CN1803158A - Drop pills containing red-rooted salvia and dalbergia wood and its preparation method - Google Patents
Drop pills containing red-rooted salvia and dalbergia wood and its preparation method Download PDFInfo
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- CN1803158A CN1803158A CN 200510013088 CN200510013088A CN1803158A CN 1803158 A CN1803158 A CN 1803158A CN 200510013088 CN200510013088 CN 200510013088 CN 200510013088 A CN200510013088 A CN 200510013088A CN 1803158 A CN1803158 A CN 1803158A
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Abstract
The invention discloses a dripping pill for treating cardiovascular and cerebrovascular diseases and its preparing process, wherein the medicament is prepared from root of red rooted saliva and rosewood through extracting, refining, molting the extract with base material and adjuvant, mixing homogenously, dropping into condensation agent and drying.
Description
Technical field
The present invention relates to a kind of Chinese medicine dripping pills and method for making thereof for the treatment of angina pectoris, myocardial infarction.A kind of specifically Chinese medicine dripping pills that Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae effective site and substrate and other adjuvant make and preparation method thereof that contains.
Background technology
Cardiovascular disease such as coronary heart disease, angina pectoris is serious threat human life and healthy commonly encountered diseases, frequently-occurring disease.At its prevalence height of developed country, the disability rate height is the adult's of most developed countries and many developing countries a major causes of death, also is the modal cause of death in the world wide.According to the numeral of World Health Organization (WHO) issue, last year, the whole world was about 1,700 ten thousand because of the number of cardiovascular disease death, account for the whole world dead 1/3rd, in other words, it is cardiovascular disease that every dead 3 people in the whole world just have 1 people.The cardiovascular diseases accounts for population of China cause of the death first place.Along with the growth of the average life span, the affluence of material conditions and the variation of life culture mode, cardiovascular disease, particularly Incidence of CHD and mortality rate are increasing year by year, and the trend of rejuvenation is arranged.Thereby protection heart, prevention and treatment cardiovascular disease are more and more paid attention to by people and are paid close attention to.Though the cardiovascular drug species is more at present, the cardiovascular drugs of research and development highly effective and safe is still the task of top priority.
XIANGDAN ZHUSHEYE (more domestic pharmacy corporations are referred to as the coronary heart disease injection again) is ministry standard side's (17 200 pages of ministry standards), form by Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae two flavor Chinese crude drugs, prescription is formed rationally, has blood vessel dilating, promote the effect of coronary artery blood flow, be used for angina pectoris, also can be used for myocardial infarction etc., have clinically widely and use.
Radix Salviae Miltiorrhizae is the conventional Chinese medicine of blood circulation promoting and blood stasis dispelling, is widely used in the Chinese medicine compound such as cardiovascular, is that the Chinese medicine preparation exploitation of principal agent is also quite active with the Radix Salviae Miltiorrhizae.Have the active composition of blood circulation promoting and blood stasis dispelling in the Radix Salviae Miltiorrhizae two classes are arranged: fat-soluble tanshinone and water solublity salvianolic acid.The water solublity salvianolic acid is absorbed by the body easily, is the main active of Radix Salviae Miltiorrhizae cardiovascular pharmacological effect.Pharmacological research shows that the salvianolic acid constituents has antiplatelet aggregative activity, anti-thrombosis function, microcirculation improvement effect, anti-oxidative damage effect and multipath performance myocardium protecting action.
Lignum Dalbergiae Odoriferae is a kind of conventional Chinese medicine, derives from the trunk of leguminous plant Lignum Dalbergiae Odoriferae wingceltis and the dry duramen of root.The main component of Lignum Dalbergiae Odoriferae heartwood is volatile oil and flavone compound.Volatile oil content 2-9%.Pharmacological research shows that volatile oil of Lignum Dalbergiae Odoriferae is irritated stomach can obviously suppress rat experiment thrombosis.
In order better to bring into play the clinical efficacy of XIANGDAN ZHUSHEYE, medical worker has carried out a large amount of research to said preparation, and present existing dosage form has XIANGDAN ZHUSHEYE, Xiang Dan (glucose) injection, fragrant red drip liquid.More domestic pharmacy corporations are raw material with the distillate branch of the vapor distillation of the Lignum Dalbergiae Odoriferae layer that deoils, make the sterile water solution preparation with the merging of salvia-soluble extracting solution, still, Lignum Dalbergiae Odoriferae large usage quantity in the fragrant red prescription, difficulty is retained in its volatile oil composition in the preparation in the injection, can't guarantee curative effect.Though injection and drip liquid are a kind of quick-acting dosage forms, also exist anaphylaxis more, carry, transport inconvenience, use shortcomings such as inconvenience.In addition, injection ubiquity poor stability easily produces untoward reaction.
