CN118477137A - Pharmaceutical composition for treating wind-cold-dampness arthralgia, preparation and application thereof - Google Patents

Pharmaceutical composition for treating wind-cold-dampness arthralgia, preparation and application thereof

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Publication number
CN118477137A
CN118477137A CN202410938268.3A CN202410938268A CN118477137A CN 118477137 A CN118477137 A CN 118477137A CN 202410938268 A CN202410938268 A CN 202410938268A CN 118477137 A CN118477137 A CN 118477137A
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parts
pharmaceutical composition
cold
wind
dampness arthralgia
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刘琼
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Hualong Shengai Traditional Chinese Medicine Group Co ltd
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Hualong Shengai Traditional Chinese Medicine Group Co ltd
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Abstract

The invention discloses a pharmaceutical composition for treating wind-cold-dampness arthralgia, a preparation and application thereof, wherein the pharmaceutical composition comprises the following components in parts by weight: 9-15 parts of Heishan tablet, 6-10 parts of cassia twig, 5-12 parts of achyranthes root, 6-12 parts of Chinese taxillus twig, 5-10 parts of cortex acanthopanacis, 5-10 parts of obscured homalomena rhizome, 6-10 parts of eucommia bark, 6-10 parts of Chinese angelica, 6-10 parts of white paeony root, 3-9 parts of radix angelicae pubescentis, 3-9 parts of large-leaved gentian, 3-9 parts of pawpaw and 2-6 parts of liquorice. The pharmaceutical composition can be added with pharmaceutically acceptable auxiliary materials to prepare a preparation. The pharmaceutical composition and the preparation can be used for preparing medicines for treating wind-cold-dampness arthralgia.

Description

Pharmaceutical composition for treating wind-cold-dampness arthralgia, preparation and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and in particular relates to a pharmaceutical composition for treating wind-cold-dampness arthralgia, a preparation and application thereof.
Background
The arthralgia refers to the condition of pain, numbness, heavy attachment, difficult flexion and extension of muscles, bones and joints, and even swelling and burning heat of joints caused by deficiency of healthy qi, invasion of exogenous pathogenic factors such as wind, cold, dampness, heat and the like into the human body, blockage of channels and collaterals and unsmooth qi and blood circulation. The meaning of arthralgia-syndrome is broadly and narrowly defined. The present invention mainly aims at the arthralgia of the limbs and the channels, which is the arthralgia of the limbs and the channels.
The diseases of western medicine such as rheumatic arthritis, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, sciatica and the like are characterized clinically by limb arthralgia and correspond to arthralgia syndrome in traditional Chinese medicine. Western medicine is used for treating the diseases by taking anti-inflammatory, analgesic and symptom relieving as principles, and clinically taking non-steroidal anti-inflammatory drugs, opioid drugs and glucocorticoid as main therapeutic drugs, has the advantages of rapidly relieving pain and improving joint functions, but western medicine has the advantages of multiple side effects, high adverse reaction incidence and high recurrence rate. Therefore, it is necessary to develop a drug with high safety, low recurrence rate and personalized treatment.
Disclosure of Invention
Aiming at the defects existing in the prior art, the invention aims to provide a pharmaceutical composition for treating wind-cold-dampness arthralgia, and a preparation and application thereof. The pharmaceutical composition has good treatment effect on wind-cold-dampness arthralgia.
The invention aims at realizing the following technical scheme:
A pharmaceutical composition for treating wind-cold-dampness arthralgia comprises the following components in parts by weight: 9-15 parts of Heishan tablet, 6-10 parts of cassia twig, 5-12 parts of achyranthes root, 6-12 parts of Chinese taxillus twig, 5-10 parts of cortex acanthopanacis, 5-10 parts of obscured homalomena rhizome, 6-10 parts of eucommia bark, 6-10 parts of Chinese angelica, 6-10 parts of white paeony root, 3-9 parts of radix angelicae pubescentis, 3-9 parts of large-leaved gentian, 3-9 parts of pawpaw and 2-6 parts of liquorice.
