid. Modern pharmacological research shows that rehmannia root has the functions of promoting blood circulation, enhancing immunity, reducing blood sugar, resisting coagulation, regulating nucleic acid metabolism, protecting liver, promoting urination, resisting infection, resisting allergy and the like.

Chinese magnoliavine fruit: qi tonifying, body fluid generating, exterior strengthening and sweat stopping. Modern pharmacological researches show that schisandra chinensis can calm, reduce myocardial oxygen consumption, resist ulcer, resist oxidation and myocardial ischemia, and effectively protect injuries of ischemia and hypoxia in burn shock stage and occurrence of stress ulcer.

All Chinese angelica: replenishing blood, activating blood and relieving pain. Modern pharmacological studies have shown that they all have the following actions: 1. an anti-hypoxia effect; 2. regulating the immune function of the organism; 3. blood replenishing and activating effects; 4. antibacterial and skin care effects.

Radix Salviae Miltiorrhizae: promoting blood circulation, removing blood stasis, nourishing heart and tranquillizing. Modern pharmacological studies show that the traditional Chinese medicine composition has the following effects: 1. improving blood rheological property: inhibiting platelet aggregation; anticoagulation; promoting fibrinolysis; antithrombotic; reducing blood lipid and resisting atherosclerosis. 2. Improving microcirculation. 3. Improving hemodynamics. 4. And is effective in relieving myocardial ischemia. 5. And can be used for treating cerebral ischemia injury. 6. And (3) resisting liver injury. 7. Improving renal function. 8. Promoting tissue repair and regeneration. Is suitable for the mechanism of traditional Chinese and western medicine for repairing burn shock ischemia and hypoxia and tissue injury.

Hangzhou white peony root: nourish yin, astringe yin and relieve pain. Modern pharmacological studies are as follows: (1) effects on the cardiovascular system: white peony root has the functions of dilating coronary artery and reducing blood pressure. (2) liver protection effect: white peony root has obvious protective effect on liver injury caused by carbon tetrachloride and aflatoxin B, D-galactosamine. (3) spasmolytic effect: paeoniflorin, the main component of paeonia has better spasmolytic effect. (4) analgesic effect: the white paeony root has obvious analgesic effect on the acetic acid-induced torsion reaction, and is combined with the liquorice methanol compound, and the white paeony root and the liquorice methanol compound have synergistic analgesic effect on the acetic acid torsion reaction. (5) antibacterial action. Traditional Chinese and western medicine for treating burns improve circulatory disturbance and anti-infection mechanism.

Fu Alismatis rhizoma: induce diuresis and excrete dampness. Modern pharmacological researches have the effects of obviously expanding coronary artery, inhibiting platelet aggregation, resisting inflammation and promoting urination, and effectively improving circulation and relieving heart load in shock stage.

Polyporus umbellatus). Induce diuresis and excrete dampness. Modern pharmacological research shows that Polyporus umbellatus has diuretic and immunostimulant effects.

Poria cocos: induce diuresis and excrete dampness, invigorate spleen and calm heart. Pharmacological researches show that poria cocos has obvious effects of promoting urination, calming, resisting ulcer, protecting liver, reducing blood sugar, increasing myocardial contractility, enhancing immunity, delaying aging and the like, and can effectively improve the stress state of burn shock organisms and relieve circulatory load.

Semen plantaginis: clear heat, induce diuresis and excrete dampness. Modern pharmacological studies have shown that plantain seed can induce diuresis and resist inflammation.

Raw white atractylodes rhizome: strengthening spleen, eliminating dampness, tonifying qi and promoting diuresis. Modern pharmacological researches have shown that bighead atractylodes rhizome has the effects of promoting urination, resisting blood coagulation, resisting bacteria and the like, and effectively relieves burn shock circulatory disturbance and recovery of infection.

The weight of the above components is calculated by crude drug. Each part can be 1g, can also be kilogram or ton, and if the gram is used as a unit, the formula can be prepared into 1000 doses of the pharmaceutical preparation. The 1000 doses refer to finished medicinal preparations, such as 1000g and the like, which can be prepared into large packages, such as 100-500 bags, particularly 100 bags, 125 bags, 200 bags, 250 bags, 500 bags and the like, and each bag can be taken as a dose.

The above components can be made into 50-1000 times of dosage, such as granule, 125 bags, 1-2 bags for each administration, and 62.5-125 times.

