CN108310123A - A kind of pharmaceutical composition and its preparation method and application for preventing and/or treating hyperuricemia - Google Patents

A kind of pharmaceutical composition and its preparation method and application for preventing and/or treating hyperuricemia Download PDF

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Publication number
CN108310123A
CN108310123A CN201810265726.6A CN201810265726A CN108310123A CN 108310123 A CN108310123 A CN 108310123A CN 201810265726 A CN201810265726 A CN 201810265726A CN 108310123 A CN108310123 A CN 108310123A
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parts
preparation
pharmaceutical composition
rosa roxburghii
raw material
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刘沁琴
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Sichuan Long Zhong Chengda Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/738Rosa (rose)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/82Theaceae (Tea family), e.g. camellia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
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  • Pharmacology & Pharmacy (AREA)
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  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The present invention provides a kind of pharmaceutical compositions and its preparation method and application for preventing and/or treating hyperuricemia, it is the preparation that the raw material matched containing following weight is prepared:30~50 parts of Rosa roxburghii Tratt, 10~30 parts of Pu'er tea, 10~30 parts of Radix Astragali.The composition further includes following raw material:5~20 parts of 10~30 parts of pueraria lobata and/or sea-buckthorn.The results show, compared with the drug of existing treatment hyperuricemia and gout, composition of the invention is more safe and effective, has a vast market application prospect.