Preferably, the pharmaceutical composition for treating wind-cold-dampness arthralgia comprises the following components in parts by weight: 10-14 parts of Heishan tablet, 7-9 parts of cassia twig, 6-11 parts of achyranthes root, 7-11 parts of Chinese taxillus twig, 6-9 parts of cortex acanthopanacis, 6-9 parts of obscured homalomena rhizome, 6-9 parts of eucommia bark, 6-9 parts of Chinese angelica, 6-9 parts of white paeony root, 4-8 parts of radix angelicae pubescentis, 4-8 parts of large-leaved gentian, 4-8 parts of pawpaw and 2-5 parts of liquorice.
Preferably, the pharmaceutical composition for treating wind-cold-dampness arthralgia comprises the following components in parts by weight: 11-13 parts of Heishan tablet, 7-8 parts of cassia twig, 7-10 parts of achyranthes root, 8-10 parts of Chinese taxillus twig, 7-8 parts of cortex acanthopanacis, 7-8 parts of obscured homalomena rhizome, 7-8 parts of eucommia bark, 7-8 parts of Chinese angelica, 7-8 parts of white paeony root, 5-7 parts of radix angelicae pubescentis, 5-7 parts of large-leaved gentian, 5-7 parts of pawpaw and 3-4 parts of liquorice.
Preferably, the pharmaceutical composition for treating wind-cold-dampness arthralgia also comprises 6-12 parts of erythrina bark and 9-12 parts of herba siegesbeckiae.
Preferably, the pharmaceutical composition for treating wind-cold-dampness arthralgia also comprises 6-12 parts of red sage root and 9-15 parts of suberect spatholobus stem.
Preferably, the pharmaceutical composition for treating wind-cold-dampness arthralgia also comprises 9-20 parts of coix seed and 9-15 parts of poria cocos.
The preparation of the pharmaceutical composition for treating the wind-cold-dampness arthralgia is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition. Preferably, the preparation is in the form of decoction, granule, capsule or pill prepared by conventional method.
The pharmaceutical composition and the preparation for treating the wind-cold-dampness arthralgia can be used for preparing a medicament for treating the wind-cold-dampness arthralgia.
The traditional Chinese medicine considers that the exterior deficiency and the exterior instability are the internal basis of the occurrence of arthralgia syndrome, and the feeling that the external pathogenic factor is the external condition of the occurrence of arthralgia syndrome, the pathogenic factor blocks the tendons and vessels of the limbs, and the qi and blood obstruction of the meridians is the basic pathogenesis. Pathogenic wind-cold-dampness is the common cause of arthralgia syndrome. Wind-cold-dampness pathogenic factors are usually caused by long-time damp lands, severe cold and cold injury, greedy and cold and overfall, sleeping and falling as wind, heavy rain and showering, water-in-water operation or sweating as water and the like, and exogenous pathogenic factors are infused in muscle and skin striae and collaterals to stagnate joint tendons and bones, resulting in qi-blood obstruction and wind-cold-dampness arthralgia. Just as in Su-Bi Lun: wind-cold-dampness mixed with three qi is also known as arthralgia. The symptoms are different due to the excessive nature of pathogenic factors, wherein the wind evil is migratory arthralgia, the cold evil is painful arthralgia, the damp evil is arthralgia, the long-term arthralgia and the wind-cold-dampness is unobvious, and the wind-cold-dampness is considered as wind-cold-dampness arthralgia.
