CN111588823A

CN111588823A - Ointment for treating synovitis and preparation method thereof

Info

Publication number: CN111588823A
Application number: CN202010605704.7A
Authority: CN
Inventors: 杜志谦; 刘培建; 李记天; 王秋生; 郭继锋; 郑旭霞; 陈晓霞
Original assignee: HENAN ORTHOPEDIC-TRAUMATOLOGY RESEARCH INSTITUTE
Current assignee: HENAN ORTHOPEDIC-TRAUMATOLOGY RESEARCH INSTITUTE
Priority date: 2020-06-29
Filing date: 2020-06-29
Publication date: 2020-08-28

Abstract

The invention relates to the field of medical treatment and health, and discloses an ointment for treating synovitis, which consists of the following components: radix astragali, radix Gentianae Macrophyllae, radix Angelicae sinensis, radix Dipsaci, cortex moutan, bupleuri radix, rhizoma Wenyujin Concisa, radix Rubiae, herba Taxilli, rhizoma Dioscoreae Septemlobae, radix Cyathulae, Glycyrrhrizae radix, and adjuvants including Mel, oleum Sesami and water. A preparation method of an unguent for treating synovitis comprises the steps of weighing the components according to the weight component medicine ratio, mixing and grinding the components into powder, and screening by using a mesh screen to obtain powder passing through the mesh screen; step two, taking honey and adding water, decocting into honey water, cooling the honey water, adding sesame oil, and uniformly stirring for later use; and step three, taking the powder obtained by screening in the step one, adding the honey water, and blending into paste to obtain the required ointment. The traditional Chinese medicine composition is reasonable in composition, simple to use, remarkable in curative effect, less in side effect and environment-friendly, and the treatment effect can be achieved by using a small amount of medicine.

Description

Ointment for treating synovitis and preparation method thereof

Technical Field

The invention relates to the field of medical treatment and health, in particular to an ointment for treating synovitis and a preparation method thereof.

Background

Joints in a human body, such as knee joints, hip joints, ankle joints, elbow joints and the like, can cause joint damage during long-term heavy-duty labor or unreasonable movement, and are very common diseases, and joint softness or movement difficulty, joint effusion, swelling, pain and the like caused by joint damage further troubles daily life of people. The traditional Chinese medicine considers that the joints are soft or are not movable, and the joint effusion, swelling and pain belong to muscle injury and arthralgia, the mechanism is qi stagnation and blood stasis and water retention, and the treatment should be based on the principles of activating blood and stimulating the menstrual flow, eliminating dampness and removing arthralgia, and inducing diuresis and relieving swelling.

The currently common traditional Chinese medicine external ointment medicaments comprise a black ointment medicament, a rubber ointment, a cataplasm, a film coating agent and the like, individual components of the traditional Chinese medicine are decocted through high-temperature oil refining in the manufacturing process or extracted simply, the effective components of the medicine are destroyed completely, the medicine effect is greatly reduced, the treatment of acute soft tissue injury is not benefited, and a large amount of precious medicinal material resources are wasted.

Disclosure of Invention

In order to solve the technical problems, the invention provides the ointment for treating the synovitis, which has the effects of activating blood and stimulating the menstrual flow, eliminating dampness and removing arthralgia, and inducing diuresis and reducing edema and is used for treating symptoms such as knee joint softness or movement difficulty, joint effusion, swelling, pain and the like caused by knee joints, hip joints, ankle joints and elbow joints and the preparation method thereof.

An ointment for treating synovitis mainly comprises the following medicines in parts by weight: 8-12g of astragalus membranaceus, 3-7g of gentiana macrophylla, 3-7g of angelica sinensis, 3-7g of teasel roots, 3-7g of moutan barks, 3-7g of bupleurum chinense, 3-7g of rhizoma wenyujin concinnatae, 3-7g of madder, 3-7g of parasitic loranthus, 3-7g of rhizoma dioscoreae septemlobae, 1-3g of radix cyathulae and 1-3g of liquorice.

