CN106138763A - A kind of compound niacin injection and its preparation method and application - Google Patents

A kind of compound niacin injection and its preparation method and application Download PDF

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Publication number
CN106138763A
CN106138763A CN201610848825.8A CN201610848825A CN106138763A CN 106138763 A CN106138763 A CN 106138763A CN 201610848825 A CN201610848825 A CN 201610848825A CN 106138763 A CN106138763 A CN 106138763A
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parts
injection
chinese medicine
formulated
extraction liquid
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陈薇
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Anhui Eagle Dragon Industrial Design Co Ltd
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Anhui Eagle Dragon Industrial Design Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/19—Acanthaceae (Acanthus family)
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286—Carthamus (distaff thistle)
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    • A61K36/88—Liliopsida (monocotyledons)
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention discloses a kind of compound niacin injection and its preparation method and application, formulated by principal agent, additives and solvent, principal agent is formulated by nicotinic acid, berberine sulphate or atropine sulfate, Mequindox, lactic acid TMP, Chinese medicine extraction liquid；Additives are formulated by sodium sulfite, sodium thiosulfate and disodiumedetate；Chinese medicine extraction liquid is formed by Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami alcohol extraction.This compound niacin injection is for treating the intestinal tract disease of human body.The compound niacin injection of the present invention, the various antibacterials such as the escherichia coli in human body intestinal canal, staphylococcus, pylori had good inhibiting effect, curative effect is better than including the single preparations of ephedrine of each medicine, and reasonable recipe, the raw material used is the high potency drugs that anti-intestinal infects, and uses safety, curative effect obvious.

