CN114375196A - Traditional Chinese medicine composition for treating osteoarthritis - Google Patents
Traditional Chinese medicine composition for treating osteoarthritis Download PDFInfo
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- CN114375196A CN114375196A CN201980031548.3A CN201980031548A CN114375196A CN 114375196 A CN114375196 A CN 114375196A CN 201980031548 A CN201980031548 A CN 201980031548A CN 114375196 A CN114375196 A CN 114375196A
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- 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
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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)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
- A61K36/8994—Coix (Job's tears)
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- 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
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
Abstract
A Chinese medicinal composition for the treatment of osteoarthritis comprises radix astragali, flos Lonicerae, cortex Phellodendri, rhizoma Atractylodis, Coicis semen, radix scrophulariae, radix Angelicae sinensis, radix Paeoniae alba, Glycyrrhrizae radix, Hirudo, Scolopendra, and Scorpio etc. Animal and clinical tests show that the traditional Chinese medicine composition has good treatment effect on joint diseases, particularly osteoarthritis, can obviously reduce inflammatory factors, reduce inflammatory response, obviously improve clinical symptoms and improve life quality of patients, and is suitable for further popularization and application.
Description
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating osteoarthritis.
Osteoarthritis (OA), also known as proliferative osteoarthritis, hyperosteogeny, degenerative joint disease, senile arthritis, hypertrophic arthritis, is a disease characterized by the occurrence of bone destruction, secondary hyperosteogeny, joint deformation, joint pain, limited movement and other symptoms when abnormal load is applied, due to degeneration and degeneration of soft tissues such as cartilage, intervertebral disc, ligament and the like constituting the joint, bony spur formation at the joint margin, synovial pachynsis and other changes, which are classified into primary and secondary types. Hyperosteogeny is a frequently encountered disease, a common disease, and a disease causing arthralgia.
The main purpose of treating osteoarthritis is to relieve pain, improve function and improve quality of life. The treatment options include various dosage forms (emulsion, paste, patch, etc.) of non-steroidal anti-inflammatory drugs (NSAIDs), full-blown pain preparation, glucosamine chondroitin, local injection of sodium hyaluronate for lubrication of joints to relieve pain, acupuncture and moxibustion, and joint replacement surgery in severe cases.
With the continuous development of traditional Chinese medicines and the intensive research on osteoarthritis, compared with western medicines, the traditional Chinese medicine for treating osteoarthritis has the advantages of definite curative effect and small toxic and side effects. Various treatment methods and the like. Modern pharmacology also indicates that the traditional Chinese medicine for treating osteoarthritis can effectively reduce inflammatory reaction, improve microcirculation in joints, promote cartilage repair, obviously improve clinical symptoms, improve life quality and reduce economic burden.
Chinese patent CN1201787C discloses a Chinese medicinal composition for treating thrombophlebitis, which comprises 12 medicinal materials of astragalus, honeysuckle, phellodendron, rhizoma atractylodis, semen coicis, radix scrophulariae, angelica, radix paeoniae alba, liquorice, leech, centipede and scorpion, and the Chinese medicinal composition has the functions of clearing away heat and toxic materials, removing blood stasis, dredging collaterals, inducing diuresis and reducing edema, has better curative effect on clinical treatment of thrombophlebitis, and also has certain prevention and treatment effects on thromboangiitis obliterans. The product based on the patent is marketed and is named as Mailuoshutong granules/pills, and is mainly used for treating superficial thrombophlebitis caused by damp-heat stasis in veins, and lower limb swelling, pain, dark red skin color or accompanied with cord-like substances caused by non-acute deep vein thrombosis.
Based on the CN1201787C patent technology, a series of Mailuoshutong products are produced, and the invention further develops and researches new application of the traditional Chinese medicine composition in the patent, namely the Mailuoshutong product on the basis of the series of Mailuoshutong products.
One of the purposes of the present invention is to provide a traditional Chinese medicine composition for treating joint diseases, especially osteoarthritis, wherein the traditional Chinese medicine composition comprises medicinal materials such as astragalus, honeysuckle, golden cypress, rhizoma atractylodis, semen coicis, radix scrophulariae, angelica, radix paeoniae alba, liquorice, leech, centipede, scorpion and the like.
The joint diseases are mainly characterized by one or more of joint pain and tenderness, joint stiffness, joint swelling, joint movement limitation and joint deformity.
The osteoarthritis is primary osteoarthritis or secondary osteoarthritis.