Summary of the invention
In order to solve the problem that exists in the above-mentioned preparation, the purpose of this invention is to provide a kind of stable in properties, quick-acting drop pill efficient, easy to use and method for making thereof.
The technical solution adopted in the present invention is: a kind of drop pills containing red-rooted salvia and dalbergia wood, and it is made up of by following parts by weight proportioning Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract and substrate and other adjuvant:
Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract (in dry) 20-60 part
Substrate 10-100 part
Other adjuvant 0-5 part
Drop pills containing red-rooted salvia and dalbergia wood of the present invention, the parts by weight proportioning of each component can be preferably:
Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract (in dry) 40-60 part
Substrate 40-80 part
Other adjuvant 0-3 part
Described substrate is the mixture of polyethylene glycol 6000 or Macrogol 4000 and polyethylene glycol 6000.Wherein the weight ratio of Macrogol 4000 and polyethylene glycol 6000 mixture is 1: 0.1-20 is preferably 1: 0.2-10.
Described other adjuvant can be one of following or arbitrary two or more mixture: 1. 2. 3. 4. insect wax of Tween 80 of sodium lauryl sulphate of stearic acid
Described Radix Salviae Miltiorrhizae extract is the ethanol extraction that adopts water or arbitrary proportion, makes through the macroporous adsorbent resin separation and purification, and described Lignum Dalbergiae Odoriferae extract makes through steam distillation.Concrete steps comprise:
1.. get red rooted salvia and be ground into coarse grain; The ethanol extraction of water or arbitrary proportion, extracting method comprise decoction repeatedly, hot reflux, percolation, ultrasonic, microwave; Extracting solution concentrates or without concentrating through decompression (60～70 ℃); Extracting solution eliminates ethanol after macroporous adsorptive resins, water elution impurity, arbitrary proportion ethanol elution effective ingredient; Collect eluent, eliminate ethanol, concentrate, spray drying becomes fine powder, gets Radix Salviae Miltiorrhizae extract;
2. described Lignum Dalbergiae Odoriferae extract is the Lignum Dalbergiae Odoriferae pulverizing medicinal materials, and steam distillation extracts volatile oil to carrying to the greatest extent, collects oil, gets Lignum Dalbergiae Odoriferae extract.
Wherein, macroporous adsorbent resin can be HPD-100, D101, AB-8 or LSA-30; Arbitrary proportion ethanol elution concentration is generally 30%-95%, the ethanol liquid of preferred 30%-70%.The preparation method of drop pills containing red-rooted salvia and dalbergia wood of the present invention comprises the following steps:
(1) fusion: get substrate and other adjuvant is heated to fusion in oil bath, Radix Salviae Miltiorrhizae extract, volatile oil of Lignum Dalbergiae Odoriferae are added, mixing, fusion is in the insulation down of 60 ℃ of-90 ℃ of states.
(2) drip system: said mixture is inserted special-purpose drop pill machine, and the speed of dripping with per minute 20-80 splashes in the condensing agent, after the drop pill molding, takes out, and removes condensing agent, drying, promptly.
Optimum condition is 80 ℃ of insulations in preparation method, splashes in the dimethicone condensing agent with the speed of 50 ± 5 of per minutes.
Radix Salviae Miltiorrhizae extract is the assay index with the salvianolic acid B, adopts high effective liquid chromatography for measuring content, chromatographic condition: C
18Post (200 * 4.6mm, 5 μ m), mobile phase: (33: 9: 56: 2), flow velocity 1.0mL/min detected wavelength 280nm to methanol-acetonitrile-water-glacial acetic acid;
Through preliminary test, effective component in red sage is made the drop pill good stability, and volatile oil of Lignum Dalbergiae Odoriferae effectively utilizes, and dissolubility greatly improves, and stability also improves a lot.
This drop pill outward appearance is brown, and roundness is even, and every index all meets " the pertinent regulations of an appendix of Chinese pharmacopoeia version in 2000.
The invention has the advantages that:
(1) 'Xiangdan ' does not still have peroral dosage form at present, and salvianolic acid character instability is easily decomposed through gastrointestinal tract, drops of the present invention makes effective ingredient pass through the absorption of mucosa upper epidermis cell, directly enter blood circulation, avoided first pass effect, overcome the decomposition of effective ingredient.
(2) difficulty is retained in the volatile oil of Lignum Dalbergiae Odoriferae constituents in the preparation in the injection, and drops of the present invention has kept a large amount of effective ingredient volatile oil.Drops of the present invention adopts solid dispersion technology, makes the dispersion of medicine in substrate be molecularity, has increased the stripping and the absorption of effective ingredient, has reduced the zest of volatilization wet goods effective ingredient.
