CN117482060A - Traditional Chinese medicine dripping pill for reducing uric acid and preparation method thereof - Google Patents
Traditional Chinese medicine dripping pill for reducing uric acid and preparation method thereof Download PDFInfo
- Publication number
- CN117482060A CN117482060A CN202311823747.2A CN202311823747A CN117482060A CN 117482060 A CN117482060 A CN 117482060A CN 202311823747 A CN202311823747 A CN 202311823747A CN 117482060 A CN117482060 A CN 117482060A
- Authority
- CN
- China
- Prior art keywords
- polyethylene glycol
- uric acid
- dripping pill
- volatile oil
- chinese medicine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- LEHOTFFKMJEONL-UHFFFAOYSA-N Uric Acid Chemical compound N1C(=O)NC(=O)C2=C1NC(=O)N2 LEHOTFFKMJEONL-UHFFFAOYSA-N 0.000 title claims abstract description 62
- 239000003814 drug Substances 0.000 title claims abstract description 56
- 239000006187 pill Substances 0.000 title claims abstract description 55
- TVWHNULVHGKJHS-UHFFFAOYSA-N Uric acid Natural products N1C(=O)NC(=O)C2NC(=O)NC21 TVWHNULVHGKJHS-UHFFFAOYSA-N 0.000 title claims abstract description 53
- 229940116269 uric acid Drugs 0.000 title claims abstract description 53
- 230000001603 reducing effect Effects 0.000 title claims abstract description 21
- 238000002360 preparation method Methods 0.000 title description 8
- 239000000341 volatile oil Substances 0.000 claims abstract description 52
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 45
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 45
- 229920001661 Chitosan Polymers 0.000 claims abstract description 20
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 18
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims abstract description 18
- 239000011159 matrix material Substances 0.000 claims abstract description 18
- 244000062241 Kaempferia galanga Species 0.000 claims abstract description 16
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- 235000014113 dietary fatty acids Nutrition 0.000 claims abstract description 16
- 239000000194 fatty acid Substances 0.000 claims abstract description 16
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- -1 fatty acid salt Chemical class 0.000 claims abstract description 13
- 229930003427 Vitamin E Natural products 0.000 claims abstract description 9
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims abstract description 9
- 239000003921 oil Substances 0.000 claims abstract description 9
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- 235000019165 vitamin E Nutrition 0.000 claims abstract description 9
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- 239000004353 Polyethylene glycol 8000 Substances 0.000 claims abstract description 8
- 229940085678 polyethylene glycol 8000 Drugs 0.000 claims abstract description 8
- 235000019446 polyethylene glycol 8000 Nutrition 0.000 claims abstract description 8
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- 238000010438 heat treatment Methods 0.000 claims description 19
- 238000006243 chemical reaction Methods 0.000 claims description 13
- 238000002156 mixing Methods 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 238000003756 stirring Methods 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 7
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 5
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- 239000003054 catalyst Substances 0.000 claims description 4
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- 238000001816 cooling Methods 0.000 claims description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical group [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 229930006000 Sucrose Natural products 0.000 claims description 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 2
- 239000012298 atmosphere Substances 0.000 claims description 2
- 125000004432 carbon atom Chemical group C* 0.000 claims description 2
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- 239000005662 Paraffin oil Substances 0.000 description 8
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 8
- 230000002401 inhibitory effect Effects 0.000 description 8
- 241000125175 Angelica Species 0.000 description 7
- 201000001431 Hyperuricemia Diseases 0.000 description 7
- 239000002994 raw material Substances 0.000 description 7
