CN104721208B - A kind of pharmaceutical preparation preventing and treating fatty liver and reducing blood lipid - Google Patents
A kind of pharmaceutical preparation preventing and treating fatty liver and reducing blood lipid Download PDFInfo
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- CN104721208B CN104721208B CN201510052475.XA CN201510052475A CN104721208B CN 104721208 B CN104721208 B CN 104721208B CN 201510052475 A CN201510052475 A CN 201510052475A CN 104721208 B CN104721208 B CN 104721208B
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- saikoside
- liver
- lipoic acid
- fatty liver
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Abstract
The invention discloses saikoside A and lipoic acid to prevent and treat the purposes in fatty liver and hyperlipidemia disease in preparation.Pharmacological research, which shows that pharmaceutical composition of the invention has, significantly reduces hepatic lipid peroxidation damage, reduces the level of serum total cholesterol and triglycerides, effectively prevents and treats fatty liver.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition being made of saikoside A and lipoic acid and preparation method thereof and medicines
Compositions are preventing and treating the application in fatty liver and hyperlipidemia, belong to pharmaceutical technology field.
Background technique
Relevant information shows fatty liver adult prevalence rate 5%~9%, it has also become is only second to the second largest of virus hepatitis
Hepatopathy.Trophic disturbance, heavy drinking, diabetes, infection, Drug damage, metabolism and dysendocrinism etc. can lead to fat
Liver.As fat is accumulated in liver cell, liver function damage can be directly caused, liver function decline can seriously cause liver fibrosis, most
Cirrhosis occurs eventually and causes poor prognosis.Fat medicament (clofibrate class, gallbladder predominantly drop in the current clinical treatment drug of fatty liver
Alkali, methionine, niacin class, Statins etc.), protect liver degreasing medicine (unsaturated fatty acid and phospholipid, S-adenosylmethionine
Class, protecting liver, lowering enzymes medicine etc.) and Chinese medicine (Tea Pigment, Effects of Xuezhikang, Zhibituo and silibinin).And fat-reducing medicament itself can lead to
Apparent liver damage.Authorities,medical is it is believed that lipid-lowering medicine passes through and becomes to making blood lipid to focus more on liver to be metabolized, fatty liver
It is often accompanied by Liver Lipid Metabolism obstacle, so promoting accumulation in the liver of lipid after fat-reducing medicament application, further damaging liver function
Energy.Bupleurum Chinese is bitter in taste, cool, enters in liver and gallbladder warp and inducing diaphoresis, soothing the liver, rising Yang.Control fevers and chills alternate, fullness in the chest and hypochondriac pain, bitter taste ear
It is deaf, headache and dizziness, malaria, lower benefit rectal prolapse, irregular menstruation, metroptosis.Modern pharmacological studies have shown that radix bupleuri is with anti-inflammatory, immune
A variety of pharmacological activity such as adjusting, anti-hepatic fibrosis and liver protection.
Saikoside A(SSa) have the function of anti-inflammatory, antiviral, anticancer, in addition there are reducing blood lipid, liver-protective function
Effect.The absorption of saikoside oral digestion road is poor, clinically usually using injection.But saikoside is made with apparent haemolysis
It should be noted that when with, use.1. anti-inflammatory effect, saikoside A has significant anti-inflammatory effect to implantation granuloma induced by implantation of cotton pellets, also has anti-
Transudation.2. hepatoprotective effect, saikoside A can inhibit carbon tetrachloride to the liver toxicity of rat, drop peroxidating matter content
It is low, and content of triglyceride reduces explanation with protection hepatocellular injury and promotes lipid-metabolism effect in liver in liver.③
Effect for reducing blood fat, radix bupleuri soap A play the role of significantly reducing blood lipid, and wherein triglyceride reducing is stronger than glycyrrhizin effect, and drops gallbladder
Sterol effect is then weak compared with the latter.Saikoside A has been reported as unique effective ingredient and is inhibiting liver fibroblast proliferation
It is applied in drug, it is inhibited to fibroblast NIH/3T3 proliferation, significantly inhibit the occurrence and development of liver fibrosis
(Huang Cheng's steel etc., CN101062046 B, 2011).
