CN110101694A - The application of andrographolide and the preparation method of andrographolide rectal suppository - Google Patents

The application of andrographolide and the preparation method of andrographolide rectal suppository Download PDF

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CN110101694A
CN110101694A CN201910470016.1A CN201910470016A CN110101694A CN 110101694 A CN110101694 A CN 110101694A CN 201910470016 A CN201910470016 A CN 201910470016A CN 110101694 A CN110101694 A CN 110101694A
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andrographolide
rectal suppository
parts
powder
weight
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刘琦
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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Abstract

The invention discloses a kind of application of andrographolide in terms of acute kidney injury drug is treated in preparation, and the preparation method of the andrographolide rectal suppository for treating acute kidney injury, 220~240 parts of semi-synthetic fatty glycerides are heated to molten, 5~15 parts of andrographolide powder are added, it is cooled to room temperature after mixing evenly, rectal suppository mold is injected, is demoulded after suppository solidification.The effective component of andrographolide rectal suppository prepared by the present invention is easier to be absorbed, and discharges fastly, and efficacy time is permanent.

Description

The application of andrographolide and the preparation method of andrographolide rectal suppository
Technical field
The present invention relates to medicinal usage fields.It is more particularly related to a kind of andrographolide application and wear The preparation method of heart lotus lactone rectal suppository.
Background technique
Acute kidney injury (acute kidney injury, AKI) is a kind of critical disease that clinic is common, disease incidence It is the one of the major reasons for leading to death just in trend is risen year by year.Andrographolide (andrographolide, AD) It is the main diterpenoid-lactone effective constituents of Herba Andrographitis [Andrographis paniculata (Burm.f.) Nees].Herba Andrographitis It is acanthaceous plant, also known as golden vanilla, andrographis paniculata, India's grass, eel grass etc., as the medicinal plant of great application value, has Clearing heat and detoxicating, alleviating pain and detumescence, cool blood anti-inflammatory effect.It is antiviral, anti-swollen that modern pharmacology research shows that andrographolide has The effects of tumor, immunological regulation, treatment diabetes, treatment hypertension, treatment diseases associated with inflammation.Due to andrographolide it is fat-soluble at Point, dissolubility is poor in water, so that its bioavilability is low, it is bad to treat various disease effects.
Summary of the invention
It is an object of the present invention to provide a kind of applications of andrographolide, and specifically prepared by andrographolide The application in terms of acute kidney injury drug is treated, effective component is easier to be absorbed in the drug, and discharges fastly, and efficacy time is long Long.
Preferably, the dosage form for treating acute kidney injury drug is suppository.
The present invention also provides a kind of for treating the andrographolide rectal suppository of acute kidney injury, including andrographolide powder End and auxiliary material, auxiliary material described here include preparing the common medicine auxiliary material of suppository, such as semi-synthetic fatty glyceride, cocoa bean Rouge, Myrj 45, hydrogenated vegetable oil, glycerin gelatine, polyethylene glycols or other appropriate substances.
Preferably, andrographolide rectal suppository includes following raw material: 5~15 parts of andrographolide powder, 40 ~80 parts of ginsengs, 70~120 portions of Radix Paeoniae Albas, 30~50 portions of glutinous rehmannia, 130~150 portions of green tea, 10~40 portions of schizonepeta, 1~6 part of borneol, 20~50 parts of thallus laminariaes, 220~240 parts of semi-synthetic fatty glycerides.
The present invention also provides a kind of preparation methods of andrographolide rectal suppository, by the semi-synthetic fat of 220~240 parts by weight Acid glyceride is heated to molten, and 5~15 parts by weight andrographolide powder are added, are cooled to room temperature after mixing evenly, injects Rectal suppository mold demoulds after suppository solidification.
Preferably, the number of semi-synthetic fatty glyceride is 230 parts, and the number of andrographolide powder is 10 parts.
Preferably, semi-synthetic fatty glyceride uses heating water bath, and bath temperature is 80 DEG C.
Preferably, andrographolide powder is first sieved with 100 mesh sieve using preceding.