Preferably, the secondary osteoarthritis is osteoarthritis which mainly refers to osteoarthritis generated secondarily from one or more diseases including but not limited to meniscus injury, intra-articular or periarticular fracture, joint ligament injury, femoral head necrosis, congenital malformation or joint infection.
Preferably, the osteoarthritis is mainly manifested by one or more of articular cartilage degeneration injury, articular cartilage denudation, joint margin and subchondral bone reactive hyperplasia, hyperosteogeny, meniscus injury and synovitis.
Preferably, the site of onset of osteoarthritis includes, but is not limited to, one or more of the hands, knees, hips, feet, spine.
The second purpose of the invention is to provide the composition of the traditional Chinese medicine composition, namely the traditional Chinese medicine composition is prepared from the following components:
1000 parts of 300 astragalus membranaceus, 300 parts of 300 honeysuckle and 500 parts of 100 parts of cortex phellodendri
100 parts of rhizoma atractylodis, 500 parts of coix seed, 300 parts of coix seed, 1000 parts of figwort, 300 parts of figwort root
100 portions of angelica, 500 portions of white peony root, 100 portions of licorice, 50 to 150 portions
Leech 180 and centipede 500 weight portions and scorpion 50-150 weight portions.
Preferably, the traditional Chinese medicine composition is prepared from the following components:
500 portions of astragalus root, 850 portions of 500 portions of honeysuckle, 250 portions of phellodendron, and 450 portions of
250 parts of rhizoma atractylodis, 850 parts of 500 parts of coix seed, 850 parts of 500 parts of figwort root, 850 parts of
250 portions of angelica sinensis, 450 portions of white paeony root, 250 portions of white paeony root, 450 portions of liquorice and 50 to 150 portions of
Leech 250 and centipede 450 weight portions and scorpion 50-150 weight portions;
further preferably, the traditional Chinese medicine composition is prepared from the following components:
astragalus 833 weight parts honeysuckle 833 weight parts phellodendron 417 weight parts
Rhizoma atractylodis 417, coix seed 833, figwort 833
417 parts of Chinese angelica root, 417 parts of white peony root, 138 parts of licorice root
Leech 417 parts by weight, centipede 33 parts by weight, scorpion 138 parts by weight;
in a further preferred embodiment, the Chinese medicinal composition is prepared from the following components
500 parts by weight of astragalus membranaceus, 500 parts by weight of honeysuckle and 250 parts by weight of golden cypress
250 parts of rhizoma atractylodis, 500 parts of semen coicis, 500 parts of radix scrophulariae
250 parts of angelica sinensis, 250 parts of white peony root, 83 parts of liquorice
250 parts of leech, 20 parts of centipede and 83 parts of scorpion.
The invention also provides a traditional Chinese medicine preparation of the traditional Chinese medicine composition, wherein the traditional Chinese medicine preparation is a granule, a pill, a capsule and/or a liquid preparation; preferably, the Chinese medicinal preparation is a pill.
Specifically, the traditional Chinese medicine pills are Mailuoshutong pills, and the traditional Chinese medicine granules are Mailuoshutong granules.
The invention also aims to provide a preparation method of the pills or the granules, which comprises the following specific operations:
1) soaking honeysuckle, rhizoma atractylodis, figwort, angelica and white paeony root in water according to the prescription amount, and distilling to extract volatile oil for later use; distilling to obtain water solution and residue;
2) mixing the astragalus, the phellodendron, the coix seed, the liquorice, the leech, the centipede and the scorpion according to the prescription amount of 1/2 and the distilled medicine residue obtained in the step 1), adding water and decocting twice, and combining decoction for later use;
3) mixing the decoction obtained in the step 2) with the aqueous solution distilled in the step 1), filtering, concentrating the filtrate to obtain a clear paste with a relative density of 1.10-1.20 (80 ℃), adding ethanol to ensure that the ethanol content reaches 60%, standing, filtering, recovering ethanol under reduced pressure, concentrating to obtain a clear paste with a relative density of 1.10-1.18 (80 ℃) or a thick paste with a relative density of 1.30-1.35 (80 ℃), drying, and crushing into fine powder to obtain extract powder for later use;
4) pulverizing the rest 1/2 prescription amount of Hirudo, Scolopendra, and Scorpio into powder;
5) adding cyclodextrin into the volatile oil obtained in the step 1) to prepare an inclusion compound, uniformly mixing the inclusion compound with the extract powder obtained in the step 3), the medicinal powder obtained in the step 4) and celecoxib, and preparing a clinically acceptable dosage form directly or by adding pharmaceutically acceptable excipients through conventional procedures;
or mixing the extract powder obtained in step 3), the medicinal powder obtained in step 4) and celecoxib uniformly, granulating, spraying the volatile oil obtained in step 1) and mixing uniformly, and preparing into clinically acceptable dosage forms directly or by adding pharmaceutically acceptable excipients through conventional procedures.