Description

A kind of pharmaceutical composition and its preparation for preventing and/or treating hyperuricemia Method and purposes
Technical field
The present invention relates to a kind of pharmaceutical composition for preventing and/or treating hyperuricemia and preparation method thereof and use On the way.
Background technology
Uric acid is the final product of human body purine metabolism, is mainly generated by liver metabolism, and kidney excretion goes out in vitro.Antihyperuricemic Disease (hyperuricemia, HUA) is that uric acid is excessive or kidney excretion uric acid is reduced since liver metabolism generates in blood, or The reason of the two has concurrently generates uric acid in blood level and increases, and even higher than blood uric acid generates saturated concentration (416.5 μ of crystallization Mol/L pathological state).Patients with Hyperuricemia can be precipitated because of monosodium urate salt (monosodium, MSU) crystal and gradually accumulate It is tired to induce gout, it is also possible to symptom do not occur, but the uric acid total amount of patient's body will be apparently higher than normal person in the case of two kinds Group.In recent years, with the improvement of people's living standards, the change of dietary structure and living habit, the illness rate of hyperuricemia Increase year by year, epidemiological study data shows that the morbidity of hyperuricemia and primary gout is in rising trend, in China, Through there is 1.2 hundred million HUA crowd, the 10% of total population is accounted about, person in middle and old age and postclimacteric women are group of people at high risk, are sent out in recent years The sick age is also in the trend of rejuvenation.
Currently, the drug of clinical treatment hyperuricemia is generally divided into three classes.(1) releasing uric acid prescription medicine:Uricosuric Include mainly probenecid, Sulfinpyrazone, Benzbromarone etc..Such drug can prevent reabsorption of the renal tubule to uric acid, increase urine The discharge of acid, to play the role of reducing serum uric acid level in human body, also human body while side effect multiple rows of uric acid Other trace elements also excrete, and can cause low blood sodium, Diagnostic value, low blood calcium, so use cannot be grown, but also to liver, kidney There is side effect, use can not be grown.(2) drug for inhibiting uric acid to generate:The drug for clinically commonly uric acid being inhibited to generate is other Fast alcohol, the medicine are a kind of purine oxidase inhibitor of strength, can effectively reduce uric acid and generate, reduce uric acid level in human body Drug, but Allopurinol has the side effects such as the systemic allergics symptoms such as generation fash, poisoning syndrome, bone marrow suppression, hepatic injury, It is very careful using upper requirement.(3) drug of alkalized urine:The alkalinity medicine such as sodium bicarbonate, potassium citrate and citron mixture acid Object this acted on without anti-trioxypurine but can alkalized urine, increase solubility of the uric acid in blood, uric acid made to be not easy to gather and shape in urine At crystallization.Calculus urate action speed is treated in phleboclysis, and common drug has sodium lactate solution and 5% sodium bicarbonate molten Liquid, due to the use of when need close observation blood pressure situations such as, it is therefore desirable to hospitalization;Oral sodium bicarbonate is the most convenient, still May easily cause and have a stomach upset, before beging half an hour be administered at empty stomach, because stomach is acidic environment, especially feed after be even more such as This, and in stomach long-time indwelling stomach, at this moment such as eating sodium bicarbonate alkaline drug can neutralize with hydrochloric acid in gastric juice quickly, can not absorb Enter blood and flow into kidney alkalized urine, and many gases generated keep stomach more glutted, the people if any stomach trouble such as gastric ulcer is easy Bleeding and perforation.
Therefore, it is badly in need of a kind of safe, treatment hyperuricemia without side-effects drug now.
Invention content
In order to solve the above technical problem, the present invention provides a kind of medicines for preventing and/or treating hyperuricemia Compositions, it is the preparation that the raw material matched containing following weight is prepared:30~50 parts of Rosa roxburghii Tratt, Pu'er tea 10~30 Part, 10~30 parts of Radix Astragali.
Further, it is the preparation that the raw material matched containing following weight is prepared:40 parts of Rosa roxburghii Tratt, Pu'er tea 20 Part, 20 parts of Radix Astragali.
Further, described pharmaceutical composition further includes following raw material:5~20 parts of 10~30 parts of pueraria lobata and/or sea-buckthorn.
Further, the pueraria lobata is 20 parts, and the sea-buckthorn is 10 parts.
Further, the Rosa roxburghii Tratt is rose family rose rosa roxburghii Rosa roxburghii Tratt and single-lobe The fruit of rosa roxburghii.
Further, it is active constituent that it, which is by the medicinal powder of bulk pharmaceutical chemicals, the water of bulk pharmaceutical chemicals or extractive with organic solvent, in addition The preparation that acceptable auxiliary material or complementary ingredient are prepared in pharmacy.
Further, the preparation is oral preparation;Preferably, the oral preparation is decoction, powder, capsule, piece Agent, granule.
The present invention also provides a kind of methods preparing aforementioned pharmaceutical compositions, it includes the following steps:
1) each raw material is weighed by weight ratio;
2) medicinal powder, water or extractive with organic solvent of bulk pharmaceutical chemicals are taken, and in pharmacy acceptable auxiliary material or it is complementary at Divide and is prepared into preparation.
The present invention also provides above-mentioned compositions to prepare the purposes in preventing and/or treating the drug of hyperuricemia.
The present invention also provides above-mentioned compositions to prepare the purposes in preventing and/or treating the drug of gout.
The results show, compared with the drug of existing treatment hyperuricemia and gout, composition of the invention is more Safely and effectively, application prospect is had a vast market.
Obviously, the above according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific implementation mode of form by the following examples remakes further specifically the above of the present invention It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on the above of the present invention The technology realized all belongs to the scope of the present invention.
Specific implementation mode
The preparation of embodiment 1, pharmaceutical composition of the present invention
It since tea bag is across tea beverage, health products, three big gold industry of medicinal herb tea, can not only sip tea, but also energy health care, and can support It is raw.It is specific as follows the following provide the preparation method of teabag of food of the present invention, health products or pharmaceutical composition:
