CN1365809A

CN1365809A - Nano medicine 'Fuke Tongjing' and its preparing process

Info

Publication number: CN1365809A
Application number: CN 01102107
Authority: CN
Inventors: 杨孟君
Original assignee: Individual
Current assignee: Individual
Priority date: 2001-01-18
Filing date: 2001-01-18
Publication date: 2002-08-28

Abstract

A nanometre medicine "Fuke Tongjing" is prepared from the nanometre powders of 15 Chinese medicinal materials including croton fruit, cypterus rotundus, safflower, rhubarb, etc. through proportioning, microwave extracting, pressure reduction concentrating and supersonic-jet spray drying. Its grain fineness reaches 1200-1500 meshes and grain diameters are 0.1-200 nm. Its advantages are high biological utilization rate and high curative effect.

Description

Nano medicine ' Fuke Tongjing ' and preparation method thereof

The present invention relates to a kind of dissipating blood stasis to promote menstruationg, resolving depression analgesic nano medicine ' Fuke Tongjing ', the invention still further relates to the method for this medication preparation.

Gynecological's pill for relaxing nerve is a kind of classical Chinese patent medicine, mainly contains effects such as blood vessel dilating, microcirculation improvement, adjusting uterine contraction, analgesia, antitumor, is used for diseases such as dysmenorrhea, amenorrhea, chest and diaphragm painful abdominal mass are vexed, waist abdominal distention and pain.But traditional gynecological's pill for relaxing nerve disintegrate is slower, absorbs not exclusively, and bioavailability is not high, slow curative effect.

The object of the present invention is to provide a kind of bioavailability height, solid dispersion is good, absorbs fully the nano medicine ' Fuke Tongjing ' of increase evident in efficacy.

Another object of the present invention provides the preparation method of this nano medicine ' Fuke Tongjing '.

To achieve these goals, the present invention takes following technical scheme:

Medicine of the present invention is to make (consumption is a weight portion) by following component:

Nanometer Fructus Crotonis 50-120 part nanometer Resina Toxicodendri 100-250 part nano cyperus tuber 100-300 part

Nano safflower 150-350 part nano rhubarb 100-250 part nanometer Lignum Aquilariae Resinatum 100-250 part

Nanometer Radix Aucklandiae 150-350 part nanometer Rhizoma Curcumae 100-250 part nanometer rhizoma sparganic 100-250 part

Nanometer Radix Curcumae 100-250 part nanometer Radix Scutellariae 100-250 part nanometer Folium Artemisiae Argyi 40-95 part

Nanometer Carapax Trionycis 100-250 part nanometer Sal Ammoniacus 60-150 part nanometer Squama Manis 100-250 part

The formula optimization weight proportion scope of medicine of the present invention is:

Nanometer Fructus Crotonis 65-100 part nanometer Resina Toxicodendri 120-200 part nano cyperus tuber 150-250 part

Nano safflower 180-300 part nano rhubarb 120-200 part nanometer Lignum Aquilariae Resinatum 120-200 part

Nanometer Radix Aucklandiae 180-300 part nanometer Rhizoma Curcumae 120-200 part nanometer rhizoma sparganic 120-200 part

Nanometer Radix Curcumae 120-200 part nanometer Radix Scutellariae 120-200 part nanometer Folium Artemisiae Argyi 50-90 part

Nanometer Carapax Trionycis 120-200 part nanometer Sal Ammoniacus 80-120 part nanometer Squama Manis 120-200 part

The optimum weight proportioning of medicine of the present invention is:

200 parts of 160 parts of nano cyperus tubers of 80 parts of nanometer Resina Toxicodendri of nanometer Fructus Crotonis

163 parts of 160 parts of nanometer Lignum Aquilariae Resinatum of 225 parts of nano rhubarbs of nano safflower

163 parts of 163 parts of nanometer rhizoma sparganic of 225 parts of nanometer Rhizoma Curcumae of the nanometer Radix Aucklandiae

75 parts of 163 parts of nanometer Folium Artemisiae Argyis of 163 parts of nanometer Radix Scutellariaes of nanometer Radix Curcumae

163 parts of 100 parts of nanometer Squama Maniss of 163 parts of nanometer Sal Ammoniacuss of nanometer Carapax Trionycis

Technical scheme of the present invention is based on the modern material technology.One of modern material Developing Trend in Technology is to develop to the more and more littler direction of yardstick.The granule of the past composition material, its size all are at micron or more than the millimeter magnitude, and have occurred the material to the nanoscale development now.Because extremely refinement of granule, the shared percentage by volume of crystal boundary increases, and makes some performance of material that outstanding variation take place.