The present invention also provides the preparation methods of another andrographolide rectal suppository, comprising the following steps:
Step 1: powder will be made after the ginseng of above-mentioned parts by weight, Radix Paeoniae Alba, glutinous rehmannia respectively chip drying and mix, then press Solid-liquid ratio be 1:30~40g/ml be added volume fraction be 35~45% ethanol solution, heating water bath refluxing extraction 40~ 50min, bath temperature is 45~55 DEG C, then ethanol solution is filtered to obtain the first crude extract and filter residue, and filter residue is added to by CO2 In the expanded solvents of ethyl alcohol composition, 1.0~1.5MPa of pressurization forms intumescent system, at room temperature 30~40min of ultrasonic extraction, Supersonic frequency is 30~35kHz, and release after having extracted, filtering obtains the second crude extract, by the first crude extract and the conjunction of the second crude extract And then vacuum rotary steam be discharged ethyl alcohol, be subsequently added into ginseng, Radix Paeoniae Alba, the cellulase of glutinous rehmannia total weight 1% and ginseng, Radix Paeoniae Alba, The pectase of yellow total weight 0.5%, after mixing evenly adjust pH value be 5~7, carried out at 45~55 DEG C heat preservation enzymatic hydrolysis 40~ 50min is finally warming up to 85~95 DEG C, keeps 8~12min, carries out high temperature enzyme deactivation, obtains the first refining liquid；
Step 2: the green tea of above-mentioned parts by weight, schizonepeta, thallus laminariae are placed in smashing and grinding into slurries, slurry weight 3 is added ~5 times of yellow rice wine stirs evenly, and extracts 1~1.5h with 450~550W of microwave power, then with 5000~7000r/min's Revolving speed is centrifuged 10~15min, separates to obtain supernatant and insoluble matter, insoluble matter is placed in deionized water and is decocted twice, for the first time 8000~10000 parts by weight of deionized water are added, decocting temperature is 70~80 DEG C, 40~50min is decocted, third crude extract is obtained, Second of 6000~7000 parts by weight of deionized water of addition, decocting temperature is 50~60 DEG C, decocts 20~30min, and it is thick to obtain the 4th Extract uses cation exchange resin exchange adsorption after merging supernatant, third crude extract and the 4th crude extract, then uses anion Exchanger resin exchange adsorption obtains the second refining liquid；
Step 3: the first refining liquid and the second refining liquid are merged, then it is spray-dried by cryogenic vacuum and composite powder is made, The charging rate of cryogenic vacuum spray drying is 700ml/h, and vacuum degree is 0~10Pa, and temperature is 60 DEG C, and borneol is ground into a powder It is spare；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, above-mentioned parts by weight punching is added Composite powder made from lotus lactone powder, step 3 and borneol powder, are cooled to room temperature after mixing evenly, inject rectal suppository mold, to It is demoulded after suppository solidification.
The present invention is include at least the following beneficial effects:
1, the present invention develops optimal supp anal, both improved from the administration route for changing andrographolide The compliance of the medication of patient, and the bioavilability of andrographolide is increased, to reach better treatment disease Effect.
2, by adding ginseng, Radix Paeoniae Alba, glutinous rehmannia, green tea, schizonepeta, borneol, thallus laminariae into andrographolide rectal suppository, according to The monarch relationship of traditional Chinese medicine ingredients further improves Herba Andrographitis so that generating preferable syneryistic effect between drug The drug effect of lactone rectal suppository.
3, have acute kidney injury caused by largely being taken with ginsenoside treatment as cis-platinum in the prior art, but should Drug will appear the case where kidney lymphocyte quantity is reduced in use, this is easy to cause germ infection-induced to generate it His complication, and andrographolide rectal suppository provided by the invention participates in the compatibility of other Chinese medicines by adding people, alleviates leaching The symptom of bar cell quantity reduction.
Further advantage, target and feature of the invention will be partially reflected by the following instructions, and part will also be by this The research and practice of invention and be understood by the person skilled in the art.
Detailed description of the invention
Fig. 1 is that rat carries out LPS modeling and to the morphologic picture of renal tissue after different pharmaceutical in the present invention；
Fig. 2 is that rat carries out the curve that changes over time of blood concentration after tablet and supp anal administration respectively in the present invention Figure.
Specific embodiment
The present invention is described in further detail with reference to the accompanying drawings and examples, to enable those skilled in the art's reference Specification word can be implemented accordingly.
It should be noted that experimental method described in following embodiments is unless otherwise specified conventional method, institute Reagent and material are stated, unless otherwise specified, is commercially obtained.
<instrument material>
Healthy SPF grades of SD rat, 200~220g of weight are purchased from University Of Suzhou, credit number (2018112903).Rouge is more Sugared (Lipopolysaccharide, LPS) is purchased from Sigma Co., USA；Oxidative stress kit is purchased from Xin Bosheng company, ground plug The loose sodium phosphate injection (DEX) (Chen Xin medicine company limited liability company, national drug standard H37021969) of rice, paraformaldehyde (traditional Chinese medicines point It analyses pure)；0.9% sodium chloride injection (Qidu Pharmaceutical Co., Ltd., Shandong Prov.)；(Shanghai Seiko produces electronic balance FA2104S；Number Formula pipettor gun (Olympus CX31 microscope)；Supercentrifuge (Hunan Xiang Yi Laboratory Instruments development corporation, Ltd.)；-20 It spends refrigerator (Sanyo product)；LEICA RM2135 slicer (German LEICA company)；III type embedding machine of BMJ- (prestige in Changzhou Electron equipment Co., Ltd)；Instrument (Changzhou Texlab Electronic Instrument Co., Ltd.) is dried in the drift of III type pathological tissue of PAY-；III type of BMJ- Pathologic tissue packing freezing stage (Changzhou Texlab Electronic Instrument Co., Ltd.)；
<embodiment 1>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: the semi-synthetic fatty glyceride of 34# 1.15g, andrographolide powder 50mg.