1 prescription:Rosa roxburghii Tratt 40g, Pu'er tea 20g, Radix Astragali 20g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 2, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 40g, Pu'er tea 20g, Radix Astragali 20g, pueraria lobata 20g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 3, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 40g, Pu'er tea 20g, Radix Astragali 20g, sea-buckthorn 10g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 4, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 40g, Pu'er tea 20g, Radix Astragali 20g, pueraria lobata 20g, sea-buckthorn 10g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 5, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 30g, Pu'er tea 10g, Radix Astragali 10g, pueraria lobata 10g, sea-buckthorn 5g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 6, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 50g, Pu'er tea 30g, Radix Astragali 30g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 7, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 50g, Pu'er tea 30g, Radix Astragali 30g, pueraria lobata 30g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
The preparation of embodiment 8, pharmaceutical composition of the present invention
1 prescription:Rosa roxburghii Tratt 50g, Pu'er tea 30g, Radix Astragali 30g, sea-buckthorn 20g
2 preparation methods:Each raw material of recipe quantity, mixing is taken to beat powder, sieve with 100 mesh sieve, all after mixing, by every bag of 3- 5g is dispensed, and tea bag is made in irradiation sterilization.
3 occupation modes:One day 3 bags, brewed with water it is i.e. drinkable, it is each primary in the morning, afternoon and evening.
Illustrate beneficial effects of the present invention below by way of the mode of test example.
Test example 1, hyperuricemia clinical case statistics
(1) patient criteria is accepted for medical treatment
Patients with Hyperuricemia, 30-70 years old ages, male 50, women 30.
(2) diagnostic criteria of hyperuricemia
Under normal purine diet state, non-empty stomach serum uric acid level male twice on the same day>416 μm of ol/L (7mg/dl), Women>357 μm of ol/L (6mg/dl), as hyperuricemia.
(3) standard is treated
It is effective:Testing the empty stomach serum uric acid level of Patients Before And After reduces by 35% or more.
Effectively:Testing the empty stomach serum uric acid level of Patients Before And After reduces by 20% or more.
In vain:The empty stomach serum uric acid level of Patients Before And After is tested without reduction.
(4) therapy
1) medication:After clarifying a diagnosis, treatment group is treated using composition prepared by the embodiment of the present invention 4;It is right It is treated using benzbromarone tablets according to group.
Treatment group:40 patients are all made of following drug:Rosa roxburghii Tratt 40g, Pu'er tea 20g, pueraria lobata 20g, sea-buckthorn 10g.It prepares Process:Above-mentioned each raw material is weighed, mixing is beaten powder, is sieved with 100 mesh sieve, and all after mixing, is dispensed by every bag of 3g, irradiation sterilization, Tea bag is made.Application method:Boiling water is taken after mixing it with water, and three times a day, 1 bag every time, 12 weeks as a treatment course.
Control group:Benzbromarone tablets, 50mg*10 pieces, Kunshan dragon lantern Rui Di pharmaceutical Co. Ltds, lot number 161005.It uses Method:Oral 50mg (1) every time, once a day, early to take after the meal, 3 weeks as a treatment course.
2) without apparent medication taboo, without other complications.
(5) treatment results
Treatment time:12 weeks
Efficacy determination:The results are shown in Table 1
1 hyperuricemia Comparison of therapeutic table of table
From the above it is found that the pharmaceutical composition of the present invention is suitable with the therapeutic effect of benzbromarone tablets, but take After benzbromarone tablets, often there is digestive discomfort sense (such as nausea, vomitting, feeling of repletion and diarrhea etc. in stomach), scratchiness, face in patient The adverse reactions such as face is rubescent, erythema, photoallergy, edema, precordial region sense of discomfort.And after taking the pharmaceutical composition of the present invention, Patient is not in any adverse reaction.Therefore, compared with existing drug, pharmaceutical composition of the invention is safer.
Test example 2, gout clinical case statistics
(1) patient criteria is accepted for medical treatment
Patient with gout, 23-70 years old ages, male 47, women 40
(2) diagnostic criteria of gout
The gout contingency table released with reference to American society of rheumatism in 2015 and European rheumatism alliance ACR/Eular joints Standard, criteria for classification include 3 projects, and 8 entries amount to 23 points, but need to only meet 8 points can be diagnosed as gout, and details are shown in Table 2:
2 gout diagnostic criteria of table
(3) standard is treated
It is effective:Gout score value reduces by 40%.
Effectively:Gout score value reduces by 20%.
In vain:Gout score value is without reduction.
(4) therapy
1) medication:After clarifying a diagnosis, treatment group is treated using composition prepared by the embodiment of the present invention 4;It is right Effects of Colchicine In Treating is used according to group.
Treatment group:44 patients are all made of following drug:Rosa roxburghii Tratt 40g, Pu'er tea 20g, pueraria lobata 20g, sea-buckthorn 10g.It prepares Process:Above-mentioned each raw material is weighed, mixing is beaten powder, is sieved with 100 mesh sieve, and all after mixing, is dispensed by every bag of 5g, irradiation sterilization, Tea bag is made.Application method:Boiling water is taken after mixing it with water, and three times a day, 1 bag every time, 5 weeks as a treatment course.
Control group:Colchicines tablets, 0.5mg*20 pieces, Yunnan Plant Pharmaceutical Industry Co., Ltd., lot number 20170202.User Method:Acute stage:Adult's usual amounts are to take 0.5~1mg (1~2) in every 1~2 hour, until joint symptoms are alleviated, or abdomen occur It rushes down or vomits, reach therapeutic dose and be generally 3~5mg (6~10), no more than 6mg (12) in 24 hours, withdraw 72 hours Afterwards daily dose be 0.5-1.5mg (1~3), part vic, totally 7 days.Prevent:0.5~1mg (1~2) on the one takes by several times With.
2) without apparent medication taboo, without other complications.
(5) treatment results
Treatment time:12 weeks
Efficacy determination:The results are shown in Table 3
3 gout Comparison of therapeutic table of table
From the above it is found that the pharmaceutical composition of the present invention is better than the therapeutic effect of colchicines tablets, and the present invention Composition have no toxic side effect, safety.
To sum up, compared with the drug of existing treatment hyperuricemia and gout, composition of the invention is more safe and effective, Have a vast market application prospect.

