CN114129701A - Stomach-nourishing aucklandia and amomum fruit emulsion and preparation method thereof - Google Patents

Stomach-nourishing aucklandia and amomum fruit emulsion and preparation method thereof Download PDF

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Publication number
CN114129701A
CN114129701A CN202111491930.8A CN202111491930A CN114129701A CN 114129701 A CN114129701 A CN 114129701A CN 202111491930 A CN202111491930 A CN 202111491930A CN 114129701 A CN114129701 A CN 114129701A
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stomach
stomach nourishing
weight
preparation
emulsion
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Inventor
陈波
阙素云
曹海燕
戴琳
毛欣
甘小辉
傅保庚
刘红波
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Jiangxi Guangenhe Pharmaceutical Co ltd
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Jiangxi Guangenhe Pharmaceutical Co ltd
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Priority to CN202111491930.8A priority Critical patent/CN114129701A/en
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Priority to CN202211566184.9A priority patent/CN115887609B/en
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    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285—Aucklandia
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Abstract

The invention discloses a stomach nourishing Xiangsha emulsion and a preparation method thereof, relating to the field of traditional Chinese medicine preparations. According to the stomach nourishing aucklandia root and amomum fruit emulsion, the composite particle dispersion liquid containing the nano particles is added, the used nano particles are hydrophilic, the polymer polymerized by the polymer monomer has hydrophobicity, and the dispersion liquid has very good amphipathy, so that the emulsion can show very good dispersity and stability, and no layering phenomenon occurs.