The invention takes the Heixing tablet and the cassia twig as monarch drugs, the Heixing tablet is pungent and hot, and can warm the channel, dispel cold, dehumidify and open and close; gui Zhi Xin Wenzhi has the actions of warming meridians to dispel cold, dredging meridians to dispel arthralgia and astringing, gui Fu is monarch in order to warm meridians to dispel cold and unblock meridians to alleviate pain. Arthralgia syndrome affects tendons, bones, muscles and joints, can damage liver and kidney in a long time, and achyranthes root, mistletoe, cortex acanthopanacis, obscured homalomena rhizome and eucommia bark are all ministerial drugs, and have the effects of tonifying liver and kidney, strengthening tendons and bones and dispelling wind-damp. The achyranthes root can remove blood stasis and promote menstruation, so that the arthralgia syndrome is not stagnated after long-term blood stasis, and the medicine guiding force can descend to waist and legs; herba Taxilli, cortex Acanthopancis, rhizoma homalomenae, and cortex Eucommiae for nourishing liver and kidney and strengthening tendons and bones. The cortex acanthopanacis and the obscured homalomena rhizome have pungent and warm properties, can be matched with monarch drugs to enhance the effects of dispelling cold, eliminating dampness and dredging channels, and also have the effects of warming and dredging blood vessels, activating blood and removing stasis, can enhance the effects of the monarch drugs on warming and dredging channels, has the effects of removing stasis and removing stasis together with achyranthes and can be used for treating cold and blood stasis of joints and bones of a patient for a long time. Radix Angelicae sinensis, radix Paeoniae alba, radix Angelicae Pubescentis, radix Gentianae Marcrophyllae and fructus Chaenomelis are adjuvant drugs, radix Angelicae sinensis Xin Xiangxing is open but not left, radix Paeoniae alba is acid-collecting but not left, two drugs are matched together, pungent but not scattered, acid but not excessive, one open and one close, and blood nourishing and blood replenishing effects are the best. In addition, dang Gui can tonify liver and blood to promote blood circulation and stop pain, bai Shao can astringe liver yin and nourish blood to harmonize nutrient to stop pain, and the two herbs are combined to enhance blood and stop pain. Du Huo is pungent and bitter in flavor and dry in nature, and is good at dispelling wind-dampness and relieving arthralgia, especially suitable for arthralgia due to wind-cold-dampness. The gentiana macrophylla and the papaya have the effects of dispelling wind-damp, relieving arthralgia, relaxing tendons and activating collaterals, and are suitable for arthralgia syndrome injuries and tendons and collaterals. White peony root and papaya are sour, can be used for astringing, and can be used for treating excessive heat, and the pungent and warm drugs can be used for preventing excessive heat. The recipe uses licorice as guiding drug and harmonizes the drugs. The whole formula has the effects of dispelling cold, relieving pain, dispelling wind and removing dampness.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention plays the characteristic advantages of the traditional Chinese medicine, and has the obvious advantages of high safety, low recurrence rate and personalized treatment in the aspect of treating arthralgia.
2. The invention has good curative effect by summarizing years of clinical experience, taking the basic principle of eliminating pathogenic factors and dredging collaterals, dispelling wind and cold, removing dampness and dredging collaterals, and being used for treating joint cold pain, swelling and numbness, soreness of waist and knees and other symptoms caused by wind-cold-dampness arthralgia.
Detailed Description
The present invention will be further described with reference to examples, but the present invention is not limited to the examples.
Example 1
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 15g of Heishan tablet, 10g of cassia twig, 12g of achyranthes root, 12g of Chinese taxillus twig, 10g of cortex acanthopanacis, 10g of obscured homalomena rhizome, 10g of eucommia bark, 10g of Chinese angelica, 10g of white peony root, 9g of pubescent angelica root, 9g of large-leaved gentian, 9g of pawpaw and 6g of liquorice.
Example 2
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 12g of Heishan tablet, 8g of cassia twig, 8g of achyranthes root, 9g of Chinese taxillus twig, 8g of cortex acanthopanacis, 7g of obscured homalomena rhizome, 8g of eucommia bark, 8g of Chinese angelica, 8g of white peony root, 6g of pubescent angelica root, 6g of gentiana macrophylla, 6g of papaya and 4g of liquorice.
Example 3
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 9g of Heishan tablet, 6g of cassia twig, 5g of achyranthes root, 6g of Chinese taxillus twig, 5g of cortex acanthopanacis, 5g of obscured homalomena rhizome, 6g of eucommia bark, 6g of angelica, 6g of white peony root, 3g of radix angelicae pubescentis, 3g of gentiana macrophylla, 3g of papaya and 2g of liquorice.
Example 4
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 9g of Heishan tablet, 7g of cassia twig, 7g of achyranthes root, 10g of Chinese taxillus twig, 9g of cortex acanthopanacis, 10g of obscured homalomena rhizome, 6g of eucommia bark, 7g of angelica, 8g of white peony root, 7g of radix angelicae pubescentis, 8g of gentiana macrophylla, 9g of pawpaw and 2g of liquorice.
Example 5
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 10g of Heishan tablet, 8g of cassia twig, 10g of achyranthes root, 11g of Chinese taxillus twig, 10g of cortex acanthopanacis, 5g of obscured homalomena rhizome, 7g of eucommia bark, 8g of Chinese angelica, 9g of white peony root, 8g of pubescent angelica root, 9g of gentiana macrophylla, 3g of pawpaw and 3g of liquorice.