Lipoic acid is a kind of coenzyme for being present in mitochondria, and similar vitamin enters cell after intestinal absorption in vivo,
Fat-soluble and water-soluble characteristic is had both, therefore can be gone everywhere without any hindrance here in whole body, any one cell area is reached, due to α-sulphur
The oxidation-reduction potential of octanoic acid is very low, and it and is the metabolite for being present in intracorporal natural type that molecule is again small, be tool it is fat-soluble with
Water-soluble universal antioxidant, it is considered that it can save and regenerate other antioxidants, such as vitamin C and E, and can put down
Weigh blood sugar concentration.Lipoic acid is the restricted required nutrition of one kind needed for body cell generates energy using energy substances such as carbohydrates
Substance is widely used in and treats and prevents a variety of diseases such as heart disease, diabetes, effectively enhancing vivo immuning system, from certainly
By the destruction of base.
Cause about the composition of saikoside A and lipoic acid for treating fatty liver, infection, drug, dysbolism etc.
The hepatic injury that is caused of hepatic cell fattydegeneration, hyperlipidemia has not been reported and patent disclosure.
Summary of the invention
The present invention provides a kind of pharmaceutical composition of prevention and treatment fatty liver, preparation method and its usage.
Pharmaceutical composition of the invention is made of saikoside A and lipoic acid and pharmaceutically acceptable auxiliary material.Radix bupleuri soap
The compound medicine of glycosides A and lipoic acid composition have the function of preventing and treating fatty liver, it is possible to reduce hepatic lipid peroxidation
Damage improves lipid-metabolism, reduces the level of serum triglyceride.
Pharmaceutical composition of the invention is made of saikoside A and lipoic acid, and can be added has improvement liver new when necessary
One of old metabolic inosine, coacetylase, glucurone are or several.
Compound medicinal formulation of the invention, every 1000 dosage units contain sulphur containing 0.1~100 part of saikoside A
0.1~800 part of octanoic acid.It is preferred to contain 0.1~50 part of saikoside A, contain 0.1~300 part of lipoic acid.Further preferably
Contain 0.1~20 part of saikoside A, contain 0.5~50 part of lipoic acid.
Application of the pharmaceutical preparation provided by the invention in the drug that preparation prevents and treats fatty liver.
Pharmaceutical composition of the invention is mainly made of saikoside A and lipoic acid.The present invention is pungent by saikoside A and sulphur
Acid is applied in combination, by improving lipoid peroxidization resistant and improving lipid-metabolism, reduction hepatic lipid peroxidation damage, thus
Check the pathogenic process of fatty liver and hyperlipidemia；Saikoside A and lipoic acid are applied in combination, blood lipid water can be both significantly reduced
It is flat, and the dosage of saikoside A can be reduced, and significantly improve its curative effect for preventing and treating fatty liver and hyperlipidemia.
Experimental study shows that the radix bupleuri aglycon A generated after saikoside A hydrolysis and lipoic acid combination have similar pharmacology
Effect.The ester or salt of saikoside A or its aglycon and lipoic acid after chemical bonding also have similar pharmacological action.
Saikoside A radix bupleuri aglycon A lipoic acid
The composition of radix bupleuri aglycon A and lipoic acid that further requirement saikoside A hydrolysis of the present invention generates are being treated
With the application in the drug of prevention fatty liver and hyperlipidemia condition.The present invention also further requirement saikoside A or its bavin
The ester or salt of Hu aglycon A and lipoic acid after chemical bonding are in the drug for treating and preventing fatty liver and hyperlipidemia condition
In application.
Compound preparation of the invention can make suitable any preparation, as tablet, injection, capsule, pill,
Micropill preparation, granule etc..When supporting pharmaceutical preparation, the pharmaceutically acceptable auxiliary material that can be added, filling out including solid pharmaceutical preparation
Fill agent, adhesive, disintegrating agent, lubricant and glidant: cosolvent, pH adjusting agent and solvent including injection.
