CN103191225A - Application of hedan preparation in preparation of medicine for preventing and treating lipid disorders - Google Patents
Application of hedan preparation in preparation of medicine for preventing and treating lipid disorders Download PDFInfo
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- CN103191225A CN103191225A CN2013101318040A CN201310131804A CN103191225A CN 103191225 A CN103191225 A CN 103191225A CN 2013101318040 A CN2013101318040 A CN 2013101318040A CN 201310131804 A CN201310131804 A CN 201310131804A CN 103191225 A CN103191225 A CN 103191225A
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Abstract
The invention relates to application of a hedan preparation in preparation of a medicine for preventing and treating lipid disorders. The hedan preparation adopts lotus leaves as the main medicine and adopts lotus leaves, red-rooted salvia roots, hawthorns, folium sennae and fructus psoraleae as the prescription medicines; the hedan preparation has the functions of reducing phlegm and descending the turbid and promoting blood circulation to remove blood stasis, and is clinically used for a patient with hyperlipemia phlegm stagnation symptoms. According to the research and the accidental discoveries, the hedan preparation has the effect of preventing and treating lipid disorders.
Description
Technical field
The present invention relates to the application of Chinese medicinal formulae, particularly the lotus pellet preparation is in preparation prevention and the application for the treatment of in the blood fat disorder medicine.
Technical background
Metabolism disorder of blood lipid refers generally to that cholesterol in serum (TC), triglyceride (TG) and low density lipoprotein, LDL (LDL) raise unusually and/or the unusual reduction of high density lipoprotein (HDL), and the situation severe patient is called hyperlipemia or hyperlipidemia clinically.International and the domestic diagnostic criteria of still not having unified hyperlipemia at present, domestic generally with the adult on an empty stomach serum total cholesterol surpass 5.72 mMs/liter, triglyceride above 1.70 mMs/liter, be diagnosed as hyperlipemia.
Thought all in the past that blood fat disorder and hyperlipemia mainly betided middle-aged and elderly people, yet many epidemiological studies show in recent years, blood fat disorder has started from child and teenager.Particularly blood fat disorder often just can take place in Fei Pang child and teenager before 10 years old, and its health check-up data generally do not reach the diagnostic criteria of hyperlipemia, but physical presence elevated cholesterol in the blood.Child's blood fat disorder can also reverse in early days, often just is difficult to reverse but enter the later stage.Therefore, prevent child and teen-age blood fat disorder early, and it is carried out early intervention, carries out prevention and Drug therapy, just can control its dyslipidemia level effectively, prevent that its differentiation from becoming hyperlipemia.
The clinical epidemiology result of study shows, though fat-reducing medicament commonly used such as Statins, the special class of shellfish all have certain regulating action to HDLC in theory at present, practical application is not ideal enough mostly, even can produce retroaction.DYSIS-Spain Study research is a polycentric cross-sectional study, estimates the plasma lipid profile after cardiovascular patient is accepted statin treatment, and statin treatment is after 3 months, 2273 high-risk cardiovascular patients, and a kind of metabolism disorder of blood lipid appears in 78.9% patient at least.Obviously not the medicine of desirable blood fat disorder.
Hedan tablet is principal agent with the Folium Nelumbinis, and the circulation of qi promoting damp eliminating cooperates Fructus Crataegi to regulate the flow of vital energy to help digestion, Folium Sennae loosening bowel to relieve constipation and resolving phlegm lowering turbidity, with Fructus Psoraleae temperature compensation Liver and kidney, and the Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, clinical in hyperlipemia.Through clinical verification Hedan tablet highly effective and safe, hepatic and renal function there is not influence, can take for a long time.The present invention finds unexpectedly that through research the lotus pellet preparation has prevention and treatment to metabolism disorder of blood lipid.
Summary of the invention
The object of the present invention is to provide a kind of lotus pellet preparation in preparation prevention and the application for the treatment of in the blood fat disorder medicine.Lotus pellet preparation of the present invention is to make (consumption is weight portion) by following Chinese medicinal raw materials medicine:
Folium Nelumbinis: 30-90 part Radix Salviae Miltiorrhizae: 5-20 part Fructus Crataegi: 15-60 part Folium Sennae: 2-4 part Fructus Psoraleae: 5-20 part.
Preferred proportioning (consumption is weight portion) is as follows:
Folium Nelumbinis: 60 parts of Radix Salviae Miltiorrhizaes: 10 portions of Fructus Crataegis: 30 portions of Folium Sennae: 3 parts of Fructus Psoraleaes: 10 parts.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, can be unit with the kilogram as large-scale production, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, be raw material with this material, add the medicine acceptable carrier when needing, make according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by common extraction raw material of Chinese medicine, also can obtain by other means, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the Chinese medicine preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form refers to the unit of preparation, as every of tablet, and every capsules of capsule, every bottle of oral liquid, every bag of granule etc.