The property of nano material be since special construction----the material grains size of nano material less than the ultra-micro powder of 100nm, its body surface area is very big, the atom number ratio at crystal boundary place makes it to produce four big effects up to 15--50%: i.e. small-size effect, quantum effect (containing macro quanta tunnel effect), skin effect and interfacial effect.Thereby has the not available physical and chemical performance of traditional material.Nanotechnology will bring a technological revolution of the field of Chinese medicines.

One of method of above-mentioned each component being made medicine of the present invention is:

1. divide and get the Chinese crude drug of respectively distinguishing the flavor of, be processed into the common Chinese decoction pieces according to process of preparing Chinese medicine of Chinese Pharmacopoeia version in 2000.

2. divide and get the common Chinese decoction pieces of respectively distinguishing the flavor of, be processed into the nanometer prepared slices of Chinese crude drugs, its method comprises the following steps:

1. the common Chinese decoction pieces is placed extraction pot, solubilizer also imports microwave extracting, makes it do the change in polarity motion with hundred million seconds/second speed of 20--30, and the temperature of its microwave extracting is 30 ℃--and 60 ℃, time 1-10 hour;

2. above-mentioned extract is carried out concentrating under reduced pressure, temperature is 30 ℃--60 ℃, the time is 3-72 hour, collects volatile material in the Chinese medicine simultaneously in addition;

3. decompressed concentrate and volatile material merging are placed spray drying tower, use the supersonic jet technology, 330 meters of effluxvelocities--990 meter per seconds, at 30 ℃--60 ℃ of temperature, under 0 to the 0.05MPa pressure,, promptly make the nanometer prepared slices of Chinese crude drugs with the instantaneous drying of hypersonic velocity.

3. the nanometer prepared slices of Chinese crude drugs (powder) are prepared mixing in described ratio, according to Chinese Pharmacopoeia version two-shift system in 2000 agent standard, make pill, powder, tablet, suppository, granule, membrane, capsule, microcapsule, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral solution.

Two of medicine method for making of the present invention is:

1. be equipped with whole common Chinese decoction pieces in the proportioning ratio, place extraction pot, solubilizer also imports microwave extracting, makes its speed with 20--30 hundred million times/second do the change in polarity motion, and the temperature of its microwave extracting is 30 ℃-60 ℃, time 1-10 hour;

3. decompressed concentrate and volatile material merging are placed spray drying tower, use the supersonic jet technology, 330 meters of effluxvelocities--990 meter per seconds, at 30 ℃--60 ℃ of temperature, under 0 to the 0.05MPa pressure,, get the 'Fuke Tongjing ' nano powder with the instantaneous drying of hypersonic velocity jet;

4. its nano powder is made aforementioned various preparation according to Chinese Pharmacopoeia version standard preparation in 2000.

The pharmacological effect that above-mentioned two kinds of methods are made nano medicine ' Fuke Tongjing ' is identical.

A kind of important feature of the present invention is: the made drug material of the present invention has reached nanoscale, common gynecological pill for relaxing nerve preparation material is micron or the above particle diameter of millimeter, can only cross the 80-120 mesh sieve, the drug material that the present invention is made, particle diameter is at 0.1--200nm, the overwhelming majority can be crossed the 1200--1500 mesh sieve less than 100nm.

Another important feature of the present invention is: solid preparation of the present invention disintegrate rapidly, and solid dispersion is good in water, absorb fully, the bioavailability height, the pharmacological action effect that mainly contains effective constituent is significantly higher than conventional formulation.

The pharmaceutical preparation that the present invention is made does not need to add any adjuvant, and is more favourable to human body.

The present invention has also created the new drug formulation that powder, tablet, suppository, granule, membrane, capsule, microcapsule, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral solution of nano medicine ' Fuke Tongjing ' etc. is had no precedent in the past.

Pharmaceutical preparation of the present invention can be used for treatment of conditions such as dysmenorrhea, amenorrhea, endometriosis, and clinical efficacy significantly is better than traditional gynecological's pill for relaxing nerve.

The present invention's added solvent in microwave extracting is water or ethanol.

The present invention carries out in the concentrating under reduced pressure step at extract, and its concentrating under reduced pressure is conventional scheme.