The traditional Chinese medicine considers that the main pathogenesis of osteoarthritis is deficiency and excess, flaccidity and arthralgia; because the liver stores blood, governs tendons, kidneys store essence, governs bones, and liver and kidney deficiency, essence and blood deficiency can cause malnutrition of muscles and bones, empty and deficient skin striae and skin striae, and easily cause wind-cold-dampness. The traditional Chinese medicine for treating knee osteoarthritis forms a comprehensive treatment system mainly based on drug treatment and combining a plurality of methods such as manipulation, acupuncture, functional exercise and the like. The traditional Chinese medicine composition is prepared from 12 traditional Chinese medicines, and mainly comprises radix astragali, honeysuckle, phellodendron, rhizoma atractylodis, semen coicis, radix scrophulariae, angelica, radix paeoniae alba, liquorice, leech and the like, wherein the radix astragali is the monarch, and is intended to be the commander of blood, qi circulation leads to blood circulation, diuresis and detumescence, toxin expelling and tissue regeneration are realized, the honeysuckle is used for clearing heat, detoxifying and eliminating dampness, the cortex phellodendri, rhizoma atractylodis and semen coicis are used for clearing heat, dispelling dampness and strengthening spleen, so as to help to clear damp-heat evil, the leech, centipede and scorpion are used for activating blood, removing stasis, dredging collaterals, attacking toxin, dissipating binds and relieving pain, so as to help to discharge blood stasis toxin, the evil is used as ministerial medicines together, the angelica and the radix paeoniae alba are used for replenishing blood, softening liver and nourishing blood, the radix paeoniae alba is used for relieving pain slowly, harmonizing ying and defending, the radix scrophulariae is used for nourishing yin, cooling blood, softening hardness, removing blood stasis, dredging collaterals, clearing heat, and removing dampness.
(1) The traditional Chinese medicine composition has reasonable compatibility and obvious treatment effect. Animal experiments show that the traditional Chinese medicine composition can effectively reduce the content of inflammatory factors such as IL-1 beta, TNF-alpha, MMP-3 and the like in the serum of knee osteoarthritis rats and reduce inflammatory reaction; clinical tests show that the total effective rate of the Mailuoshutong pill group is 88.1 percent, which is slightly superior to 83.3 percent of the total effective rate of the celecoxib group, the contents of inflammatory factors IL-1 beta, TNF-alpha and MMP-3 of a patient are obviously reduced after treatment, the pain of the patient is relieved, and the life quality of the patient is improved.
(2) Compared with western medicines, the Chinese medicinal composition has the same or better treatment effect than the western medicines, but is a pure Chinese medicinal preparation with small toxic or side effect.
EXAMPLE 1 Capsule preparation
The formula is as follows: 300g of astragalus root, honeysuckle flower and 1000g of phellodendron bark 500 g
Rhizoma atractylodis 100 g coix seed 300g figwort 1000g
Chinese angelica root 100 g white peony root 500 g licorice root 150 g
Leech 180g centipede 10g scorpion 150 g
The preparation method comprises the following steps: (1) pulverizing Hirudo, Scolopendra, and Scorpio (1/2 prescription amount) into fine powder;
(2) soaking honeysuckle, rhizoma atractylodis, figwort, angelica and white paeony root in the formula according to the prescription amount in water, distilling and extracting volatile oil, and adding cyclodextrin into the volatile oil to prepare an inclusion compound for later use; the distilled water solution and the medicine dregs are reserved;
(3) mixing radix astragali, cortex Phellodendri, Coicis semen, Glycyrrhrizae radix, Hirudo, Scolopendra, Scorpio and distilled residues, decocting with water twice, and mixing decoctions; mixing the decoction with the distilled water solution, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), adding ethanol to make ethanol content reach 60%, standing, filtering, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.10-1.18 (80 deg.C), and spray drying to obtain fine powder of extract;
(4) and (3) mixing the fine powder obtained in the step (1), the inclusion compound obtained in the step (2) and the extract fine powder obtained in the step (3), adding starch, uniformly mixing, granulating, drying, preparing 1000g, and filling into capsules to obtain the capsule.