Further comprises 5-10g of honey, 1-3ml of sesame oil and 40-60ml of water as auxiliary materials.

Further, the medicine mainly comprises the following components by weight: 10g of astragalus membranaceus, 5g of gentiana macrophylla, 4g of angelica sinensis, 4g of teasel roots, 4g of moutan bark, 4g of bupleurum chinense, 4g of rhizoma wenyujin concinnatae, 5g of madder, 4g of loranthus parasiticus, 5g of rhizoma dioscoreae septemlobae, 2g of radix cyathulae and 1g of liquorice.

A preparation method of an ointment for treating synovitis comprises the following steps:

weighing traditional Chinese medicine decoction pieces of astragalus, gentiana macrophylla, angelica sinensis, teasel roots, moutan barks, bupleurum chinense, rhizoma wenyujin concinnatae, madder roots, loranthus parasiticus, rhizoma dioscoreae septemlobae, radix cyathulae and liquorice according to the medicine proportion of the weight components, mixing and grinding the weighed traditional Chinese medicine decoction pieces into powder, and screening the powder by using a mesh screen to obtain powder passing through the mesh screen for later use;

step two, taking honey and adding water, decocting into honey water, cooling the honey water, adding sesame oil into the honey water after cooling, and uniformly stirring for later use;

and step three, according to the area of the injured part of the patient, taking the powder obtained by screening in the step one, adding the honey water mixed with the sesame oil in the step two into the powder, and stirring and blending into paste to obtain the required ointment.

Further, the mesh size in the first step is 100 meshes.

Further, the temperature of the honey water decocted in the second step is 60 ℃ after cooling.

Astragalus root: invigorating qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting fluid production, nourishing blood, activating stagnancy, relieving arthralgia, removing toxic substance, expelling pus, healing sore, and promoting granulation.

Large-leaved gentian: dispelling wind-damp, clearing damp-heat, relieving arthralgia, and relieving deficiency heat, and can be used for treating rheumatalgia, spasm of channels, joint pain, jaundice due to damp-heat, and hectic fever.

Chinese angelica: tonify blood, activate blood, regulate menstruation, alleviate pain, moisten intestines to relieve constipation, and can be used for treating rheumatalgia, traumatic injury, carbuncle, cellulitis, sore and ulcer.

Teasel root: tonify liver and kidney, strengthen tendons and bones, reunite fractured bones and stop metrorrhagia and metrostaxis, and is used for treating rheumatic arthralgia, traumatic injury, tendon injury and fracture.

Moutan bark: clear heat and cool blood, activate blood and resolve stasis, and it is indicated for heat entering nutrient-blood, traumatic injury, abscess, swelling and sore.

Bupleurum chinense nakai: disperse and abate fever, soothe the liver and relieve depression, lift yang qi.

Rhizoma Wenyujin Concisa: break blood and move qi, dredge meridians to alleviate pain, and indicated for stabbing pain in chest and hypochondrium, pain in shoulder and arm due to wind-damp, and pain in traumatic injury.

Madder root: cool blood, dispel blood stasis, stop bleeding and dredge meridians, and are indicated for traumatic hemorrhage, amenorrhea due to stasis, arthralgia, traumatic injury with swelling pain.

Parasitic loranthus: dispel wind-damp, tonify liver and kidney, strengthen tendons and bones, and can be used for treating rheumatic arthralgia, soreness and weakness of waist and knees, and weakness of tendons and bones.

Rhizoma Dioscoreae Septemlobae: promoting diuresis, removing turbidity, dispelling pathogenic wind and removing arthralgia, and can be used for treating rheumatalgia, joint discomfort, and pain of waist and knee.

Radix cyathulae: removing blood stasis, dredging channels, promoting joint movement, inducing diuresis, and treating stranguria, and can be used for treating traumatic injury, rheumatalgia, flaccidity of feet, and spasm of tendons.

Licorice root: invigorating spleen and replenishing qi, clearing heat and detoxicating, relieving spasm and pain, and harmonizing the medicines, and can be used for treating limb spasm and pain, carbuncle swelling and sore, and relieving drug toxicity and severity.