Description

A kind of compound niacin injection and its preparation method and application
Technical field
The present invention relates to injection field, specifically a kind of compound niacin injection and its preparation method and application.
Background technology
Enteritis is gastroenteritis, enteritis and the colitis that antibacterial, virus, fungus and parasite etc. cause.Clinical manifestation has Nausea and vomiting, suffer from abdominal pain, suffer from diarrhoea, dilute aquiform stool or mucopurulent bloody stool.Some patients can have heating and tenesmus sensation, therefore is also known as Infectious diarrhea.Enteritis is different by course of disease length, is divided into acute and chronic two classes；By cause of disease classification can be divided into viral enteritis, Enterotoxin, aggressive bacterial enteritis and mixed infection etc..
At present whole nation medicine is usually: compound sulfonamide methyl isoxazole (bactrim), pipemidic acid, gentamycin, Amikacin, erythromycin, gentamycin, chloromycetin, tetracycline, neomycin, colistin, nystatin, amphotericin B, Dosage form mostly is tablet, capsule two kinds, how to imitate in stomach just absorption or degraded fall, then get to intestinal through blood after oral absorption Portion, onset time is long, and effect metering is few, and therefore curative effect is scarcely obvious, has a greatly reduced quality, easily produces the vital organs of the human body in human body again Damage, has gastrointestinal reaction.
Summary of the invention
It is an object of the invention to provide a kind of compound niacin injection and its preparation method and application, to solve the above-mentioned back of the body The problem proposed in scape technology.
For achieving the above object, the present invention provides following technical scheme:
A kind of compound niacin injection, is that 10～20 parts of principal agents, 6～10 parts of additives and 400～500 parts are molten by weight portion Matchmaker is formulated, principal agent by weight portion be 6～10 parts of nicotinic acid, 2～4 parts of berberine sulphates or 6～8 parts of atropine sulfates, 3～5 Part Mequindox, 12～16 parts of lactic acid TMPs, 5～7 parts of Chinese medicine extraction liquid are formulated；Additives are by weight portion The disodiumedetate being the sodium sulfite of 2～3 parts, the sodium thiosulfate of 1～2 part and 0.6～1.0 part is formulated；
Described Chinese medicine extraction liquid by the Herba Andrographis that weight portion is 6～8 parts, the Herba Dendrobii of 4～6 parts, the Radix Et Rhizoma Rhei of 3～5 parts and 6～ The Flos Carthami of 8 parts forms with the alcohol extraction of 40～50 parts.
As the further scheme of the present invention: described solvent uses ethanol, propylene glycol, injectable dextrose monohydrate liquid or injection chlorination One or more in sodium solution.
The preparation method of a kind of described compound niacin injection, specifically comprises the following steps that
(1) by Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami volume fraction be 60～70% ethanol reflux at 70～80 DEG C Extract 2～3h, after being cooled to room temperature, filter, dialyse 2～3 days with the dialyzer that molecular cut off is 2000～6000, take out thoroughly Liquid in analysis bag, obtains Chinese medicine extraction liquid, standby；
(2) nicotinic acid, berberine sulphate or atropine sulfate, Mequindox, lactic acid TMP are mixed by proportioning Close uniformly, add Chinese medicine extraction liquid, be stirring evenly and then adding in the solvent of half, after stirring, then be separately added into sulfurous acid Sodium, sodium thiosulfate and disodiumedetate, after stirring, add residue solvent, stir,.
The application of a kind of described compound niacin injection, this compound niacin injection is for treating the intestinal disease of a poultry Sick.
Compared with prior art, the invention has the beneficial effects as follows:
The compound niacin injection of the present invention, various to the escherichia coli in human body intestinal canal, staphylococcus, pylori etc. Antibacterial has good inhibiting effect, and curative effect is better than including the single preparations of ephedrine of each medicine, and reasonable recipe, the raw material of employing is equal The high potency drugs infected for anti-intestinal, uses safety, curative effect obvious.
Detailed description of the invention
Below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described, Obviously, described embodiment is only a part of embodiment of the present invention rather than whole embodiments.Based in the present invention Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under not making creative work premise, all Belong to the scope of protection of the invention.
Embodiment 1