The preparation method of above-mentioned andrographolide rectal suppository: matrix is measured after 80 DEG C of heating water bath meltings by prescription and is added Recipe quantity andrographolide powder (100 mesh), ultrasonic agitation are uniformly mixed, are cooled to room temperature, inject corresponding rectal suppository mold, to Suppository solidification, scrape off overflow part, demoulding to get.
<embodiment 2>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: the semi-synthetic fatty glyceride of 34# 1.10g, andrographolide powder 25mg.
The preparation method of above-mentioned andrographolide rectal suppository is same as Example 1.
<embodiment 3>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: the semi-synthetic fatty glyceride of 34# 1.20g, andrographolide powder 75mg.
The preparation method of above-mentioned andrographolide rectal suppository is same as Example 1.
<embodiment 4>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: andrographolide powder 50mg, ginseng 300mg, Radix Paeoniae Alba 480mg, glutinous rehmannia 200mg, green tea 700mg, schizonepeta 130mg, borneol 17mg, the semi-synthetic rouge of thallus laminariae 170mg, 34# Fatty acid glyceride 1.15g.
The preparation method of above-mentioned andrographolide rectal suppository, comprising the following steps:
Step 1: powder will be made after the ginseng of above-mentioned parts by weight, Radix Paeoniae Alba, glutinous rehmannia respectively chip drying and mix, then press Solid-liquid ratio is the ethanol solution that 1:35g/ml is added that volume fraction is 40%, and heating water bath refluxing extraction 45min, bath temperature is 50 DEG C, then ethanol solution is filtered into obtain the first crude extract and filter residue, filter residue is added to by CO2With the expanded solvents of ethyl alcohol composition In, pressurization 1.3MPa forms intumescent system, at room temperature ultrasonic extraction 35min, supersonic frequency 33kHz, release after having extracted, Filtering, obtains the second crude extract, and the first crude extract and the second crude extract are merged, then ethyl alcohol is discharged in vacuum rotary steam, is subsequently added into people Ginseng, Radix Paeoniae Alba, the cellulase of glutinous rehmannia total weight 1% and ginseng, Radix Paeoniae Alba, glutinous rehmannia total weight 0.5% pectase, after mixing evenly Adjusting pH value is 6, and heat preservation enzymatic hydrolysis 45min is carried out at 50 DEG C, 90 DEG C is finally warming up to, keeps 10min, carry out high temperature enzyme deactivation, Obtain the first refining liquid；
Step 2: the green tea of above-mentioned parts by weight, schizonepeta, thallus laminariae are placed in smashing and grinding into slurries, slurry weight 4 is added Yellow rice wine again stirs evenly, and extracts 1.3h with microwave power 500W, then be centrifuged 13min, separation with the revolving speed of 6000r/min Supernatant and insoluble matter are obtained, insoluble matter is placed in deionized water and is decocted twice, 45g deionized water is added for the first time, decocts temperature Degree is 75 DEG C, decocts 45min, obtains third crude extract, and second of addition 33g deionized water, decocting temperature is 55 DEG C, is decocted 25min obtains the 4th crude extract, is exchanged after supernatant, third crude extract and the 4th crude extract are merged with cation exchange resin Absorption, then with anion exchange resin exchange adsorption, obtain the second refining liquid；
Step 3: the first refining liquid and the second refining liquid are merged, then it is spray-dried by cryogenic vacuum and composite powder is made, The charging rate of cryogenic vacuum spray drying is 700ml/h, and vacuum degree 5Pa, temperature is 60 DEG C, borneol is ground into a powder standby With；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, above-mentioned parts by weight punching is added Composite powder made from lotus lactone powder, step 3 and borneol powder, are cooled to room temperature after mixing evenly, inject rectal suppository mold, to It is demoulded after suppository solidification.
<embodiment 5>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: andrographolide powder 25mg, ginseng 200mg, Radix Paeoniae Alba 350mg, glutinous rehmannia 150mg, green tea 650mg, schizonepeta 50mg, borneol 5mg, the semi-synthetic fat of thallus laminariae 100mg, 34# Acid glyceride 1.10g.