The components are proportioned by weight, and can be increased or reduced according to corresponding proportion during production, for example, large-scale production can be carried out by taking kilograms as a unit or taking tons as a unit, small-scale production can be carried out by taking milligrams as a unit, and the weight can be increased or reduced, but the proportion of the weight proportion of crude drugs among the component drugs is unchanged.

In order to better improve the anti-seepage and expansion effects of the traditional Chinese medicine composition, the dosage of each component of the formula is further adjusted and optimized, and the traditional Chinese medicine composition is preferably prepared from the following raw materials: 450-550 parts of raw astragalus root, 220-280 parts of radix codonopsis pilosulae, 120-180 parts of raw white atractylodes rhizome, 220-280 parts of whole angelica, 220-280 parts of dried rehmannia root, 220-280 parts of white peony root, 220-280 parts of red sage root, 220-280 parts of rhizoma alismatis, 220-280 parts of plantain seed, 220-280 parts of polyporus umbellatus, 220-280 parts of poria cocos and 120-180 parts of schisandra chinensis, and more preferably, the Chinese medicinal composition comprises the following raw materials: 500 parts of raw astragalus, 250 parts of radix codonopsis pilosulae, 150 parts of raw bighead atractylodes rhizome, 250 parts of whole angelica, 250 parts of dried rehmannia root, 250 parts of white peony root, 250 parts of red sage root, 250 parts of rhizoma alismatis, 250 parts of plantain seed, 250 parts of Polyporus, 250 parts of poria cocos and 150 parts of schisandra chinensis.

Based on the beneficial effects of the traditional Chinese medicine composition provided by the invention, the second aspect of the invention also provides application of the traditional Chinese medicine composition in preparing a pharmaceutical preparation for impervious expansion in burn shock period.

According to a third aspect of the present invention there is provided a pharmaceutical formulation comprising an active ingredient and a pharmaceutically acceptable adjuvant;

the active ingredients comprise the traditional Chinese medicine composition;

the pharmaceutically acceptable auxiliary materials comprise: solvents, propellants, solubilizing agents, co-solvents, emulsifiers, colorants, binders, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adherents, antioxidants, chelating agents, permeation enhancers, pH adjusters, buffers, plasticizers, surfactants, foaming agents, defoamers, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and deflocculants, filter aids or release retarders, and may be selected according to the actual needs.

The above-mentioned Chinese medicinal composition can be made into any orally acceptable preparation form, for example, but not limited to tablet, capsule, granule, powder, pill or syrup.

According to a fourth aspect of the present invention, there is provided a method for preparing the above pharmaceutical preparation, comprising reflux-extracting each component of the formulation amount with ethanol for 2 times, concentrating the extract to a relative density of 1.05 of the liquid medicine, centrifuging to remove impurities, combining the centrifugate with the ethanol extract, concentrating under reduced pressure to a relative density of 1.15 of the liquid medicine, and preparing the extract powder from the obtained concentrate.

Specifically, each component in the formula amount is added with 10 times of 70% ethanol for reflux extraction for 1.0 hour, the extraction is carried out twice, the extraction solutions are combined, and the ethanol is recovered. Concentrating at 60deg.C under reduced pressure to relative density of 1.05 (30deg.C), and centrifuging with a tube centrifuge at 14000 rpm to remove impurities. Mixing the centrifugate and ethanol extract, and concentrating at 60deg.C under reduced pressure to relative density of 1.15 (measured at 60deg.C). The concentrated solution is used for preparing extract powder by a spray dryer (controlling the spray speed to be 2000ml/min, the temperature of an air inlet to be 140 ℃ and the temperature of an air outlet to be 85 ℃).

Wherein, the obtained extract powder can be further processed into different dosage forms according to the requirement.

When the medicinal preparation is a granule, the preparation method further comprises the step of wetting and granulating after the extract powder is mixed with dextrin and sugar powder, and the granule is obtained after drying.

Specifically, mixing 1g of dry extract powder with 0.75 g of dextrin and 1g of sugar powder, wetting and granulating with 85% ethanol, drying wet granules (air temperature 50 ℃), granulating, and making into granule 1000.

When the pharmaceutical preparation is a tablet, the preparation method further comprises the steps of mixing the extract powder with lactose, proteoglycan and ethanol, granulating, drying, adding magnesium stearate, uniformly mixing, and tabletting to obtain the tablet.

Specifically, 495g of lactose, 45g of proteoglycan and 50ml of 90-95% ethanol are added into 1g of extract powder to prepare granules, 30g of magnesium stearate is added into dry granules to be uniformly mixed, and then tabletting is carried out, thus obtaining 1000 tablets.

