CN106309825A - Pharmaceutical composition conducive to reducing liver injury and preparation method thereof - Google Patents
Pharmaceutical composition conducive to reducing liver injury and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a prescription of a pharmaceutical composition conducive to reducing liver injury, a preparation method, application and main pharmacodynamics research result. The prescription of the drug (or health food) is characterized by involving: 5-300g of Schisandra chinensis, 10-300g of Salvia Miltiorrhiza, 5-300g of wild chrysanthemum, 10-300g of Poria cocos, and 2-300g of cyperus rotundus. By means of the combined action of all the traditional Chinese medicines, the pharmaceutical composition can be dialectically used for replenishing qi and invigorating spleen, activating blood, removing dampness and eliminating toxicity, the Chinese medicinal composition mainly treats liver injury caused spleen asthenia, excessive dampness and stasis syndrome, and belongs to the traditional Chinese medicine or health care food field. The preparation has simple process and reasonable formula, and is a safe and effective drug of first choice for prevention and treatment of liver injury.
Description
Technical field
The present invention relates to a kind of compositions contributing to reducing hepatic injury, particularly relate to a kind of for replenishing QI to invigorate the spleen, activating blood and eliminatng dampness detoxifies, and cures mainly hepatic injury and belongs to insufficiency of the spleen leading to overabundance of dampness and hold concurrently the Chinese medicine composition of blood stasis syndrome, belongs to health food or the field of Chinese medicines.
Background technology
Alcoholic liver disease (alcoholic liver disease, ALD) refers to a series of pathological changes such as the liver injury that causes due to Ethanol intake excess.China's alcoholic liver disease is the situation such as sickness rate raises year by year, liver injury degree increases the weight of, impaired Functional tissue increases, and population of China health has caused systematicness harm.Result of study shows: China's patients with alcoholic liver disease hepar damnification is serious, and wherein alcoholic hepatitis patient accounts for 28.8%, and alcoholic cirrhosis patient accounts for 37.4%.Focusing on early intervention for hepatic injury, therefore development function is definite, without any side effects, long-term taking, carrying convenience, the functional food that vast patients with liver deficiency is liked is significant.
Fructus Schisandrae Chinensis is as the key medicine of the liver protecting and ALT lowering, and the existing numerous studies of its anti-liver injury effect are reported and are widely applied in clinical practice.The hepatic injury that the poisonous substances such as ethanol, carbon tetrachloride, thioacetamide are caused by Fructus Schisandrae Chinensis has good protective effect; Fructus Schisandrae Chinensis can significantly reduce hepatic injury mice serum ALT, AST, reduces glutamate pyruvate transaminase (SGPT), strengthens liver detoxification function, induction hepatomicrosome drug metabolizing enzyme P-450.Fructus Schisandrae Chinensis is Jilin Province's advantage genuine medicinal materials, and yield accounts for the 70% of the whole nation.With it as raw material, developing into no side effects, functional factor is clear and definite, quality controllable, contributes to the third generation health food of alcoholic liver injury, is not only feasible, is also very important.Also can pull medical material plant husbandry simultaneously, improve crude drug value-added content of product.
Health food, can either be in good taste as eating bread and cheese between medicine and food, takes, easy to carry, reaches the purpose of health care the most again.This product sweet and sour taste, gas perfume (or spice) uniqueness is pleasant, it is believed that the development of this green health care food will bring bigger economic benefit and social benefit.
Summary of the invention
It is an object of the invention to develop a kind of Chinese medicine composition being effectively reduced hepatic injury, including composition, preparation method, purposes, Pharmacodynamics result of study and the toxicity research result of medicine.
The invention have the advantage that pharmaceutical composition of the present invention is made up of the five tastes such as Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Flos Chrysanthemi Indici, Poria, Rhizoma Cyperi not only edible but also pharmaceutically useful Chinese medicine, on the basis of comprehensive multiple reduction liver injury medicament by organic for side's Chinese medicine, dialectical ground compatibility together, with conventional reduce hepatic injury Chinese medicine compared with there is certain uniqueness.
