CN109589391A - A kind of strong liver disappears pharmaceutical composition and preparation method thereof, preparation and the application of rouge - Google Patents

A kind of strong liver disappears pharmaceutical composition and preparation method thereof, preparation and the application of rouge Download PDF

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Publication number
CN109589391A
CN109589391A CN201811599554.2A CN201811599554A CN109589391A CN 109589391 A CN109589391 A CN 109589391A CN 201811599554 A CN201811599554 A CN 201811599554A CN 109589391 A CN109589391 A CN 109589391A
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parts
rouge
pharmaceutical composition
radix
liver
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温伟波
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Yunnan Provincial Hospital of Traditional Chinese Medicine
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Yunnan Provincial Hospital of Traditional Chinese Medicine
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Abstract

Disappear pharmaceutical composition of rouge and preparation method thereof, preparation and application the invention discloses a kind of strong liver.The disappear pharmaceutical composition of rouge of the strong liver includes 10~20 parts of Radix Salviae Miltiorrhizae of parts by weight of raw materials, 3~7 parts of Radix Notoginseng, 10~20 parts of curcuma zedoary, 12~30 parts of hawthorn, 12~30 parts of Radix Astragali, 5~15 parts of green peel, 10~20 parts of radix paeoniae rubra, 10~20 parts of turmeric, 10~20 parts of rhizoma alismatis, 10~20 parts of chrysanthemum, 10~20 parts and 5~15 parts of Radix Glycyrrhizae of lotus leaf, through pre-treatment, Radix Notoginseng crushes, volatile oil extracting, inclusion essential oil, water-soluble medicinal extract extract and mixing and etc. be prepared preparation be the strong liver disappear rouge pharmaceutical composition in the decoction of pharmaceutically acceptable auxiliary material preparation is added, pill, particle, tablet, capsule, the clinic suitable dosage forms such as mixture.The application in preventing/treating nonalcoholic fatty liver drug is being prepared using for the disappear pharmaceutical composition of rouge of the strong liver.Pharmaceutical composition of the present invention can reduce blood lipid in the deposition of liver more significantly and improve liver function, to prevent and treat nonalcoholic fatty liver.

Description

A kind of strong liver disappears pharmaceutical composition and preparation method thereof, preparation and the application of rouge
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of strong liver disappear rouge pharmaceutical composition and preparation method thereof, Preparation and application.
Background technique
According to its characteristics of incidence and clinical manifestation, non-alcohol fatty liver is belonged to hypochondriac pain, feeling of fullness, phlegm by traditional Chinese medicine The scopes such as turbid, liver addiction.Chinese medicine thinks that the interpretation of the cause, onset and process of an illness of non-alcohol fatty liver is related with phlegm, wet, the stasis of blood etc., and phlegm is turbid, hemostasis is at this It plays a crucial role during sick occurrence and development.Phlegm is turbid, phlegm-blood stasis and hand over resistance or phlegm-blood stasis alternate can occur in vivo for hemostasis, as " all diseases Source, which is waited, discusses phlegm retention disease duke or princess under an emperor " institute's cloud: " all phlegm persons, this is jammed by blood vessels, and drinking-water is gathered without dissipating, therefore at phlegm." " Dan Xi Heart method " also speech " phlegm press from both sides hemostasis, then at nest capsule ", illustrate phlegm-blood stasis and hand over resistance, glue is solid not to be changed, deep hiding in hiding, and it is hot to accumulate longization, accumulate at Poison is dark to consume liver body.Have statistics to show: document of nearly more than ten coming year about traditional Chinese medicine treatment fatty liver prompts phlegm and blood stasis It is the different TCM syndrome types of fatty liver and the basic pathogenesis of fatty liver.Current many scholars tend to phlegm reduction of blood circulation promoting method and treat non-wine Essence fatty liver disease, it is believed that activating microcirculation and removing stasis medicinal can play synergistic effect in conjunction with resolving phlegm lowering turbidity, and stagnation resolvation is conducive to phlegm and goes, and phlegm has been gone Conducive to stagnation resolvation, the effect for the treatment of non-alcohol fatty liver can be improved.