When the pharmaceutical preparation is a capsule, the preparation method further comprises the step of filling the extract powder into a capsule to obtain the capsule.

The invention is further illustrated by the following examples. The materials in the examples were prepared according to the existing methods or were directly commercially available unless otherwise specified.

Example 1

The embodiment provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials:

500 parts of raw astragalus, 250 parts of radix codonopsis pilosulae, 150 parts of raw bighead atractylodes rhizome, 250 parts of whole angelica, 250 parts of dried rehmannia root, 250 parts of white peony root, 250 parts of red sage root, 250 parts of rhizoma alismatis, 250 parts of plantain seed, 250 parts of Polyporus, 250 parts of poria cocos and 150 parts of schisandra chinensis.

Example 2

The embodiment provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials: 400 parts of raw astragalus, 300 parts of radix codonopsis pilosulae, 100 parts of raw bighead atractylodes rhizome, 300 parts of whole angelica, 200 parts of dried rehmannia root, 300 parts of white peony root, 200 parts of red sage root, 300 parts of rhizoma alismatis, 200 parts of plantain seed, 300 parts of polyporus, 200 parts of poria cocos and 200 parts of schisandra chinensis.

Example 3

The embodiment provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials: 600 parts of raw astragalus, 200 parts of radix codonopsis pilosulae, 200 parts of raw bighead atractylodes rhizome, 200 parts of whole angelica, 300 parts of dried rehmannia root, 200 parts of white peony root, 300 parts of red sage root, 200 parts of rhizoma alismatis, 300 parts of plantain seed, 200 parts of Polyporus, 300 parts of poria cocos and 100 parts of schisandra chinensis.

Example 4

The embodiment provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials: 450 parts of raw astragalus, 280 parts of radix codonopsis pilosulae, 120 parts of raw bighead atractylodes rhizome, 280 parts of whole angelica, 220 parts of dried rehmannia root, 280 parts of white peony root, 220 parts of red sage root, 280 parts of rhizoma alismatis, 220 parts of plantain seed, 280 parts of polyporus, 220 parts of poria cocos and 180 parts of schisandra chinensis.

Example 5

The embodiment provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials: 550 parts of raw astragalus, 220 parts of radix codonopsis pilosulae, 180 parts of raw bighead atractylodes rhizome, 220 parts of whole angelica, 280 parts of dried rehmannia root, 220 parts of white peony root, 280 parts of red sage root, 220 parts of rhizoma alismatis, 280 parts of plantain seed, 220 parts of polyporus, 280 parts of poria cocos and 120 parts of shizandra berry.

Example 6

The embodiment provides a pharmaceutical preparation (granule) prepared by the following method:

(1) The 14 drugs provided in example 1 were extracted with 10 times of 70% ethanol under reflux for 1.0 hour, extracted twice, and the extracts were combined to recover ethanol. Concentrating at 60deg.C under reduced pressure to relative density of 1.05 (30deg.C), and centrifuging with a tube centrifuge at 14000 rpm to remove impurities. Mixing the centrifugate and ethanol extract, and concentrating at 60deg.C under reduced pressure to relative density of 1.15 (measured at 60deg.C). The concentrated solution is used for preparing extract powder by a spray dryer (controlling the spray speed to be 2000ml/min, the temperature of an air inlet to be 140 ℃ and the temperature of an air outlet to be 85 ℃).

(2) Mixing 1g dry extract powder with 0.75 dextrin and 1g sugar powder, wetting with 85% ethanol, granulating, drying the wet granule (wind temperature 50 deg.C), and granulating to obtain granule 1000.

Example 7

The present example provides a pharmaceutical formulation (tablet) prepared by the following method:

(2) Adding 495g lactose, 45g proteoglycan and 50ml 90-95% ethanol into 1g dry paste powder, granulating, adding 30g magnesium stearate into the dry granules, mixing, tabletting, and making into 1000 tablets.

Example 8

The embodiment provides a pharmaceutical preparation (capsule) prepared by the following method:

(2) Pulverizing the above dry extract into fine powder, encapsulating, and making into capsule 100 granule.

Comparative example 1

The comparative example provides a traditional Chinese medicine composition for impervious dilatation in burn shock period, which is prepared from the following raw materials: 380 parts of raw astragalus root, 320 parts of radix codonopsis pilosulae, 80 parts of raw bighead atractylodes rhizome, 320 parts of whole angelica, 180 parts of dried rehmannia root, 320 parts of white peony root, 180 parts of red sage root, 320 parts of rhizoma alismatis, 180 parts of plantain seed, 320 parts of polyporus, 180 parts of poria cocos and 220 parts of schisandra chinensis.