Chinese medicine preparation of the present invention can be to appoint the pharmaceutically useful dosage form of lotus, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc.Most preferably tablet, capsule.
Chinese medicine preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
Following data declaration beneficial effect of the present invention by experiment:
Experiment purpose: setting up on the rat fat disorders model basis, observe the rat fat level of He Dan, oxidation resistance, the mRNA of liver low density lipoprotein receptor (LDLR) and the influence of aspects such as protein level and function, inquire into the effect molecular mechanism that He Dan regulates the lipid metabolism in rats disorder.
1. experiment material
1.1 laboratory animal
60 of health SD rats in 6 age in week, 200 ± 2g, male and female half and half are all purchased in the Zhejiang Academy of Medical Sciences Experimental Animal Center.Through adapting to laboratory condition after 1 week, be divided into 6 groups at random: the normal control group, feed normal diet; Model control group is fed high lipid food; The red experimental group of the lotus of 3 dosage and positive controls be the feeding high lipid food also, and irritates stomach respectively and give Hedan tablet and (be respectively 5,10 and 20mgkg
-1) and ginkgetin sheet (10mgkg
-1), once a day, continuous 8 weeks.Simultaneously, normal control group and model control group are irritated stomach respectively and are given equal-volume NS.
1.2 feedstuff
Normal feedstuff is formed (%): standard flour 36, Semen Maydis flour 35, wheat bran 15, bean flour 10, cod-liver oil 1, yeast powder 1, fishbone powder 1, salt 1.Normal feedstuff accounts for 88.30-/0 in the high fat high cholesterol diet, and Adeps Sus domestica accounts for 100-/0, and cholesterol accounts for 1.5%, and cholate accounts for 0.2%.
1.3 sample treatment
After the pentobarbital anesthesia.The femoral artery blood sampling, anticoagulant heparin is measured blood fat, superoxide dismutase (SOD) and malonaldehyde (MDA).Get liver, liquid nitrogen freezing ,-70 ℃ of preservations by no RNA ase operation.Get liver and measure SOD and MDA.
1.4 testing index and method
1.4.1 lipid determination: T-CHOL (TC), triglyceride (TG), LDL-C (LDL-C), highdensity lipoprotein-cholesterol (HDL-C), ApoAl and ApoB are with giving birth to biological reagent company kit measurement in Beijing.
1.4.2 blood and liver SOD, MDA and whole blood glutathion peroxidase (GSH-Px) determination of activity: SOD xanthine oxidase, MDA are pressed the thiobarbituricacid method and are measured; GSH-Px presses the DTNB colorimetric method for determining.
1.4.3 rat liver RNA extracts and reverse transcription-polymerase chain reaction (RT-PCR) amplification: with TRIZOL@Reagent(Gibco BRL product) the total RNA of extraction rat liver; With Super Script Preamplification System(CibcoBRL product) carry out RT-PCR.
1.4.4 rat liver LDLR Protein Detection: extract the rat liver epicyte protein, carry out protein quantification with Coomassie brilliant blue G-250 staining, primary antibodie is the anti-Mus LDLRlgG(Amsham of rabbit product); Two anti-are goat-anti rabbit lgG(Beijing Zhong Shan biotech company product), other reagent is Promega company product.
1.4.5 rat liver LDLR functional examination: the preparation rat liver homogenate, LDL(Sigma company) and liver homogenate press Lowrv standard measure protein content.Rat liver homogenate with
125I_LDL association reaction liquid cumulative volume is totally 200 μ l, hatches 120min respectively for 4 ℃, gets 90 μ l and adds on the cellulose acetate film and filter, and buffer is washed film 8 times, surveys the radioactivity of film at the γ calculating instrument.
1.5 statistical analysis: carry out variance analysis with SAS (6.12 editions), relatively check with Tukey between two groups.
2. experimental result
2.1 rat fat changes
Each blood lipids index of rat that gives He Dan when feeding high lipid food is clearly better.In the lotus pellet, TG, the TC of heavy dose of experimental group rat and LDL-C level maintain 73.2,86.4 respectively, 51.7mg100ml
-1With 67.2,84.0,47.5mg100ml
-1, compare model group and obviously descend.The red experimental group of lotus (10 and 20mgkg
-1D
-1) the HDL-C level of rat is elevated to 48.6 and 50.5mg100ml respectively
-1, compare model group HDL-C level and only be 33.8mg100ml
-1, difference tool significance.See the following form:
2.2 rat erythrocyte and liver MDA and SOD and blood GSH-Px activity change:
Normal control group and each experimental group rat blood serum and liver MDA content are starkly lower than model control group.And erythrocyte and liver SOD, blood GSH-Px activity are significantly higher than model control group, and prompting lotus pellet can significantly strengthen the oxidation resistance of rat.See the following form:
2.3 the influence to rat LDLR genetic transcription and protein expression
The total RNA of rat hepatocytes is 35 pcr amplifications behind reverse transcription, and LDLR cDNA fragment is 340bp, and glyceraldehyde 3-phosphate dehydro-genase (GAPDH) cDNA fragment is 300bp, and the corresponding cDNA with designed is identical respectively.Fig. 1 normal control group as can be seen is significantly higher than model control group with each administration group LDLRmRNA level, and prompting lotus pellet can prevent that rat liver LDLR gene expression from descending.