Non-alcohol fatty liver (non-alcoholic fatty liver disease, NAFLD) is and insulin Resist (Insulin Resistance, IR) and the closely related metabolic stress hepar damnification of inheritance susceptible.As people are raw The change of mode living, Asian countries NAFLD illness rate rapid development and in the incidence trend that becomes younger in the past 20 years, Chinese is upper Developed regions adult's NAFLD illness rates such as sea, Guangzhou and Hong Kong are 15% or so.It is more and more heavy that NAFLD has become chronic liver disease The cause of disease wanted seriously endangers public health, but still lacks ideal therapeutic scheme at present.
Summary of the invention
The first object of the present invention is to provide the pharmaceutical composition that a kind of strong liver disappears rouge;Second be designed to provide it is described Strong liver disappear rouge pharmaceutical composition preparation method;Third is designed to provide the strong liver and disappears the pharmaceutical composition of rouge Preparation;4th be designed to provide the strong liver disappear rouge pharmaceutical composition application.
The first object of the present invention is achieved in that the disappear pharmaceutical composition of rouge of the strong liver includes parts by weight of raw materials 10~20 parts of Radix Salviae Miltiorrhizae, 3~7 parts of Radix Notoginseng, 10~20 parts of curcuma zedoary, 12~30 parts of hawthorn, 12~30 parts of Radix Astragali, 5~15 parts of green peel, 10~20 parts of radix paeoniae rubra, 10~20 parts of turmeric, 10~20 parts of rhizoma alismatis, 10~20 parts of chrysanthemum, 10~20 parts of lotus leaf and Radix Glycyrrhizae 5~15 Part, through pre-treatment, Radix Notoginseng crushings, volatile oil extracting, inclusion essential oil, water-soluble medicinal extract extract and mix and etc. be prepared.
The second object of the present invention is achieved in that including pre-treatment, Radix Notoginseng crushing, volatile oil extracting, volatile oil packet Conjunction, the extraction of water-soluble medicinal extract and mixing and etc., it specifically includes:
A, pre-treatment:
Selected medicinal material removes impurity;
B, Radix Notoginseng crushes
Take it is selected after Radix Notoginseng, 80 DEG C or less drying, crush, sieving, by be formulated needed for weight weighing, obtain Radix Notoginseng powder a;
C, volatile oil extracting
Take it is selected after the curcuma zedoary of formulation ratio, turmeric and green peel mixing, curcuma zedoary, turmeric and green peel total weight 2-5 is added Water again, steam distillation extract to obtain volatile oil b, extracting solution c and dregs of a decoction d;
D, inclusion essential oil
(1) volatile oil b obtained by step C is taken, 2-5 times of weight of volatile oil b of 95% ethyl alcohol is added to make to dissolve;
(2) beta cyclodextrin for weighing 5-15 times of weight of volatile oil b of gained, adds water that saturated solution is made;
(3) in the case of stirring, it is added dropwise to volatile oil ethanol solution into the water saturation solution of beta cyclodextrin, is wrapped It closes.Including temperature is 30-60 DEG C, and the inclusion time is 2-4 hours;
(4) inclusion solution sets 0-5 DEG C of refrigeration 8-12 hours, filters, and 50 DEG C or less dryings obtain volatile oil clathrate compound e;
E, water-soluble medicinal extract extracts
(1) by the resulting dregs of a decoction d of step C and it is selected after composition of raw materials proportion Radix Salviae Miltiorrhizae, hawthorn, Radix Astragali, radix paeoniae rubra, pool Rush down, chrysanthemum, lotus leaf and Radix Glycyrrhizae are mixed to get material f, water decoction 2-4 times of 8-10 times of weight of material f is added in material f, every time 1-3h, filtering, merging filtrate obtain material g;
(2) extracting solution c obtained by step C and step E (1) resulting material g is mixed, is concentrated under reduced pressure to give thick paste h;
(3) thick paste h is dried under reduced pressure, makes into solid, control moisture content≤8%, crushed, obtain water-soluble extract powder i;
F, it mixes
Take water solubility extract powder i mixing obtained by volatile oil clathrate compound e obtained by Radix Notoginseng powder a, step D obtained by step B and step E Uniformly, it sterilizes and disappears the pharmaceutical composition of rouge to get to the strong liver of object.
The third object of the present invention be achieved in that the strong liver disappear rouge pharmaceutical composition in be added and pharmaceutically may be used Clinical applicable dosage form, including but not limited to decoction, pill, particle, piece is made using conventional formulation technique in the auxiliary material of receiving Agent, capsule, mixture etc..
