CN106511498B

CN106511498B - Pharmaceutical composition for treating gout and bone diseases

Info

Publication number: CN106511498B
Application number: CN201611189281.5A
Authority: CN
Inventors: 何天祺
Original assignee: Sichuan Ho Ho Hospital Management Co Ltd
Current assignee: Sichuan Ho Ho Hospital Management Co Ltd
Priority date: 2016-12-21
Filing date: 2016-12-21
Publication date: 2020-02-14
Anticipated expiration: 2036-12-21
Also published as: CN106511498A

Abstract

The invention discloses a pharmaceutical composition for treating gout and bone diseases, which belongs to the technical field of medicines and comprises the following components in parts by weight: 35-38 parts of semen plantaginis, 10-14 parts of astragalus membranaceus, 10-14 parts of pseudo-ginseng, 10-14 parts of rheum officinale, 10-14 parts of liquorice and 10-14 parts of honeysuckle; the traditional Chinese medicine composition is relatively simple in components, the components are common traditional Chinese medicines without toxic and side effects, the safety is high, no toxic and side effects exist after the mouse experiment is carried out for 1 month, and no toxic and side effects exist after the mouse composition is clinically used for 2 months; the curative effect is exact, the effective rate for treating gout reaches 96.7%, and the cure rate can reach 85.6%.

Description

Pharmaceutical composition for treating gout and bone diseases

Technical Field

The invention relates to the technical field of medicines, and particularly relates to a pharmaceutical composition for treating gout and bone diseases.

Background

Gout, which is characterized by red swelling, severe pain and inability to stretch, is clinically manifested by hyperuricemia, gouty acute arthritis, tophus deposition, characteristic chronic arthritis and arthritis deformity, often involving the kidney, causing chronic interstitial nephritis and nephrouric acid calculus, and the gouty arthritis is often the first manifestation of the syndrome.

From the perspective of western medicine, gout is purine metabolic disorder, a group of metabolic diseases caused by urate crystal deposition soft tissue due to continuous increase of blood uric acid concentration, and the biochemical marker of gout is hyperuricemia, is closely related to the occurrence of hypertension, hyperlipidemia, atherosclerosis, obesity and insulin resistance, and becomes a serious metabolic disease threatening human health. At present, the western medicine basically treats gout symptomatically, and can only relieve and control symptoms but can not radically treat gout.

From the perspective of traditional Chinese medicine, gout is formed by mixing wind, cold and dampness, and belongs to 'arthralgia syndrome'. It is usually caused by liver and kidney deficiency, wind, cold, dampness, invasion of joints, heat accumulation, and qi and blood stagnation. The clinical symptoms of gout are also classified into 4 types, namely migratory arthralgia, painful arthralgia, migratory arthralgia and pyretic arthralgia. Many traditional Chinese medicines are reported and clinically used for treating gout, such as semen plantaginis, but only semen plantaginis is adopted, so the treatment effect is poor, and then, many reports that semen plantaginis is adopted to be compatible with other traditional Chinese medicines for treating gout are also provided, such as a traditional Chinese medicine formula disclosed in a Chinese patent with application number 201110284614.3 entitled "a traditional Chinese medicine for treating gout", but the components of the traditional Chinese medicine are up to 23, the components are complex, the interaction among the components is also complex, the safety is greatly uncertain, and the curative effect is also to be improved; for another example, the invention discloses a traditional Chinese medicine formula disclosed in chinese patent application No. 201410526496.6 entitled "a traditional Chinese medicine for treating gout", which has 14 components, also has many components, unclear interaction and problems in safety, although the patent discloses the safety of a 7-day experiment on mice, the medicine needs to be taken for a long time, the long-term safety is in doubt, the toxic and side effects after long-term taking are uncertain, and the curative effect needs to be further improved.

Disclosure of Invention

The invention aims to: a pharmaceutical composition for treating gout and bone disease is provided to solve the above problems.

The technical scheme adopted by the invention is as follows: a pharmaceutical composition for treating gout and bone diseases comprises the following components in parts by weight:

35-38 parts of semen plantaginis, 10-14 parts of astragalus membranaceus, 10-14 parts of pseudo-ginseng, 10-14 parts of rheum officinale, 10-14 parts of liquorice and 10-14 parts of honeysuckle.

The inventor of the invention obtains through a large number of experiments: the components are in proper proportion and cooperate with each other, can clear heat, expel toxin, reduce swelling, promote diuresis, dredge collaterals and relieve pain, is particularly suitable for red swelling and pain of joints, red tongue, yellow fur and the like, and has definite curative effect.