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- 229940093429 polyethylene glycol 6000 Drugs 0.000 description 5
- KDCGOANMDULRCW-UHFFFAOYSA-N 7H-purine Chemical compound N1=CNC2=NC=NC2=C1 KDCGOANMDULRCW-UHFFFAOYSA-N 0.000 description 4
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 4
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- 125000002091 cationic group Chemical group 0.000 description 4
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- 238000004519 manufacturing process Methods 0.000 description 4
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- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical group [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 description 4
- 238000000967 suction filtration Methods 0.000 description 4
- 238000001291 vacuum drying Methods 0.000 description 4
- PQGCEDQWHSBAJP-TXICZTDVSA-N 5-O-phosphono-alpha-D-ribofuranosyl diphosphate Chemical compound O[C@H]1[C@@H](O)[C@@H](O[P@](O)(=O)OP(O)(O)=O)O[C@@H]1COP(O)(O)=O PQGCEDQWHSBAJP-TXICZTDVSA-N 0.000 description 3
- 241000213006 Angelica dahurica Species 0.000 description 3
- TYPSVDGIQAOBAD-DZGCQCFKSA-N Atractylone Chemical compound C([C@]1(C)C2)CCC(=C)[C@@H]1CC1=C2OC=C1C TYPSVDGIQAOBAD-DZGCQCFKSA-N 0.000 description 3
- TYPSVDGIQAOBAD-UHFFFAOYSA-N atractylone Natural products C1C2(C)CCCC(=C)C2CC2=C1OC=C2C TYPSVDGIQAOBAD-UHFFFAOYSA-N 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
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- 238000001914 filtration Methods 0.000 description 3
- 229920001993 poloxamer 188 Polymers 0.000 description 3
- 229940044519 poloxamer 188 Drugs 0.000 description 3
- 230000006825 purine synthesis Effects 0.000 description 3
- 210000002966 serum Anatomy 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- WEEGYLXZBRQIMU-UHFFFAOYSA-N Eucalyptol Chemical compound C1CC2CCC1(C)OC2(C)C WEEGYLXZBRQIMU-UHFFFAOYSA-N 0.000 description 2
- 102000018251 Hypoxanthine Phosphoribosyltransferase Human genes 0.000 description 2
- UGQMRVRMYYASKQ-KQYNXXCUSA-N Inosine Chemical compound O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1N1C2=NC=NC(O)=C2N=C1 UGQMRVRMYYASKQ-KQYNXXCUSA-N 0.000 description 2
- 101800000628 PDH precursor-related peptide Proteins 0.000 description 2
- 102000005773 Xanthine dehydrogenase Human genes 0.000 description 2
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- 230000009286 beneficial effect Effects 0.000 description 2
- 229960002529 benzbromarone Drugs 0.000 description 2
- WHQCHUCQKNIQEC-UHFFFAOYSA-N benzbromarone Chemical compound CCC=1OC2=CC=CC=C2C=1C(=O)C1=CC(Br)=C(O)C(Br)=C1 WHQCHUCQKNIQEC-UHFFFAOYSA-N 0.000 description 2
- 210000000941 bile Anatomy 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 239000006227 byproduct Substances 0.000 description 2
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- 238000004821 distillation Methods 0.000 description 2
- 239000000284 extract Substances 0.000 description 2
- 229930003935 flavonoid Natural products 0.000 description 2
- 150000002215 flavonoids Chemical class 0.000 description 2
- 235000017173 flavonoids Nutrition 0.000 description 2
- 239000010646 galangal oil Substances 0.000 description 2
- UYTPUPDQBNUYGX-UHFFFAOYSA-N guanine Chemical compound O=C1NC(N)=NC2=C1N=CN2 UYTPUPDQBNUYGX-UHFFFAOYSA-N 0.000 description 2
- RQFCJASXJCIDSX-UUOKFMHZSA-N guanosine 5'-monophosphate Chemical compound C1=2NC(N)=NC(=O)C=2N=CN1[C@@H]1O[C@H](COP(O)(O)=O)[C@@H](O)[C@H]1O RQFCJASXJCIDSX-UUOKFMHZSA-N 0.000 description 2
- FDGQSTZJBFJUBT-UHFFFAOYSA-N hypoxanthine Chemical compound O=C1NC=NC2=C1NC=N2 FDGQSTZJBFJUBT-UHFFFAOYSA-N 0.000 description 2
- 230000005764 inhibitory process Effects 0.000 description 2
- 230000004060 metabolic process Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000012299 nitrogen atmosphere Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 238000002791 soaking Methods 0.000 description 2
- 238000001256 steam distillation Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- VZGDMQKNWNREIO-UHFFFAOYSA-N tetrachloromethane Chemical compound ClC(Cl)(Cl)Cl VZGDMQKNWNREIO-UHFFFAOYSA-N 0.000 description 2
- 210000002700 urine Anatomy 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- SDOFMBGMRVAJNF-KVTDHHQDSA-N (2r,3r,4r,5r)-6-aminohexane-1,2,3,4,5-pentol Chemical compound NC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO SDOFMBGMRVAJNF-KVTDHHQDSA-N 0.000 description 1