Example 6
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 11g of Heishan tablet, 9g of cassia twig, 11g of achyranthes root, 12g of Chinese taxillus twig, 5g of cortex acanthopanacis, 6g of obscured homalomena rhizome, 8g of eucommia bark, 9g of Chinese angelica, 10g of white peony root, 9g of pubescent angelica root, 3g of large-leaved gentian, 4g of pawpaw and 4g of liquorice.
Example 7
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 13g of Heishan tablet, 10g of cassia twig, 12g of achyranthes root, 6g of Chinese taxillus twig, 6g of cortex acanthopanacis, 7g of obscured homalomena rhizome, 9g of eucommia bark, 10g of angelica, 6g of white peony root, 3g of radix angelicae pubescentis, 4g of gentiana macrophylla, 5g of pawpaw and 5g of liquorice.
Example 8
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 14g of Heishan tablet, 6g of cassia twig, 5g of achyranthes root, 7g of Chinese taxillus twig, 7g of cortex acanthopanacis, 8g of obscured homalomena rhizome, 10g of eucommia bark, 6g of angelica, 7g of white peony root, 4g of radix angelicae pubescentis, 5g of gentiana macrophylla, 7g of papaya and 6g of liquorice.
Example 9
A pharmaceutical composition for treating wind-cold-dampness arthralgia consists of the following components: 15g of Heishan tablet, 8g of cassia twig, 6g of achyranthes root, 8g of Chinese taxillus twig, 8g of cortex acanthopanacis, 9g of obscured homalomena rhizome, 6g of eucommia bark, 10g of angelica, 6g of white peony root, 5g of pubescent angelica root, 7g of large-leaved gentian, 8g of pawpaw and 2g of liquorice.
Example 10
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of examples 1 to 9, and 6g of erythrina bark and 9g of herba siegesbeckiae.
Example 11
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of examples 1-9, 9g erythrina bark, 12g siegesbeckia herb.
Example 12
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of examples 1 to 9, and 12g of erythrina bark and 10g of herba siegesbeckiae.
Example 13
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition according to any one of embodiments 1 to 9, and 6g of Salvia Miltiorrhiza and 9g of Spatholobus stem.
Example 14
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of embodiments 1-9, and 9g of red sage root and 15g of spatholobus stem.
Example 15
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition according to any one of embodiments 1 to 9, 12g of Salvia Miltiorrhiza and 12g of Spatholobus suberect.
Example 16
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of embodiments 1-9, 9g of coix seed and 12g of poria cocos.
Example 17
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of embodiments 1-9, and 20g of coix seed and 15g of poria cocos.
Example 18
A pharmaceutical composition for treating wind-cold-dampness arthralgia, comprising: the pharmaceutical composition of any one of embodiments 1-9, and 14g of coix seed and 9g of poria cocos.
Example 19
A preparation of a pharmaceutical composition for treating arthralgia due to wind-cold-dampness is prepared by decocting HEISHU tablet (prepared by radix Aconiti lateralis Preparata according to the method carried in Chinese pharmacopoeia) with water for 4 hr, adding ramulus Cinnamomi, herba Taxilli, fructus Chaenomelis, and radix Gentianae Marcrophyllae, decocting for 1.5 hr, filtering, collecting the rest medicinal materials, mixing and pulverizing to obtain fine powder, mixing the fine powder with the decoction, and making into tablet, powder, pill, etc.
Example 20
A pill of a pharmaceutical composition for treating arthralgia due to wind-cold-dampness, the pharmaceutical composition of any one of examples 1-18 is prepared according to the following steps:
(1) Decocting HEISHUN tablet with water for 4 hr, adding ramulus Cinnamomi, herba Taxilli, fructus Chaenomelis, and radix Gentianae Marcrophyllae, and decocting for 1.5 hr (the water amount is 4-6 times of the amount of the medicinal materials).
(2) Filtering, concentrating the filtrate under reduced pressure below 80deg.C to relative density of 1.05-1.10 (50deg.C) for use.
(3) Mixing the rest materials, pulverizing, and sieving with 80 mesh sieve to obtain fine powder; adding the fine powder into a mixer, and mixing for 35min for later use.
(4) Taking the fine powder of the medicinal materials, making pills with decoction, covering with medicinal charcoal, oven drying below 80deg.C until the water content is qualified (less than 9.0%), polishing, and making into pill.
Application example-the pharmaceutical composition of the invention is used for clinical observation of wind-cold-dampness arthralgia.