Pharmaceutical preparation of the invention, preparation method are pharmacy conventional methods, including by saikoside A and lipoic acid,
The step of with the mixing of pharmaceutically acceptable auxiliary material.
Pharmaceutical preparation of the invention, dosage form are oral agents or injection, and preferred dosage form is water needle, the agent of powder faller gill, glue
Wafer, granule, dripping pill, dispersible tablet, more preferably injection, such as water needle, powder needle, the auxiliary material that can be added has filler, pH
Value regulator and appropriate solvent, most preferably solid orally ingestible, such as tablet, capsule, granule, dripping pill, dispersible tablet,
Appropriate pharmaceutical auxiliary material can be added for tablet, capsule, granule, dripping pill, dispersible tablet.
Pharmaceutical preparation of the invention can orally be taken, and can take 1~4 time daily, every time 1~3 dosage unit；
Can also parenteral administration, daily to use 1 time, 1~2 dosage unit every time.The dosage unit refers to every dose, such as tablet
Every, every etc. of capsule.
In formula composition of the invention, part of drug is parts by weight, and every portion can be 1 gram, be also possible to kilogram or
Ton, if with gram as unit of, which can be made into 1000 doses of pharmaceutical preparation namely above-mentioned 1000 dosage units.It is described
1000 doses or 1000 dosage units refer to that the amount of manufactured final drug dosage is such as made capsule preparations 1000, tablet 1000
Piece, 1000 bottles of injection, big packaging can also be made as granule in granule 1000g etc., specifically can be with such as 100-500 bags
It is 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as 1 taking dose.
Composition described above is by weight as proportion, and in production, mountable corresponding proportion increases or reduces, such as extensive
Production can by kilogram as unit of, or as unit of ton, small-scale production can also as unit of milligram, weight can increase or
It reduces, but the constant rate of the medicinal material weight proportion between each composition.
Drug of the invention is improving lipid-metabolism, anti peroxidation of lipid damage, protection liver plasma membrane stability, antagonism liver
Cellular damage, liver function protecting etc. have synergistic effect.
Pharmaceutical composition of the invention compared with prior art, has the advantage that
(1) pharmacological evaluation shows that saikoside A and lipoic acid are applied in combination pharmaceutical composition of the invention, improves anti-
Lipid peroxidation and improvement lipid-metabolism, reduce hepatic lipid peroxidation damage, interfere fatty liver, infection, drug, metabolism
There is good clinic to answer for the hepatic injury that hepatic cell fattydegeneration caused by obstacle etc. is caused, the pathogenic process of hyperlipidemia
With value.
(2) pharmaceutical composition of the invention has the level for significantly reducing serum total cholesterol and triglycerides.
(3) pharmaceutical composition of the invention reduces the dosage of saikoside A, reduces it and damages to the toxicity of liver cell
Wound effect, and enhance liver-protecting and blood fat-reducing curative effect.
Specific embodiment
The specific embodiment of form by the following examples makees further specifically above content of the invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to following embodiment.It is all to be based on above content of the present invention
The technology realized all belongs to the scope of the present invention.The auxiliary material of each dosage form can be with pharmaceutically acceptable auxiliary in following embodiment
Material replacement, or reduce, increase.Wherein, 10%PVPK30 ethanol, " appropriate " meaning: by taking tablet as an example, dosage is generally 2%
~5%, concentration is generally 0.5%~5%.
The preparation of 1 present composition tablet of embodiment
1, prescription:
Prescription 1
| Saikoside A | 1g |
| Lipoic acid | 100g |
| Microcrystalline cellulose | 50g |
| Pregelatinized starch | 100g |
| 10%PVPK30 ethanol | In right amount |
| Magnesium stearate | 3g |
| Preparation altogether | 1000 |
Prescription 2
| Saikoside A | 3g |
| Lipoic acid | 200g |
| Microcrystalline cellulose | 60g |
| Pregelatinized starch | 100g |
| 10%PVPK30 ethanol | In right amount |
| Magnesium stearate | 3g |
| Preparation altogether | 1000 |
2, preparation process:
It is spare that raw material and auxiliary material crushed 80 meshes respectively；Granulation solution preparation: take PVP K30 that concentration is added to be 30~95%
5~10% solution is made in medicinal alcohol；Raw material and auxiliary materials and mixing are taken, granulation solution softwood processed in right amount is added, 20 mesh are pelletized, and 50
After~70 DEG C of dryings, 18 mesh whole grains are added magnesium stearate and mix；Measure granule content, capsule filling, random detection loading amount；At
Product full inspection, is packed and stored.