- KJPRLNWUNMBNBZ-QPJJXVBHSA-N (E)-cinnamaldehyde Chemical compound O=C\C=C\C1=CC=CC=C1 KJPRLNWUNMBNBZ-QPJJXVBHSA-N 0.000 description 1
- MSWZFWKMSRAUBD-GASJEMHNSA-N 2-amino-2-deoxy-D-galactopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@H](O)[C@@H]1O MSWZFWKMSRAUBD-GASJEMHNSA-N 0.000 description 1
- 206010065553 Bone marrow failure Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000546188 Hypericum Species 0.000 description 1
- 235000017309 Hypericum perforatum Nutrition 0.000 description 1
- UGQMRVRMYYASKQ-UHFFFAOYSA-N Hypoxanthine nucleoside Natural products OC1C(O)C(CO)OC1N1C(NC=NC2=O)=C2N=C1 UGQMRVRMYYASKQ-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 229930010555 Inosine Natural products 0.000 description 1
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- CCRCUPLGCSFEDV-UHFFFAOYSA-N cinnamic acid methyl ester Natural products COC(=O)C=CC1=CC=CC=C1 CCRCUPLGCSFEDV-UHFFFAOYSA-N 0.000 description 1
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- 229940117916 cinnamic aldehyde Drugs 0.000 description 1
- WJSDHUCWMSHDCR-VMPITWQZSA-N cinnamyl acetate Natural products CC(=O)OC\C=C\C1=CC=CC=C1 WJSDHUCWMSHDCR-VMPITWQZSA-N 0.000 description 1
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- BQSJTQLCZDPROO-UHFFFAOYSA-N febuxostat Chemical compound C1=C(C#N)C(OCC(C)C)=CC=C1C1=NC(C)=C(C(O)=O)S1 BQSJTQLCZDPROO-UHFFFAOYSA-N 0.000 description 1
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- 210000003494 hepatocyte Anatomy 0.000 description 1
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- 230000007246 mechanism Effects 0.000 description 1
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- 230000008018 melting Effects 0.000 description 1
- CCRCUPLGCSFEDV-BQYQJAHWSA-N methyl trans-cinnamate Chemical compound COC(=O)\C=C\C1=CC=CC=C1 CCRCUPLGCSFEDV-BQYQJAHWSA-N 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
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- 231100000572 poisoning Toxicity 0.000 description 1
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- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 1
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- DBABZHXKTCFAPX-UHFFFAOYSA-N probenecid Chemical compound CCCN(CCC)S(=O)(=O)C1=CC=C(C(O)=O)C=C1 DBABZHXKTCFAPX-UHFFFAOYSA-N 0.000 description 1
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Classifications
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9062—Alpinia, e.g. red ginger or galangal
-
- 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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
-
- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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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)
- A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
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Abstract
The invention provides a traditional Chinese medicine dripping pill for reducing uric acid, which comprises the following components: modified polyethylene glycol, vitamin E oil, traditional Chinese medicine volatile oil and auxiliary agent; the modified polyethylene glycol is prepared by reacting polyethylene glycol with carboxymethyl chitosan and fatty acid salt. According to the invention, the galangal volatile oil, the rhizoma atractylodis volatile oil, the angelica volatile oil and the cinnamon volatile oil are mixed to be used as the traditional Chinese medicine volatile oil, and the multiple components are compounded to have good functions of protecting liver and kidney and regulating viscera, so that uric acid is reduced; in addition, the dripping pill matrix is prepared by compounding modified polyethylene glycol, polyethylene glycol 8000 and vitamin E oil, has good compatibility with medicines, can generate a synergistic effect among various components, further improves the stability and the medicine loading capacity, overcomes the defects in the prior art, and has good application prospect.
Description
Technical Field
The invention relates to the field of pharmaceutical preparations, in particular to a traditional Chinese medicine dripping pill for reducing uric acid and a preparation method thereof.