Example 2 preparation of granules
The formula is as follows: 1000g of astragalus root, honeysuckle flower, 300g of phellodendron bark, 100 g
Rhizoma atractylodis 500 g coix seed 1000g figwort 300g
Chinese angelica root, radix Paeoniae alba 500 g, radix Glycyrrhizae 50g
Leech 500 g centipede 40 g scorpion 50g
The preparation method comprises the following steps: (1) pulverizing Hirudo, Scolopendra, and Scorpio (1/2 prescription amount) into fine powder;
(2) soaking honeysuckle, rhizoma atractylodis, figwort, angelica and white paeony root in the formula according to the prescription amount in water, distilling and extracting volatile oil for later use; the distilled water solution and the medicine dregs are reserved;
(3) mixing radix astragali, cortex Phellodendri, Coicis semen, Glycyrrhrizae radix, Hirudo, Scolopendra, Scorpio and distilled residues, decocting with water twice, and mixing decoctions; mixing the decoction with the distilled water solution, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.15-1.20 (80 deg.C), adding ethanol to make ethanol content reach 60%, standing, filtering, recovering ethanol under reduced pressure, concentrating to obtain soft extract with relative density of 1.30-1.35 (80 deg.C), vacuum drying, and pulverizing into fine powder to obtain extract fine powder;
(4) and (3) mixing the fine powder obtained in the step (1) and the extract fine powder obtained in the step (3), adding beta-cyclodextrin, aspartame, sodium carboxymethyl starch and dextrin according to the formula ratio, uniformly mixing, granulating, drying, spraying the volatile oil obtained in the step (2), uniformly mixing, and preparing 1000 g.
Example 3 preparation of granules
The formula is as follows: 500 g of astragalus root, 500 g of honeysuckle flower and 250g of phellodendron bark
Rhizoma atractylodis 250g coix seed 500 g figwort 500 g
250g of angelica, 250g of white peony root, 250g of liquorice and 150 g of liquorice
Leech 450 g centipede 40 g scorpion 150 g
The preparation method comprises the following steps: the same as in example 2.
Example 4 preparation of granules
The formula is as follows: 500 g of astragalus root, 500 g of honeysuckle flower and 250g of phellodendron bark
Rhizoma atractylodis 250g coix seed 500 g figwort 500 g
250g of Chinese angelica, 250g of white peony root, 83 g of liquorice
Leech 250g centipede 20g scorpion 83 g
The preparation method comprises the following steps: the same as in example 2.
EXAMPLE 5 pellet preparation
The formula is as follows: astragalus root 900 g honeysuckle flower 900 g phellodendron bark 450 g
Atractylodes lancea rhizome 450 g coix seed 900 g figwort root 900 g
Angelica sinensis 450 g white peony root 450 g licorice root 50g
Leech 250g centipede 10g scorpion 150 g
The preparation method comprises the following steps:
(1) pulverizing Hirudo, Scolopendra, and Scorpio (1/2 prescription amount) into fine powder;
(2) soaking honeysuckle, rhizoma atractylodis, figwort, angelica and white paeony root in the formula according to the prescription amount in water, distilling and extracting volatile oil, and adding cyclodextrin into the volatile oil to prepare an inclusion compound for later use; the distilled water solution and the medicine dregs are reserved;
(3) mixing radix astragali, cortex Phellodendri, Coicis semen, Glycyrrhrizae radix, Hirudo, Scolopendra, Scorpio and distilled residues, decocting with water twice, and mixing decoctions; mixing the decoction with the distilled water solution, filtering, concentrating the filtrate to obtain fluid extract with relative density of 1.10-1.20 (80 deg.C), adding ethanol to make ethanol content reach 60%, standing, filtering, recovering ethanol under reduced pressure, concentrating to obtain fluid extract with relative density of 1.10-1.18 (80 deg.C), and spray drying to obtain fine powder of extract;
(4) and (3) mixing the fine powder obtained in the step (1), the inclusion compound obtained in the step (2) and the extract fine powder obtained in the step (3), adding starch, uniformly mixing, making pills, and drying to prepare 1000 g.