The fourth object of the present invention is achieved in that the disappear pharmaceutical composition of rouge of the strong liver is prevented/controlled in preparation Treat the application in nonalcoholic fatty liver drug.
Radix Salviae Miltiorrhizae, Radix Notoginseng, curcuma zedoary, hawthorn are monarch in inventive formulation, and function is with phlegm reduction of blood circulation promoting;With Radix Astragali, green peel, radix paeoniae rubra, ginger Yellow, rhizoma alismatis is minister, there is the benefits of QI invigorating promoting flow of qi and blood circulation, dampness removing resolving sputum, further enhances the function of monarch drug in a prescription phlegm reduction of blood circulation promoting, chrysanthemum, lotus leaf, Radix Glycyrrhizae is that assistant is allowed to product.The kind current blood vessels of Radix Salviae Miltiorrhizae in monarch drug in a prescription, Radix Notoginseng function can removing blood stasis and hemostasis, curcuma zedoary breaking blood and promoting the circulation of qi, clearing stagnation and killing pain are preceding The benefits of three taste medicines are combined into monarch drug in a prescription promoting blood circulation effect by force, separately reuse hawthorn, and row digestion-promoting is turbid, promoting the circulation of qi resolving sputum, four medicines play phlegm reduction of blood circulation promoting altogether Therapy;Radix Astragali replenishes qi to invigorate the spleen in ministerial drug, and green peel is soothing the liver relieving stagnant Qi, disperse accumulationization are stagnant, then matches radix paeoniae rubra clearing heat and cooling blood, removing blood stasis and acesodyne, with The effect of rhizoma alismatis inducing diuresis for removing edema, eliminating dampness and resolving phlegm, turmeric blood-activating and qi-promoting, ventilation analgesic further enhance phlegm reduction of blood circulation promoting;Adjutant: chrysanthemum It clears liver and detoxifies, lotus leaf dampness removing rising Yang;Make medicine: Radix Glycyrrhizae, coordinating the drug actions of a prescription are invigorated the spleen and benefited qi, clearing heat and detoxicating.Make a general survey of the recipe more promoting blood circulation The stasis of blood, dampness removing resolving sputum, and give the benefits of medicines such as QI invigorating promoting the circulation of qi, clearing liver, dampness removing can consolidate phlegm reduction of blood circulation promoting and reach treatment The purpose of secondary illness is to shoot the arrow at the target, guides drugs to illness station for non-alcohol fatty liver syndrome of intermin-gled phlegm and blood stasis person.Entirely Not only principal and subordinate is orderly for square monarch, but also Each performs its own functions, can guide drugs to illness station, also make overall plans, and disappears for phlegm reduction of blood circulation promoting, promoting the circulation of qi turbid good Side.
The invention has the following advantages:
1, blood lipid can be reduced more significantly in the deposition of liver and improves liver function, to prevent and treat fatty liver.
2, oxidative stress-lipid peroxidation injury in liver cell can be effectively inhibited, fatty liver pathological change is significantly improved;Its Mechanism of action may deposit in liver by reducing lipid and mitigate peroxide injury improvement fatty liver.
3, non-alcohol fatty liver can effectively be treated, it is particularly possible to improve its insulin resistance, can also reduce Alanine aminotransferase, Aspartate aminotransferase, gamma glutamyltransferase, triglycerides, total cholesterol, low-density Lipoprotein cholesterol, waistline, weight, constitutional index are horizontal, improve syndrome of qi stagnation and blood stasis symptom.
4, after treating 24 weeks, patient ALT, TBiL, TC, TG be decreased significantly, and have significant difference before and after treatment.Treatment The judgement of front and back comprehensive therapeutic effect, effective 32 account for 64%, and effective 11 account for 22%, total effective rate 86%.
5, acute toxicity very little can not measure the LD50 of inventive formulation by gastric infusion, be given with the daily maximum of mouse Dose, which is that 400g/kg is equivalent, to be calculated, and 156 times for being adult clinical daily dosage, inventive formulation group mouse has no that other are abnormal anti- It answers.Prove inventive formulation clinical application safety.
Specific embodiment
Below with reference to embodiment, the present invention is further illustrated, but the present invention is limited in any way, Based on present invention teach that it is made it is any transform or replace, all belong to the scope of protection of the present invention.