Background
In normal human body, more than 99% of blood circulation exists in the form of sodium urate (referred to as urate for short), and the fluctuation of serum urate is in a narrow range, and according to domestic data of "gout theory" (metabolism of purine nucleotide in chapter III and hyperuricemia, authors Miao Zhimin, published in 2006, people health publishers), men are 5.7mg/dl (healthy people range from 4.0 to 6.0 mg/dl), and women are 4.3mg/dl (healthy people range from 3.0 to 5.0 mg/dl). Hyperuricemia is generally diagnosed when serum uric acid levels are repeatedly detected within one week under normal diet conditions, at a level of 7.0mg/dl or more. A national study (Wu J, qia L, cheng XQ, et al Hypericum and clustering of cardiovascular risk factors in the Chinese adult preparation, sci Rep.2017 Jul 14;7 (1): 5456) conducted by affiliated hospitals at university of Beijing, kyoho, showed a prevalence of hyperuricemia of 13% in the Chinese population, 18.5% in men and 8% in women.
Hyperuricemia is the basis of gout and can cause elevated blood urate concentrations when uric acid production is increased and/or uric acid excretion is decreased. Uric acid is the end product of purine metabolism, leading to elevated blood urate concentrations, i.e. an increase in purine synthesis, possibly through several mechanisms: 1. the substrate phosphoribosyl pyrophosphate and/or glutamine is increased; 2. an increase in the amount or activity of the enzyme or a decrease in sensitivity to feedback inhibition by purine nucleosides; 3. when the inhibition of the enzyme is decreased by decreasing adenylate or guanylate, the purine synthesis is increased and the production of allouric acid is increased. Clinically, some patients with hyperuricemia are caused by a deficiency of xanthine-guanine phosphoribosyl transferase (HGPRT), which promotes the conversion of inosine to inosine nucleotides, and guanine to guanylic acid, and when HGPRT is deficient, PRPP consumption decreases and PRPP accumulates to accelerate purine synthesis and uric acid production. Of course, there are also some patients, and uric acid production is not increased, because of reduced renal clearance.
At present, drugs for reducing uric acid clinically are mainly classified into two types: firstly, a medicament for promoting uric acid excretion represented by benzbromarone and probenecid; secondly, the drug which is mainly composed of allopurinol and febuxostat and used for inhibiting uric acid generation. But also with various degrees of side effects such as liver injury, bone marrow depression. Domestic researches show (Xue Xuemei, xu Xin, yin Chaodeng) that different extracts of galangal have the effects of reducing uric acid and inhibiting xanthine oxidase (GmbH) and experimental researches [ J ] university of Yangtze river (from the department edition), 2017,14 (24): 1-3, 22), and the galangal oil extracted from galangal has the remarkable effect of inhibiting Xanthine Oxidase (XOD), and the XOD is a key enzyme for catalyzing the metabolism of purine substances of human bodies into uric acid, so that the activity of the Xad can reduce the concentration of uric acid in the human body, compared with the diuretic benzbromarone, the side effect of the galangal oil is smaller, and the galangal has great advantages in promoting the excretion of uric acid.
The dripping pill is prepared by heating and melting solid or liquid medicine and proper matrix, dissolving, emulsifying or suspending in matrix, dripping into immiscible condensate, and cooling to obtain pellet. At present, polyethylene glycol is generally used as a water-soluble matrix for preparing the oral dripping pill, and the water-soluble matrix can enable the medicine to be rapidly dissolved in the gastrointestinal tract, so that the bioavailability and the medicine effect are improved. However, polyethylene glycol has a low drug loading and poor compatibility with hydrophobic drugs.
Disclosure of Invention
In order to solve the defects, the invention provides a traditional Chinese medicine dripping pill for reducing uric acid, which adopts the mixture of galangal volatile oil, rhizoma atractylodis volatile oil, angelica volatile oil and cinnamon volatile oil as the traditional Chinese medicine volatile oil, and the combination of multiple components has good liver and kidney protecting and viscera regulating functions, and is beneficial to reducing uric acid; in addition, the dripping pill matrix is prepared by compounding modified polyethylene glycol, polyethylene glycol 8000 and vitamin E oil, has good compatibility with medicines, can generate a synergistic effect among various components, further improves the stability and the medicine loading capacity, overcomes the defects in the prior art, and has good application prospect.