1. Research method
Patients meeting the inclusion standard of arthralgia syndrome (wind-cold-dampness arthralgia) within 2 years are selected, and the pharmaceutical composition is used for treatment, so that the clinical curative effect and adverse reaction of the patients are observed.
2. Study object
Patients with arthralgia syndrome (wind-cold-dampness arthralgia).
3. Diagnostic criteria
Diagnostic criteria for traditional Chinese medicine (refer to New century fifth edition of Chinese medicine science)
Pain of the joints and muscles of the limbs, or wandering or aggravating when encountering cold, and getting pain of the heat, or soreness, heavy attachment, swelling and diffusion of the joints of the limbs, or numbness and no pain of the skin, difficulty in flexing and extending the joints, pale tongue with thin white or greasy coating, wiry and tight or soft pulse.
(II) Western diagnostic criteria
In western medicine, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, sciatica, scapulohumeral periarthritis, cervical spondylosis and the like belong to the category of arthralgia syndrome, and the rheumatoid arthritis and the cervical spondylosis are selected in the study.
1. Rheumatoid Arthritis (RA) diagnostic criteria (refer to the Min's health press ninth edition, science)
(1) Morning stiffness
Joint or surrounding morning stiffness lasts at least 1 hour.
(2) Arthritis of more than or equal to 3 joint areas
At least 3 of the following 14 joint areas (proximal interphalangeal joint, metacarpophalangeal joint, wrist, elbow, knee, ankle, and metatarsophalangeal joint) had soft tissue swelling or fluid accumulation (not mere bone bulge).
(3) Arthritis of hands
At least one joint area in the wrist, metacarpophalangeal or proximal interphalangeal joint area is swollen.
(4) Symmetric arthritis
The left and right side joints are affected simultaneously (bilateral proximal interphalangeal joints, metacarpophalangeal joints, and plantar-phalangeal joints are not necessarily absolutely symmetrical).
(5) Rheumatoid nodules
Subcutaneous nodules are present at the apophyseal sites, extensor surfaces or around the joints.
(6) Serum RF positivity
The RF content in serum was increased (the method used had a positive rate of <5% in healthy people).
(7) Imaging changes
There is a typical RA imaging change in the posterior anterior image of the hand and wrist: must include bone erosion or definite bone decalcification of affected joints and their vicinity.
Note that: those who met 4 or more of the above 7, except other arthritic conditions, may be diagnosed with RA (requiring at least 6 weeks from 1 st to 4 th course).
2. Cervical spondylosis diagnosis Standard (refer to cervical spondylosis typing, diagnosis and non-operative therapist consensus (2018))
Cervical spondylosis I and cervical spondylosis
(1) The patient complains about the abnormal sensation of pain in the pillow, neck, shoulder, etc., which may be accompanied by corresponding tenderness points.
(2) Imaging examination results showed degenerative changes of the cervical spine.
(3) Except for cervical symptoms caused by other cervical disorders or other diseases.
II, cervical spondylosis of nerve root type
(1) Has more typical nerve root symptoms (numbness and pain of arms) and the range of the symptoms is consistent with the region innervated by cervical spinal nerves, and the physical examination cervical test or the brachial plexus traction test is positive.
(2) The imaging examination is seen to be consistent with clinical manifestations.
(3) Except for cervical vertebra, diseases such as chest and outlet syndrome, tennis elbow, carpal tunnel syndrome, scapulohumeral periarthritis, tenosynovitis of biceps brachii and pulmonary toe tumor, etc. are caused by pain of upper limbs.
III, cervical spondylosis of spinal cord type
(1) Clinically, typical cervical spinal marrow lesions are manifested mainly by dyskinesia, paresthesia and reflex abnormalities of the limbs.
(2) Imaging examination revealed clear signs of spinal cord compression and corresponded to clinical symptoms.
(3) Except amyotrophic lateral sclerosis, intraspinal space occupation, acute spinal cord injury, subacute joint degeneration of spinal cord, syringomyelia, chronic multiple peripheral neuropathy, etc.
IV, other cervical spondylosis
The typing covers vertebral artery type and sympathogenic cervical spondylosis in the past typing.
(1) Clinically manifested as dizziness, blurred vision, tinnitus, hand numbness, hearing impairment, tachycardia, precordial pain, and a series of sympathological symptoms. Physical examination can be positive in cervical spin test.