Compound niacin injection, is that 10 parts of principal agents, 6 parts of additives and 400 parts of propylene glycol are formulated by weight portion, principal agent It is that 6 parts of nicotinic acid, 4 parts of berberine sulphates, 3 parts of Mequindox, 16 parts of lactic acid TMPs, 5 parts of Chinese medicines carry by weight portion Take liquid formulated；Additives are by the ethylenediamine tetrem of the sodium sulfite that weight portion is 2 parts, the sodium thiosulfate of 2 parts and 0.6 part Acid disodium is formulated.
Chinese medicine extraction liquid by the Flos Carthami of the Herba Andrographis that weight portion is 6 parts, the Herba Dendrobii of 6 parts, the Radix Et Rhizoma Rhei of 3 parts and 8 parts with 40 parts Alcohol extraction form.
The preparation process of above-mentioned compound niacin injection is as follows:
(1) it is the ethanol of 60% reflux, extract, 3h at 70 DEG C by Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami volume fraction, After being cooled to room temperature, filter, dialyse 2～3 days with the dialyzer that molecular cut off is 2000～6000, take out liquid in bag filter Body, obtains Chinese medicine extraction liquid, standby；
(2) nicotinic acid, berberine sulphate, Mequindox, lactic acid TMP are uniformly mixed according to a ratio, in addition Medicament extracting solution, is stirring evenly and then adding in the propylene glycol of half, after stirring, then is separately added into sodium sulfite, thiosulfuric acid Sodium and disodiumedetate, after stirring, add residue propylene glycol, stir,.
Embodiment 2
Compound niacin injection, weight portion be 15 parts of principal agents, 8 parts of additives and the preparation of 450 parts of injectable dextrose monohydrate liquid and Become, principal agent by weight portion be 8 parts of nicotinic acid, 3 parts of atropine sulfates, 4 parts of Mequindox, 14 parts of lactic acid TMPs, 6 parts Chinese medicine extraction liquid is formulated；Additives are by the sodium sulfite that weight portion is 2.5 parts, the sodium thiosulfate of 1.5 parts and 0.8 part Disodiumedetate is formulated.
Chinese medicine extraction liquid by the Flos Carthami of the Herba Andrographis that weight portion is 7 parts, the Herba Dendrobii of 5 parts, the Radix Et Rhizoma Rhei of 4 parts and 7 parts with 45 parts Alcohol extraction form.
The preparation process of above-mentioned compound niacin injection is as follows:
(1) by Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami volume fraction be 60～70% ethanol reflux at 70～80 DEG C Extract 2～3h, after being cooled to room temperature, filter, dialyse 2～3 days with the dialyzer that molecular cut off is 2000～6000, take out thoroughly Liquid in analysis bag, obtains Chinese medicine extraction liquid, standby；
(2) nicotinic acid, atropine sulfate, Mequindox, lactic acid TMP are uniformly mixed according to a ratio, in addition Medicament extracting solution, is stirring evenly and then adding in the injectable dextrose monohydrate liquid of half, after stirring, then is separately added into sodium sulfite, sulfur Sodium thiosulfate and disodiumedetate, after stirring, add residue injectable dextrose monohydrate liquid, stir,.
Embodiment 3
Compound niacin injection, is 20 parts of principal agents, 10 parts of additives and 500 parts of injection sodium chloride solution preparations by weight portion Form, principal agent by weight portion be 10 parts of nicotinic acid, 8 parts of atropine sulfates, 5 parts of Mequindox, 12 parts of lactic acid TMPs, 7 parts of Chinese medicine extraction liquid are formulated；Additives are by the sodium sulfite that weight portion is 3 parts, the sodium thiosulfate of 1 part and 1.0 parts Disodiumedetate is formulated.
Chinese medicine extraction liquid by the Flos Carthami of the Herba Andrographis that weight portion is 8 parts, the Herba Dendrobii of 4 parts, the Radix Et Rhizoma Rhei of 5 parts and 6 parts with 50 parts Alcohol extraction form.
The preparation process of above-mentioned compound niacin injection is as follows:
(1) it is the ethanol of 70% reflux, extract, 2h at 80 DEG C by Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami volume fraction, After being cooled to room temperature, filter, dialyse 2～3 days with the dialyzer that molecular cut off is 2000～6000, take out liquid in bag filter Body, obtains Chinese medicine extraction liquid, standby；
(2) nicotinic acid, atropine sulfate, Mequindox, lactic acid TMP are uniformly mixed according to a ratio, in addition Medicament extracting solution, is stirring evenly and then adding in the injection sodium chloride solution of half, after stirring, then be separately added into sodium sulfite, Sodium thiosulfate and disodiumedetate, after stirring, add residue injection sodium chloride solution, stir, i.e. Can.
Clinical trial:
1, test material
(1) experimental animal: select suffer from the white mouse drawing dysentery.
(2) trial drug
Drug test 1 group: compound niacin injection (nicotinic acid+lactic acid TMP), nicotinic acid 0.5g+ lactic acid diformazan Oxygen benzyl Aminometradine 0.2g；
Drug test 2 groups: compound niacin injection (nicotinic acid+Mequindox), nicotinic acid 0.5g+ Mequindox 1g；