Wherein Semen Plantaginis (Plantagini Semen) is dry mature seed of Plantaginaceae plant herba Plantaginis or Plantaginaceae, and has sweet taste and cold property; it enters liver, kidney, lung and small intestine meridians. Clearing away heat, promoting urination, eliminating dampness, stopping diarrhea, improving eyesight, eliminating phlegm, cooling blood, and removing toxic substance. It is mainly used for treating dysuria, edema, carbuncle, swelling and sore. The plantain herb can effectively treat nephritis and gouty arthritis. The herbal treatise is to say that the herb of plantain, which treats hematuria, can tonify five internal organs, improve eyesight, benefit small dried feces of plantain and dredge five stranguria. The plantain herb is often used in the treatment of gout, clinically, the single-component tea of the plantain herb is often used for soaking, so that uric acid can be reduced, but the curative effect is poor, and the plantain herb is often used for prevention;

radix astragali (Astragalus membranaceus (Fisch.) Bunge) is the rhizome of Astragalus membranaceus (Fisch.) bge of Leguminosae, is sweet in taste and slightly warm, enters lung, spleen, liver and kidney channels, and has the effects of enhancing organism immunity, protecting liver, promoting urination, resisting aging, resisting stress, lowering blood pressure and broad antibacterial action;

dried root and rhizome of Panax notoginseng (Radix Panax pseudoginseng), Panax notoginseng (Burk.) F.H.Chen of Araliaceae, sweet, slightly bitter, and warm in taste; it belongs to liver and stomach channels, has effects of removing blood stasis, stopping bleeding, and relieving swelling and pain, and can be used for hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia and metrostaxis, traumatic hemorrhage, thoracico-abdominal pain, and traumatic swelling and pain;

rhubarb (Rheum palmatum L.), dry root and rhizome of Rheum palmatum L., Rheum officinale (Rheum palmatum L.), Rheum officinale of Polygonaceae, Rheum officinale of Rheum officinale Baill., Rheum tanguticum Maxim. ex Balf.), Rheum tanguticum Maxim. having bitter and cold taste; it is used to treat diseases of spleen, stomach, large intestine, liver and pericardium, eliminate pathogenic accumulation, clear heat, remove heat from blood, remove toxic materials, remove blood stasis, promote menstruation, remove dampness, and treat jaundice. Can be used for treating constipation due to excessive heat accumulation, hematemesis, epistaxis, conjunctival congestion, pharyngeal swelling, carbuncle, furuncle, intestinal carbuncle, abdominal pain, blood stasis, amenorrhea, puerperal blood stasis, traumatic injury, damp-heat dysentery, jaundice, dark urine, stranguria, and edema; it can be used for external treatment of burn and scald. The wine rhubarb is good at clearing heat and toxicity in the upper jiao and blood system. It can be used for treating conjunctival congestion, pharyngeal swelling, and gingival swelling and pain. The cooked rhubarb has the functions of relieving the purgation, purging fire and removing toxicity. It can be used for treating pyocutaneous disease due to fire toxin. Rhubarb charcoal cools blood, removes stasis and stops bleeding. Can be used for treating blood heat with blood stasis and hemorrhage;

glycyrrhrizae radix (Glycyrrhiza uralensis Fisch) is root and rhizome of Glycyrrhiza uralensis Fisch of Leguminosae, and can be used for clearing away heat and toxic materials, eliminating phlegm, relieving cough, and abdominal pain.

Flos Lonicerae (Lonicera japonica), which is the dried bud or the flower of Lonicera japonica of Caprifoliaceae, has cold and sweet taste, enters lung, heart and stomach channels, and has effects of clearing away heat and toxic materials, relieving inflammation, tonifying deficiency and treating wind.

The preferable technical scheme is that the composition comprises the following components in parts by weight:

36-37 parts of plantain seed, 11-13 parts of astragalus root, 11-13 parts of pseudo-ginseng, 11-13 parts of rhubarb, 11-13 parts of liquorice and 11-13 parts of honeysuckle.

The further preferable technical scheme is that the composition comprises the following components in parts by weight:

36 parts of plantain seed, 12 parts of astragalus, 12 parts of pseudo-ginseng, 11 parts of rheum officinale, 12 parts of liquorice and 12 parts of honeysuckle.

The invention also provides a pharmaceutical preparation prepared from the composition.

The preparation is preferably pill, and can be other oral preparations or external preparations

The preparation method of the pill adopts the following steps: pulverizing the above materials, sieving, mixing, making into pill with water, and drying.

As a preferred technical scheme: sieving with 60 mesh sieve.

In summary, due to the adoption of the technical scheme, the invention has the beneficial effects that: the traditional Chinese medicine composition is relatively simple in components, the components are common traditional Chinese medicines without toxic and side effects, the safety is high, no toxic and side effects exist after the mouse experiment is carried out for 1 month, and no toxic and side effects exist after the mouse composition is clinically used for 2 months; the curative effect is exact, the effective rate for treating gout reaches 96.7%, and the cure rate can reach 85.6%.

Detailed Description

The present invention will be described in detail below.