(2) Imaging performance: x-ray films may exhibit segmental instability; MRI may manifest as degeneration of the cervical disc.
(3) Except for other system diseases such as ophthalmonogy, cardiogenic, brain-derived and aural vertigo.
4. Inclusion criteria
1. Meets the diagnosis standard of traditional Chinese medicine for diagnosing arthralgia syndrome (wind-cold-dampness arthralgia);
2. Meets the diagnosis standard of Western diagnosis of rheumatoid arthritis and cervical spondylosis;
3. Age 18-70 years, and is not limited for men and women;
4. signing a treatment informed consent form and following the doctor's advice to treat the patient according to the course of treatment.
5. Exclusion criteria
1. Those who do not meet the diagnostic standards of traditional Chinese and Western medicine;
2. patients under 18 years of age, or over 70 years of age;
3. Serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system are combined;
4. Mental patients;
5. allergic to the study drug;
6. the inclusion standard is not met, and the administration is not regulated, so that the treatment effect or the influence of incomplete data and the like on the treatment effect or the safety judgment cannot be judged.
Administration method
Is orally taken. 4g each time and 2 times a day, and is taken with warm boiled water after meals. The treatment is carried out for 3 courses.
7. Therapeutic effect criterion
Formulating curative effect evaluation standards by referring to the guidelines (trial) of clinical study of new traditional Chinese medicines:
Therapeutic index n= (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100% (nimodipine method)
Clinical recovery: the clinical symptoms and signs of the traditional Chinese medicine disappear or basically disappear, and the integral of symptoms is reduced by more than or equal to 95%;
the effect is shown: the clinical symptoms and signs of the traditional Chinese medicine are obviously improved, and the integral of symptoms is reduced by more than or equal to 70 percent and is less than 95 percent;
The method is effective: the clinical symptoms and signs of the traditional Chinese medicine are all improved, and the integral of symptoms is reduced by more than or equal to 30 percent and is less than 70 percent;
invalidation: the clinical symptoms and physical signs of the traditional Chinese medicine are not obviously improved or even aggravated, and the integral of symptoms is reduced by less than 30 percent.
Total effective rate= (clinical cure + onset + efficacy)/total case number x 100%.
8. Summary of clinical efficacy
The study observed a total of 120 effective cases. Of these, 54 male patients and 66 female patients; 19 cases of age 18-30 years old, 32 cases of age 30-45 years old, 45 cases of age 45-60 years old, and 24 cases of age above 60 years old.
The pharmaceutical composition provided by the application is used for treating 120 cases of wind-cold-dampness arthralgia, 3 treatment courses (67 days) are observed, 30 cases (25%) are cured, 45 cases (37.5%) are obvious in effect, 37 cases (30.8%) are effective, and 8 cases (6.7%) are ineffective. The total effective rate is 93.3%, see Table 1.
9. Case of cases
1. Patients Li Mou, women, 50 years old, and 2023, 12 months 30 days visit.
Complaints: pain in the right shoulder and back was aggravated for 1 year with pain in the finger joints for 2 weeks.
Checking: the fingers are swollen, pressed and painful, the movement is unfavorable, and the skin color and skin temperature are normal. A red tongue with thin and white coating and a deep, thready and wiry pulse.
Auxiliary inspection: normal liver and kidney function, anti-O' (-), elevation of Rheumatoid Factor (RF) (+), elevation of C-reactive protein (CRP), blood sedimentation (ESR) of 35mm/h, blood convention shows that: white Blood Cells (WBC) 6.8X109/L, hemoglobin (HGB) 108g/L.
Diagnosis: arthralgia-syndrome.
Syndrome differentiation: wind-cold-dampness arthralgia.
The treatment method comprises the following steps: dispelling wind and cold, removing dampness and dredging collaterals.
Treatment: the pharmaceutical composition described in example 1 was taken orally, 4g once a day, for 3 weeks according to the preparation method described in example 20.
Two diagnoses: relieving pain of shoulder and back, finger joint pain, aversion to cold, fatigue, red tongue, thin and white coating, deep, thready and wiry pulse. Checking: the pain of the two fingers is weak and positive, the remainders are the same. The wind-cold-dampness evil is removed and the yang qi is weakened, and the patients take the medicine for 3 weeks.