The preparation of the capsule of the pharmaceutical composition of the present invention of embodiment 2
1, prescription:
Prescription 1
| Saikoside A | 1g |
| Lipoic acid | 100g |
| Microcrystalline cellulose | 50g |
| Pregelatinized starch | 100g |
| 10%PVPK30 ethanol | In right amount |
| Magnesium stearate | 3g |
| Preparation altogether | 1000 |
Prescription 2
| Saikoside A | 3g |
| Lipoic acid | 200g |
| Microcrystalline cellulose | 60g |
| Pregelatinized starch | 100g |
| 10%PVPK30 ethanol | In right amount |
| Magnesium stearate | 3g |
| Preparation altogether | 1000 |
2, preparation process:
It is spare that raw material and auxiliary material crushed 80 meshes respectively；Granulation solution preparation: take PVP K30 that concentration is added to be 30~95%
5~10% solution is made in medicinal alcohol；Raw material and auxiliary materials and mixing are taken, granulation solution softwood processed in right amount is added, 20 mesh are pelletized, and 50
After~70 DEG C of dryings, 18 mesh whole grains are added magnesium stearate and mix；Measure granule content, capsule filling, random detection loading amount；At
Product full inspection, is packed and stored.
The preparation of the medicament composition granule of the invention of embodiment 3
1, prescription:
Prescription 1:
| Saikoside A | 0.5g |
| Lipoic acid | 200g |
| Icing Sugar | 1000g |
| 2%HPMC50% ethanol solution | In right amount |
| Preparation altogether | 1000 packets |
Prescription 2:
| Saikoside A | 1g |
| Lipoic acid | 300g |
| Icing Sugar | 1200g |
| 2%HPMC50% ethanol solution | In right amount |
| Preparation altogether | 1000 packets |
2, specific steps:
Raw material and auxiliary material crushing are sieved with 100 mesh sieve, it is spare；Raw material and auxiliary material are weighed according to recipe quantity, by raw material and Icing Sugar
It is uniformly mixed in the method that equivalent is progressively increased, addition 2%HPMC50% ethanol solution is appropriate, stirs evenly, suitable softwood, mistake is made
20 meshes granulation, 60 DEG C of drying, crosses 18 mesh sieves；Sampling, semi-finished product chemically examine the content of main ingredient in particle, determine loading amount, point
Dress；Finished product full inspection, is packed and stored.
The preparation of 4 present composition water needle of embodiment
1, prescription:
Prescription 1:
| Saikoside A | 2g |
| Lipoic acid | 100g |
| Polyoxyethylene sorbitan monoleate | 20g |
| Water for injection | 5000ml |
| Preparation altogether | 1000 |
Prescription 2:
| Saikoside A | 5g |
| Lipoic acid | 150g |
| Polyoxyethylene sorbitan monoleate | 50g |
| Water for injection | 10000ml |
| Preparation altogether | 1000 |
2, preparation process:
Production is cleared up with liquid with container tool, instrument and equipment etc. with ampoule, degerming, depyrogenation；Original is weighed by prescription
Material and auxiliary material, take polyoxyethylene sorbitan monoleate to add the water for injection with liquid measure 80%, stirring and dissolving；The needle with liquid measure 0.05% is added to live
Property charcoal, stir 15min, filtering, take off charcoal, raw material is added into solution, stirring and dissolving measures and adjust the pH value of solution, adds
Water for injection is to full dose, constant volume；Medical fluid passes through 0.22 μm of miillpore filter refined filtration, checks clarity, the inspection of semifinished product；By medical fluid
Loaded in ampoule, 100 DEG C of flowing steam sterilization 30min hunt leak, lamp inspection；Finished product full inspection, is packed and stored.