The disappear pharmaceutical composition of rouge of strong liver of the present invention includes 10~20 parts of the Radix Salviae Miltiorrhizae of parts by weight of raw materials, Radix Notoginseng 3~7 Part, 10~20 parts of curcuma zedoary, 12~30 parts of hawthorn, 12~30 parts of Radix Astragali, 5~15 parts of green peel, 10~20 parts of radix paeoniae rubra, turmeric 10~20 Part, 10~20 parts of rhizoma alismatis, 10~20 parts of chrysanthemum, 10~20 parts of lotus leaf and 5~15 parts of Radix Glycyrrhizae crush, volatilization through pre-treatment, Radix Notoginseng Oil extract, inclusion essential oil, water-soluble medicinal extract extract and mixing and etc. be prepared.
The disappear pharmaceutical composition of rouge of the strong liver includes 13~17 parts of the Radix Salviae Miltiorrhizae of parts by weight of raw materials, 5~8 parts of Radix Notoginseng, cowherb 13~17 parts of art, 16~25 parts of hawthorn, 16~25 parts of Radix Astragali, 8~12 parts of green peel, 16~25 parts of radix paeoniae rubra, 13~17 parts of turmeric, pool 10~20 parts, 10~20 parts of chrysanthemum, 10~20 parts of lotus leaf and 5~15 parts of Radix Glycyrrhizae are rushed down, through pre-treatment, Radix Notoginseng crush, volatile oil mentions Take, inclusion essential oil, water-soluble medicinal extract extract and mixing and etc. be prepared.
Strong liver of the present invention disappear rouge pharmaceutical composition preparation method, including pre-treatment, Radix Notoginseng crush, volatile oil Extraction, inclusion essential oil, the extraction of water-soluble medicinal extract and mixing and etc., it specifically includes:
A, pre-treatment:
Selected medicinal material removes impurity;
B, Radix Notoginseng crushes
Take it is selected after Radix Notoginseng, 80 DEG C or less drying, crush, sieving, by be formulated needed for weight weighing, obtain Radix Notoginseng powder a;
C, volatile oil extracting
Take it is selected after the curcuma zedoary of formulation ratio, turmeric and green peel mixing, curcuma zedoary, turmeric and green peel total weight 2-5 is added Water again, steam distillation extract to obtain volatile oil b, extracting solution c and dregs of a decoction d;
D, inclusion essential oil
(1) volatile oil b obtained by step C is taken, 2-5 times of weight of volatile oil b of 95% ethyl alcohol is added to make to dissolve;
(2) beta cyclodextrin for weighing 5-15 times of weight of volatile oil b of gained, adds water that saturated solution is made;
(3) in the case of stirring, it is added dropwise to volatile oil ethanol solution into the water saturation solution of beta cyclodextrin, is wrapped It closes.Including temperature is 30-60 DEG C, and the inclusion time is 2-4 hours;
(4) inclusion solution sets 0-5 DEG C of refrigeration 8-12 hours, filters, and 50 DEG C or less dryings obtain volatile oil clathrate compound e;
E, water-soluble medicinal extract extracts
(1) by the resulting dregs of a decoction d of step C and it is selected after composition of raw materials proportion Radix Salviae Miltiorrhizae, hawthorn, Radix Astragali, radix paeoniae rubra, pool Rush down, chrysanthemum, lotus leaf and Radix Glycyrrhizae are mixed to get material f, water decoction 2-4 times of 8-10 times of weight of material f is added in material f, every time 1-3h, filtering, merging filtrate obtain material g;
(2) extracting solution c obtained by step C and step E (1) resulting material g is mixed, is concentrated under reduced pressure to give thick paste h;
(3) thick paste h is dried under reduced pressure, makes into solid, control moisture content≤8%, crushed, obtain water-soluble extract powder i;
F, it mixes
Take water solubility extract powder i mixing obtained by volatile oil clathrate compound e obtained by Radix Notoginseng powder a, step D obtained by step B and step E Uniformly, it sterilizes and disappears the pharmaceutical composition of rouge to get to the strong liver of object.
It is pulverized and sieved described in step B to crushed 100~200 meshes.
Sterilizing described in F-step is hot air sterilization, ultraviolet sterilization or microwave sterilization.