Comparative example 2

This comparative example provides a Chinese medicinal composition for permeation resistance and capacity expansion in burn shock period, which is different from example 1 in that it does not contain radix astragali.

Comparative example 3

This comparative example provides a traditional Chinese medicine composition for permeation resistance and dilatation during burn shock period, which is different from example 1 in that it does not contain dried rehmannia root.

Comparative example 4

This comparative example provides a Chinese medicinal composition for permeation resistance and capacity expansion in burn shock period, which is different from example 1 in that it does not contain schisandra chinensis.

Experimental example

Experimental example 1 animal model preparation and treatment

32 healthy SD rats, with unlimited male and female, with a weight of 210-250 g, purchased from the university laboratory animal center of Anhui medical science, and qualification number: SCXK (Anhui) 2011-002. All rats were divided into 4 groups according to the random number table method: group of sham injury, scald, LR and LR Chinese medicine, 8 (n=8) each.

Rats were anesthetized by intraperitoneal injection of 10% chloral hydrate (300 mg/kg), shaved back hair, and cannulated tail vein. Immersing the back of the rat in 98 ℃ water for 12s to cause a 30% total surface area (TBSA) III degree scald, and continuously supplementing liquid through tail vein; the backs of the sham group rats were shaved and immersed in 37 ℃ water for 12s. Immediately after the rats in the LR group and the LR traditional Chinese medicine group are injured, the LR is intravenously administered, the 1 st 24h fluid infusion amount (according to the weight fluid infusion, 120mL/kg of the LR group) is calculated according to a classical park fluid infusion formula, the fluid infusion speed is 1/8 of the total amount fed 2h after injury, half of the total amount is fed in the first 8h, and the fluid infusion is not fed in the false injury group and the scald group; the LR traditional Chinese medicine group is infused with LR, 1ml of the traditional Chinese medicine composition for impervious capacity expansion in burn shock period provided by the examples 1-5 and the comparative examples 1-4 is respectively administrated to perform gastric lavage, the process is repeated once after 4 hours, and the rest groups are not subjected to gastric lavage.

All rat treatments in this experiment were performed according to animal ethics standards and were approved by the laboratory animal ethics committee of the university of Anhui medical science (approval number: LLSC 20160138).

The rats are sacrificed immediately by the detection index false injury group, the remaining three groups are sacrificed 8 hours after injury, 5mL of abdominal aortic blood is extracted, supernatant is taken after centrifugation, and the supernatant is placed in a refrigerator at the temperature of minus 80 ℃ for freezing preservation so as to be used for detecting the levels of TNF-alpha, IL-18 and IL-10; the left lung tissue is taken and equally divided into 3 parts, the 1 st part instantly detects the dry and wet weight of the lung, the 2 nd part is placed in a refrigerator at the temperature of minus 80 ℃ for freezing preservation so as to be used for detecting the MDA content and the MPO/SOD activity, and the 3 rd part is also placed in a refrigerator at the temperature of minus 80 ℃ for freezing preservation so as to be used for detecting the p38MAPK and ERK1/2 channel activity.

Blood TNF- α, IL-18 and IL-10 content assay: 200 mu L of thawed serum is taken, the content of TNF-alpha, IL-18 and IL-10 is detected by ELISA method, and the specific operation is carried out according to the steps of the instruction of the kit.

Lung tissue moisture content determination: the lung tissue was weighed wet and then baked in a 72 ℃ oven for 72 hours, the specimens were removed, rapidly weighed dry, and the lung water content was reflected in a wet/dry (W/D) ratio.

Determination of MDA content and MPO and SOD activity of lung tissue: after the lung tissue is thawed, preparing 10% lung tissue homogenate according to the weight-volume ratio, centrifuging, taking supernatant homogenate, measuring absorbance value by using an ultraviolet spectrophotometer, strictly carrying out the steps according to the specification, and respectively calculating MDA content and MPO and SOD activity according to a related formula.

Statistical methods all data were statistically analyzed using SPSS 19.0 software. Carrying out a normalization test on the metering data by using a Kolmogorov-Smirnov method, wherein the data are expressed by mean ± standard deviation (x ± s), the data between groups are compared by adopting a single factor analysis of variance, and the data between groups are compared by adopting an LSD test; the difference of P < 0.05 is statistically significant.