The preparation of the pharmaceutical composition powder needle of the invention of embodiment 6
1, prescription:
Prescription 1:
| Saikoside A | 2g |
| Lipoic acid | 100g |
| Dextran | 100g |
| Water for injection | 5000ml |
| Preparation altogether | 1000 |
Prescription 2:
| Saikoside A | 5g |
| Lipoic acid | 200g |
| Dextran | 200g |
| Water for injection | 10000ml |
| Preparation altogether | 1000 |
2, preparation process:
Cillin bottle, rubber plug used will be produced and cleared up with liquid with container tool, instrument and equipment etc., degerming, depyrogenation；It presses
Prescription weighs raw material and auxiliary material, by dextran plus matches 80% water for injection of liquid measure, stirring and dissolving；Then it is added and matches liquid measure
0.05% needle-use activated carbon, stirs 15min, and filtering takes off charcoal, raw material is added into solution, stirring and dissolving is measured and adjusted molten
The pH value of liquid, benefit add to the full amount of water for injection, constant volume；Medical fluid passes through 0.22 μm of miillpore filter refined filtration, checks clarity, half at
Product examine is tested；Medical fluid dispenses 2ml in cillin bottle, half tamponade, freeze-drying, tamponade, Zha Gai；Finished product full inspection, is packed and stored.
7 biological experiment of embodiment
Below by way of the beneficial effect of experiment the present invention is further explained pharmaceutical composition.Pharmaceutical composition of the present invention has
Following beneficial effect, but this should not be interpreted as to pharmaceutical composition of the present invention only there is following beneficial effect.Drug of the invention
Protective effect of the composition to alcoholic fatty liver caused by rat complex factors:
Experimental animal: healthy Wistar male rat, 180~220 g of weight are mentioned by Shandong University's Experimental Animal Center
For.
Experiment reagent and drug: SSa is purchased from the source Zhong Shankangzhi Biotechnology Co., Ltd, and lipoic acid is purchased from Shandong all medicine together
Industry Co., Ltd.
Pharmaceutical composition MC1:SSa(0.30 mg/kg)
MC2:SSa(0.15 mg/kg)+lipoic acid (54 mg/kg)
Experimental method: all rat adaptive feedings are randomly divided into Normal group (A), model group after 7 days, by weight
(B), 1,2 group of drug (C1, C2) and Bifendate positive controls (D).Normal group commonly feeds 2 weeks, model group
Give self-control Low protein diet (+0.5% cholesterol of+20% lard of 79.5% maize flour) high in fat with each administration group, while first week every
Its 15% alcohol of stomach-filling, 5% alcohol of second week stomach-filling, modeling period are 2 weeks.While modeling, each group is according to 10 ml/kg weight
MC1 is given in gastric infusion, A and B stomach-filling distilled water, C1 group stomach-filling, and MC2 is given in C2 group stomach-filling, and bifendate drop is given in D group stomach-filling
4.05 mg/kg of ball.One time a day, continuous 14 days.Cervical dislocation puts to death animal after 20 h of last dose, plucks eyeball and takes blood, centrifuging and taking
Serum measures serum glutamic pyruvic transminase (ALT), glutamic-oxalacetic transaminease (AST), total cholesterol (TC), triglycerides (TG), malonaldehyde
(MDA), superoxide dismutase (SOD).Aorta pectoralis is taken, is rinsed, is gone with pre- cold saline after removing adventitial fat tissue
Except bloodstain, filter paper wipes dry, weighing, and blood vessel is immersed cold saline 9 times of blood vessel (physiological saline quality be), is shredded,
10% tissue homogenate is made in ice-water bath, centrifuging and taking supernatant detects Lectin-like oxidized low density lipoprotein receptor-1
(LOX-1) expression.
Experimental result: compared with Normal group, model group rats Serum ALT and AST level are sharply increased, TC in blood
It is increased with TG content conspicuousness, pathologic finding finds different degrees of hepatic cell fattydegeneration, judges modeling success.With model group
It comparing, saikoside A can significantly reduce ALT, AST, TC, TG level in rat blood serum and mitigate liver tissue injury, a small amount of
SSa use in conjunction lipoic acid, becomes apparent from the improvement of These parameters, more preferable to the protective effect effect of liver.