Claims (10)

1. a kind of pharmaceutical composition for preventing and/or treating hyperuricemia, it is characterised in that:It is containing following weight The preparation that the raw material of proportioning is prepared:30~50 parts of Rosa roxburghii Tratt, 10~30 parts of Pu'er tea, 10~30 parts of Radix Astragali.
2. pharmaceutical composition according to claim 1, it is characterised in that:It is prepared by the raw material matched containing following weight Made of preparation:40 parts of Rosa roxburghii Tratt, 20 parts of Pu'er tea, 20 parts of Radix Astragali.
3. pharmaceutical composition according to claim 1 or 2, it is characterised in that:The composition further includes following raw material:Pueraria lobota 5~20 parts of 10~30 parts of root and/or sea-buckthorn.
4. pharmaceutical composition according to claim 3, it is characterised in that:The pueraria lobata is 20 parts, and the sea-buckthorn is 10 parts.
5. pharmaceutical composition according to claims 1 to 4, it is characterised in that:The Rosa roxburghii Tratt is rose family rose The fruit of rosa roxburghii Rosa roxburghii Tratt and single-lobe rosa roxburghii.
6. according to Claims 1 to 5 any one of them pharmaceutical composition, it is characterised in that:It is medicinal powder by bulk pharmaceutical chemicals, original Expect that the water of medicine or extractive with organic solvent are active constituent, and in pharmacy acceptable auxiliary material or complementary ingredient prepare and At preparation.
7. according to claim 1~6 any one of them pharmaceutical composition, it is characterised in that:The preparation is oral preparation;It is excellent Choosing, the oral preparation is decoction, powder, capsule, tablet, granule.
8. a kind of method preparing any one of claim 1~7 described pharmaceutical composition, it is characterised in that:It includes following step Suddenly:
1) each raw material is weighed by weight ratio;
2) medicinal powder, water or extractive with organic solvent of bulk pharmaceutical chemicals are taken, in addition acceptable auxiliary material or complementary ingredient system in pharmacy For at preparation.
9. any one of claim 1~7 composition is preparing the use in preventing and/or treating the drug of hyperuricemia On the way.
10. any one of claim 1~7 composition is preparing the purposes in preventing and/or treating the drug of gout.
CN201810265726.6A 2018-03-28 2018-03-28 A kind of pharmaceutical composition and its preparation method and application for preventing and/or treating hyperuricemia Pending CN108310123A (en)

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CN112121144A (en) * 2020-09-20 2020-12-25 武汉宏博云智生物科技有限公司 Roxburgh rose composition and preparation method and application thereof
CN118059205A (en) * 2024-02-06 2024-05-24 贵州瑞诚新材料技术有限公司 Roxburgh rose traditional Chinese medicine compound composition for reducing uric acid, process and application

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CN112121144A (en) * 2020-09-20 2020-12-25 武汉宏博云智生物科技有限公司 Roxburgh rose composition and preparation method and application thereof
CN112121144B (en) * 2020-09-20 2021-11-12 武汉宏博云智生物科技有限公司 Roxburgh rose composition and preparation method and application thereof
CN118059205A (en) * 2024-02-06 2024-05-24 贵州瑞诚新材料技术有限公司 Roxburgh rose traditional Chinese medicine compound composition for reducing uric acid, process and application

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