The preparation method of above-mentioned andrographolide rectal suppository, comprising the following steps:
Step 1: powder will be made after the ginseng of above-mentioned parts by weight, Radix Paeoniae Alba, glutinous rehmannia respectively chip drying and mix, then press Solid-liquid ratio is the ethanol solution that 1:30g/ml is added that volume fraction is 35%, and heating water bath refluxing extraction 40min, bath temperature is 45 DEG C, then ethanol solution is filtered into obtain the first crude extract and filter residue, filter residue is added to by CO2With the expanded solvents of ethyl alcohol composition In, pressurization 1.0MPa forms intumescent system, at room temperature ultrasonic extraction 30min, supersonic frequency 30kHz, release after having extracted, Filtering, obtains the second crude extract, and the first crude extract and the second crude extract are merged, then ethyl alcohol is discharged in vacuum rotary steam, is subsequently added into people Ginseng, Radix Paeoniae Alba, the cellulase of glutinous rehmannia total weight 1% and ginseng, Radix Paeoniae Alba, glutinous rehmannia total weight 0.5% pectase, after mixing evenly Adjusting pH value is 5, and heat preservation enzymatic hydrolysis 40min is carried out at 45 DEG C, 85 DEG C is finally warming up to, keeps 8min, carry out high temperature enzyme deactivation, obtain First refining liquid；
Step 2: the green tea of above-mentioned parts by weight, schizonepeta, thallus laminariae are placed in smashing and grinding into slurries, slurry weight 3 is added Yellow rice wine again stirs evenly, and extracts 1h with microwave power 450W, then be centrifuged 10min with the revolving speed of 5000r/min, separates Insoluble matter is placed in deionized water and decocts twice by supernatant and insoluble matter, and 40g deionized water is added for the first time, decocts temperature It is 70 DEG C, decocts 40min, obtain third crude extract, second of addition 30g deionized water, decocting temperature is 50 DEG C, 20min is decocted, The 4th crude extract is obtained, cation exchange resin exchange adsorption will be used after the merging of supernatant, third crude extract and the 4th crude extract, then With anion exchange resin exchange adsorption, the second refining liquid is obtained；
Step 3: the first refining liquid and the second refining liquid are merged, then it is spray-dried by cryogenic vacuum and composite powder is made, The charging rate of cryogenic vacuum spray drying is 700ml/h, and vacuum degree 0Pa, temperature is 60 DEG C, borneol is ground into a powder standby With；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, above-mentioned parts by weight punching is added Composite powder made from lotus lactone powder, step 3 and borneol powder, are cooled to room temperature after mixing evenly, inject rectal suppository mold, to It is demoulded after suppository solidification.
<embodiment 6>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: andrographolide powder 75mg, ginseng 400mg, Radix Paeoniae Alba 600mg, glutinous rehmannia 250mg, green tea 750mg, schizonepeta 200mg, borneol 30mg, the semi-synthetic rouge of thallus laminariae 250mg, 34# Fatty acid glyceride 1.20g.
The preparation method of above-mentioned andrographolide rectal suppository, comprising the following steps:
Step 1: powder will be made after the ginseng of above-mentioned parts by weight, Radix Paeoniae Alba, glutinous rehmannia respectively chip drying and mix, then press Solid-liquid ratio is the ethanol solution that 1:40g/ml is added that volume fraction is 45%, and heating water bath refluxing extraction 50min, bath temperature is 55 DEG C, then ethanol solution is filtered into obtain the first crude extract and filter residue, filter residue is added to by CO2With the expanded solvents of ethyl alcohol composition In, pressurization 1.5MPa forms intumescent system, at room temperature ultrasonic extraction 40min, supersonic frequency 35kHz, release after having extracted, Filtering, obtains the second crude extract, and the first crude extract and the second crude extract are merged, then ethyl alcohol is discharged in vacuum rotary steam, is subsequently added into people Ginseng, Radix Paeoniae Alba, the cellulase of glutinous rehmannia total weight 1% and ginseng, Radix Paeoniae Alba, glutinous rehmannia total weight 0.5% pectase, after mixing evenly Adjusting pH value is 7, and heat preservation enzymatic hydrolysis 50min is carried out at 55 DEG C, 95 DEG C is finally warming up to, keeps 12min, carry out high temperature enzyme deactivation, Obtain the first refining liquid；
Step 2: the green tea of above-mentioned parts by weight, schizonepeta, thallus laminariae are placed in smashing and grinding into slurries, slurry weight 5 is added Yellow rice wine again stirs evenly, and extracts 1.5h with microwave power 550W, then be centrifuged 15min, separation with the revolving speed of 7000r/min Supernatant and insoluble matter are obtained, insoluble matter is placed in deionized water and is decocted twice, 50g deionized water is added for the first time, decocts temperature Degree is 80 DEG C, decocts 50min, obtains third crude extract, and second of addition 35g deionized water, decocting temperature is 60 DEG C, is decocted 30min obtains the 4th crude extract, is exchanged after supernatant, third crude extract and the 4th crude extract are merged with cation exchange resin Absorption, then with anion exchange resin exchange adsorption, obtain the second refining liquid；
Step 3: the first refining liquid and the second refining liquid are merged, then it is spray-dried by cryogenic vacuum and composite powder is made, The charging rate of cryogenic vacuum spray drying is 700ml/h, and vacuum degree 10Pa, temperature is 60 DEG C, borneol is ground into a powder standby With；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, above-mentioned parts by weight punching is added Composite powder made from lotus lactone powder, step 3 and borneol powder, are cooled to room temperature after mixing evenly, inject rectal suppository mold, to It is demoulded after suppository solidification.