Compared with Normal group, the apparent increase of MDA content, SOD content are substantially reduced in model group rats blood, rat master
The expression of arterial wall LOX-1 obviously increases.After giving certain drug, the change of These parameters is substantially reduced.After dosage halves
SSa and the liver-protecting and blood fat-reducing effect ratio of lipoic acid group are applied alone SSa group more preferable.
Protective effect of the pharmaceutical composition of the invention of table 1 to rat alcoholic fatty liver
Protective effects of the pharmaceutical composition of the invention of table 2 to rat alcoholic fatty liver
Conclusion:
Low protein diet combination alcohol high in fat can shorten the modeling period for causing Rats adiposis hepatica.This method can cause liver thin
The damage of after birth structure and function, TC and TG content increases in blood, and intracellular ALT, AST overflow, and leads to ALT, AST activity in blood
It increases.We have discovered that pharmaceutical composition of the invention can significantly reduce ALT and AST level in rat blood serum, blood is reduced
Middle TC and TG content, and liver cell accumulation of fat there is significant protection to make rat fat hepatic injury caused by complex factors
With.Wherein, SSa and lipoic acid collaboration use, and can reduce the dosage of SSa, and enhance the hepatoprotective effect of SSa.Its liver protection mechanism
It is reacted with anti-lipid peroxidation, the expression for reducing Lectin-like oxidized low density lipoprotein receptor-1 is related.
Claims (1)
1. a kind of composition is preparing the application in drug for treating alcoholic fatty liver, which is characterized in that composition by
Saikoside A and lipoic acid composition, optionally also contain pharmaceutically acceptable auxiliary material, wherein the quality of saikoside A and lipoic acid
Than being 0.15: 54.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510052475.XA CN104721208B (en) | 2015-02-02 | 2015-02-02 | A kind of pharmaceutical preparation preventing and treating fatty liver and reducing blood lipid |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510052475.XA CN104721208B (en) | 2015-02-02 | 2015-02-02 | A kind of pharmaceutical preparation preventing and treating fatty liver and reducing blood lipid |
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| Publication Number | Publication Date |
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| CN104721208A CN104721208A (en) | 2015-06-24 |
| CN104721208B true CN104721208B (en) | 2019-01-18 |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1778391A (en) * | 2005-03-07 | 2006-05-31 | 淮北市辉克药业有限公司 | Safety and high-efficient compound hypolipidemic medicine |
| CN102090453A (en) * | 2011-02-21 | 2011-06-15 | 苟春虎 | Weight-reducing and beautifying milk tea |
| CN102488722A (en) * | 2011-12-05 | 2012-06-13 | 广东众生药业股份有限公司 | Preparation method and quality detection method of bupleurum oral solution |
-
2015
- 2015-02-02 CN CN201510052475.XA patent/CN104721208B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1778391A (en) * | 2005-03-07 | 2006-05-31 | 淮北市辉克药业有限公司 | Safety and high-efficient compound hypolipidemic medicine |
| CN102090453A (en) * | 2011-02-21 | 2011-06-15 | 苟春虎 | Weight-reducing and beautifying milk tea |
| CN102488722A (en) * | 2011-12-05 | 2012-06-13 | 广东众生药业股份有限公司 | Preparation method and quality detection method of bupleurum oral solution |
Non-Patent Citations (3)
| Title |
|---|
| 柴胡总皂甙及柴胡皂甙a、c、d对MES惊厥小鼠的影响;谢炜等;《中药药理与临床》;20060228;第22卷(第1期);39-40 |
| 生物抗氧化剂——硫辛酸的研究;刘俊栋等;《饲料工业》;20050131;第26卷(第2期);14-17 |
| 长白柴胡中柴胡皂甙a对小鼠实验性肝损伤保护作用的实验研究;李廷利等;《中医药学报》;19880301(第1期);44-45 |
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