Honey and sesame oil: mixing with the prepared powder, and applying topically can relieve irritation to skin, and can also act as adhesive to facilitate application of the powder on skin.

Compared with the prior art, the invention has the following advantages: the ointment prepared by the invention has good curative effect, promotes blood circulation, dredges the menstrual flow, eliminates dampness, removes arthralgia, induces diuresis and reduces edema, and can be used for treating symptoms such as knee joint softness or movement difficulty, joint effusion, swelling, pain and the like caused by knee joints, hip joints, ankle joints and elbow joints; the shock wave is combined with the synovitis ointment for external application, so that symptoms such as knee joint swelling, pain and limited activity of patients with acute knee joint synovitis (phlegm-fluid-retention-fluid-infusion syndrome) can be effectively relieved, and the synovitis ointment is worthy of further clinical research and popularization; the traditional Chinese medicine composition is reasonable in composition, simple to use, remarkable in curative effect, less in side effect and environment-friendly, and the treatment effect can be achieved by using a small amount of medicine.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in detail below with reference to embodiments and clinical applications.

An ointment for treating synovitis comprises the following medicinal components in parts by weight: 10g of astragalus membranaceus, 5g of gentiana macrophylla, 4g of angelica sinensis, 4g of teasel roots, 4g of moutan bark, 4g of bupleurum chinense, 4g of rhizoma wenyujin concinnatae, 5g of madder, 4g of loranthus parasiticus, 5g of rhizoma dioscoreae septemlobae, 2g of radix cyathulae and 1g of liquorice.

Weighing according to the proportion and manufacturing by the following steps:

step one, weighing traditional Chinese medicine decoction pieces of astragalus membranaceus, gentiana macrophylla, angelica sinensis, teasel roots, moutan barks, bupleurum chinense, rhizoma wenyujin concinnatae, madder, loranthus parasiticus, rhizoma dioscoreae septemlobae, radix cyathulae and liquorice with 12 dosage according to the medicine proportion of the components by weight, mixing and grinding the weighed traditional Chinese medicine decoction pieces into powder, and screening the powder by using a 100-mesh screen to obtain powder passing through the screen for later use;

step two, taking 10g of honey, adding 50ml of water, decocting into honey water, cooling the honey water, cooling to about 60 ℃, adding 1ml of sesame oil into the honey water, and uniformly stirring for later use;

Clinical trials of the invention

Synovitis is a particular manifestation of a variety of diseases (e.g., trauma, tuberculosis, degenerative joint changes, rheumatic diseases, hyperpigmented villous nodules, surgical irritation, etc.) in synovial tissue. The diseases can cause the synovial membrane of the joints to be stimulated by machinery, biology, chemistry and the like, and cause the clinical symptoms of joint swelling, pain, limited activity and the like due to the fact that the synovial membrane tissue is congested, edematous, high in vascular permeability, excessive in synovial fluid secretion and reduced in absorption. Arthromeningitis is not a disease, and is a group of symptoms caused by various intra-articular injuries, such as articular cartilage injury, intra-articular fracture, joint dislocation, ligament rupture, joint free body and the like, which can cause the destructive inflammation of the synovium.

The synovial membrane of the knee joint is the most extensive and complex in area in the joints of the human body, and also forms the largest synovial cavity, and because the synovial membrane of the knee joint is wide and is positioned on the superficial parts of limbs, the synovial membrane has more chances of being damaged and infected, and therefore, the synovitis is frequently expressed in the synovitis of the knee joint clinically.

Common causes of gonarthromeningitis are trauma, chronic strain, joint degeneration, and can be divided into acute traumatic synovitis, chronic synovitis, and degenerative synovitis. After the knee joint suffers from injuries such as fracture, dislocation, ligament rupture, cartilage injury and the like, the synovial membrane of the joint can be simultaneously damaged, and effusion of the joint after injury causes the knee joint to generate heat, swelling and pain, muscular contracture and joint flexion and extension disorder, thus forming acute synovitis. Chronic synovitis can develop from either acute phase of improper treatment or chronic strain over a long period of time.