Strong liver of the present invention disappear rouge pharmaceutical composition preparation be the strong liver disappear rouge pharmaceutical composition in Pharmaceutically acceptable auxiliary material is added, using conventional formulation technique, is made clinical applicable dosage form, including but not limited to decoction, Pill, particle, tablet, capsule, mixture etc..
The disappear application of pharmaceutical composition of rouge of strong liver of the present invention is that the disappear pharmaceutical composition of rouge of the strong liver exists Prepare the application in preventing/treating nonalcoholic fatty liver drug.
Case is embodied, the present invention will be further described below:
Preparation method concrete operations are as follows:
Selected medicinal material removes impurity;Take it is selected after Radix Notoginseng, 80 DEG C or less drying, crush, sieving, by formula needed for weight Amount weighs, and obtains Radix Notoginseng powder a;Take it is selected after the curcuma zedoary of formulation ratio, turmeric and green peel mixing, curcuma zedoary, turmeric and green peel is added 2-5 times of total weight of water, steam distillation extract to obtain volatile oil b, extracting solution c and dregs of a decoction d;Volatile oil b is taken, volatile oil b is added 2-5 times of weight of 95% ethyl alcohol makes to dissolve;The beta cyclodextrin for weighing 5-15 times of weight of volatile oil b of gained adds water that saturation is made molten Liquid;In the case of stirring, it is added dropwise to volatile oil ethanol solution into the water saturation solution of beta cyclodextrin, is included.Inclusion temperature Degree is 30-60 DEG C, and the inclusion time is 2-4 hours;Inclusion solution sets 0-5 DEG C of refrigeration 8-12 hours, filters, 50 DEG C or less dryings, Obtain volatile oil clathrate compound e;By dregs of a decoction d and it is selected after composition of raw materials proportion Radix Salviae Miltiorrhizae, hawthorn, Radix Astragali, radix paeoniae rubra, rhizoma alismatis, chrysanthemum, Lotus leaf and Radix Glycyrrhizae are mixed to get material f, and 8-10 times of weight of material f of water is added in material f and decocts 2-4 times, each 1-3h, mistake Filter, merging filtrate obtain material g;Extracting solution c and material g is mixed, thick paste h is concentrated under reduced pressure to give;Thick paste h is dried under reduced pressure, Make into solid, control moisture content≤8%, crushes, obtain water-soluble extract powder i;Take Radix Notoginseng powder a, volatile oil clathrate compound e and water-soluble Property extract powder i be uniformly mixed, sterilize and disappear the pharmaceutical composition of rouge to get to the strong liver of object.
The strong liver disappear rouge pharmaceutical composition in pharmaceutically acceptable auxiliary material is added, using conventional formulation technique, Clinical applicable dosage form, including but not limited to decoction, pill, particle, tablet, capsule, mixture etc. is made.
Specific part case study on implementation chinese raw materials composition and corresponding parts by weight see the table below (unit: part):
Test example 1
The pharmaceutical composition being prepared respectively with 1~embodiment of embodiment 10 is carried out treatment fatty liver clinic respectively and seen It examines, specific as follows:
1, data and method
Case selection: 50 patients, wherein male 31, female 19, youngest person 21 years old, the maximum 62 years old, average year Age 43.6 ± 7.2 years old, 7.2 ± 5.4a of average course of disease (5~18a), there are hepatitis B medical history person 3, no history of virus hepatitis 47 has History of drinking history 28, overweight people 32,50 patients ALT >=48U/L, TBil≤50mmol/L, TC >=6.0mmol/L, TG >= 1.8mmol/L, B ultrasound prompt fatty liver, and all cases have different degrees of hepatic region dull pain, secret anguish or shouting pain, with fatigue and weakness, Abdominal distension gas, defecate uncomfortable person 26.
Treatment method: general treatment (1) is suitably rested, and the patient of ALT >=100U/L is based on resting, ALT≤100U/L Or after ALT is normal, appropriate exercise;(2) for diet based on low fat, low-carb, sugar is taken the photograph in control, mostly supplement fresh vegetables; (3) forbid drinking.50 patients give clothes decoction of the present invention on the basis of the above.
Observation index: before treatment, have a blood test respectively after 1 course for the treatment of routine, hepatic and renal function, blood lipid, B ultrasound.