EXAMPLE 6 pellet preparation
The formula is as follows: astragalus 833 g honeysuckle 833 g phellodendron 417 g
Rhizoma Atractylodis 417 g Coicis semen 833 g radix scrophulariae 833 g
Chinese angelica root 417 g white peony root 417 g licorice root 138 g
Leech 417 g centipede 33 g scorpion 138 g
The preparation method comprises the following steps: the same as in example 5.
In order to verify the effect of the traditional Chinese medicine composition in treating joint diseases, the inventor carries out related animal and clinical tests, and it is worth to be noted that the following animal and clinical tests only take the knee joint in osteoarthritis as an example to carry out pharmacodynamic description, the inventor also carries out research on other joint diseases, and the research result shows that the traditional Chinese medicine composition can achieve the same or similar effect of treating knee osteoarthritis on other types of joint diseases. The following animal and clinical trials are not intended to limit the present invention.
The traditional Chinese medicine composition has the treatment effect on the osteoarthritis rats
1. Laboratory animal
Male SD-grade rats, weight 180-220 g, laboratory animal license number: SCXK (Shandong) 20140007, provided by Jinanpunyue laboratory animal Breeding Co., Ltd, was acclimatized prior to the experiment for one week.
2. Experimental drug and administration dosage
2.1 Experimental drugs
Positive drugs: celecoxib capsules;
the invention comprises the following steps: pellets obtained in examples 5 and 6.
2.2 dosage administration
Celecoxib capsules: 18 mg/kg;
example 5 pellets: 6.48 g/kg;
example 6 pellets: 6.48g/kg (high dose), 3.24g/kg (medium dose), 1.62g/kg (low dose).
3 grouping and molding method
3.1 grouping
70 rats were divided into a blank group, a model group, a positive drug group, an example 5 group, and an example 6 group (high, medium, and low dose groups), and 10 rats were collected.
3.2 Molding method
The method comprises the following steps of establishing a knee osteoarthritis model of each group of rats by adopting an improved Hulth modeling method, and specifically operating as follows:
the left lower limb of the rat was subjected to a depilatory treatment 1 day before the operation. Before operation, the patient is fasted for 12 hours, and water is forbidden for 4 hours. After anesthetizing a rat, fixing the rat on a mouse board in a supine mode, after the left knee of the rat is disinfected conventionally, taking the inner side of the left knee joint of the rat as an operation point, cutting the left knee joint of the rat longitudinally from the side of the patellar tendon, wherein the range is about 1cm long, cutting an internal anterior cruciate ligament, removing an internal meniscus, carrying out drawer experiment examination, after the rat is positive, alternately washing the rat by using complex iodine and physiological saline for 2 times, cleaning blood liquid in a wound, infiltrating an operation field by using gentamicin sulfate injection to prevent intra-articular infection, then suturing the wound and wrapping, and ending the operation.
Among these, the blank group was given a sham surgical treatment, with only the joint cavity opened, without damaging ligaments and meniscus, and the wound was sutured and bandaged.
The injured limb after operation is not fixed, so that the injured limb can move freely, gentamicin is injected into the rat after the operation for three consecutive days, and the wound is disinfected to prevent wound infection.
4. Administration of drugs
After 1 week of operation, all groups of rats survived, the wound has no red swelling and suppuration phenomena, the wound is basically healed, the response is sensitive, the excretion has no abnormality, and the forced movement of the rats is started, 1 time a day, 30min each time and 8 weeks continuously. The administration is performed simultaneously with the forced activity.
The group of positive drugs, example 5, example 6 (high, medium and low dose groups) were administered the corresponding drugs, respectively; the model group and the blank group were given the same amount of physiological saline. The administration was continued by gavage for 8 weeks.
5. Observation index
After the last administration, fasting water is carried out for 12 hours, abdominal aorta blood sampling is carried out on each group of rats after anesthesia, centrifugation is carried out, supernatant fluid is taken, and the contents of IL-1 beta, TNF-alpha and MMP-3 in the blood of the rats are detected by adopting an enzyme linked immunosorbent assay.
6. Results of the experiment
6.1 during the experiment period of the general conditions of the rats in each group, the rats in the blank group have good mental state and normal autonomic activity, diet, drinking water and defecation; the rats in the model group have reactions such as reduced autonomic activity, lying, laziness in movement and the like, and the drinking water and diet are reduced compared with the defecation in the blank group; with the increase of the administration time, the mental state of the rats in each administration group is gradually improved, the autonomous activity is obviously increased, and the drinking water and defecation are gradually increased.