The controlled alcoholic liver injury of we, card belongs to insufficiency of the spleen leading to overabundance of dampness holds concurrently the stasis of blood, in alcoholism enters, first kills and cuts down taste, cause taste impaired, dysfunction of the spleen in transportation, and damp stops up Jiao, functional activity of QI being not smooth, then depression of liver-QI, stasis blocking liver network in resistance；Damp-stagnancy with the passing of time heat-transformation, accumulates then suffocating of liver and gall not normal in Shi Re Bing Pian.Fructus Schisandrae Chinensis supplementing QI for promoting the production of body fluid in side, the essence and blood of big tonifying liver spleen kidney, for monarch drug；Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, Flos Chrysanthemi Indici suppressing the hyperactive liver to relieve the wind syndrome, the clear profit head, the two is ministerial drug, plays replenishing QI to invigorate the spleen altogether, the effect that dampness removing promotes the production of body fluid；Assistant, with Poria invigorating the spleen for eliminating dampness, makes with Rhizoma Cyperi, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving, activating QI to alleviate the depression.
Chewable tablet refers to chew in oral cavity or suck the tablet that clothes make sheet swallow after dissolving, and is commonly incorporated into the sweeting agent such as sucrose, Oleum menthae and flavorant adjusts taste, and through chewing, rear surface is long-pending to increase tablet, can promote medicine dissolving in vivo and absorption.Taking convenience, can swallow, chew containing sucking or taking after water-dispersible.Through chewing, rear surface is long-pending to increase tablet, even if medicine dissolving in vivo and absorption can be promoted under exsiccosis it is also ensured that take medicine on time, it is especially suitable for old man, child, paralytic, swallows difficulty and the patient of gastrointestinal function difference, it is possible to reduce gastrointestinal is born by medicine.
It is an object of the invention to be realized by following measures:
1, a kind of Chinese medicine composition contributing to reducing alcoholic liver injury, the pharmaceutical preparation formed by the raw material of Chinese medicine of following weight ratio:
Fructus Schisandrae Chinensis 5-300g Radix Salviae Miltiorrhizae 10-300g Flos Chrysanthemi Indici 5-300g Poria 10-300g Rhizoma Cyperi 2-300g
2, the preferred proportion of compound Chinese medicinal preparation is:
Fructus Schisandrae Chinensis 50g Radix Salviae Miltiorrhizae 100 g Flos Chrysanthemi Indici 50 g Poria 100 g Rhizoma Cyperi 20 g
3, preparation method:
The five tastes in side, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae add 8 times amount 90% alcohol heating reflux extract 3 times, each 1.5 h, merge alcohol extract, decompression recycling ethanol, concentrated solution is concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa)；Medicinal residues after alcohol extraction and remaining three tastes, 10 times amount decoctings 3 times, each 1.5 h, merge decocting liquid, be concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa), standby；Merging the dry cream of decocting and cream promoted by alcohol, pulverize, addition microcrystalline Cellulose, mannitol, starch, sucrose, cyclamate etc., to 1000g, dehydrated alcohol wet granulation, are dried, granulate, are made solid preparation, to obtain final product.
4, Pharmacodynamic test of active extract
Method
Packet, modeling, administration: take healthy Kunming mouse 60, body weight 18 ~ 20g, male, adapt to after environment raises 3 days, divide equally 6 groups: Normal group, model group, chewable tablet basic, normal, high dosage group.In addition to Normal group, remaining is respectively organized gavage and gives 53 degree of Chinese liquor 0.07ml/10/ days, every day 1 time, increases to 0.10ml/10g/ day the most afterwards, every day 1 time, increasing to 0.12ml/10g/ day after continuous 4 days, every day 1 time, from the beginning of modeling the 8th day, before filling Chinese liquor every day, 30min respectively organizes gavage and gives corresponding test medicine, Normal group and model group give isopyknic distilled water, every day 1 time, more continuous 5 weeks.Dosage: preserved sliced ginseng Normal group 0.65g kg-1, chewable tablet group, low dosage 0.33 g kg-1, middle dosage group 0.65 g kg-1, high dose group 1.30 g kg-1。
Testing index: last is administered latter 12 hours and starts fasting 12 hours, weighs, and eyeball takes blood centrifuging and taking serum, takes liver and weighs, and takes 0.5g liver and makes 10% homogenate, is put by remaining hepatic tissue in 10% formalin fixing.