Embodiment 1:

Prepare nano raw material by preceding method:

Production method is as follows:

In the GMP cleaning shop, after the above-mentioned nanometer prepared slices of Chinese crude drugs or powder prepared mixing in described ratio, according to Chinese Pharmacopoeia version two-shift system in 2000 agent capsules agent standard, do not add adjuvant, do not granulate, directly divide encapsulated with the fully-automatic capsule racking machine, make capsule, every capsules content of dispersion is the 0.1--0.6 gram, and the patient takes the 1-5 grain at every turn, and take 1-4 every day.

Embodiment 2:

Prepare nano raw material by preceding method:

Production method is as follows:

In the GMP cleaning shop, with the above-mentioned nanometer prepared slices of Chinese crude drugs or the described mixed of powder good after, according to 2000 editions two-shift system agent of Chinese Pharmacopoeia powder needle injection standard, do not add any adjuvant, making stimulate the menstrual flow powder needle injection, every injection content of nanometer women is the 5-20 milligram, each consumption is that 1-2 props up, and use 1-3 every day.

Embodiment 3:

Prepare nano raw material by preceding method:

Production method is as follows:

In the GMP cleaning shop, with the above-mentioned nanometer prepared slices of Chinese crude drugs or powder by described mixed good after, according to 2000 editions two-shift system agent of Chinese Pharmacopoeia membrane standard, filmogen adopts polyvinyl alcohol, make the nanometer women membrane that stimulates the menstrual flow, every membrane area size is the 2-100 square centimeter, and content of dispersion is the 1-50 gram, every medicine film pasted 1-7 days, pasted the medicine position: abdominal part.

Claims

1, a kind of nano medicine ' Fuke Tongjing ' is characterized in that it is the medicament that the nano raw material of following weight proportioning is made:

And adopt following method to make: to select the formula Chinese drug material to concoct and be processed into the prepared slices of Chinese crude drugs; Place extraction pot, solubilizer also imports microwave extracting, makes it do the change in polarity motion with hundred million times/second speed of 20--30, and the temperature of its microwave extracting is 30--60 ℃, time 1-10 hour; Above-mentioned extract is carried out concentrating under reduced pressure, and temperature is 30--60 ℃, and the time is 3-72 hour, collects volatile material in the Chinese medicine simultaneously in addition; Decompressed concentrate and volatile material merging are placed spray drying tower, use the Supersonic fluidics, 30--60 ℃ of temperature, under 0 to the 0.05MPa pressure, with hypersonic velocity instantaneous jet drying, wherein supersonic jet speed is 330 meters-990 meter per seconds, promptly makes the nanometer prepared slices of Chinese crude drugs.

2, nano medicine ' Fuke Tongjing ' according to claim 1, wherein the weight proportion of each nano raw material is:

3, nano medicine ' Fuke Tongjing ' according to claim 1, wherein the weight proportion of each nano raw material is:

4,, it is characterized in that said medicine is pill, powder, tablet, suppository, granule, membrane, capsule, microcapsule, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral solution according to claim 1 or 2 or 3 described nano medicine ' Fuke Tongjing 's.

5,, it is characterized in that this method comprises the steps: to select the formula Chinese drug material to concoct and is processed into the prepared slices of Chinese crude drugs according to the pharmaceutical methods of claim 1 or 2 or 3 described nano medicine ' Fuke Tongjing 's; Place extraction pot, solubilizer also imports microwave extracting, makes it do the change in polarity motion with hundred million times/second speed of 20--30, and the temperature of its microwave extracting is 30--60 ℃, time 1-10 hour; Above-mentioned extract is carried out concentrating under reduced pressure, and temperature is 30--60 ℃, and the time is 3-72 hour, collects volatile material in the Chinese medicine simultaneously in addition; Decompressed concentrate and volatile material merging are placed spray drying tower, use the Supersonic fluidics, 30--60 ℃ of temperature, under 0 to the 0.05MPa pressure, with hypersonic velocity instantaneous jet drying, wherein supersonic jet speed is 330 meters-990 meter per seconds, promptly makes the nanometer prepared slices of Chinese crude drugs.

6, wherein respectively distinguish the flavor of Chinese medicine in the ratio of prescription or Chinese crude drug concoct be processed into the prepared slices of Chinese crude drugs after mixing, or after making the nanometer prepared slices of Chinese crude drugs mixing.