CN105616481A - Chinese and western medicine preparation with blood fat reducing function and preparation method thereof - Google Patents
Chinese and western medicine preparation with blood fat reducing function and preparation method thereof Download PDFInfo
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- CN105616481A CN105616481A CN201610121158.3A CN201610121158A CN105616481A CN 105616481 A CN105616481 A CN 105616481A CN 201610121158 A CN201610121158 A CN 201610121158A CN 105616481 A CN105616481 A CN 105616481A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/482—Cassia, e.g. golden shower tree
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/455—Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Natural Medicines & Medicinal Plants (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a Chinese and western medicine preparation with a blood fat reducing function and a preparation method thereof. The Chinese and western medicine preparation comprises effective ingredients and pharmaceutic adjuvants. The effective ingredients comprise, by weight, 1-5 parts of lovastatin, 20-30 parts of niacin and 40-60 parts of cassia seed alcohol extract. According to the Chinese and western integrated medicine preparation, hyperlipemia can be well relieved, adverse reactions can be reduced, and the treatment effect is superior to that of a current commercially-available niacin and lovastatin sustained-release preparation.
Description
Technical field
The present invention relates to pharmaceutical field, particularly the chinese-western medicine preparation of a kind of reducing blood-fat.
Background technology
Hyperlipidaemia refers to a kind of whole body Anomalous lipid metablism that cholesterol in serum (TC), tri-glyceride (TG) and (or) low-density lipoprotein (LDL) are too high and (or) serum high-density LP (HDL) is too low. In recent years, no matter cardiovascular disorder is as a class disease of serious harm humans health, sickness rate and mortality ratio are all the situation that obviously rises, in China, cardiovascular and cerebrovascular diseases incidence is up to 8%, mortality ratio, close to the 50% of general mortality rate, on average just has a people dead because of cardiovascular and cerebrovascular diseases for every 20 minutes. Cardiovascular and cerebrovascular diseases mainly comes from atherosclerosis, and the atherosclerosis of more than 80% is caused by hyperlipidaemia. According to investigation, 15-69 year was done in the crowd of lipid examination, and hyperlipidaemia person accounts for 40%. A large amount of research data shows, hyperlipidaemia is cerebral apoplexy, coronary heart disease, myocardial infarction, cardiac sudden death independently important Hazard Factor. In addition, hyperlipidaemia is also the important risk factor promoting hypertension, impaired glucose tolerance, diabetes. Hyperlipidaemia also can cause fatty liver, liver cirrhosis, cholelithiasis, pancreatitis, retinal hemorrhage, blind, peripheral vascular disease, limping, hyperuricemia. Also can there is the symptom such as xanthoma, arcus juvenilis around tendon shape, nodositas, palm plane and eye socket in some primary and familial hyperlipidemia patient. 20 for many years, is confirmed by many clinical trials of coronary heart disease two grades He primary prevention, reduces serum LDL cholesterol (LDL-C) and can significantly reduce incidence of cardiovascular disease, case fatality rate and general mortality rate.
Research and development combination of Chinese tradiational and Western medicine medicine reduces hyperlipidemia at present a lot, but respectively has superiority and respectively have deficiency, so can better reduce hyperlipidaemia can reduce again untoward reaction. Product has its huge social value and economic worth.
Summary of the invention
For solving the problem, it is an object of the invention to provide a kind of reducing blood-fat chinese-western medicine preparation, it can better reduce hyperlipidaemia, can reduce again untoward reaction, super quality and competitive price.
Present invention also offers the preparation method of above-mentioned chinese-western medicine preparation.
The object of the present invention is achieved like this: a kind of reducing blood-fat chinese-western medicine preparation, comprise effective constituent and pharmaceutical excipient, it is characterized in that: calculate by weight, effective constituent comprises following component: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts.
Preferably, calculating by weight, effective constituent comprises following component: lovastatin 1��3 part, 22��28 parts, nicotinic acid, Semen Cassiae alcohol extract 44��56 parts.
Optimum, calculating by weight, effective constituent comprises following component: lovastatin 2 parts, 24 parts, nicotinic acid, Semen Cassiae alcohol extract 50 parts.
Described reducing blood-fat chinese-western medicine preparation formulation is tablet.
Described tablet is slow releasing tablet.