6.2 serum IL-1 beta, TNF-alpha, MMP-3 content changes
TABLE 1 changes in the IL-1 beta, TNF-alpha, MMP-3 content in the serum of rats of each group
Note: in contrast to the blank group,#p is less than 0.01; in contrast to the model set,@P＜0.01。
as can be seen from Table 1, the blank group comparison shows that the contents of IL-1 beta, TNF-alpha and MMP-3 in the serum of the rats in the model group are obviously higher, the difference has statistical significance (P is less than 0.01), the contents of IL-1 beta, TNF-alpha and MMP-3 in the rats in each administration group are also higher, and the difference has statistical significance (P is less than 0.01); compared with the model group, the contents of IL-1 beta, TNF-alpha and MMP-3 in the serum of rats of each administration group are obviously reduced, and the difference has statistical significance (P is less than 0.01).
The results show that the traditional Chinese medicine composition can effectively reduce the content of inflammatory factors such as IL-1 beta, TNF-alpha, MMP-3 and the like in the blood serum of knee osteoarthritis rats, and the traditional Chinese medicine composition can be used for treating the knee osteoarthritis.
Based on the animal experiment, the inventor carries out animal experiments on the traditional Chinese medicine composition after adding or subtracting the medicine flavor and changing the medicine dosage, and the experiment result shows that the traditional Chinese medicine composition after adding or subtracting the medicine flavor or changing the medicine dosage can not achieve the experiment effect of the invention.
Secondly, the clinical trial research of the traditional Chinese medicine composition
1. General data
1.1 selecting 84 cases of knee osteoarthritis patients who are collected from an orthopedic clinic in 2016 to 2018 and are randomly divided into a celecoxib group and a venation dredging group according to different treatment methods, wherein each group comprises 42 patients; wherein the celecoxib groups were 19 men, 23 women, aged 56-78 years, averaged 66.7 ± 13.5 years, 26 single knees, 16 double knees, according to the Kellgren-Lawrence classification criteria: 19 cases of I stage, 15 cases of II stage and 8 cases of III stage; in the choroid sutong group, 17 men and 25 women, aged 56-79 years, averaged 67.5 ± 14.2 years, 23 single knees and 19 double knees, according to the Kellgren-Lawrence classification: 20 cases of I stage, 15 cases of II stage and 7 cases of III stage. The general data differences of sex, age and disease grade of two groups of patients are not statistically significant (P > 0.05), and are comparable.
1.2 inclusion criteria:
the diagnosis standard of knee joint osteoarthritis is met, wherein the diagnosis standard of osteoarthritis diagnosis and treatment guidelines for osteoarthritis (2007 edition) is the bone science division of the Chinese medical society; the X-ray film shows that the joint clearance is narrowed, and the articular cartilage is hardened or cystic change; the knee joint repeatedly feels pain for more than one month and has friction sound during movement; signing an informed consent.
1.3 exclusion criteria:
combining rheumatic arthritis and rheumatoid arthritis; ② patients with liver and kidney function deficiency, serious cardiovascular and cerebrovascular diseases or drug allergy; ③ those aged more than 80 years who have communication disorder and are unconscious.
2. Method of treatment
Celecoxib (celecoxib, fevery pharmaceuticals ltd., national drug standard: J20120063) is administered in the celecoxib group at 0.2g per day;
mailuoshutong pills (Lunan Kaiping Co., Ltd., specification: 12 g/bottle, national Standard: Z19991025) are taken in the group of Mailuoshutong pills, one bottle at a time, three times a day.
The administration period is as follows: 4 weeks.
3. Determination of therapeutic effect
3.1 clinical efficacy
The clinical curative effect is evaluated according to the clinical research guiding principle of the new traditional Chinese medicine and the international WOMAC scale score of knee osteoarthritis. The WOMAC scale scoring content comprises three items of arthralgia, stiffness and functional activity, scoring is carried out in a question-asking mode, 24 questions are asked, each question is 0-4 points, and the higher the WOMAC score is, the more serious the symptom is.