<comparative example 1>
A kind of andrographolide dispersed tablet, every 50mg containing andrographolide.
<comparative example 2>
It is a kind of for treating the andrographolide rectal suppository of acute kidney injury, comprising: andrographolide powder 50mg, ginseng 300mg。
The preparation method of above-mentioned andrographolide rectal suppository, comprising the following steps:
Step 1: powder will be made, then pressing solid-liquid ratio is 1:35g/ml addition after the ginseng chip drying of above-mentioned parts by weight The ethanol solution that volume fraction is 40%, heating water bath refluxing extraction 45min, bath temperature are 50 DEG C, then by ethanol solution mistake The first crude extract and filter residue are filtered to obtain, filter residue is added to by CO2In the expanded solvents of ethyl alcohol composition, pressurization 1.3MPa forms swollen Swollen system, ultrasonic extraction 35min, supersonic frequency 33kHz, release after having extracted, filtering obtain the second crude extract at room temperature, First crude extract and the second crude extract are merged, then ethyl alcohol is discharged in vacuum rotary steam, is subsequently added into the cellulase of ginseng weight 1% With the pectase of ginseng weight 0.5%, adjusting pH value after mixing evenly is 6, heat preservation enzymatic hydrolysis 45min is carried out at 50 DEG C, finally 90 DEG C are warming up to, 10min is kept, high temperature enzyme deactivation is carried out, obtains refining liquid；
Ginsenoside powder is made Step 2: refining liquid is spray-dried by cryogenic vacuum, cryogenic vacuum spray drying Charging rate is 700ml/h, and vacuum degree 5Pa, temperature is 60 DEG C；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, above-mentioned parts by weight punching is added Ginsenoside powder, is cooled to room temperature after mixing evenly made from lotus lactone powder and step 2, rectal suppository mold is injected, to suppository It is demoulded after solidification.
<LPS modeling and administration>
1, experimental principle and purpose: lipopolysaccharides (LPS) is the modeling medicine of common acute kidney injury model, can simulate people Acute kidney injury caused by class LPS.This experiment uses rat LPS model, evaluates andrographolide supp anal of the present invention To rat creatinine, urea nitrogen, myeloperoxidase (MPO), superoxide dismutase (SOD) and catalase (Catalase) Horizontal influence.
2, LPS modeling and detection
The animal house of raising animal is kept quite ventilation, and raising temperature is 20 ± 2 DEG C, and animal illumination is all using 12h light dark Phase, animal house indoor humidity protect 60 ± 10%.Raising animal is desirable for irradiated feed and sterile corncob, the reference water of rat For the tap water of boiled cooling.Experiment is ratified through the animal welfare committee, is grasped in strict accordance with laboratory animal related specifications After the completion of being tested, cervical dislocation execution is carried out to rat according to principle of humanitarianism and puts animal after confirming animal dead To fixed animal carcass storeroom, cleaning is sterilized, ventilation.
100 healthy rats are chosen, every group 10, are divided into blank group, modeling group, andrographolide rectal suppository group, punching Lotus lactone tablet group, dexamethasone control group, modeling group, andrographolide rectal suppository group, andrographolide tablet group and ground Sai meter Song control group gives 10mg/kg LPS in rats by intraperitoneal injection and carries out LPS modeling, and blank group is given in rats by intraperitoneal injection Same amount of normal saline.
Andrographolide rectal suppository group 2h before modeling, is handled to rat with suppository, and 12h gives a suppository again after modeling； Andrographolide tablet group rat oral gavage andrographolide tablet, gives in the same dose of Herba Andrographitis of andrographolide rectal suppository group Ester；Dexamethasone control group 2h tail vein injection before modeling gives DEX, dosage 5mg/kg.Per being administered once for 24 hours, continuously 48h is administered.12h fasting before modeling, free water.