The preparation method of a kind of reducing blood-fat chinese-western medicine preparation, it is characterised in that comprise the following steps: lovastatin and nicotinic acid, Semen Cassiae alcohol extract are sieved by (1); (2) by nicotinic acid, Semen Cassiae alcohol extract and auxiliary material mixing granulation; (3) compressing tablet, obtains sheet core; (4) dressing, after being distributed in coating liquid by lovastatin, carries out the obtained tablet of dressing to sheet core, and the effective constituent in every sheet tablet is calculated as by weight: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts.
The preparation method of described Semen Cassiae alcohol extract: (1) depends on that pine torch adds the 40-60% ethanol of 8-12 times amount; Infiltrate 30-90 minute; (2) 50-70 DEG C of lixiviate 2-3 hour; (3) vat liquor is filtered; (4) being evaporated to relative density is 1.10-1.30; (5) centrifugal; (6) spraying dry.
The present invention is Chinese and Western bound drug preparation, can better reduce hyperlipidaemia, can reduce again untoward reaction, and curative effect is better than nicotinic acid commercially available at present and Lovastatin sustained-release agent.
Accompanying drawing explanation
Fig. 1 is the preparation flow figure of preparation of the present invention.
Embodiment
The present invention is a kind of reducing blood-fat chinese-western medicine preparation, comprises effective constituent and pharmaceutical excipient, it is characterised in that: calculating by weight, effective constituent comprises following component: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts.
Preferably, calculating by weight, effective constituent comprises following component: lovastatin 1��3 part, 22��28 parts, nicotinic acid, Semen Cassiae alcohol extract 44��56 parts.
Optimum, calculating by weight, effective constituent comprises following component: lovastatin 2 parts, 24 parts, nicotinic acid, Semen Cassiae alcohol extract 50 parts.
By adding Semen Cassiae alcohol extract, (Semen Cassiae alcohol extract contains Schuttgelb glucoside, Schuttgelb anthrone, rheochrysidin etc. and falls fat composition in the present invention, because it has catharsis effect, enteron aisle can be reduced and to the absorption of cholesterol and increase excretion, by feedback regulation low-density lipoprotein metabolism, thus reduce serum cholesterol level. ), (lovastatin is a kind of HMG-CoA reductase inhibitor with lovastatin, the synthesis of endogenous cholesterol can be stoped, reduce low density in blood, extra-low density and intermediate density lipoprotein (LDL, VLDL, TDL), energy is high density lipoprotein increasing (HDL) slightly), (nicotinic acid becomes nicotine urine purine dinucleotides in body internal conversion to nicotinic acid under NAD coenzyme systemic effect, low density in blood can be reduced, extra-low density and intermediate density lipoprotein (LDL, VLDL, TDL), energy is high density lipoprotein increasing (HDL) slightly) there is synergistic effect, clinical test results, its lipid-lowering effect is very good, is better than any one of marketed drugs, and side effect does not increase.
Semen Cassiae alcohol extract can adopt commercial goods, it is also possible to obtains by following preparation method: (1) depends on that pine torch adds the 40-60% ethanol of 8-12 times amount; Infiltrate 30-90 minute; (2) 50-70 DEG C of lixiviate 2-3 hour; (3) vat liquor is filtered; (4) being evaporated to relative density is 1.10-1.30; (5) centrifugal; (6) spraying dry.
Medicine of the present invention can be prepared into corresponding formulation by the common process of pharmaceutics and auxiliary material, such as capsule or tablet etc., it is preferable to tablet. The preparation method of tablet comprises the following steps: lovastatin and nicotinic acid, Semen Cassiae alcohol extract are sieved by (1); (2) by nicotinic acid, Semen Cassiae alcohol extract and auxiliary material mixing granulation; (3) compressing tablet, obtains sheet core; (4) dressing, after being distributed in coating liquid by lovastatin, carries out the obtained tablet of dressing to sheet core, and the effective constituent in every sheet tablet is calculated as by weight: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts. Gained tablet is slow releasing tablet.
Below in conjunction with concrete example, the present invention is further explained, but the present invention is not limited to this specific examples.
Embodiment 1
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 2 parts, 24 parts, nicotinic acid, Semen Cassiae alcohol extract 50 parts.