The invention aims at providing a traditional Chinese medicine dripping pill for reducing uric acid, which consists of a dripping pill matrix and traditional Chinese medicine volatile oil;
wherein the components of the dripping pill matrix comprise modified polyethylene glycol, polyethylene glycol 8000, vitamin E oil and auxiliary agent;
the modified polyethylene glycol is prepared by reacting polyethylene glycol with carboxymethyl chitosan and fatty acid salt.
Further, the mass ratio of the polyethylene glycol to the carboxymethyl chitosan to the fatty acid salt is 1:1-3:1-5.
Further, the average molecular weight of the polyethylene glycol is 5000-10000; preferably, the polyethylene glycol is selected from polyethylene glycol 6000.
Further, the auxiliary agent is one or more selected from glycerol, sucrose, honey, hydroxypropyl cellulose, sodium carboxymethyl starch, methyl cellulose, glycerogelatin and poloxamer.
Further, the fatty acid salt is selected from fatty acid salts with carbon chain of 16-24 carbon atoms; preferably, the fatty acid salt is selected from sodium stearate.
Further, the mass ratio of the modified polyethylene glycol, the polyethylene glycol 8000 and the vitamin E oil in the dripping pill matrix is 1:2-3:2-3.
Further, the mass ratio of the traditional Chinese medicine volatile oil to the dripping pill matrix is 1:3-8.
Further, the traditional Chinese medicine volatile oil is galangal volatile oil, rhizoma atractylodis volatile oil, angelica volatile oil and cinnamon volatile oil.
The traditional Chinese medicine composition has the following functions:
galangal is a dried rhizome of plants of Zingiberaceae, and mainly contains flavonoids, volatile oils and diarylheptanoids. The rhizome contains volatile oil 0.5-1.5%, wherein the main components are 1, 8-cineole and methyl cinnamate. From two acute hyperuricemia model tests of promoting uric acid generation and inhibiting uric acid excretion by hypoxanthine, it can be seen that galangal has remarkable Xanthine Oxidase (XOD) inhibitor effect, and XOD is a key enzyme for catalyzing purine substances of human body to be metabolized into uric acid, and can inhibit the activity of the key enzyme and reduce the uric acid concentration in the body.
The rhizoma Atractylodis effective component is volatile oil, and contains atractylone, beta-eucalyptol, etc. The atractylin can promote bile secretion, and experiments show that the atractylin has a promoting effect on the synthesis of mouse liver protein, thereby improving liver function. The beta-eucalyptol and atractylone contained in the extract have certain protection effect on liver poisoning known by galactosamine or carbon tetrachloride. In addition, atractylone has inhibitory effect on hepatic cell injury caused by tert-butyl peroxide. Yuan Gongyu, and the like, the rhizoma atractylodis volatile oil can remarkably reduce blood uric acid level by promoting uric acid excretion and can inhibit inflammation.
Chinese angelica is mainly composed of volatile oil and water-soluble components. Wherein the volatile oil can regulate pH value of human body, alkalize urine, inhibit uric acid formation, and relieve gout. Can improve the filtering function of glomerulus and the absorption function of tubular, reduce kidney damage and prevent and treat various kidney diseases caused by gout.
The effective part of the cinnamon is volatile oil with the content of 1-2%, and the main components are cinnamaldehyde, a small amount of cinnamyl acetate and the like. Zhao X et al found that the volatile oil extracted from cinnamon had the effect of lowering serum liver uric acid level of hyperuricemia big tree and inhibiting xanthine dehydrogenase and xanthine oxidase.
Further, the raw materials of the traditional Chinese medicine volatile oil comprise the following medicinal materials in parts by mass: 3-6 parts of galangal, 3-9 parts of rhizoma atractylodis, 6-12 parts of Chinese angelica and 1-5 parts of cinnamon; preferably, the raw materials of the traditional Chinese medicine volatile oil adopt the following medicinal materials in parts by mass: 6 parts of galangal, 6 parts of rhizoma atractylodis, 8 parts of Chinese angelica and 3 parts of cinnamon.
Further, the preparation method of the traditional Chinese medicine volatile oil comprises the following steps: weighing the medicinal materials according to the formula, soaking in water until the core is completely penetrated, filtering to obtain water absorption of 90-100%, adding water 5-10 times the weight of the raw materials, extracting by steam distillation to obtain 4-6 h, and dehydrating to obtain the final product.