After the test, using 10% chloral hydrate anesthesia rat, abdominal aortic blood 5mL, blood biochemistry is detected in serum Urea nitrogen (BUN), creatinine (Crea), the results are shown in Table 1.
ELISA detection is carried out using oxidative stress kit, MPO, SOD and Catalase in serum is detected, as a result sees Table 2.
By the andrographolide tablet of blank group, modeling group, the andrographolide rectal suppository group of embodiment 1, comparative example 1 Rat in group, dexamethasone control group takes part renal tissue in 4% paraformaldehyde phosphate buffer (pH value 7.4) respectively It is fixed, then part renal tissue is taken to be fixed with 2.5% glutaraldehyde, (A is blank group to the result is shown in Figure 1, B is modeling group, C is punching Lotus lactone rectal suppository group, D are andrographolide tablet group, E is dexamethasone control group).
3, experimental result
As it can be seen from table 1 modeling group rat blood serum Crea and BUN level content is obviously high after LPS modeling processing 48h In blank group (#P < 0.05,##P < 0.01), illustrate the AKI model success of LPS (10mg/kg) induction.And andrographolide suppository Group and dexamethasone control group mice serum BUN content are significantly lower than modeling group (* P < 0.05, * * P < 0.01), and Herba Andrographitis Lactone tablet group serum creatinine and urea nitrogen content are slightly below modeling group, illustrate andrographolide tablet group effect much worse than punching Lotus rectal suppository group.And in Herba Andrographitis rectal suppository group, 4~6 groups of the embodiment of the present invention of rat blood serum Crea and BUN level content Significantly lower than Examples 1 to 3 group, illustrate by adding ginseng, Radix Paeoniae Alba, glutinous rehmannia, green tea, chaste tree into andrographolide rectal suppository Mustard, borneol, thallus laminariae further improve andrographolide rectal suppository so that generating preferable syneryistic effect between drug Drug effect.
Content detection in BUN and Creatine in 1. each group rat of table
Data indicate with Mean ± SE, every group of n=10；#P < 0.05,##P < 0.01, model group is compared with blank control group；* P < 0.01 P < 0.05, * *, model administration group is compared with model group.
From table 2 it can be seen that after drug treatment 48h, modeling group rat blood serum MPO and Catalase level content and blank Group increases than more significant, and SOD declines.MPO the and Catalase content of andrographolide rectal suppository group is equal compared with modeling group It is substantially reduced (* * * P < 0.001), and MPO the and Catalase content of andrographolide tablet group is declined slightly, but effect is not Obviously, illustrate that andrographolide rectal suppository can more obviously inhibit MPO, improve the SOD activity that LPS is reduced.Dexamethasone control Group MPO and Catalase compared with modeling group is significantly reduced, and SOD increases (* P < 0.05), but is inhibiting MPO, increased SOD side Face is still not as good as andrographolide rectal suppository group.This illustrates that andrographolide rectal suppository can reduce MPO and Catalase in serum It is horizontal to improve SOD for level, it may be possible to its one of mechanism of action of AKI for treating LPS induction.In Herba Andrographitis rectal suppository group, this For 4~6 groups of inventive embodiments of rat blood serum MPO and Catalase level content significantly lower than Examples 1 to 3 group, SOD is horizontal Content is apparently higher than Examples 1 to 3 group, illustrates 4~6 groups of embodiment to MPO and Catalase inhibiting effect, and to SOD's Facilitation is more obvious, this also illustrates by adding the drugs such as ginseng into andrographolide rectal suppository, so that in Herba Andrographitis The drug effect of ester rectal suppository further improves.
Influence of the andrographolide to MPO, SOD and Catalase in 2 each group rat of table.
Data indicate with Mean ± SE, every group of n=10；#P < 0.05,##P < 0.01, model group is compared with blank control group；* P < 0.05, * * P < 0.01, * the * * model administration group of P < 0.001 are compared with model group.
It will be seen from figure 1 that discovery modeling group (B figure) rat renal tubular epithelial cells are swollen by optical microphotograph sem observation It is swollen, be denaturalized, fall off, it is congested, or even necrosis；Lumen reduces, and has cast and exudate in lumen, renal interstitial oedema has a small amount of inflammation Cell leaching；And andrographolide rectal suppository group (C figure), dexamethasone control group (E figure), compared with modeling group, above-mentioned performance is obvious Mitigate.