Criterion of therapeutical effect: lipid-lowering effect is evaluated referring to the efficacy assessment standard of " Clinical Researches of New Drugs guideline ", that is, is combined Clinical symptoms, the comprehensive descisions such as liver function, blood lipid, B ultrasound.(1) effective: clinical symptoms disappear, and ALT, TBiL are normal, and TC decline >= 20% or TG40%;Liver B ultrasound shows that echo front is obviously weakened in liver, and rear portion decaying is substantially reduced, and pipe-line system trend is clear Clear, it is not strong that liver kidney compares echo;(2) effectively: clinical symptoms improve, ALT, TBiL part restore, TC decline 10%~19% or TG decline 20%~39%, B ultrasound prompt fatty liver take a favorable turn;(3) invalid: not up to effective standard, liver B ultrasound do not improve.
2, treatment results
Pretherapy and post-treatment ALT, TBil and Blood Lipid situation are shown in Table 1.
The pretherapy and post-treatment liver function of table 1 and Blood Lipid compare
Itself compare before and after treatment, t is examined, P < 0.01.After treating 24 weeks, patient ALT, TBiL, TC, TG have obviously Decline, there is significant difference (P < 0.01) before and after treatment.Pretherapy and post-treatment comprehensive therapeutic effect judgement, effective 32 account for 64%, effective 11 Example accounts for 22%, total effective rate 86%.
Test example 2
Treatment qi stagnation and blood stasis type is carried out respectively with the pharmaceutical composition that 1~embodiment of embodiment 10 is prepared respectively NAFLD clinical test, specific as follows:
80 qi stagnation and blood stasis type NAFLD patients are selected to be randomly divided into two groups of (73 practical because midway case falls off, treatments Group 37, control group 36), treatment group takes orally the pharmaceutical composition (5g/ times, 3 times/d) that the embodiment of the present invention is prepared, right According to oral Hedan tablet (1.46g/ times, 3 times/d) is organized, the course for the treatment of is 3 months, observe pretherapy and post-treatment tcm syndrome, liver and spleen CT ratio, The change of liver B ultrasound, blood lipid, liver function Enzyme target.
As a result: (1) preferably (treatment group has the total effect of medicine composite for curing NAFLD that the embodiment of the present invention is prepared Efficiency is 81.1%;Control group effective percentage is that 58.3%), see the table below 2;
2 two groups of total effects of table compare [n (%)]
(2) treatment group is better than control group (treatment group 78.4% in terms of improving syndrome total effective rate;Control group 55.6%), Difference is statistically significant (P < 0.05), see the table below 3;
3 two groups of diseases of table improve total effective rate and compare (example)
Note: compared with the control group,*P < 0.05
(3) treatment group is better than control group (treatment group 62.2% in terms of improving Hepatic enzyme total effective rate;Control group 27.8%), difference is statistically significant (P < 0.05), see the table below 4;
4 two groups of table are improving Hepatic enzyme index, the efficient comparison of blood lipids index (example)
Note: compared with the control group,*P < 0.05
(4) treatment group in terms of improving blood lipid total effective rate compared with the control group, no significant difference (P > 0.05) 4, are shown in Table;
(5) treatment group is better than control group (treatment group 73.0% in terms of improving abdominal B-scan ultrasonography total effective rate;Control group 50.0%), difference is statistically significant (P < 0.05), see the table below 5;
5 two groups of improvement abdominal B-scan ultrasonography curative effects of table compare (example)
Note: compared with the control group,*P < 0.05
(6) treatment group in terms of increasing liver and spleen CT ratio compared with the control group, no significant difference (P > 0.05), It see the table below 6.
6 two groups of improvement abdominal CT curative effects of table compare (example)
Illustrate: due to being influenced by patient compliance, completing pretherapy and post-treatment liver and spleen CT ratio observation of curative effect example in our current research Number is less, and 17 in total, wherein treatment group 8, control group 9.
Conclusion: it is serious that the pharmaceutical composition that the embodiment of the present invention is prepared improves NAFLD patient's tcm syndrome, NAFLD Degree, liver function Enzyme target, blood lipids index effect are preferable, have preferable clinical efficacy to NAFLD;Improving liver enzyme Be better than Hedan tablet in terms of liver B ultrasound, clinical symptoms, in terms of improving liver and spleen CT ratio and blood fat with Hedan tablet curative effect Quite.