The knee joint is a main load bearing joint of a human body due to complex structure and is extremely easy to damage, and gonarthromeningitis is a common disease. The current treatment, which is commonly used in modern medicine, comprises non-steroids, antibiotics, hormone medicines, joint puncture to extract effusion, even operation and the like, and has the defects of more side effects, easy relapse of symptoms, high infection risk and the like. The research is based on the treatment based on the syndrome differentiation of the traditional Chinese medicine theory, and the externally applied synovitis ointment combines with the shock wave to treat the acute gonarthromeningitis (phlegm-fluid retention and fluid injection syndrome) with satisfactory curative effect, which is concretely as follows.

1. Description of the experiments

In order to observe the clinical efficacy of the synovitis ointment for external application in combination with shock waves in the treatment of acute gonarthromeningitis (phlegm-fluid retention and fluid injection). Dividing 64 cases of patients with acute gonarthromeningitis into two groups at random, wherein 32 cases are respectively used as a control group and a test group, the control group is treated by shock waves, and the patients are guided to carry out conventional functional exercise during the treatment period; the synovitis ointment is externally applied to the test group on the basis of the control group. And observing the functional scores of Lysholm knee joints, VAS scores and clinical effects of the two groups before and after treatment.

Wherein, the selected cases need to meet the following standards:

1.1 case selection

The following criteria were developed with reference to "practical bone science" and "clinical medical guidelines (orthopedics book"):

western diagnostic criteria for gonarthromeningitis:

(1) medical history

It can be caused by acute onset, chronic persistence, or trauma.

(2) Symptoms and signs

There is localized swelling of the knee, with tenderness and fluctuating swelling consistent with the anatomical location of the bursa.

② pain (distending pain or dull pain and discomfort).

And thirdly, the knee joint is limited in flexion and difficult to squat, and the knee joint can only be in a slightly flexed position when the fluid is accumulated seriously.

Fourthly, the local skin temperature is slightly high, and the general poisoning symptom can be met or not met.

Atrophy of muscles adjacent to joints.

(3) The test of special examination of floating patella test is positive (floating patella test), and the test of joint effusion induced swelling is positive (Archer-Berman sign test), and the test is divided into 4 grades according to the effusion condition:

stage I: the examiner presses the suprapatellar sac by a tiger's mouth with one hand, and mild floating patellar test positive can be led out;

and II, stage: the relatively healthy side of the patella is slightly raised, and even if an inspector does not press the suprapatellar sac by a tiger's mouth, a slight patella floating test positive can be led out;

grade III: the obvious raised patella side can be seen, and the positive patella test can be obviously led out;

IV stage: the obvious protrusion of the healthy side of the patella can be seen, and the patella cannot be pushed to the femoral condyle articular surface;

(4) auxiliary examination

Routine laboratory examination shows that the routine blood, the blood sedimentation and the C-reactive protein are normal generally, and the blood sedimentation and the C-reactive protein can be slightly increased in a few serious inflammation patients, but the blood sedimentation can not exceed 30-35 mm/h.

② X-ray examination and observation of joint capsule swelling, and simultaneously excluding other reasons causing gonarthromeningitis pathological changes.

And the synovial fluid examination of affected joints such as accompanied synovitis can cause increase of the amount of the synovial fluid, the synovial fluid of the affected joints is clear and transparent and is faint yellow, turbid and bloody exudation are occasionally seen, and the viscosity is normal or reduced. Leukocytes are slightly to moderately elevated, mostly below 8X 109/L, and mainly lymphocytes.

(5) Differential diagnosis is to eliminate hematoma in joints, suppurative arthritis, rheumatoid arthritis, pigmented villous nodular synovitis, tuberculous synovitis, gouty synovitis, and hemophilia arthritis.