(3) drops of the present invention is rapid-action, and effect is strong, and the bioavailability height is more suitable in the treatment cardio-cerebrovascular disorder as first aid medicine.Stable in properties, easy to use, easy to carry and transport.
(4) aspect production, the drop pill process equipment is simple, and is easy to operate, the automaticity height.Cost is low, is easy to control of quality, and helps sanitation and hygiene and labor protection, is applicable to the big production of industry.
(5) violent condition such as the chance acid of salvianolic acid, alkali, heat can be degraded, and adopts salvianolic acid B for containing the survey index, is beneficial to the control quality of the pharmaceutical preparations, has specificity.
Further specify good effect of the present invention below by experimental data:
The effects
Drop pills containing red-rooted salvia and dalbergia wood of the present invention is studied different conditions of molding.
| Substrate | With the medicine amalgamation | Coolant | Drip the system situation | The molding situation |
| PEG4000 | Easily melt mutually | Methyl-silicone oil | It is very fast to drip speed, and it is slower to sink | Oblate spheroid, ball is less, and ball is softer |
| PEG4000 | Easily melt mutually | Liquid paraffin | It is very fast to drip speed, and it is very fast to sink | Oblate spheroid, ball is less, and ball is softer |
| PEG4000 | Easily melt mutually | Methyl-silicone oil: liquid paraffin (1: 1) | It is very fast to drip speed, and it is very fast to sink | Oblate spheroid, ball is less, and ball is softer |
| PEG4000 | Easily melt mutually | Methyl-silicone oil: liquid paraffin (2: 1) | It is very fast to drip speed, and it is very fast to sink | Oblate spheroid, ball is less, and ball is softer |
| PEG4000 | Easily melt mutually | Methyl-silicone oil: liquid paraffin (3: 1) | It is very fast to drip speed, and it is moderate to sink | Oblate spheroid, ball is less, and ball is softer |
| PEG6000 | Easily melt mutually | Methyl-silicone oil | It is very fast to drip speed, and it is moderate to sink | Spheroidal, ball is less, and is uniform and smooth |
| PEG4000∶ PEG6000 | Easily melt mutually | Methyl-silicone oil | It is very fast to drip speed, and it is moderate to sink | Spheroidal, ball is less, and is uniform and smooth |
The result shows: the drop pill mouldability that PEG4000 and above-mentioned condensing agent are made is all relatively poor, and PEG6000 and PEG4000-PEG6000 adopt condensing agent methyl-silicone oil effect better.
Guanxinning drip pill accelerated stability of the present invention is investigated and the result:
The drop pills containing red-rooted salvia and dalbergia wood of getting embodiment 3 preparations in 40 ℃ of temperature, was placed 3 months under relative humidity 75% condition under the listing terms of packing, in experimental session each investigation in the 0th, 1,2,3 month once, the results are shown in Table 1.
Table 1 accelerated test is investigated the result
| 040103 | Brown solid | 0.81 | |
| January | 040101 | Brown solid | 0.72 |
| 040102 | Brown solid | 0.73 | |
| 040103 | Brown solid | 0.75 | |
| February | 040101 | Brown solid | 0.65 |
| 040102 | Brown solid | 0.68 | |
| 040103 | Brown solid | 0.70 | |
| March | 040101 | Brown solid | 0.68 |
| 040102 | Brown solid | 0.71 | |
| 040103 | Brown solid | 0.74 |
The result shows that sample was placed 3 months under relative humidity 75% condition 40 ℃ of temperature, and every index all meets the quality standard requirement, can determine tentatively that according to the rules the effect duration of this product is 3 years.
The specific embodiment
The present invention is described further below in conjunction with embodiment, and embodiment only means never that for indicative it limits the scope of the invention by any way.
The preparation of Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract:
Get Radix Salviae Miltiorrhizae, the Lignum Dalbergiae Odoriferae medical material cleaned out, take by weighing Radix Salviae Miltiorrhizae 2000g, decoct with water three times, each 1.0h, collecting decoction filters, and filtrate is concentrated into about 2000ml (0.1MP, 70 ℃).Concentrated solution is by HPD-100 type macroporous adsorptive resins purification, flow velocity 1BV/mL, earlier with 4BV distilled water eluting, reuse 30% ethanol 6BV eluting, collect 30% ethanol elution, concentrating under reduced pressure (0.1MP, 60 ℃) gets Radix Salviae Miltiorrhizae extract (it is 0.53g/g that HPLC measures salvianolic acid B content) to equivalent extract.The Lignum Dalbergiae Odoriferae pulverizing medicinal materials is crossed 10 mesh sieves, takes by weighing Lignum Dalbergiae Odoriferae medicinal material coarse powder 1000g, adds 10 times of amount volume water logging bubbles after 2 hours, and steam distillation extracts volatile oil to carrying to the greatest extent, collects oil, volatile oil of Lignum Dalbergiae Odoriferae.