The invention also provides a preparation method of the uric acid reducing traditional Chinese medicine dripping pill, which comprises the following steps:
s1, mixing polyethylene glycol and carboxymethyl chitosan in an inert atmosphere, and heating and performing ultrasonic reaction under the condition of a catalyst to obtain polyethylene glycol grafted with carboxymethyl chitosan;
s2, dissolving fatty acid salt in water, then blending with polyethylene glycol grafted with carboxymethyl chitosan, heating for reaction, stirring, and performing post-treatment to obtain modified polyethylene glycol;
s3, blending the modified polyethylene glycol with other components, heating, preserving heat, dripping into cooling liquid, cooling and solidifying to obtain the uric acid-reducing traditional Chinese medicine dripping pill.
Further, in step S1, the heating temperature is 70-100 ℃ and the heating time is 1-3 h.
Further, in the step S2, the temperature of the heating reaction is 70-100 ℃ and the time is 1-2 h
Further, in the step S3, the temperature of heating and heat preservation is 60-90 ℃.
Further, in step S3, the cooling liquid is selected from paraffin oil and methyl silicone oil.
The invention has the beneficial effects that:
(1) The polyethylene glycol as the raw material of the modified polyethylene glycol has good biocompatibility with chitosan, has good affinity to human cells, and does not generate rejection reaction. The invention firstly reacts with carboxyl of carboxymethyl chitosan through hydroxyl at two ends of polyethylene glycol to form stable ester bond, then reacts with fatty acid, chitosan is a cationic polyamine, amine group on a molecular chain of the cationic polyamine has strong reactivity and strong adsorptivity, and the cationic polyamine can be combined with fatty acid to form an ionic complex, and because long alkyl chain in fatty acid molecules has hydrophobicity, the compatibility with oily drugs is excellent, and the cationic polyamine can interact with hydrophobic groups in the oily drugs, the oily drug molecules can be aggregated to form micelle or microemulsion structures under the action of fatty acid by the interaction, the stability and the drug aggregation effect of the dripping pill and the drug loading capacity of the polyethylene glycol are improved.
(2) According to the invention, the galangal volatile oil, the rhizoma atractylodis volatile oil, the angelica volatile oil and the cinnamon volatile oil are mixed to serve as the traditional Chinese medicine volatile oil, and synergistic and complementary effects are generated between the galangal volatile oil, the rhizoma atractylodis volatile oil, the angelica volatile oil and the cinnamon volatile oil, so that uric acid reducing effect of the dripping pill is greatly enhanced: the xanthine oxidase inhibitor in the galangal and the uric acid excretion promotion effect in the rhizoma atractylodis can be mutually cooperated, so that the uric acid reduction effect is enhanced; the alkalization urine effect of angelica and the xanthine dehydrogenase and xanthine oxidase inhibiting effect in cinnamon play a synergistic role, so that the uric acid reducing effect is further enhanced; the functions of promoting bile secretion and protecting liver in rhizoma atractylodis can supplement the protection function of flavonoids and volatile oil components in rhizoma alpiniae officinarum on liver; the functions of regulating the pH value and improving the kidney function in the angelica can be complementary with the protection function of the rhizoma atractylodis and the galangal on the kidney; the uric acid reducing and xanthinase inhibiting effects of cinnamon can be complemented with the uric acid reducing effects of other medicinal materials.
Detailed Description
The present invention will be further described with reference to the specific embodiments, and it should be noted that, on the premise of no conflict, new embodiments may be formed by any combination of the embodiments or technical features described below. Materials and equipment used in this example are commercially available, except as specifically noted. The specific embodiments are illustrative only, and are not intended to limit the scope of the present application.
The preparation method of the traditional Chinese medicine volatile oil provided by the embodiment of the invention comprises the following steps:
soaking 6 parts by mass of galangal, 6 parts by mass of rhizoma atractylodis, 8 parts by mass of angelica and 3 parts by mass of cinnamon in 40 parts by mass of water for 24 h, filtering, adding 100 parts of water, extracting 6 h by a steam distillation method, and dehydrating to obtain the traditional Chinese medicine volatile oil.
The fatty acid salt of the embodiment of the invention is sodium stearate.