Confirmed the effect ((Fig. 2) of specific antibody to liver cell LDLR albumen with Western Blot.
1, dosage group 5, the red high dose group 6 of lotus, positive controls in normal control group 2, model control group 3, the red low dose group 4 of lotus, the lotus pellet
The protein band of antibodies is shown as about 140ku at the SDS-PAGE electrophoresis.Normal control group and each experimental group LDLR albumen abundance are significantly higher than model control group, illustrate that high fat high cholesterol diet can significantly suppress the expression of rat liver LDLR albumen, and the lotus pellet can prevent that rat liver LDLR gene expression from descending.Each mRNA level and protein content of organizing rat liver cell LDLR is the collimation variation, proposes the LDLR expression and may depend primarily on the mRNA level.See Fig. 3:
2.4 the function regulating action to LDLR:
From following table as can be seen the maximum combined power Bmax of normal control group and each administration group rat liver cell membrane LDLR and LDL be significantly higher than model control group, and the Kd value no significant difference of each group, propose the activity that He Dan has obviously strengthened rat liver LDLR, but the affinity of receptor does not change obviously.
| ? | Bmax | Kd |
| Normal control | 90.29±1.98 | 23.46±1.31 |
| The model contrast | 57.65±4.56 | 24.42±4.82 |
| The red low dosage of lotus | 81.24±4.35 | 24.84±3.29 |
| Dosage in the lotus pellet | 86.87±5.04 | 26.82±3.70 |
| The red high dose of lotus | 85.31±5.10 | 26.47±3.79 |
| Positive control | 78.18±4.89 | 24.54±3.81 |
Conclusion: feed high fat high cholesterol diet rat LDLR active reduction in this research, and the level of serum LDL-C and ApoB has raise, existing studies confirm that not is because ApoB is synthetic, the secretion increase, but because LDLR expresses to reduce blood lipid metabolism taken place unusually.He Dan has significantly increased
125I_LDL is combined with liver plasma membrane LDLR, and namely Bmax raises, and to analyze the LDLR increased functionality be not owing to the rising of LDL and LDLR affinity but due to the LDLR number increases from Kd value.
He Dan raises erythrocyte and liver SOD, blood GSH-Px activity in this research, opposite with the liver MDA changes of contents with serum, the antioxidation that shows He Dan is not only owing to contain the direct effect of reducing substanceses such as flavone, the more important thing is to work by the activity that strengthens the antioxidase system.
In sum, LDLR is active to be taken place with raising oxidation resistance prevention blood fat disorder He Dan by strengthening.
Description of drawings
Each group of Fig. 1 is to the influence of rat LDLR genetic transcription and protein expression
Fig. 2 has confirmed the effect of specific antibody to liver cell LDLR albumen with Western Blot
1, dosage group 5, the red high dose group 6 of lotus, positive controls in normal control group 2, model control group 3, the red low dose group 4 of lotus, the lotus pellet
Fig. 3 respectively organizes LDLR and expresses the mRNA level that depends primarily on
The specific embodiment
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1:
Medicine of the present invention is to be made by following component
Folium Nelumbinis: 7500g Radix Salviae Miltiorrhizae: 1250g Fructus Crataegi: 3750g Folium Sennae: 375g Fructus Psoraleae: 1250g
The above five tastes, Folium Sennae each 30 minutes, merges soak, filtration, filtrate for later use with 90 ℃ of hot-water soaks three times; Radix Salviae Miltiorrhizae powder is broken into coarse powder, extracts 1.5 hours with alcohol heating reflux, filter, and filtrate recycling ethanol, standby; Folium Nelumbinis, Fructus Psoraleae, Fructus Crataegi and Radix Salviae Miltiorrhizae decoction dregs decoct with water secondary, and each 2 hours, decocting liquid filtered, and filtrate merges, being evaporated to relative density is 1.20(60 ℃), place, when treating that fluid temperature is down to about 40 ℃, add the ethanol of 2 times of amounts, stir evenly, left standstill 48 hours, get supernatant, filter, filtrate recycling ethanol merges with above-mentioned Radix Salviae Miltiorrhizae ethanol extract, is concentrated in right amount spray drying, add an amount of adjuvant, mixing is made granule, be pressed into 1000, the bag film-coat, namely.