And (3) evaluating the clinical curative effect:
and (3) healing: the symptoms such as arthralgia and the like disappear, the joint moves normally, the WOMAC score is reduced by more than or equal to 95 percent, and the X-ray examination shows that the joint is normal;
the effect is shown: the symptoms such as arthralgia and the like are obviously relieved, the joint movement is not limited, the WOMAC score is reduced by less than 95 percent when the WOMAC is more than or equal to 70 percent, and the X-ray examination shows that the joint is obviously improved;
the method has the following advantages: the symptoms such as arthralgia and the like are relieved, the joint movement is slightly limited, the WOMAC score is reduced by less than 70 percent and is more than or equal to 30 percent, and the X-ray examination shows that the joint is improved;
and (4) invalidation: the symptoms such as arthralgia and the like and joint movement are not obviously improved, the WOMAC score is reduced by less than 30 percent, and the X-ray examination is not changed.
3.2 DOA Scoring
Scoring with Leguesene index 4 as international DOA scoring standard, wherein the scoring content includes knee joint rest pain, athletic pain, tenderness, joint mobility, morning stiffness and walking ability, and the higher the score is, the more serious the symptoms are[9]。
3.3 examination of inflammatory factors
Extracting 1.5mL of joint fluid from knee and eye positions of affected limbs, injecting into a silicified test tube, centrifuging at high speed for 10min, collecting supernatant, and detecting the level changes of interleukin-1 beta (IL-1 beta), tumor necrosis factor-alpha (TNF-alpha) and Matrix Metalloproteinase (MMPs) in the joint fluid before and after treatment by ELISA method, wherein the kit is selected from Wuhan doctor German bioengineering Co., Ltd, and the operation is strictly carried out according to the kit instruction.
3.4 statistical methods
Statistical analysis was performed on all experimental data using software SPSS19.0, all measurements represented as variances, using t-test, and counts using X2Examination of all comparison data P<0.05 is statistically significant.
4. Results
4.1 comparison of clinical efficacy
The results of the clinical efficacy evaluations of the two groups of patients are shown in table 2. As can be seen from Table 2, the celecoxib group healed 11 cases (26.2%), which is similar to the choroid-soothing group (28.6%); meanwhile, the total effective rate of the celecoxib group is 83.3 percent, and the total effective rate of the venation dredging group is 88.1 percent, which is slightly superior to the celecoxib group.
TABLE 2 comparison of clinical efficacy of two groups of patients (n,%)
4.2 DOA score comparison of clinical signs
The DOA score results for clinical signs before and after treatment in both groups of patients are shown in table 3. As can be seen from Table 3, the difference in the score of each clinical sign before treatment was not statistically significant (P > 0.05); the score of each clinical sign after treatment is obviously reduced compared with that before treatment. Wherein, the difference between the choroid sutural group and the celecoxib group before and after treatment has statistical significance (P is less than 0.05), the difference between the celecoxib group before and after treatment also has statistical significance (P is less than 0.05), and the difference between the scores of each sign of the choroid sutural group and the celecoxib group after treatment has no statistical significance (P is more than 0.05).
TABLE 3 comparison of DOA scores for clinical signs before and after treatment in two groups of patients
Note: compared with the treatment before the treatment,*p is less than 0.05; compared with the celecoxib group, P is more than 0.05.
4.3 inflammatory factor level comparison
The results of the inflammatory factor levels before and after treatment in both groups of patients are shown in table 4. As can be seen from Table 4, there was no statistical difference in the levels of IL-1. beta., TNF-. alpha., and MMP-3 in the first two groups (P > 0.05); after treatment, IL-1 beta, TNF-alpha and MMP-3 levels in both groups of patients were reduced compared to before treatment. Wherein the difference of the level values of the factors before and after the treatment of the two groups has statistical significance (P is less than 0.05).
TABLE 4 comparison of the changes in the levels of inflammatory factors in two groups (
，mg/ml）
Note: compared with the treatment before the treatment,*P＜0.05。
in conclusion, the Mailuoshutong pill can improve the cure rate of patients with osteoarthritis, reduce the level of inflammatory factors, relieve the pain of the patients, improve the life quality of the patients and is suitable for clinical application.
Claims (10)
- A Chinese medicinal composition for treating joint diseases is prepared from radix astragali, flos Lonicerae, cortex Phellodendri, rhizoma Atractylodis, Coicis semen, radix scrophulariae, radix Angelicae sinensis, radix Paeoniae alba, Glycyrrhrizae radix, Hirudo, Scolopendra, and Scorpio.
- The use according to claim 1, wherein the joint disease is manifested by one or more of joint pain and tenderness, joint stiffness, joint swelling, joint mobility limitation, or joint deformity.
- The use according to claim 1, wherein the joint disease is osteoarthritis.
- The use according to claim 3, wherein the osteoarthritis is primary osteoarthritis or secondary osteoarthritis.