Description

Stomach-nourishing aucklandia and amomum fruit emulsion and preparation method thereof
Technical Field
The invention relates to the field of traditional Chinese medicine preparations, in particular to a stomach nourishing aucklandia root and amomum fruit emulsion and a preparation method thereof.
Background
The xiangsha yangwei pill is a variety recorded in the first Chinese pharmacopoeia of 2000 edition, has wide clinical application, has the main function of warming the middle-jiao and harmonizing the stomach, and is used for anorexia, acid regurgitation, gastric cavity fullness and stuffiness and limb lassitude, and the whole formula consists of 14 traditional Chinese medicines of costustoot, fructus amomi, bighead atractylodes rhizome, dried orange peel, poria cocos, pinellia ternate, rhizoma cyperi, immature bitter orange, fructus amomi, mangnolia officinalis, pogostemon cablin, liquorice, ginger and Chinese date. The preparation is prepared from ten traditional Chinese medicinal materials of costustoot, fructus amomi, bighead atractylodes rhizome, dried orange peel, rhizoma cyperi, immature bitter orange, round cardamom, officinal magnolia bark, cablin potchouli herb and ginger, has high content of volatile oil, has the effects of relieving gastrointestinal smooth muscle spasm, regulating qi, relieving epigastric distention, warming stomach, promoting digestion, promoting gastric secretion and enhancing digestive ability, and is a main effective component of the preparation.
The xiangsha yangwei oral liquid and the xiangsha yangwei soft capsule are recorded in the twentieth book (pharmacopoeia committee of the ministry of health of the people's republic of China, 1998) of "pharmaceutical standard Chinese medicine prescriptions published by the ministry of health of the people's republic of China. On the basis of the traditional Chinese medicine preparation of the stomach-nourishing pill, the stomach-nourishing pills are improved in the field to obtain a series of stomach-nourishing preparations of the stomach-nourishing pills, the stomach-nourishing capsules, the stomach-nourishing tablets, the stomach-nourishing oral liquid and the like. However, in these stomach-nourishing products, the active ingredients of the traditional Chinese medicine are not sufficiently released, limited to be absorbed, and low in bioavailability, and the traditional Chinese medicine ingredients therein have a great bad smell and are poorly accepted by consumers.
Therefore, there is still a need to further develop other stomach-nourishing formulation forms of fructus amomi to overcome the above-mentioned disadvantages of the stomach-nourishing product.
However, the preparation of emulsions generally requires the use of various types of surfactants effective in reducing interfacial tension, so that the surface tension of the microdroplets formed by emulsification is reduced sufficiently small that the inner phase of the microdroplets no longer fuses with the inner phase of other microdroplets in the outer phase due to interfacial rupture, thus forming a physically stable two-or multiphase system with homogeneous dispersion of oil and water. However, the existing emulsion still has the phenomenon of layering and is poor in stability.
Disclosure of Invention
The invention aims to at least solve one of the technical problems in the prior art and provides a stomach nourishing aucklandia root and amomum fruit emulsion and a preparation method thereof.
The technical solution of the invention is as follows:
the stomach nourishing aucklandia root and amomum fruit emulsion comprises the following raw materials:
stomach nourishing liquid medicine, a compound emulsifier, a co-emulsifier, an antioxidant, a preservative, a surfactant and a solvent;
also included are composite particle dispersions containing nanoparticles.
As a preferred embodiment of the present invention, the nanoparticles are one or more of hydrophilic silica, titania, alumina, and zinc oxide.
As a preferable aspect of the present invention, the composite particle dispersion liquid further includes a polymer monomer.
As a preferred embodiment of the present invention, the surfactant is sodium oleate.
As a preferable scheme of the invention, the compound emulsifier comprises an adsorbent, bicyclol and a phospholipid material.
The invention also discloses a preparation method of the stomach nourishing aucklandia root and amomum fruit emulsion, which comprises the following steps:
mixing stomach nourishing medicinal liquid, antioxidant and antiseptic uniformly to obtain oil phase, mixing composite emulsifier, auxiliary emulsifier, surfactant, composite particle dispersion containing nanoparticles and water uniformly, adding into oil phase, homogenizing, emulsifying, bottling, and sterilizing.
As a preferable embodiment of the present invention, the method for preparing the nanoparticle-containing composite particle dispersion liquid comprises: adding water into the nano particles, uniformly mixing, adding a polymer monomer under high-speed stirring, polymerizing, and standing to obtain the nano-particle.
As a preferable scheme of the invention, the preparation method of the compound emulsifier comprises the following steps: mixing dicyclic alcohol and phospholipid material, adding organic solvent to dissolve, reacting at 40-60 deg.c for 1-2 hr, rotary evaporating to eliminate organic solvent until the solution is viscous, adding adsorbent, stirring and drying.
In a preferred embodiment of the present invention, the adsorbent is one or more of lactose, microcrystalline cellulose, aerosil and calcium phosphate.
The invention has the beneficial effects that:
(1) according to the stomach nourishing aucklandia root and amomum fruit emulsion, the composite particle dispersion liquid containing the nano particles is added, the used nano particles are hydrophilic, the polymer polymerized by the polymer monomer has hydrophobicity, and the dispersion liquid has very good amphipathy, so that the emulsion can show very good dispersity and stability, and no layering phenomenon occurs.
(2) According to the stomach nourishing aucklandia root and amomum fruit emulsion, the composite emulsifier is compounded by adopting the phospholipid material with the hydroxyl hydrophilic group and the hydrophobic phospholipid, so that the hydrophilicity and the lipophilic property of the medicine are greatly improved, and the migration of the stomach nourishing liquid medicine between oil and water phases is reduced.
(3) The stomach nourishing aucklandia root and amomum fruit emulsion of the present invention has surfactant added to adsorb and inlay the emulsion on the interface film of formed emulsion drop, and this increases the thickness of the double electric layer between the emulsion grains, increases the repulsion force between the grains, reduces flocculation and aggregation and makes the emulsion stable.
Detailed Description
The following examples are intended to further illustrate the invention but are not intended to be in any way limiting.
The preparation method of the stomach nourishing liquid medicine in the following embodiment is as follows:
taking 70g of costustoot, 70g of fructus amomi, 100g of rhizoma atractylodis macrocephalae, 100g of dried orange peel, 100g of poria cocos, 100g of processed pinellia ternate, 70g of vinegar-processed rhizoma cyperi, 70g of fried immature bitter orange, 70g of shelled round cardamom, 70g of ginger-processed cortex magnoliae officinalis, 70g of pogostemon cablin and 30g of liquorice to extract volatile oil, collecting the volatile oil for later use, decocting the residual medicine residues with water, filtering, concentrating the filtrate to obtain clear paste with the relative density of 1.2 at 75 ℃, cooling to 40 ℃, adding ethanol with the alcohol content of 80%, standing for 12 hours, taking supernate, recovering the ethanol to obtain clear paste with the relative density of 1.2 at 75 ℃, adding deionized water into the residual medicine liquid, adjusting the pH value to 4, standing for 12 hours, filtering to obtain clear aqueous solution extract, and mixing the water-soluble extract and the volatile oil to obtain the stomach nourishing medicine liquid.