Embodiment 2:
Medicine of the present invention is to be made by following component
Folium Nelumbinis: 3750g Radix Salviae Miltiorrhizae: 625g Fructus Crataegi: 1875g Folium Sennae: 187.5g Fructus Psoraleae: 625g
The above five tastes, Folium Sennae is cleaned, with 90 ℃ of hot-water soaks of 10 times of amounts three times, each 30 minutes, merge three times medicinal liquid, filter filtrate for later use; Radix Salviae Miltiorrhizae powder is broken into coarse powder, with 3 times of amount 95% alcohol heating reflux 1.5 hours (65 ℃), filters, and filtrate recycling ethanol gets the Radix Salviae Miltiorrhizae ethanol extract, and is standby; Folium Nelumbinis, Fructus Psoraleae, Fructus Crataegi and Radix Salviae Miltiorrhizae decoction dregs add 10 times of water gagings and decoct 2 times, and each 2 hours, decocting liquid filtered, filtrate and Folium Sennae filtrate merge, and being evaporated to relative density is 1.20(60 ℃), place, treat that fluid temperature is down to about 40 ℃, add 2 times of amount 95% ethanol, stir evenly, left standstill 48 hours, get supernatant, filter, reclaim ethanol, merge with above-mentioned Radix Salviae Miltiorrhizae ethanol extract, being evaporated to relative density is 1.30(60 ℃) thick paste, drying under reduced pressure (60-70 ℃) is pulverized, and adds starch 48g, magnesium stearate 1.6g, mixing, incapsulate, make 1000, namely.
Claims (8)
1. the lotus pellet preparation is in preparation prevention and the application for the treatment of in the blood fat disorder medicine.
2. according to the application of claim 1, it is characterized in that described lotus pellet preparation is to be made by following Chinese medicinal raw materials medicine:
Folium Nelumbinis: 30-90 part Radix Salviae Miltiorrhizae: 5-20 part Fructus Crataegi: 15-60 part Folium Sennae: 2-4 part Fructus Psoraleae: 5-20 part.
3. according to the application of claim 1, it is characterized in that described lotus pellet preparation is to be made by following Chinese medicinal raw materials medicine:
Folium Nelumbinis: 60 parts of Radix Salviae Miltiorrhizaes: 10 portions of Fructus Crataegis: 30 portions of Folium Sennae: 3 parts of Fructus Psoraleaes: 10 parts.
4. according to the application of claim 1, it is characterized in that described lotus pellet preparation is any pharmaceutically useful dosage form.
5. according to the application of claim 1, it is characterized in that described lotus pellet preparation is selected from tablet, capsule, oral liquid, sucks agent, granule, pill, powder, unguentum, sublimed preparation, suspensoid, powder, injection, suppository, ointment, plaster, cream, spray, drop, patch.
6. according to the application of claim 1, it is characterized in that described lotus pellet preparation is preferably tablet, capsule.
7. according to the application of claim 1, it is characterized in that described application is that the lotus pellet preparation can be used for prevention and treatment blood fat disorder.
8. according to the application of claim 1, it is characterized in that described blood fat disorder especially refers to not reach as yet the blood fat disorder of the diagnostic criteria of hyperlipemia.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103655791A (en) * | 2013-12-12 | 2014-03-26 | 南昌济顺制药有限公司 | Lotus leaf-based preparation for treating phlegm and blood stasis simultaneously and application thereof |
| CN103705594A (en) * | 2013-12-12 | 2014-04-09 | 南昌济顺制药有限公司 | Traditional Chinese medicine composition for treating hyperlipidemia and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101708236A (en) * | 2009-12-14 | 2010-05-19 | 南昌济顺制药有限公司 | Application of Hedan tablet in treating fatty liver |
-
2013
- 2013-04-16 CN CN2013101318040A patent/CN103191225A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101708236A (en) * | 2009-12-14 | 2010-05-19 | 南昌济顺制药有限公司 | Application of Hedan tablet in treating fatty liver |
Non-Patent Citations (1)
| Title |
|---|
| 郭玉岩等: "荷丹片治疗2型糖尿病合并脂代谢紊乱疗效观察", 《实用糖尿病杂志》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103655791A (en) * | 2013-12-12 | 2014-03-26 | 南昌济顺制药有限公司 | Lotus leaf-based preparation for treating phlegm and blood stasis simultaneously and application thereof |
| CN103705594A (en) * | 2013-12-12 | 2014-04-09 | 南昌济顺制药有限公司 | Traditional Chinese medicine composition for treating hyperlipidemia and preparation method thereof |
| CN103655791B (en) * | 2013-12-12 | 2016-11-23 | 南昌济顺制药有限公司 | A kind of lotus leaf-based preparation for treating phlegm and blood stasis simultaneously and application thereof |
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Application publication date: 20130710 |