The auxiliary agent of the embodiment of the invention is sodium carboxymethyl starch and poloxamer 188.
The cooling liquid of the embodiment of the invention is paraffin oil.
The carboxymethyl chitosan of the embodiment of the invention has an average molecular weight of 8000.
The parts and the parts in the embodiment of the invention refer to parts by mass.
Example 1; a traditional Chinese medicine dripping pill for reducing uric acid comprises the following steps:
s1, under the nitrogen atmosphere, mixing 1 part by mass of polyethylene glycol 6000 and 2 parts by mass of carboxymethyl chitosan, adding 5 parts by mass of anhydrous dimethyl sulfoxide, stirring for 10 min, then adding 70% sulfuric acid serving as a catalyst (the sulfuric acid dosage is 0.2 wt% of that of the polyethylene glycol), heating to 85 ℃ for ultrasonic reaction to 2.5 h, removing unreacted raw materials and byproducts through reduced pressure distillation, and obtaining polyethylene glycol grafted with carboxymethyl chitosan after suction filtration and vacuum drying;
s2, dissolving 2 parts by mass of sodium stearate in 15 parts by mass of hot water with the temperature of 70 ℃, then blending with polyethylene glycol grafted with carboxymethyl chitosan, heating to 80 ℃, stirring for reaction of 1.5 h, carrying out suction filtration, washing with pure water for 3 times, and carrying out vacuum drying to obtain the modified polyethylene glycol;
s3, mixing 1 part by mass of modified polyethylene glycol, 2 parts by mass of polyethylene glycol 8000, 2 parts by mass of vitamin E oil, 1 part by mass of sodium carboxymethyl starch and 0.3 part by mass of poloxamer 188 to form a dripping pill matrix, adding the traditional Chinese medicine volatile oil while stirring (the mass ratio of the traditional Chinese medicine volatile oil to the dripping pill matrix is 1:5), heating to 70 ℃, preserving heat for 10 min, dripping each pill into ice bath paraffin oil according to 30 mg, taking out the dripping pill from the paraffin oil, sucking the paraffin oil on the surface of the dripping pill, placing the dripping pill into a closed container, and preserving at room temperature, a shade place or a cold place to obtain the traditional Chinese medicine dripping pill for reducing uric acid.
Example 2; s1, under the nitrogen atmosphere, mixing 1 part by mass of polyethylene glycol 6000 and 2 parts by mass of carboxymethyl chitosan, adding 5 parts by mass of anhydrous dimethyl sulfoxide, stirring for 10 min, then adding 70% sulfuric acid serving as a catalyst (the sulfuric acid dosage is 0.2 wt% of that of the polyethylene glycol), heating to 75 ℃ for ultrasonic reaction to 2.5 h, removing unreacted raw materials and byproducts through reduced pressure distillation, and obtaining polyethylene glycol grafted with carboxymethyl chitosan after suction filtration and vacuum drying;
s2, dissolving 2 parts by mass of sodium stearate in 15 parts by mass of hot water with the temperature of 70 ℃, then blending with polyethylene glycol grafted with carboxymethyl chitosan, heating to 75 ℃, stirring for reaction of 1.5 h, carrying out suction filtration, washing with pure water for 3 times, and carrying out vacuum drying to obtain the modified polyethylene glycol;
s3, mixing 1 part by mass of modified polyethylene glycol, 2.5 parts by mass of polyethylene glycol 8000, 2.5 parts by mass of vitamin E oil, 1 part by mass of sodium carboxymethyl starch and 0.2 part by mass of poloxamer 188 to form a dripping pill matrix, adding the traditional Chinese medicine volatile oil while stirring (the mass ratio of the traditional Chinese medicine volatile oil to the dripping pill matrix is 1:4), heating to 70 ℃, preserving heat for 10 min, dripping each pill into ice bath paraffin oil according to 30 mg, taking out the dripping pill from the paraffin oil, sucking the paraffin oil on the surface of the dripping pill, placing the dripping pill into a closed container, and preserving at room temperature, a shade place or a cold place to obtain the traditional Chinese medicine dripping pill for reducing uric acid.
Comparative example 1
A Chinese medicinal dripping pill for reducing uric acid is prepared from the same raw materials and preparation method as in example 1 except that comparative example 1 does not contain modified polyethylene glycol, but is replaced by polyethylene glycol 6000 in equal parts by weight.