Three diagnoses: the pain of the joints of the fingers at the back of the shoulder is obviously relieved, the tongue is red, the coating is thin, and the pulse is wiry and thin. The pharmaceutical composition described in example 2 was taken as a pill prepared in accordance with the method of example 20 for 3 weeks.
The pain of patients is obviously relieved and the illness state is stable after one month of follow-up.
2. Patient Sun Mou, female, 51 years old, 10 months, 12 days of 2023.
Complaints: pain in the wrist and elbow joints results from an outpatient visit for half a month.
Medical history: after the ovariectomy is carried out for 4 months, the patients are stained with cold water again, and the pain of the wrist joint and the elbow joint at two sides is caused, and the pain is even when the patients are cold, the night aggravates, the spontaneous perspiration and the night sweat, the life interest is reduced, the debilitation, the night sleep is poor, the stool is dry, the tongue is pale with white fur, and the pulse is deep and tight.
Diagnosis: arthralgia-syndrome.
Syndrome differentiation: wind-cold-dampness arthralgia (excessive cold evil).
The treatment method comprises the following steps: it is indicated for cold dispelling, dampness removing, collateral obstruction expelling and pain relieving.
Treatment: the pharmaceutical composition of example 3 was taken orally, 4g once a day, for 3 weeks according to the preparation method of example 20.
Two diagnoses: the pain was rough, the mood was improved, the recent overcast and rainy weather was more severe, the elbow joint and wrist joint were complained, and the pill of the pharmaceutical composition of example 16 prepared according to the preparation method of example 20 was taken continuously for 3 weeks.
Three diagnoses: pain is cured, the pain and the heavy feeling are obviously relieved, and the medicine is taken above for 3 weeks, and the treatment is consolidated. No recurrence was observed following the follow-up.
3. Patient Zhou Mou, female, 52 years old, 2023, 1 month, 3 first visit.
Complaints: neck pain is 1 year, aggravates pain and numbness of the right upper limb for 1 month.
The current medical history: the pain of the neck caused by long-term low head can be relieved slightly before 1 year, and physiotherapy, oral administration medicine, external plaster and other treatments are performed. Pain symptoms aggravated after 1 month of greedy cooling and cold catching, radioactive pain and numbness of the right upper limb, and heavy limbs in the morning. The symptoms are as follows: soreness of neck and shoulder, discomfort in turning side, aggravation in cold, heavy sensation of limbs, sweats, aversion to wind, thirst, insomnia, loose stool, and normal urination. Pale red tongue with teeth marks and white and slightly greasy coating. The pulse is superficial and weak, and the pulse is astringent.
Checking: the neck and shoulder muscles are tensed, the pressure pain at the two side shoulder and well points is obvious, the cervical vertebra is limited in flexion and extension and rotation movement, the right side arm cluster traction test is positive, the muscle strength and the muscle tension of the two upper limbs are normal, and the two side Huffman signs are negative.
Auxiliary inspection: cervical vertebra X-ray film prompting: the physiological curvature of cervical vertebra becomes straight and cervical vertebra regresses. Cervical vertebra magnetic resonance flat scanning: 1. cervical vertebra degeneration and instability; mild herniation of the C3/4-C5/6 disc.
Diagnosis: arthralgia syndrome (wind-cold-dampness arthralgia syndrome)
The treatment method comprises the following steps: dispelling wind and cold, dredging collaterals and relieving pain.
Treatment: the pharmaceutical composition of example 18 was taken orally, 4g once a day, for 3 weeks according to the preparation method of example 20.
Two diagnoses: the limbs are obviously improved when the morning is complained, the neck and shoulder pain is relieved before, and the right upper limb numbness is still obvious; the pharmaceutical composition described in example 12 was taken continuously for 3 weeks as a pill prepared in the preparation method described in example 20.
Three diagnoses: after the medicine is taken, the numbness and pain of the right upper limb can be obviously relieved, the neck is slightly sour and distended, and the upper part is taken for 3 weeks. The follow-up patients complain of cervicodynia and the numbness of the upper limbs does not recur.
The above cases are only part of the cases observed clinically, and the pharmaceutical composition used is also only part of the pharmaceutical composition, and in actual clinical use, the dosage of the specific drug in the pharmaceutical composition can be arbitrarily selected within the scope of the invention according to different clinical symptoms of patients.