<blood concentration detection>
1, blood specimen collection
10 healthy rats are chosen, and rat is randomly divided into two groups, every group 5, take eye socket to take blood, mined out white blood is about 1mL, anticoagulant heparin.After mined out white blood, the andrographolide supp anal of one group of gastric infusion embodiment 1, another group to identical The andrographolide tablet of dosage comparative example 1.Blood time point is taken after administration: 5,10,15,20,25,30,45,60,120,180, 240,300,420min, anticoagulant heparin.
2, testing conditions
Liquid chromatogram separation is carried out to above-mentioned each time point collected blood sample, liquid chromatogram uses C18 reverse-phase chromatography Column (150mm, 5 μm) is mixed methanol and water as mobile phase, flow velocity 1mL/min in 50:50 ratio, and Detection wavelength is 225nm, column temperature are room temperature, as a result see Fig. 2.
3, testing result
Figure it is seen that being worn after rat oral gavage gives andrographolide tablet and andrographolide supp anal respectively Heart lotus lactone supp anal group absorbed into serum is very fast, and 5min can be detected out andrographolide in blood.After 30min is administered, Blood concentration reaches maximum, and the blood concentration of andrographolide supp anal group rat is nearly that andrographolide tablet group is dense 7 times of degree.Illustrate that andrographolide supp anal was more advantageous to andrographolide enters blood, reaches better therapeutic effect.
<cis-platinum modeling and administration>
1 week rat of adaptive feeding is randomly divided into 5 groups, every group 10, respectively blank group, modeling group, Herba Andrographitis Lactone rectal suppository group (embodiment 4), andrographolide rectal suppository group (comparative example 2), ginsenoside group.Andrographolide rectal suppository Group is administered once a day by suppository, and ginsenoside group is primary by the daily gastric infusion of 10mg/kg, and continuous 7 days.7th day end, is giving After medicine 1h, modeling group, andrographolide rectal suppository group and ginsenoside group rat are disposably injected intraperitoneally 25mg/kg's Cis-platinum normal saline solution, blank group give same amount of normal saline in rats by intraperitoneal injection, continue to observe, after cis-platinum modeling 72h Abdominal aortic blood 5mL successively is carried out to each group rat, 3000r/min is centrifuged 10min and separates serum, and blood biochemistry detects in serum Urea nitrogen (BUN), creatinine (Crea), Whole blood lymphocyte number, the results are shown in Table 3.
BUN, Creatine and Whole blood lymphocyte number content detection in table 3, each group rat
From table 3 it can be seen that 2 groups of the embodiment 4 and comparative example and ginsenoside group of andrographolide rectal suppository group are big BUN and Cre level is decreased obviously in mouse serum, illustrates that animal renal impairment is alleviated, and is indicated above embodiment 4 and right 2 groups of ratio of andrographolide rectal suppository and ginsenoside can mitigate acute kidney injury caused by cis-platinum, and single The ginsenoside group drug effect of one ingredient or too late andrographolide rectal suppository group.In addition 2 groups of comparative example of Whole blood lymphocyte Number significantly decreases, and although 4 groups of embodiment of Whole blood lymphocyte number has decline, but mitigates compared with 2 degree of comparative example, explanation While acute kidney injury caused by andrographolide rectal suppository provided by the invention is largely taken in treatment as cis-platinum, moreover it is possible to Alleviate the symptom of lymphocyte quantity reduction.
Although the embodiments of the present invention have been disclosed as above, but its is not only in the description and the implementation listed With it can be fully applied to various fields suitable for the present invention, for those skilled in the art, can be easily Realize other modification, therefore without departing from the general concept defined in the claims and the equivalent scope, the present invention is simultaneously unlimited In specific details and legend shown and described herein.

Claims (9)

1. the application of andrographolide, which is characterized in that application of the andrographolide in preparation treatment acute kidney injury drug.
2. the application of andrographolide as described in claim 1, which is characterized in that treatment acute kidney injury drug dosage form be Suppository.
3. for treating the andrographolide rectal suppository of acute kidney injury, which is characterized in that including andrographolide powder and auxiliary Material.
4. andrographolide rectal suppository as claimed in claim 3, which is characterized in that including following raw material: 5~15 parts Andrographolide powder, 40~80 parts of ginsengs, 70~120 portions of Radix Paeoniae Albas, 30~50 portions of glutinous rehmannia, 130~150 parts of green tea, 10~40 Part schizonepeta, 1~6 part of borneol, 20~50 parts of thallus laminariaes, 220~240 parts of semi-synthetic fatty glycerides.
5. the preparation method of andrographolide rectal suppository as claimed in claim 3, which is characterized in that by 220~240 parts by weight Semi-synthetic fatty glyceride is heated to molten, and 5~15 parts by weight andrographolide powder are added, are cooled to after mixing evenly Room temperature injects rectal suppository mold, demoulds after suppository solidification.