Test case
10 samples were prepared according to the procedures and methods of examples 1-2 and comparative example 1, and then the effective drug loading amount of the prepared uric acid-reduced traditional Chinese medicine dripping pills and the thermal stability of the prepared uric acid-reduced traditional Chinese medicine dripping pills under a simulated gastrointestinal environment (at 65 ℃ for 20 min) were tested, and the test results were averaged and the detection results are shown in table 1.
TABLE 1 effective drug loading and thermal stability test results of uric acid-lowering Chinese medicinal dripping pills obtained in examples 1-2 and comparative example 1
As can be seen from Table 1, the uric acid-reducing traditional Chinese medicine dripping pill has better thermal stability and greatly improved drug loading. In contrast, in comparative example 1, the conventional polyethylene glycol 6000 was used instead of the modified polyethylene glycol, and the drug loading rate and the thermal stability of the dripping pill were poor.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present disclosure describes embodiments, not every embodiment is provided with a separate embodiment, and that this description is provided for clarity only, and that the disclosure is not limited to the embodiments described in detail below, and that the embodiments described in the examples may be combined as appropriate to form other embodiments that will be apparent to those skilled in the art.
Claims (10)
1. A traditional Chinese medicine dripping pill for reducing uric acid is characterized by comprising a dripping pill matrix and traditional Chinese medicine volatile oil;
wherein the components of the dripping pill matrix comprise modified polyethylene glycol, polyethylene glycol 8000, vitamin E oil and auxiliary agent;
the modified polyethylene glycol is prepared by reacting polyethylene glycol with carboxymethyl chitosan and fatty acid salt.
2. The uric acid lowering Chinese medicinal dripping pill of claim 1, wherein the polyethylene glycol has an average molecular weight of 5000-10000.
3. The uric acid lowering Chinese medicinal dripping pill of claim 1, wherein the fatty acid salt is selected from fatty acid salts with carbon chain having 16-24 carbon atoms.
4. The uric acid lowering Chinese medicinal dripping pill of claim 1, wherein the adjuvant is selected from one or more of glycerol, sucrose, honey, hydroxypropyl cellulose, sodium carboxymethyl starch, methylcellulose, glycerogelatin, and poloxamer.
5. The uric acid lowering traditional Chinese medicine dripping pill according to claim 1, wherein the mass ratio of the modified polyethylene glycol, the polyethylene glycol 8000 and the vitamin E oil in the dripping pill matrix is 1:2-3:2-3.
6. The uric acid lowering Chinese medicinal dripping pill as defined in claim 1, wherein the mass ratio of the Chinese medicinal volatile oil to the dripping pill matrix is 1:3-8.
7. The uric acid lowering Chinese medicinal dripping pill of claim 1, wherein the Chinese medicinal volatile oil is galangal volatile oil, rhizoma Atractylodis volatile oil, radix Angelicae sinensis volatile oil, and cortex Cinnamomi volatile oil.
8. The method for preparing the uric acid lowering Chinese medicinal dripping pill according to any one of claims 1 to 7, wherein the method for preparing the uric acid lowering Chinese medicinal dripping pill comprises the following steps of:
s1, mixing polyethylene glycol and carboxymethyl chitosan in an inert atmosphere, and heating and performing ultrasonic reaction under the condition of a catalyst to obtain polyethylene glycol grafted with carboxymethyl chitosan;
s2, dissolving fatty acid salt in water, then blending with polyethylene glycol grafted with carboxymethyl chitosan, heating for reaction, stirring, and performing post-treatment to obtain modified polyethylene glycol;
s3, blending the modified polyethylene glycol with other components, heating, preserving heat, dripping into cooling liquid, cooling and solidifying to obtain the uric acid-reducing traditional Chinese medicine dripping pill.
9. The method for preparing Chinese medicinal dripping pills for reducing uric acid according to claim 8, wherein in the step S1, the temperature of the heating ultrasonic reaction is 70-100 ℃ and the time is 1-3 h.
10. The method for preparing Chinese medicinal dripping pills for reducing uric acid according to claim 8, wherein in the step S2, the heating reaction is carried out at a temperature of 70-100 ℃ for a time of 1-2 h.
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