Preparation method is as shown in Figure 1:
(1) pre-treatment: main medicine lovastatin 2Kg and nicotinic acid 24Kg, Semen Cassiae alcohol extract (are depended on pine torch times amount 50% ethanol that adds 10; Infiltrate 1 hour; 60 DEG C of lixiviates 2.5 hours; Filter vat liquor; Being evaporated to relative density is 1.20; Centrifugal (rotating speed 15000��20000r/ minute); Spraying dry. ) 50Kg crosses No. 7 sieves. Auxiliary material HPMC (HPMC) 5Kg, PVPK905Kg, stearic acid 0.7Kg cross No. 7 sieves respectively.
(2) nicotinic acid tablet slug particle preparation: the HPMC (i.e. 1.5Kg) getting nicotinic acid, Semen Cassiae alcohol extract, PVPK90 and 30% recipe quantity, mixes, as powder mix, granulate with water. Wet grain puts 60 DEG C of air seasonings, and dry particle adds stearic acid after sieving whole grain through No. 2, mixed even.
(3) compressing tablet: compressing tablet, tablet hardness controls at 50��60N.
(4) preparation of coating liquid: get residue HPMC3.5Kg, poly(oxyethylene glycol) 400 1.5Kg and tween 80 0.2L, be dissolved in 60% ethanol 50L, and grind titanium dioxide 2Kg with this liquid, obtain blank coating liquid.
(5) dressing: get sheet core and weigh, put into coating pan, temperature controls at 40 �� 2 DEG C, carries out pre-bag several minutes, is distributed in coating liquid by the lovastatin crossing No. 7 sieves, sprays into coating liquid continuously, sprayed to coating liquid.
Embodiment 2
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 1 part, 22 parts, nicotinic acid, Semen Cassiae alcohol extract 44 parts.
Preparation method is as shown in Figure 1.
Embodiment 3
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 3 parts, 28 parts, nicotinic acid, Semen Cassiae alcohol extract 56 parts.
Preparation method is as shown in Figure 1.
Embodiment 4
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 1 part, 20 parts, nicotinic acid, Semen Cassiae alcohol extract 40 parts.
Preparation method is as shown in Figure 1.
Embodiment 5
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 5 parts, 30 parts, nicotinic acid, Semen Cassiae alcohol extract 60 parts.
Preparation method is as shown in Figure 1.
Embodiment 6
Effective constituent in every sheet tablet is calculated as by weight: lovastatin 4 parts, 25 parts, nicotinic acid, Semen Cassiae alcohol extract 55 parts.
Preparation method is as shown in Figure 1.
Simultaneous test
1 physical data
Choose hyperlipemia patient 100 example at random. Wherein man 57 example, female 43 example. 39��69 years old age, year mean age (54 �� 3.4). All patients all through the doctor diagnosed of specialty, make a definite diagnosis as hyperlipidaemia. The patient participating in experiment did not take any medicine that can affect blood lipid metabolism in the time having tested first two weeks.
2 methods
The 100 example patients with choosing are divided into first group, second group at random. First group is by medicine of the present invention, and second group is Advicor (nicotinic acid and Lovastatin sustained-release agent; 500mg/20mg). First group patient takes the medicine obtained by the embodiment of the present invention 1; Second group patient takes Advicor, and usage is 1/d, accepts the treatment of 28 days by a definite date. Observe patient's cholesterol, triacylglycerol, the content situation of low density lipoprotein cholesterol.
3 results
Medicine lipid-lowering effect of the present invention is remarkable, can effectively improve the blood lipid level of hyperlipidemia patient; And curative effect is better than commercial like product, data compare in Table 1-table 3.
Table 1 liang group patient's comparitive study (n)
Table 2 liang group patient treatment before blood lipids index compare (mmol/L)
Table 3 liang group patient treatment after blood lipids index compare (mmol/L)
Claims (7)
1. a reducing blood-fat chinese-western medicine preparation, comprises effective constituent and pharmaceutical excipient, it is characterised in that: calculating by weight, effective constituent comprises following component: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts.
2. reducing blood-fat chinese-western medicine preparation according to claim 1, it is characterised in that: calculating by weight, effective constituent comprises following component: lovastatin 1��3 part, 22��28 parts, nicotinic acid, Semen Cassiae alcohol extract 44��56 parts.