Body weight: survey weekly 1 body weight before medicine after body weight, medicine, last is administered latter 24 hours and surveys 1 time.
Serum ALT (glutamate pyruvate transaminase), AST(glutamic oxaloacetic transaminase, GOT): operate by test kit.
Liver index: (liver weight/body weight) × 100.
Liver homogenate SOD(superoxide dismutase), MDA(malonaldehyde): by test kit operate.
Hepatic histopathology checks: conventional section statining, checks under optical microscope.
Result
4.1 on alcoholic hepatic injury model mice body weight and the impact of liver index
Mice gavages Chinese liquor every day and increases its body weight and have obvious inhibitory action, and liver index also significantly increases.But add while gavaging Chinese liquor and respectively intervened by test product, then body weight growth inhibition be improved significantly, liver index increase also be obviously controlled.And preserved sliced ginseng group compares with dosage group in isodose chewable tablet, its improvement result the latter becomes apparent from, and is shown in Table 1.
The table 1 impact (n=10) on alcoholic hepatic injury model mice body weight and liver index
| Group | Body weight (g) before medicine | Body weight (g) after medicine | Liver wet weights (g) | Liver index |
| Normal group | 22.0±1.63c | 39.8±3.61c | 1.87±0.22c | 4.69±0.23c |
| Model group | 21.9±1.45 | 29.3±2.21 | 2.32±0.16 | 7.99±1.09 |
| Preserved sliced ginseng group | 22.2±1.32 | 32.2±2.44a | 2.16±0.20 | 6.76±0.87a |
| Low group of chewable tablet | 22.0±1.25 | 32.8±3.22a | 2.25±0.13 | 6.92±0.94a |
| Group in chewable tablet | 22.1±1.20 | 34.0±2.91c | 2.21±0.17 | 6.55±0.81b |
| Chewable tablet high group | 22.2±1.62 | 35.2±3.85c | 2.14±0.15a | 6.15±0.86c |
[note] compares with model group: a P < 0.05, b P < 0.01, c P < 0.001
4.2 on alcoholic hepatic injury model mice Serum ALT, AST and liver SOD, the impact of MDA
After mice causes alcoholic hepatic injury model, Serum ALT, AST are significantly raised, liver SOD substantially reduces, MDA is significantly raised, but add while gavaging Chinese liquor and respectively intervened by test product, then ALT, AST substantially reduce, and liver SOD is significantly raised, MDA substantially reduces.And preserved sliced ginseng group compares with dosage group in isodose chewable tablet, its improvement result the latter becomes apparent from, and is shown in Table 2.
Table 2 is on alcoholic hepatic injury model mice Serum ALT, AST and liver SOD, the impact (n=10) of MDA
| Group | ALT(U/L) | AST(U/L) | SOD(U•mg-1) | MDA(umol•mg-1) |
| Normal group | 79.98±19.44c | 100.5±14.57c | 77.24±15.07c | 10.79±1.61c |
| Model group | 200.2±37.5 | 208.9±23.49 | 39.90±9.12 | 21.15±2.54 |
| Preserved sliced ginseng group | 170.0±18.43a | 182.2±30.93a | 48.35±7.32a | 18.26±2.05a |
| Low group of chewable tablet | 172.1±16.54a | 187.8±17.95a | 50.48±8.65a | 18.33±2.36a |
| Group in chewable tablet | 146.5±14.62c | 163.4±16.49c | 53.10±9.74b | 16.78±2.24c |
| Chewable tablet high group | 133.0±22.94c | 154.6±22.40c | 57.58±9.93c | 15.60±3.26c |
[note] compares with model group: a P < 0.05, b P < 0.01, c P < 0.001
4.3 liver histopathology inspections
After mice causes alcoholic hepatic injury model, liver there will be damage in various degree, as hepatocyte obvious tumefaction, spotty necrosis, focal necrosis, portal area cell infiltration, kytoplasm loosen.But adding while gavaging Chinese liquor and respectively carried out intervening by test product, above-mentioned lesion degree is improved.