Inventor thinks the turbid three of liver depression, blood stasis, phlegm through the variation of the NAFLD interpretation of the cause, onset and process of an illness always.Liver controlling conveyance and dispersion can both be dredged Venting QI-blood body fluid, and can promote taste digestion.Rouge is turbid to be deposited on liver, influences the catharsis function of liver, first leads to depression and stagnation of QI, Blood is lost freely, and qi and blood stagnation is at the stasis of blood;Second the defeated cloth of body fluid is influenced, body fluid is stagnated turbid into phlegm;Three influence spleen and rise stomach drop, water Paddy is precise and tiny must not to go up defeated cardiopulmonary, and coke in perverse and unreasonable manner, metaplasia cream is turbid, is deposited on liver, and liver is caused further to be damaged.Therefore present invention knot This disease interpretation of the cause, onset and process of an illness and pathological characteristic are closed, proposes that disappearing with soothing the liver promoting the circulation of qi, activating microcirculation and removing stasis medicinal, lipid-loweringing turbid is that principle of reatment prevents and treats this disease, invention The strong liver that non-alcoholic fatty liver can be treated disappears rouge Chinese medicine preparation, by curcuma zedoary, turmeric, Radix Notoginseng, Radix Salviae Miltiorrhizae, radix paeoniae rubra, Radix Astragali Deng composition.Our cold, heat, warm and cool is used in combination, and tonification and purgation in combination, and giving consideration to both the incidental and fundamental is made a distinction between the important and the lesser one, up to fate blood, the stasis of blood dispel network it is logical the benefits of.
Modern research shows that contain curcumin in curcuma zedoary and turmeric, research confirm curcumin have anti-oxidant, lipid-loweringing, The effects of anti-hepatic fibrosis, and oil of zedoary turmeric also has the effects that good anti-liver cancer and anti-, improves microcirculation.Radix Notoginseng chief active object Matter is notoginseng triterpenes, has anti-aging, anti-oxidant, anti-fibrosis, effect for reducing fat.Radix Salviae Miltiorrhizae have improve liver local microcirculation, The effects of increasing hepatic blood flow, lipid-loweringing, can especially reduce TG;Radix Astragali has liver protection, norcholesterol effect.Research confirmation, this hair The bright pharmaceutical composition can effectively inhibit oxidative stress-lipid peroxidation injury in nutritional fatty liver rat hepatocytes, Significantly improve fatty liver pathological change;It can also be obviously improved hyperlipemia-fatty liver Liver Function simultaneously, reduce blood lipid And it can be effectively used to prevention and treatment hyperlipemia-fatty liver.Clinical trial confirmation, medicine composite for curing of the present invention NAFLD effect affirmative, wherein improving syndrome integral and total effective rate, improving liver function Enzyme target, the serious journey of fatty liver Degree aspect is better than Hedan tablet, similar with Hedan tablet curative effect in terms of improving blood lipid, liver and spleen CT ratio, and total effects are better than Hedan tablet, It is worthy of popularization.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims Variation is included within the present invention.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art The other embodiments being understood that.

Claims (9)

  1. The pharmaceutical composition of rouge 1. a kind of strong liver disappears, it is characterised in that the disappear pharmaceutical composition of rouge of the strong liver includes raw material weight Measure 10~20 parts of the Radix Salviae Miltiorrhizae of part, 3~7 parts of Radix Notoginseng, 10~20 parts of curcuma zedoary, 12~30 parts of hawthorn, 12~30 parts of Radix Astragali, green peel 5~ 15 parts, 10~20 parts of radix paeoniae rubra, 10~20 parts of turmeric, 10~20 parts of rhizoma alismatis, 10~20 parts of chrysanthemum, 10~20 parts of lotus leaf and Radix Glycyrrhizae 5 It~15 parts, is prepared through pre-treatment, extraction and post-processing step.
  2. The pharmaceutical composition of rouge 2. strong liver according to claim 1 disappears, it is characterised in that the strong liver disappears the drug of rouge Composition includes 13~17 parts of Radix Salviae Miltiorrhizae, 5~8 parts of Radix Notoginseng, 13~17 parts of the curcuma zedoary, 16~25 parts of hawthorn, Radix Astragali of parts by weight of raw materials 16~25 parts, 8~12 parts of green peel, 16~25 parts of radix paeoniae rubra, 13~17 parts of turmeric, 10~20 parts of rhizoma alismatis, 10~20 parts of chrysanthemum, lotus leaf It 10~20 parts and 5~15 parts of Radix Glycyrrhizae, is prepared through pre-treatment, extraction and post-processing step.