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Example 1:

a pharmaceutical composition for treating gout and bone diseases comprises the following components in parts by weight:

36 parts of semen plantaginis, 13 parts of astragalus, 11 parts of pseudo-ginseng, 13 parts of rheum officinale, 13 parts of liquorice and 13 parts of honeysuckle;

unless otherwise specified, the parts by weight of the invention refer to dry weight, namely the weight of qualified finished Chinese medicinal materials, and the water content of the finished Chinese medicinal materials is specified in the 2015 edition pharmacopoeia;

the preparation method comprises the following steps: pulverizing the above materials, sieving, mixing, making into pill with water, and drying to obtain pill 0.5 g.

Example 2

37 parts of plantain seed, 11 parts of astragalus, 13 parts of pseudo-ginseng, 11 parts of rhubarb, 11 parts of liquorice and 11 parts of honeysuckle

Example 3

Example 4

Clinical trials for gout treatment

4.1 case selection criteria:

western diagnostic criteria: reference is made to the criteria established by the american college of rheumatology in 1997:

1. acute arthritis attacks more than 1 time and reaches climax within 24 hours; 2. acute inflammation is limited to individual joints; 3. the whole joint is dark red; 4.1 st metatarsophalangeal joint swelling and pain; 5. acute inflammation of the unilateral metatarsal joint; 6. gout joints with suspect confirmation; 7. hyperuricemia; 8. asymmetric joint swelling; 9. the episode can terminate itself;

at least 4 of the 9 items are selected, secondary gout is excluded, and primary acute gout can be confirmed.

The traditional Chinese medicine diagnosis standard is as follows: the symptoms include red swelling and pain of joints, limited activity, fever, thirst, excessive perspiration, dark and dark complexion (more than grey yellow), yellow urine, yellow tongue coating, slippery and rapid pulse and the like.

4.2 case cases

Selecting 90 gout patients with different ages, sexes and disease conditions as experimental objects in a rheumatoid immune department of a large comprehensive hospital according to a standard of 4.1, wherein the gout patients are 30 patients between 31 and 40 years old, 30 patients between 41 and 50 years old and 30 patients between 51 and 65 years old; 50 men and 40 women; 30 patients with 1-2 years of disease course, 30 patients with 2-3 years of disease course and 30 patients with 3-5 years of disease course;

4.3 methods of treatment

The pills obtained in the embodiment 3 of the invention are taken 10 pills each time, 2 times a day, 10 days are a treatment course, the pills are stopped taking for 1 day after each treatment course is taken, and then the pills are taken continuously for 6 treatment courses;

4.4 criteria for evaluation of therapeutic Effect

According to the therapeutic effect judgment standard in the clinical research guideline of new traditional Chinese medicine,

the symptoms completely disappear, the joint function returns to normal, and the main physical and chemical inspection indexes are normal and are clinical cure;

the main symptoms disappear, the joint function is basically recovered, and the main physical and chemical inspection indexes are basically normal and have obvious effects;

the main symptoms basically disappear, and the main joint functions and main physical and chemical indexes are improved to be effective;

compared with the pretreatment, the treatment is ineffective without obvious improvement in all aspects

4.5 therapeutic results

The above 90 cases are 77 cured cases, 5 cases with obvious effect, 5 cases with effect and 3 cases with no effect, the effective rate is 96.7%, and the cure rate is 85.6%, which shows that the medicine has obvious therapeutic effect on ventilation; and no obvious adverse reaction is fed back;

in addition, the follow-up after half a year of treatment, only 3 cases of 77 cases cured recur, and the recurrence rate is very low.

Example 5

Typical ones of the cases of example 4 are exemplified by:

in case of a certain plum, male, 41 years old, in the river in Sichuan, the gout history is 1 year and half, the whole joint is dark red, and the 1 st metatarsophalangeal joint has swelling and pain; joint swelling and pain of two thumbs;

after the treatment according to the administration method of the embodiment 4, the symptoms completely disappear, the joint function returns to normal, and the main physical and chemical inspection indexes comprise that all uric acid is normal;

certain one of the four-season old people, women, people in the state of dada, Sichuan, 57 years old, the history of gout is 3 years, the joint pain of fingers and toes, and the severe pain and swelling of two knee joints at night, after the treatment according to the taking method of the embodiment 4, the symptoms completely disappear, the joint function returns to normal, and the main physical and chemical examination indexes comprise that all uric acid is normal.

Claims

1. The pharmaceutical composition for treating gout and bone disease is characterized by comprising the following components in parts by weight:

2. The pharmaceutical composition according to claim 1, which is prepared from the following components in parts by weight:

3. A pellet formulation prepared using the composition of claim 1 or 2.

4. A process for the preparation of a formulation according to claim 3, characterized in that: pulverizing the above materials, sieving, mixing, making into pill with water, and drying.