6. the preparation method of andrographolide rectal suppository as claimed in claim 5, which is characterized in that semi-synthetic fatty acid glycerine The number of ester is 230 parts, and the number of andrographolide powder is 10 parts.
7. the preparation method of andrographolide rectal suppository as claimed in claim 5, which is characterized in that semi-synthetic fatty acid glycerine Ester uses heating water bath, and bath temperature is 80 DEG C.
8. the preparation method of andrographolide rectal suppository as claimed in claim 5, which is characterized in that andrographolide powder makes It is first sieved with 100 mesh sieve with preceding.
9. the preparation method of andrographolide rectal suppository as claimed in claim 4, which comprises the following steps:
Step 1: powder will be made after the ginseng of above-mentioned parts by weight, Radix Paeoniae Alba, glutinous rehmannia respectively chip drying and mix, then press feed liquid Than the ethanol solution that volume fraction is 35~45%, heating water bath 40~50min of refluxing extraction, water is added for 1:30~40g/ml Bath temperature is 45~55 DEG C, then ethanol solution is filtered to obtain the first crude extract and filter residue, and filter residue is added to by CO2And ethanol group At expanded solvents in, 1.0~1.5MPa of pressurization forms intumescent system, at room temperature 30~40min of ultrasonic extraction, supersonic frequency For 30~35kHz, release after having extracted, filtering obtains the second crude extract, and the first crude extract and the second crude extract are merged, then subtracts Pressure revolving discharge ethyl alcohol, is subsequently added into ginseng, Radix Paeoniae Alba, the cellulase of glutinous rehmannia total weight 1% and ginseng, Radix Paeoniae Alba, glutinous rehmannia gross weight The pectase of amount 0.5%, adjusting pH value after mixing evenly is 5~7, heat preservation 40~50min of enzymatic hydrolysis is carried out at 45~55 DEG C, most After be warming up to 85~95 DEG C, keep 8~12min, carry out high temperature enzyme deactivation, obtain the first refining liquid；
Step 2: the green tea of above-mentioned parts by weight, schizonepeta, thallus laminariae are placed in smashing and grinding into slurries, slurry weight 3~5 is added Yellow rice wine again stirs evenly, and extracts 1~1.5h with 450~550W of microwave power, then with the revolving speed of 5000~7000r/min It is centrifuged 10~15min, supernatant and insoluble matter is separated to obtain, insoluble matter is placed in deionized water and is decocted twice, is added for the first time 8000~10000 parts by weight of deionized water, decocting temperature is 70~80 DEG C, decocts 40~50min, obtains third crude extract, second 6000~7000 parts by weight of deionized water of secondary addition, decocting temperature is 50~60 DEG C, decocts 20~30min, obtains the 4th crude extract, Cation exchange resin exchange adsorption is used after supernatant, third crude extract and the 4th crude extract are merged, then uses anion exchange Resins exchange absorption, obtains the second refining liquid；
Step 3: the first refining liquid and the second refining liquid are merged, then it is spray-dried by cryogenic vacuum and composite powder, low temperature is made The charging rate of vacuum spray drying is 700ml/h, and vacuum degree is 0~10Pa, and temperature is 60 DEG C, borneol is ground into a powder standby With；
Step 4: the semi-synthetic fatty glyceride of above-mentioned parts by weight is heated to molten, it is added in above-mentioned parts by weight Herba Andrographitis Composite powder made from ester powder, step 3 and borneol powder, are cooled to room temperature after mixing evenly, rectal suppository mold are injected, to suppository It is demoulded after solidification.
CN201910470016.1A 2019-05-31 2019-05-31 The application of andrographolide and the preparation method of andrographolide rectal suppository Pending CN110101694A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114015732A (en) * 2021-11-29 2022-02-08 陕西嘉禾生物科技股份有限公司 Industrial preparation method of andrographolide and dehydroandrographolide

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
JIAHONG CHEN等: "Andrographolide had Positive Effects on Anti-inflammatory and Protected Against LPS-induced DIC in Rabbits", 《INTERNATIONAL JOURNAL OF PHARMACOLOGY》 *
赵朝伟: "穿心莲内酯原料药及其栓剂的研究", 《成都中医药大学硕士论文》 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114015732A (en) * 2021-11-29 2022-02-08 陕西嘉禾生物科技股份有限公司 Industrial preparation method of andrographolide and dehydroandrographolide
CN114015732B (en) * 2021-11-29 2024-03-01 陕西嘉禾生物科技股份有限公司 Industrial preparation method of andrographolide and dehydroandrographolide

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Application publication date: 20190809