  3. The preparation method of the pharmaceutical composition of rouge 3. a kind of strong liver of any of claims 1 or 2 disappears, it is characterised in that including preceding place Reason, Radix Notoginseng crushing, volatile oil extracting, inclusion essential oil, the extraction of water-soluble medicinal extract and mixing and etc., it specifically includes:
    A, pre-treatment:
    Selected medicinal material removes impurity;
    B, Radix Notoginseng crushes
    Take it is selected after Radix Notoginseng, 80 DEG C or less drying, pulverize and sieve, by be formulated needed for weight weighing, obtain Radix Notoginseng powder a;
    C, volatile oil extracting
    Take it is selected after the curcuma zedoary of formulation ratio, turmeric and green peel mixing, 2-5 times of curcuma zedoary, turmeric and green peel total weight is added Water, steam distillation extract to obtain volatile oil b, extracting solution c and dregs of a decoction d;
    D, inclusion essential oil
    (1) volatile oil b obtained by step C is taken, 2-5 times of weight of volatile oil b of 95% ethyl alcohol is added to make to dissolve;
    (2) beta cyclodextrin for weighing 5-15 times of weight of volatile oil b of gained, adds water that saturated solution is made;
    (3) in the case of stirring, it is added dropwise to volatile oil ethanol solution into the water saturation solution of beta cyclodextrin, include To inclusion solution;
    (4) inclusion solution is set into 0-5 DEG C of refrigeration 8-12 hours, filtered, it is dry, obtain volatile oil clathrate compound e;
    E, water-soluble medicinal extract extracts
    (1) by the resulting dregs of a decoction d of step C and it is selected after composition of raw materials proportion Radix Salviae Miltiorrhizae, hawthorn, Radix Astragali, radix paeoniae rubra, rhizoma alismatis, chrysanthemum Flower, lotus leaf and Radix Glycyrrhizae are mixed to get material f, and 8-10 times of weight of material f of water is added in material f and decocts 2-4 times, each 1-3h, Filtering, merging filtrate obtain material g;
    (2) extracting solution c obtained by step C and step E (1) resulting material g is mixed, is concentrated under reduced pressure to give thick paste h;
    (3) thick paste h is dried under reduced pressure, makes into solid, control moisture content≤8%, crushed, obtain water-soluble extract powder i;
    F, it mixes
    Take water solubility extract powder i mixing obtained by volatile oil clathrate compound e obtained by Radix Notoginseng powder a, step D obtained by step B and step E equal It is even, it sterilizes and disappears the pharmaceutical composition of rouge to get to the strong liver of object.
  4. 4. preparation method according to claim 3, it is characterised in that pulverized and sieved described in step B to crushed 100 ~200 meshes.
  5. 5. preparation method according to claim 3, it is characterised in that the temperature of inclusion described in D step is 30-60 DEG C, Including the time is 2-4 hours.
  6. 6. preparation method according to claim 3, it is characterised in that the temperature of drying described in D step be 50 DEG C with Under.
  7. 7. preparation method according to claim 3, it is characterised in that sterilizing described in F-step is hot air sterilization, ultraviolet Sterilizing or microwave sterilization.
  8. The preparation of the pharmaceutical composition of rouge 8. a kind of strong liver of any of claims 1 or 2 disappears, it is characterised in that the strong liver disappears Decoction, pill, particle, tablet, capsule or the mixture of pharmaceutically acceptable auxiliary material preparation are added in the pharmaceutical composition of rouge.
  9. The application of the pharmaceutical composition of rouge 9. a kind of strong liver of any of claims 1 or 2 disappears, it is characterised in that the strong liver disappears The pharmaceutical composition of rouge is preparing the application in preventing/treating nonalcoholic fatty liver drug.
CN201811599554.2A 2018-12-26 2018-12-26 A kind of strong liver disappears pharmaceutical composition and preparation method thereof, preparation and the application of rouge Pending CN109589391A (en)

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Application publication date: 20190409