In clinic, prescriptions can be adjusted and modified for different patients:
(1) For patients with numbness of skin, cortex Erythrinae and Siegesbeckiae herba can be added. Both erythrina bark and siegesbeckia herb have the effects of dispelling wind-damp, benefiting joints, relaxing tendons and dredging collaterals. Both herbs are better for treating rheumatic numbness, lumbago, skelalgia and tendons and bones pain. The two herbs can also be added to enhance the effect of dispelling wind-damp.
(2) For long-term arthralgia with blood stasis, arthrocele, deformity and rigidity, saviae Miltiorrhizae radix and caulis Spatholobi can be added. The red sage root has the effects of promoting blood circulation and removing blood stasis; caulis Spatholobi has effects of promoting blood circulation, replenishing blood, relieving rigidity of muscles and activating collaterals. The two medicines are combined to have the effects of promoting blood circulation to remove blood stasis, relaxing tendons and activating collaterals, and have good treatment effect on the blood stasis obstruction.
(3) For patients with soreness and severe pain, coicis semen and Poria may be added. The coix seed and the poria cocos have the effects of strengthening spleen, promoting diuresis and removing dampness, and have good curative effects on symptoms such as muscular soreness, severe pain and the like caused by serious damp evils.

Claims (9)

1. The pharmaceutical composition for treating the wind-cold-dampness arthralgia is characterized by comprising the following components in parts by weight: 9-15 parts of Heishan tablet, 6-10 parts of cassia twig, 5-12 parts of achyranthes root, 6-12 parts of Chinese taxillus twig, 5-10 parts of cortex acanthopanacis, 5-10 parts of obscured homalomena rhizome, 6-10 parts of eucommia bark, 6-10 parts of Chinese angelica, 6-10 parts of white paeony root, 3-9 parts of radix angelicae pubescentis, 3-9 parts of large-leaved gentian, 3-9 parts of pawpaw and 2-6 parts of liquorice.
2. A pharmaceutical composition for treating wind-cold-dampness arthralgia is characterized in that 6-12 parts of erythrina bark and 9-12 parts of herba siegesbeckiae are added on the basis of the pharmaceutical composition of claim 1.
3. A pharmaceutical composition for treating wind-cold-dampness arthralgia is characterized in that 6-12 parts of red sage root and 9-15 parts of suberect spatholobus stem are added on the basis of the pharmaceutical composition of claim 1.
4. A pharmaceutical composition for treating wind-cold-dampness arthralgia is characterized in that 9-20 parts of coix seed and 9-15 parts of poria cocos are added on the basis of the pharmaceutical composition in claim 1.
5. A formulation of a pharmaceutical composition for the treatment of wind-cold-dampness arthralgia according to any one of claims 1 to 4, characterised in that the formulation is prepared from the pharmaceutical composition by adding pharmaceutically acceptable excipients.
6. The formulation of a pharmaceutical composition for treating wind-cold-dampness arthralgia according to claim 5, wherein the formulation is a decoction, a granule, a capsule or a pill.
7. A method for preparing a pill of the pharmaceutical composition for treating wind-cold-dampness arthralgia as defined in claim 6, comprising the following steps:
(1) Decocting HEISHU tablet with 4-6 times of water for 4 hr, adding ramulus Cinnamomi, herba Taxilli, fructus Chaenomelis, and radix Gentianae Marcrophyllae, and decocting for 1.5 hr;
(2) Filtering, concentrating the filtrate under reduced pressure below 80deg.C to relative density of 50deg.C 1.05-1.10;
(3) Mixing the rest materials, pulverizing, sieving with 80 mesh sieve to obtain fine powder, and mixing;
(4) Taking the fine powder of the medicinal materials, making pills with decoction, covering with medicinal charcoal, drying below 80deg.C until the water content is qualified, polishing, and making into pill.
8. Use of a pharmaceutical composition according to any one of claims 1-4 for the treatment of wind-cold-dampness arthralgia in the preparation of a medicament for the treatment of wind-cold-dampness arthralgia.
9. The use of the formulation of the pharmaceutical composition for treating wind-cold-dampness arthralgia of claim 5 for preparing a medicament for treating wind-cold-dampness arthralgia.
CN202410938268.3A 2024-07-13 2024-07-13 Pharmaceutical composition for treating wind-cold-dampness arthralgia, preparation and application thereof Withdrawn CN118477137A (en)

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Application publication date: 20240813