Example 1
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 1 part by weight of sodium sulfite and 0.5 part by weight of benzoic acid to prepare an oil phase, uniformly mixing 3.5 parts by weight of composite emulsifier, 0.05 part by weight of methylcellulose, 0.03 part by weight of sodium oleate, 9 parts by weight of composite particle dispersion liquid containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to prepare the stomach-nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into hydrophilic silicon dioxide, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Example 2
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of composite emulsifier, 0.15 part by weight of sodium alginate, 0.04 part by weight of sodium oleate, 9 parts by weight of composite particle dispersion containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to obtain the stomach-nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into hydrophilic silicon dioxide, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Example 3
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 3.2 parts by weight of composite emulsifier, 0.11 part by weight of sodium alginate, 0.04 part by weight of sodium oleate, 8 parts by weight of composite particle dispersion liquid containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to prepare the stomach-nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into titanium dioxide, uniformly mixing, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the titanium dioxide-based catalyst.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Example 4
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of composite emulsifier, 0.15 part by weight of sodium alginate, 0.04 part by weight of sodium oleate, 9 parts by weight of composite particle dispersion containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to obtain the stomach-nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into alumina, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Example 5
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 0.7 part by weight of sodium bisulfite and 0.33 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of composite emulsifier, 0.15 part by weight of Arabic gum, 0.04 part by weight of sodium oleate, 9 parts by weight of composite particle dispersion containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to obtain the stomach-nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into hydrophilic silicon dioxide, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 3 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out the stirred matter, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Comparative example 1 (No Dispersion)
Uniformly mixing 100 parts by weight of stomach-nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of composite emulsifier, 0.15 part by weight of auxiliary emulsifier, 0.04 part by weight of sodium oleate and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, filling and sealing, and sterilizing to obtain the stomach-nourishing liquid medicine.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Comparative example 2 (without surfactant)
Uniformly mixing 100 parts by weight of stomach nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of composite emulsifier, 0.15 part by weight of sodium alginate, 9 parts by weight of composite particle dispersion containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to obtain the stomach nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into hydrophilic silicon dioxide, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The preparation method of the compound emulsifier comprises the following steps: taking 6 parts by weight of bicyclol and 36.6 parts by weight of soybean phospholipid, adding 400 parts by volume of tetrahydrofuran, compounding for 1 hour at 40 ℃, performing rotary evaporation to remove most of tetrahydrofuran, adding 1.5 parts of lactose serving as an adsorbent into the viscous liquid, stirring, taking out a stirred substance, performing vacuum drying for 12 hours (25 ℃) to obtain a drug-loaded phospholipid compound, hermetically packaging, and putting into a refrigerator for refrigeration and storage.
Comparative example 3 (Single emulsifier)
Uniformly mixing 100 parts by weight of stomach nourishing liquid medicine, 0.8 part by weight of sodium bisulfite and 0.4 part by weight of calcium sorbate to prepare an oil phase, uniformly mixing 4 parts by weight of soybean lecithin, 0.15 part by weight of sodium alginate, 0.04 part by weight of sodium oleate, 9 parts by weight of composite particle dispersion liquid containing nano particles and 200 parts by weight of water, adding the mixture into the oil phase, homogenizing, emulsifying, encapsulating and sterilizing to prepare the stomach nourishing liquid medicine.
The preparation method of the composite particle dispersion liquid containing the nano particles comprises the following steps: adding water into hydrophilic silicon dioxide, mixing uniformly, adding methacrylic acid, water, ammonia water, methyl methacrylate and n-butyl acrylate under high-speed stirring, heating to 65 ℃, adding ammonium persulfate for polymerization, and standing to obtain the product.
The above examples and comparative examples were subjected to the zeta potential values (measured by electrophoretic light scattering), the appearance (whether or not delamination was observed), the particle size of the milk particles (measured by PSS-380 laser electrophoresis-particle size analyzer) at 1 month, 3 months and 9 months of standing, and the results of the tests are shown in Table 1.
TABLE 1 results of the Performance test of examples and comparative examples
Figure BDA0003398712940000081
Figure BDA0003398712940000091
As can be seen from the above table, the samples of the examples have small changes in appearance, size of emulsion particles and electric potential after being left for 9 months, which indicates that the emulsion of the present invention has good stability and no delamination phenomenon, and the main reasons may be as follows: analysis on the comparative example 1 shows that the composite particle dispersion added in the example has hydrophilic nanoparticles, the polymer polymerized from the polymer monomer has hydrophobicity, and the dispersion has good amphipathy, so that the emulsion has good dispersibility and stability, and no layering phenomenon occurs. It can be seen from the analysis of comparative example 2 that by adding a surfactant, it can be adsorbed and embedded on the interfacial film of the formed emulsion droplets, increasing the thickness of the electric double layer between the emulsion particles, so that the repulsive force between the particles is increased, flocculation and aggregation are reduced, and the emulsion is more stable; analysis of comparative example 3 shows that by using the compound emulsifier, the compound emulsifier adopts the phospholipid material with hydroxyl hydrophilic group and hydrophobic property to compound, so that the hydrophilicity and lipophilic property of the medicine are greatly improved, and the migration of the stomach-nourishing liquid medicine between oil phase and water phase is reduced.
The above description is only a preferred embodiment of the present invention, and the technical solutions that achieve the objects of the present invention by substantially the same means are within the protection scope of the present invention.