Results

Comparison of the inflammatory factor TNF- α, IL-18, IL-10 content in each group of blood (Table 1): compared with the sham injury group, the contents of TNF-alpha and IL-18 in blood are increased in 8 hours after injury of the scalded group, the LR group and the LR traditional Chinese medicine group, and the content of IL-10 is obviously reduced; however, the blood TNF-alpha and IL-18 content in both the LR group and the LR traditional Chinese medicine group are obviously lower than those in the scalded group, and the IL-10 content is higher than that in the scalded group (P is less than 0.01); compared with LR group, the blood TNF-alpha and IL-18 content in LR group is obviously reduced, and the IL-10 content is obviously increased (P is less than 0.01).

Comparison of moisture content of lung tissue for each group (table 1): compared with the false injury group, the W/D ratio of the lung of the scalded group, the LR group and the LR traditional Chinese medicine group is increased 8 hours after injury; however, the lung W/D ratio of the LR group and the LR traditional Chinese medicine group is lower than that of the scald group (P is less than 0.05); the lung W/D ratio of the LR traditional Chinese medicine group is lower than that of the LR group (P is less than 0.05).

Conclusion oral administration of the astragalus root rescue soup can obviously reduce lung exudation and effectively relieve tissue injury when LR is given for resuscitation in early stage after serious scalds and rats are injured.

TABLE 1 influence of Astragalus root Jiuxie decoction on inflammatory factor content, lung Water content, MDA content and MPO and SOD activation level (x+ -s) in groups of severely scalded rats

Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.

Claims

1. A traditional Chinese medicine composition for impervious dilatation in burn shock stage is characterized by comprising the following raw materials: 400-600 parts of raw astragalus, 200-300 parts of radix codonopsis pilosulae, 100-200 parts of raw bighead atractylodes rhizome, 200-300 parts of whole angelica, 200-300 parts of radix rehmanniae, 200-300 parts of white peony root, 200-300 parts of red sage root, 200-300 parts of rhizoma alismatis, 200-300 parts of plantain seed, 200-300 parts of Polyporus, 200-300 parts of poria cocos and 100-200 parts of schisandra chinensis.

2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following raw materials: 450 to 550 parts of raw astragalus root, 220 to 280 parts of radix codonopsis pilosulae, 120 to 180 parts of raw white atractylodes rhizome, 220 to 280 parts of whole angelica, 220 to 280 parts of dried rehmannia root, 220 to 280 parts of white peony root, 220 to 280 parts of red sage root, 220 to 280 parts of rhizoma alismatis, 220 to 280 parts of plantain seed, 220 to 280 parts of polyporus umbellatus, 220 to 280 parts of poria cocos and 120 to 180 parts of schisandra chinensis.

3. The traditional Chinese medicine composition according to claim 2, which is composed of the following raw materials: 500 parts of raw astragalus, 250 parts of radix codonopsis pilosulae, 150 parts of raw bighead atractylodes rhizome, 250 parts of whole angelica, 250 parts of dried rehmannia root, 250 parts of white peony root, 250 parts of red sage root, 250 parts of rhizoma alismatis, 250 parts of plantain seed, 250 parts of Polyporus, 250 parts of poria cocos and 150 parts of schisandra chinensis.

4. Use of a traditional Chinese medicine composition according to any one of claims 1-3 for the preparation of a pharmaceutical formulation for permeation resistance and dilatation during burn shock.

5. A pharmaceutical formulation comprising an active ingredient and a pharmaceutically acceptable adjuvant;

the active ingredient comprises the traditional Chinese medicine composition of any one of claims 1-3.

6. The pharmaceutical formulation of claim 5, wherein the dosage form of the pharmaceutical formulation comprises a tablet, capsule, granule, powder, pill, or syrup.

7. The method for preparing a pharmaceutical preparation according to claim 5 or 6, comprising reflux-extracting each component in the formulation amount with ethanol for 2 times, concentrating the extract to a relative density of 1.05, centrifuging to remove impurities, mixing the centrifugate with the ethanol extract, concentrating under reduced pressure to a relative density of 1.15, and preparing the extract powder from the obtained concentrate.

8. The preparation method of claim 7, wherein the pharmaceutical preparation is a granule, and the preparation method further comprises the step of wetting and granulating the extract powder after adding dextrin and sugar powder, and drying to obtain the granule.

9. The preparation method according to claim 7, wherein the pharmaceutical preparation is a tablet, and further comprising the step of granulating the extract powder after mixing lactose, proteoglycan and ethanol, drying, adding magnesium stearate, mixing well, and tabletting to obtain the tablet.

10. The method of claim 7, wherein the pharmaceutical formulation is a capsule, and the method further comprises encapsulating the extract powder to obtain the capsule.