Drug test 3 groups: compound niacin injection (nicotinic acid+Chinese medicine extraction liquid), nicotinic acid 0.5g+ Chinese medicine extraction liquid 0.4g；
Drug control 1 group: niacin injection, 0.5g；
Drug control 2 groups: lactic acid TMP injection, 0.5g；
Drug control 3 groups: mequindox injection, 0.5g；
Drug control 4 groups: Chinese medicine extraction liquid injection, 0.4g；
Positive controls: infect and be not administered；
Blank group: do not infect and be not administered.
2, test method
Before test after the cause of disease is made a definite diagnosis, disease pig is divided into 14 groups, as follows:
3, result evaluation
After medication 1-3 day, clinical symptoms all disappears, and the person of returning to one's perfect health is recovery from illness；After medication 3 days, clinical symptoms is basic Disappearing, the most progressively rehabilitation clients is effective；After medication 3 days, still having obvious clinical symptoms, even exacerbation of symptoms or died is nothing Effect.
4, test results and analysis
(1) curative effect situation
Each group curative effect information slip unit: head, %
Group Case load Recovery from illness number Significant figure Invalid number Effective percentage
1 group of low dosage of drug test 10 4 5 1 90.00
Dosage in drug test 1 group 17 14 2 1 94.12
1 group of high dose of drug test 16 12 3 1 93.75
2 groups of low dosages of drug test 12 4 6 2 83.33
Dosage in drug test 2 groups 15 11 3 1 93.33
2 groups of high doses of drug test 17 13 3 1 94.12
3 groups of low dosages of drug test 14 2 10 2 85.71
Dosage in drug test 3 groups 15 12 2 1 93.33
3 groups of high doses of drug test 17 12 4 1 94.12
Compare 1 group 15 6 4 5 66.67
Compare 2 groups 11 4 2 5 63.64
Compare 3 groups 16 5 6 6 54.55
Compare 4 groups 14 3 5 6 57.14
Positive controls 10 - - - -
Blank group 10 - - - -
As can be seen from the above table, in drug test group, middle dosage group effective percentage is respectively 94.12%, and 93.33%, 93.33%, compare 1 group, 2 groups, 3 groups, the effective percentage of 4 groups be respectively 66.67%, 63.64%, 54.55%, 57.14%, medicine The curative effect of the middle dosage group of test group is better than matched group, and effective percentage improves more than 20%.It is complicated with currently drawing dysentery disease pathogen, Drug resistance is high, and refractory report more is consistent, and illustrate in this treats the clinical trial that white mouse draws dysentery, nicotinic acid respectively with lactic acid two The compound injection of a kind of composition in trimethoprim, Mequindox, Chinese medicine extraction liquid, treatment white mouse draws the effect of dysentery equal It is substantially better than single preparations of ephedrine.
(2) toxic and side effects situation, in this clinical trial, sample to individual test subjects without any untoward reaction.
Clinical practice
Using the present invention to carry out clinical trial, totally 500 parts, wherein the Proportion of patients of different age group is:
The prevalence of more than 10 years old less than 20 years old patients is: 16% (the most viral patient accounts for 20, bacterial infection suffer from Person accounts for 40, mixed infection patient 20)；
21～the prevalence of 30 years old patient be that 30% (the most viral patient accounts for 30, and bacterial infection patient accounts for 100 Name, mixed infection patient 20)；
31～the prevalence of 40 years old patient be that 40% (the most viral patient accounts for 50, and bacterial infection patient accounts for 110 Name, mixed infection patient 40)；
The prevalence of more than 41 years old patients be 14% (the most viral patient accounts for 20, and bacterial infection patient accounts for 10, Mixed infection patient 40)；
The injection of the injection embodiment of the present invention 2, after treatment, its therapeutic outcome is obvious, and it is summarized as follows: cure 400, account for 80%；Effective 75, account for 15.0%；Effective 15 account for 3.0%；Invalid 10 account for 2.0%；Total effective rate is 98.0%, evident in efficacy.
Clinical practice shows, its determined curative effect, is suitable for crowd wide, has no the appearance of the toxic and side effects such as allergy, gastrointestinal tract, be A kind of safe and effective medicine.Patient is willing to accept, and is optimal a kind of medicine in current state's internal therapy this area.
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie In the case of the spirit or essential attributes of the present invention, it is possible to realize the present invention in other specific forms.Therefore, no matter From the point of view of which point, all should regard embodiment as exemplary, and be nonrestrictive, the scope of the present invention is by appended power Profit requires rather than described above limits, it is intended that all by fall in the implication of equivalency and scope of claim Change is included in the present invention.