Claims (9)

1. The stomach nourishing aucklandia root and amomum fruit emulsion is characterized by comprising the following raw materials:
stomach nourishing liquid medicine, a compound emulsifier, a co-emulsifier, an antioxidant, a preservative, a surfactant and a solvent;
also included are composite particle dispersions containing nanoparticles.
2. The stomach nourishing cream of claim 1, wherein the nanoparticles are one or more of hydrophilic silica, titanium dioxide, aluminum oxide and zinc oxide.
3. The stomach nourishing cream of claim 1, wherein said composite particle dispersion further comprises a polymer monomer.
4. The stomach nourishing cream of claim 1, wherein said surfactant is sodium oleate.
5. The stomach nourishing cream of aucklandia and amomum fruit and the preparation method thereof as claimed in claim 1, wherein the compound emulsifier comprises an adsorbent, bicyclol and a phospholipid material.
6. The preparation method of the stomach nourishing aucklandia root and amomum fruit emulsion is characterized by comprising the following steps:
mixing stomach nourishing medicinal liquid, antioxidant and antiseptic uniformly to obtain oil phase, mixing composite emulsifier, auxiliary emulsifier, surfactant, composite particle dispersion containing nanoparticles and water uniformly, adding into oil phase, homogenizing, emulsifying, bottling, and sterilizing.
7. The method for preparing the stomach nourishing xiangsha emulsion as claimed in claim 6, wherein the method for preparing the nanoparticle-containing composite particle dispersion liquid comprises the following steps: adding water into the nano particles, uniformly mixing, adding a polymer monomer under high-speed stirring, polymerizing, and standing to obtain the nano-particle.
8. The preparation method of the stomach nourishing xiangsha emulsion according to claim 6 is characterized in that the preparation method of the compound emulsifier comprises the following steps: mixing dicyclic alcohol and phospholipid material, adding organic solvent to dissolve, reacting at 40-60 deg.c for 1-2 hr, rotary evaporating to eliminate organic solvent until the solution is viscous, adding adsorbent, stirring and drying.
9. The stomach nourishing cream of claim 8, wherein the adsorbent is one or more of lactose, microcrystalline cellulose, aerosil and calcium phosphate.
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101524349A (en) * 2007-09-20 2009-09-09 中国医学科学院药物研究所 Phospholipids compound of bicyclo-ethanol and preparation method thereof
CN103665697A (en) * 2013-11-11 2014-03-26 上海交通大学 Nanoparticle and polymer composite particle and application thereof
CN103736070A (en) * 2014-01-23 2014-04-23 江西美媛春药业股份有限公司 Xiangsha (Chinese character) oral emulsion for nourishing stomach and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101524349A (en) * 2007-09-20 2009-09-09 中国医学科学院药物研究所 Phospholipids compound of bicyclo-ethanol and preparation method thereof
CN103665697A (en) * 2013-11-11 2014-03-26 上海交通大学 Nanoparticle and polymer composite particle and application thereof
CN103736070A (en) * 2014-01-23 2014-04-23 江西美媛春药业股份有限公司 Xiangsha (Chinese character) oral emulsion for nourishing stomach and preparation method thereof

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