Diagnosis of traditional Chinese medicine

The syndrome of fluid retention with fluid retention is characterized in that the following standards are drawn according to the traditional Chinese medicine disease diagnosis curative effect standard and the adult gonarthromeningitis diagnosis and clinical curative effect evaluation expert consensus:

the main symptoms are: the knee joint is heavy, swollen, painful, uncomfortable and difficult to move.

The secondary symptoms are as follows: chest oppression, anorexia, nausea, pale tongue, white and greasy coating, and deep and slow pulse.

It can be diagnosed with reference to tongue pulse, with any of primary and secondary symptoms.

1.2 inclusion criteria

Meets the above diagnostic criteria; age 19-65 years old; the patients gave informed consent.

1.3 exclusion criteria

Patients with knee joint fracture; patients with serious primary diseases such as cardiovascular and cerebrovascular diseases, liver and kidney diseases, blood coagulation system diseases and the like; pregnant or lactating women; allergic constitution or those allergic to known ingredients of the plaster; those who cannot adhere to the treatment or have serious adverse reactions.

2. Test method

64 patients with acute gonarthromeningitis (phlegm-fluid retention and fluid-flow syndrome) were selected and randomly divided into 32 cases each of the control group and the test group. Test groups 15 men and 17 women; the age is 20-62 years, and the average age is 35.26 +/-10.34 years; the disease course is 1-12 days, and the average is 4.3 +/-1.5 days; 12 cases of right knee, 9 cases of left knee and 11 cases of double knee. Control group 13 men and 19 women; the age is 25-65 years, and the average age is 37.16 +/-12.83 years; the disease course is 1-10 days, and the average is 4.7 +/-1.8 days; 7 cases of right knee, 13 cases of left knee, 12 cases of double knee. The general data of sex, age and course of disease of two groups of patients are compared, and the difference is not statistically significant (P is less than 0.05), and the two groups of patients have comparability.

The control group is treated by shock wave in combination with functional exercise, adopts Swiss E.M.S Dolor Clast type low-energy-dissipation external shock wave, and treats local part around knee joint according to pain point of patient, and then treats acupuncture points of Venezuelan, Zusanli, internal and external knee eyes, blood sea, Yinlingquan, and Beam dune. A treatment probe with the thickness of 15mm is used, the treatment pressure is 2-3 bar, the treatment part is impacted for 2000-3000 times every time, 2-3 times every week, 1 week is 1 treatment course, and 3 treatment courses are total. The functional exercises comprise quadriceps femoris muscle resistance training, popliteal muscle resistance training, pile standing training and balance training, and the strength is moderate so as not to cause new injuries.

The synovitis ointment is externally applied to the affected part of the test group on the basis of the control group, the affected part is wrapped and fixed by gauze, the medicine is changed for 1 time every day for 3 weeks, and the skin condition of the affected part is observed during the application period, so that the skin allergy or blister formation is prevented.

3. Observation index and therapeutic effect standard

3.1 Observation index

The Lysholm knee joint function score is composed of 8 aspects of lameness, load bearing, interlocking, joint instability, pain, swelling, stair climbing and squatting.

② visual simulated pain score (VAS).

And thirdly, safety observation.

3.2 therapeutic criteria

The standard of the guiding principle of clinical research of new Chinese medicine and the standard of the curative effect of the diagnosis of the traditional Chinese medicine diseases are referred to.

Clinical cure: the pain and swelling of the knee joint disappear, the functional activity is normal, and the curative effect index is more than or equal to 95 percent.

The effect is shown: the pain and swelling of the knee joint disappear, the functional activity is not limited, and the curative effect index is more than or equal to 70 percent and less than 95 percent.

The method has the following advantages: the pain and swelling of the knee joint are basically eliminated, the functional activity is slightly limited, and the curative effect index is more than or equal to 30 percent and less than 70 percent.

And (4) invalidation: the pain, swelling and functional activity of the knee joint are not obviously improved, and the curative effect index is less than 30 percent.

Efficacy index ═ integration before treatment-integration after treatment)/integration before treatment ] × 100%.