Claims (4)

1. a compound niacin injection, it is characterised in that be 10～20 parts of principal agents, 6～10 parts of additives and 400 by weight portion ～500 parts of solvents are formulated, principal agent by weight portion be 6～10 parts of nicotinic acid, 2～4 parts of berberine sulphates or 6～8 parts sulphuric acid Ah Tropine, 3～5 parts of Mequindox, 12～16 parts of lactic acid TMPs, 5～7 parts of Chinese medicine extraction liquid are formulated；Additional Agent is by the sodium sulfite that weight portion is 2～3 parts, the sodium thiosulfate of 1～2 part and the disodiumedetate of 0.6～1.0 part Formulated；
Described Chinese medicine extraction liquid is by the Herba Andrographis that weight portion is 6～8 parts, the Herba Dendrobii of 4～6 parts, the Radix Et Rhizoma Rhei of 3～5 parts and 6～8 parts Flos Carthami form with the alcohol extraction of 40～50 parts.
Compound niacin injection the most according to claim 1, it is characterised in that described solvent uses ethanol, propylene glycol, note Penetrate one or more in Glucose Liquid or injection sodium chloride solution.
3. the preparation method of a compound niacin injection as claimed in claim 1, it is characterised in that specifically comprise the following steps that
(1) by ethanol reflux, extract, at 70～80 DEG C that Herba Andrographis, Herba Dendrobii, Radix Et Rhizoma Rhei Flos Carthami volume fraction are 60～70% 2～3h, after being cooled to room temperature, filter, dialyse 2～3 days with the dialyzer that molecular cut off is 2000～6000, take out bag filter Interior liquid, obtains Chinese medicine extraction liquid, standby；
(2) by nicotinic acid, berberine sulphate or atropine sulfate, Mequindox, lactic acid TMP by proportioning mixing all Even, add Chinese medicine extraction liquid, be stirring evenly and then adding in the solvent of half, after stirring, then be separately added into sodium sulfite, sulfur Sodium thiosulfate and disodiumedetate, after stirring, add residue solvent, stir,.
4. the application of a compound niacin injection as claimed in claim 1, it is characterised in that this compound niacin injection is used Intestinal tract disease in treatment human body.
CN201610848825.8A 2016-09-23 2016-09-23 A kind of compound niacin injection and its preparation method and application Pending CN106138763A (en)

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CN101297813A (en) * 2008-04-08 2008-11-05 天津生机集团股份有限公司 Compound niacin norfloxacin injection for animals and preparation thereof
CN102058638A (en) * 2011-01-07 2011-05-18 河南亚卫动物药业有限公司 Compound andrographis paniculata injection for treating yellow-white dysentery of piglet and preparation method thereof
CN103230583A (en) * 2013-05-17 2013-08-07 江西省创欣药业集团有限公司 Animal norfloxacin nicotinate compound injection for treating intestinal diseases and preparation method of injection

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CN1985827A (en) * 2006-12-12 2007-06-27 江西省百思特动物药业有限公司 Compound ciprofloxacin injection for animal and its preparing process
CN101297813A (en) * 2008-04-08 2008-11-05 天津生机集团股份有限公司 Compound niacin norfloxacin injection for animals and preparation thereof
CN102058638A (en) * 2011-01-07 2011-05-18 河南亚卫动物药业有限公司 Compound andrographis paniculata injection for treating yellow-white dysentery of piglet and preparation method thereof
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Publication number Priority date Publication date Assignee Title
CN117919170A (en) * 2024-01-29 2024-04-26 厦门泓益检测有限公司 High-purity nicotinic acid injection and preparation method thereof
CN117919170B (en) * 2024-01-29 2024-08-30 厦门泓益检测有限公司 High-purity nicotinic acid injection and preparation method thereof

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