- The use of claim 4, wherein secondary osteoarthritis is osteoarthritis secondary to one or more diseases including but not limited to meniscal injury, intra-or peri-articular fracture, joint ligament injury, femoral head necrosis, congenital malformations, or joint infection.
- The use according to claim 3, wherein the osteoarthritis is one or more of degenerative joint cartilage damage, articular cartilage exfoliation, reactive hyperplasia of joint margin and subchondral bone, hyperosteogeny, meniscus damage, synovitis.
- The use of claim 3, wherein the site of onset of osteoarthritis includes, but is not limited to, one or more of the hands, knees, hips, feet, spine.
- The use of any one of claims 1 to 7, wherein the Chinese medicinal composition comprises the following medicinal materials:1000 parts of 300 astragalus membranaceus, 300 parts of 300 honeysuckle and 500 parts of 100 parts of cortex phellodendri100 parts of rhizoma atractylodis, 500 parts of coix seed, 300 parts of coix seed, 1000 parts of figwort, 300 parts of figwort root100 portions of angelica, 500 portions of white peony root, 100 portions of licorice, 50 to 150 portionsLeech 180 and centipede 500 weight portions 10-40 weight portions and scorpion 50-150 weight portions;more preferably:500 portions of astragalus root, 850 portions of 500 portions of honeysuckle, 250 portions of phellodendron, and 450 portions of250 parts of rhizoma atractylodis, 850 parts of 500 parts of coix seed, 850 parts of 500 parts of figwort root, 850 parts of250 portions of angelica sinensis, 450 portions of white paeony root, 250 portions of white paeony root, 450 portions of liquorice and 50 to 150 portions ofLeech 250 and centipede 450 weight portions and scorpion 50-150 weight portions;more preferably, the traditional Chinese medicine composition contains the following medicinal materials:astragalus 833 weight parts honeysuckle 833 weight parts phellodendron 417 weight partsRhizoma atractylodis 417, coix seed 833, figwort 833417 parts of Chinese angelica root, 417 parts of white peony root, 138 parts of licorice rootLeech 417 parts by weight, centipede 33 parts by weight, scorpion 138 parts by weight.
- A Chinese medicinal preparation containing the Chinese medicinal composition as claimed in claim 8, wherein the Chinese medicinal preparation is a granule, a pill, a capsule and/or a liquid preparation; preferably, the traditional Chinese medicine preparation is pills or granules.
- The Chinese medicinal preparation of claim 9, wherein the pill is a Mailuoshutong pill and the granule is a Mailuoshutong granule.
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| CN115845003A (en) * | 2022-11-15 | 2023-03-28 | 山东新时代药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating arthritis |
| CN116211914A (en) * | 2023-03-14 | 2023-06-06 | 江苏省中医药研究院 | Application of traditional Chinese medicine composition containing scorpion and centipede in preparation of medicine for preventing and/or treating osteoarthritis |
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| CN109718341A (en) * | 2017-10-31 | 2019-05-07 | 鲁南制药集团股份有限公司 | A kind of Chinese medicine composition for treating aseptic necrosis of femoral head |
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| CN109260397A (en) * | 2017-07-18 | 2019-01-25 | 鲁南制药集团股份有限公司 | A kind of Chinese medicine composition for treating Vascular retinopathy |
| CN110123968A (en) * | 2019-06-20 | 2019-08-16 | 鲁南制药集团股份有限公司 | A kind of preparation method of the easypro logical preparation of train of thought |
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| CN109718341A (en) * | 2017-10-31 | 2019-05-07 | 鲁南制药集团股份有限公司 | A kind of Chinese medicine composition for treating aseptic necrosis of femoral head |
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| 刘斌等: "综合疗法治疗暂时性髋关节滑膜炎56例", 中医药学刊, vol. 24, no. 6, pages 1162 - 1164 * |
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| CN115845003A (en) * | 2022-11-15 | 2023-03-28 | 山东新时代药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating arthritis |
| CN115845003B (en) * | 2022-11-15 | 2024-01-26 | 山东新时代药业有限公司 | Application of traditional Chinese medicine composition in preparation of medicine for treating arthritis |
| CN116211914A (en) * | 2023-03-14 | 2023-06-06 | 江苏省中医药研究院 | Application of traditional Chinese medicine composition containing scorpion and centipede in preparation of medicine for preventing and/or treating osteoarthritis |
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