3. reducing blood-fat chinese-western medicine preparation according to claim 1, it is characterised in that: calculating by weight, effective constituent comprises following component: lovastatin 2 parts, 24 parts, nicotinic acid, Semen Cassiae alcohol extract 50 parts.
4. reducing blood-fat chinese-western medicine preparation according to claim 1,2 or 3, it is characterised in that: described reducing blood-fat chinese-western medicine preparation formulation is tablet.
5. reducing blood-fat chinese-western medicine preparation according to claim 4, it is characterised in that: described tablet is slow releasing tablet.
6. the preparation method of a reducing blood-fat chinese-western medicine preparation, it is characterised in that comprise the following steps: lovastatin and nicotinic acid, Semen Cassiae alcohol extract are sieved by (1); (2) by nicotinic acid, Semen Cassiae alcohol extract and auxiliary material mixing granulation; (3) compressing tablet, obtains sheet core; (4) dressing, after being distributed in coating liquid by lovastatin, carries out the obtained tablet of dressing to sheet core, and the effective constituent in every sheet tablet is calculated as by weight: lovastatin 1��5 part, 20��30 parts, nicotinic acid, Semen Cassiae alcohol extract 40��60 parts.
7. the preparation method of reducing blood-fat chinese-western medicine preparation according to claim 6, it is characterised in that: the preparation method of described Semen Cassiae alcohol extract: (1) depends on that pine torch adds the 40-60% ethanol of 8-12 times amount; Infiltrate 30-90 minute; (2) 50-70 DEG C of lixiviate 2-3 hour; (3) vat liquor is filtered; (4) being evaporated to relative density is 1.10-1.30; (5) centrifugal; (6) spraying dry.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610121158.3A CN105616481A (en) | 2016-03-03 | 2016-03-03 | Chinese and western medicine preparation with blood fat reducing function and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610121158.3A CN105616481A (en) | 2016-03-03 | 2016-03-03 | Chinese and western medicine preparation with blood fat reducing function and preparation method thereof |
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| CN105616481A true CN105616481A (en) | 2016-06-01 |
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| CN201610121158.3A Pending CN105616481A (en) | 2016-03-03 | 2016-03-03 | Chinese and western medicine preparation with blood fat reducing function and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106075343A (en) * | 2016-07-14 | 2016-11-09 | 高文广 | A kind of blood fat reducing Chinese-western medicine preparation and preparation method thereof |
| CN107670011A (en) * | 2017-11-08 | 2018-02-09 | 罗昌兴 | A kind of chinese-western medicine preparation of reducing blood lipid and preparation method thereof |
| CN107693598A (en) * | 2017-11-08 | 2018-02-16 | 罗昌兴 | A kind of compound preparation of reducing blood lipid and preparation method thereof |
| CN115429884A (en) * | 2022-10-20 | 2022-12-06 | 黑龙江乌苏里江制药有限公司 | Combined pharmaceutical composition for preventing or treating hyperlipidemia and application thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1425374A (en) * | 2003-01-20 | 2003-06-25 | 鲁南制药股份有限公司 | Composition for treating hyperlipemia |
| CN101862367A (en) * | 2010-07-05 | 2010-10-20 | 马建中 | Cassia seed soft capsule for reducing fat and losing weight and preparation method |
-
2016
- 2016-03-03 CN CN201610121158.3A patent/CN105616481A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1425374A (en) * | 2003-01-20 | 2003-06-25 | 鲁南制药股份有限公司 | Composition for treating hyperlipemia |
| CN101862367A (en) * | 2010-07-05 | 2010-10-20 | 马建中 | Cassia seed soft capsule for reducing fat and losing weight and preparation method |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106075343A (en) * | 2016-07-14 | 2016-11-09 | 高文广 | A kind of blood fat reducing Chinese-western medicine preparation and preparation method thereof |
| CN107670011A (en) * | 2017-11-08 | 2018-02-09 | 罗昌兴 | A kind of chinese-western medicine preparation of reducing blood lipid and preparation method thereof |
| CN107693598A (en) * | 2017-11-08 | 2018-02-16 | 罗昌兴 | A kind of compound preparation of reducing blood lipid and preparation method thereof |
| CN115429884A (en) * | 2022-10-20 | 2022-12-06 | 黑龙江乌苏里江制药有限公司 | Combined pharmaceutical composition for preventing or treating hyperlipidemia and application thereof |
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Application publication date: 20160601 |