Embodiment 1
With Radix Salviae Miltiorrhizae extract (in dry 12g) and Macrogol 4000 3g, polyethylene glycol 6000 6g, stearic acid 1.5g is after heating is dissolved evenly, under 60 ℃ of states, add volatile oil of Lignum Dalbergiae Odoriferae (40g by weight), splash in the dimethicone condensing agent, after the shaping with the speed of 20 of per minutes, take out, remove condensing agent, drying gets product of the present invention (the heavy 20mg of every ball).
Embodiment 2
With Radix Salviae Miltiorrhizae extract (in dry 12g) and polyethylene glycol 6000 250g, after heating is dissolved evenly, under 90 ℃ of states, add volatile oil of Lignum Dalbergiae Odoriferae (40g by weight), splash in the dimethicone condensing agent, after the shaping with the speed of 80 of per minutes, take out, remove condensing agent, drying gets product of the present invention (the heavy 50mg of every ball).
Embodiment 3
With Radix Salviae Miltiorrhizae extract (in dry 12g) and Macrogol 4000 15g, polyethylene glycol 6000 35g, after heating is dissolved evenly, under 80 ℃ of states, add volatile oil of Lignum Dalbergiae Odoriferae (40g by weight), speed with 50 of per minutes splashes in the dimethicone condensing agent, after the shaping, take out, remove condensing agent, drying gets product of the present invention (the heavy 25mg of every ball).
Claims (7)
1, a kind of drop pills containing red-rooted salvia and dalbergia wood is characterized in that being made up of according to the following number of weight ratio with substrate and other adjuvant Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract (in dry):
Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract 20-60 part
Substrate 10-100 part
Other adjuvant 0-5 part
Radix Salviae Miltiorrhizae extract wherein is through water or ethanol extraction, and last macroporous resin separation and purification makes; Lignum Dalbergiae Odoriferae extract makes through steam distillation.
2, drop pills containing red-rooted salvia and dalbergia wood according to claim 1 is characterized in that the described extract (in dry) and the ratio of weight and number of substrate and other adjuvant are:
Radix Salviae Miltiorrhizae, Lignum Dalbergiae Odoriferae extract 40-60 part
Substrate 40-80 part
Other adjuvant 0-3 part
3, drop pills containing red-rooted salvia and dalbergia wood according to claim 1 and 2 is characterized in that described substrate is the mixture of polyethylene glycol 6000 or Macrogol 4000 and polyethylene glycol 6000.
4, Guanxinning drip pill according to claim 3, the weight ratio that it is characterized in that described Macrogol 4000 and polyethylene glycol 6000 mixture is 1: 0.1-20.
5, drop pills containing red-rooted salvia and dalbergia wood according to claim 1 and 2 is characterized in that described other adjuvant can be one of following or arbitrary two or more mixture: 1. 2. 3. 4. insect wax of Tween 80 of sodium lauryl sulphate of stearic acid.
6, claim 1 or 2 described drop pills containing red-rooted salvia and dalbergia wood preparation methoies comprise the following steps:
(1) preparation of extract: get red rooted salvia, adopt the ethanol extraction of water or arbitrary proportion, concentrate, through the macroporous adsorbent resin separation and purification, concentrate, spray drying becomes fine powder or is condensed into equivalent extract; Get the Lignum Dalbergiae Odoriferae pulverizing medicinal materials, steam distillation extracts volatile oil to carrying to the greatest extent, collects oil, gets Lignum Dalbergiae Odoriferae extract;
(2) fusion: take by weighing substrate in proportion and other adjuvant is heated to fusion in oil bath, Radix Salviae Miltiorrhizae extract, volatile oil of Lignum Dalbergiae Odoriferae are added, mixing, fusion is in the insulation down of 60-90 ℃ of state;
(3) drip system: said mixture is inserted special-purpose drop pill machine, and the speed of dripping with per minute 20-80 splashes in the condensing agent, after the drop pill molding, takes out, and removes condensing agent, drying, promptly.
7, the preparation method of drop pills containing red-rooted salvia and dalbergia wood according to claim 6 is characterized in that with 80 ℃ of insulations, splashes in the dimethicone condensing agent with the speed of 50 ± 5 of per minutes.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265907A (en) * | 2016-09-05 | 2017-01-04 | 神威药业集团有限公司 | A kind of GUANXINNING pharmaceutical composition and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265907A (en) * | 2016-09-05 | 2017-01-04 | 神威药业集团有限公司 | A kind of GUANXINNING pharmaceutical composition and preparation method thereof |
| CN106265907B (en) * | 2016-09-05 | 2019-07-05 | 神威药业集团有限公司 | A kind of perhexiline pharmaceutical composition and preparation method thereof |
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