The effective rate is (cure + significant effect + effective) case number/total case number multiplied by 100%.

4. Test results

Statistical processing the SPSS17.0 statistical software was applied. Measure data to

Representing, adopting t test; and adopting rank sum test for the grade data. The difference is statistically significant when P is less than 0.05.

4.1 comparison of clinical efficacy of two groups

The total effective rate of the test group is higher than that of the control group (P is less than 0.05), and the table 1 shows.

TABLE 1 comparison of two groups of clinical efficacy (n)

4.2 comparison of Lysholm Knee function scores before and after treatment in two groups

The difference after treatment was statistically significant (P < 0.01) compared to the Lysholm knee function score before treatment; the improvement degree of the Lysholm knee joint function score of the test group is better than that of the control group (P is less than 0.05), and the result is shown in a table 2.

Table 2 comparison of Lysholm knee function scores before and after treatment (min.%)

4.3 comparison of VAS scores before and after treatment in two groups

The differences were statistically significant (P < 0.01) compared to the pre-treatment VAS scores after treatment; the VAS score of the test group is improved better than that of the control group (P is less than 0.05), and the result is shown in Table 3.

Table 3 comparison of VAS scores before and after two groups of treatments (score,

)

in conclusion, the Lysholm knee joint function score and the VAS score in the post-treatment test group are reduced compared with the pretreatment and the control group at the same time (P is less than 0.05); the effective rate of the test group is 90.63 percent, which is obviously higher than 71.88 percent of the control group, and the difference has statistical significance (P is less than 0.05). The shock wave is combined with the synovitis ointment for external application, so that symptoms of knee joint swelling, pain, limited activity and the like of patients with acute knee joint synovitis (phlegm-fluid-retention-fluid-infusion syndrome) can be effectively relieved, and the synovitis ointment is worthy of further clinical research and popularization.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. An ointment for treating synovitis is characterized by mainly comprising the following medicaments in part by weight: 8-12g of astragalus membranaceus, 3-7g of gentiana macrophylla, 3-7g of angelica sinensis, 3-7g of teasel roots, 3-7g of moutan barks, 3-7g of bupleurum chinense, 3-7g of rhizoma wenyujin concinnatae, 3-7g of madder, 3-7g of parasitic loranthus, 3-7g of rhizoma dioscoreae septemlobae, 1-3g of radix cyathulae and 1-3g of liquorice.

2. The ointment of claim 1, wherein the ointment comprises: also comprises 5-10g of honey, 1-3ml of sesame oil and 40-60ml of water as auxiliary materials.

3. The ointment for treating synovitis according to claim 2, which is characterized by mainly comprising the following components in parts by weight: 10g of astragalus membranaceus, 5g of gentiana macrophylla, 4g of angelica sinensis, 4g of teasel roots, 4g of moutan bark, 4g of bupleurum chinense, 4g of rhizoma wenyujin concinnatae, 5g of madder, 4g of loranthus parasiticus, 5g of rhizoma dioscoreae septemlobae, 2g of radix cyathulae and 1g of liquorice.

4. A preparation method of an ointment for treating synovitis is characterized by comprising the following steps:

weighing traditional Chinese medicine decoction pieces of radix salviae miltiorrhizae, radix gentianae macrophyllae, angelica sinensis, teasel roots, moutan barks, radix bupleuri, rhizoma wenyujin concinnatae, madder roots, loranthus parasiticus, rhizoma dioscoreae septemlobae, radix cyathulae and liquorice according to the medicine proportion of the components by weight, mixing and grinding the weighed traditional Chinese medicine decoction pieces into powder, and screening the powder by using a mesh screen to obtain powder passing through the mesh screen for later use;

5. The method for preparing an ointment for the treatment of synovitis according to claim 4, wherein: the mesh size in the first step is 100 meshes.

6. The method for preparing an ointment for the treatment of synovitis according to claim 4, wherein: the temperature of the honey water decocted in the second step is 60 ℃ after cooling.