The invention will be further described the most in conjunction with the embodiments, but the present invention is not by any restriction of embodiment.
Embodiment 1(tablet)
Prescription:
Fructus Schisandrae Chinensis 100g Radix Salviae Miltiorrhizae 200 g Flos Chrysanthemi Indici 100 g Poria 200 g Rhizoma Cyperi 40 g
Preparation method:
The five tastes in side, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae add 8 times amount 90% alcohol heating reflux extract 3 times, each 1.5 h, merge alcohol extract, decompression recycling ethanol, concentrated solution is concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa)；Medicinal residues after alcohol extraction and remaining three tastes, 10 times amount decoctings 3 times, each 1.5 h, merge decocting liquid, be concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa), standby；Merging the dry cream of decocting and cream promoted by alcohol, pulverize, addition microcrystalline Cellulose, mannitol, starch, sucrose, cyclamate etc., to 500g, dehydrated alcohol wet granulation, are dried, granulate, film coating, are made 1000, to obtain final product.
Embodiment 2(capsule)
Prescription:
Fructus Schisandrae Chinensis 100g Radix Salviae Miltiorrhizae 200 g Flos Chrysanthemi Indici 100 g Poria 200 g Rhizoma Cyperi 40 g
Preparation method:
The five tastes in side, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae add 8 times amount 90% alcohol heating reflux extract 3 times, each 1.5 h, merge alcohol extract, decompression recycling ethanol, concentrated solution is concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa)；Medicinal residues after alcohol extraction and remaining three tastes, 10 times amount decoctings 3 times, each 1.5 h, merge decocting liquid, be concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa), standby；Merge the dry cream of decocting and cream promoted by alcohol, pulverize, encapsulated, make 1000, to obtain final product.
Claims (4)
1. one kind contributes to pharmaceutical composition reducing alcoholic liver injury and preparation method thereof, it is characterised in that it is made up of following raw material:
Fructus Schisandrae Chinensis 5-300g Radix Salviae Miltiorrhizae 10-300g Flos Chrysanthemi Indici 5-300g Poria 10-300g Rhizoma Cyperi 2-300g.
The preparation method of compositions the most according to claim 1 and 2, it is characterised in that:
A Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae add 8 times amount 90% alcohol heating reflux and extract 3 times, and each 1.5 h merge alcohol extract, and decompression recycling ethanol, concentrated solution is concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa)；
Medicinal residues after b alcohol extraction and remaining three tastes, 10 times amount decoctings 3 times, each 1.5 h, merge decocting liquid, be concentrated into paste, drying under reduced pressure (80 DEG C, 0.05 MPa), standby；
C merges alcohol and promotes cream a and decocting dry cream b, pulverizes, and adds appropriate amount of auxiliary materials, mixing, with 30%～95% ethanol granule, is dried, granulate, makes solid preparation, to obtain final product.
Compositions the most according to claim 1, it is characterised in that it is made up of the raw material of following weight proportioning:
Fructus Schisandrae Chinensis 50g Radix Salviae Miltiorrhizae 100 g Flos Chrysanthemi Indici 50 g Poria 100 g Rhizoma Cyperi 20 g.
4. being mainly used in replenishing QI to invigorate the spleen according to the Chinese medicine composition described in claim 1 and 2, activating blood and eliminatng dampness detoxifies, and cures mainly hepatic injury and belongs to insufficiency of the spleen leading to overabundance of dampness and hold concurrently blood stasis syndrome.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115350233A (en) * | 2022-09-02 | 2022-11-18 | 北京生泰尔科技股份有限公司 | Oral liquid for protecting livers of livestock and poultry and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115350233A (en) * | 2022-09-02 | 2022-11-18 | 北京生泰尔科技股份有限公司 | Oral liquid for protecting livers of livestock and poultry and preparation method thereof |
| CN115350233B (en) * | 2022-09-02 | 2023-08-22 | 北京生泰尔科技股份有限公司 | Oral liquid for protecting livers of livestock and poultry and preparation method thereof |
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Application publication date: 20170111 |
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