CN104940393B - Compositions purposes in the medicine of preparation treatment corticosteroid femur head necrosis - Google Patents

Abstract

The present invention relates to a kind of medicament treating corticosteroid femur head necrosis, it is made up of the material of following weight portion: 1 10 parts of Flos Carthami, traumatic injury grass 10 20 parts, Pericarpium syzygii 10 20 parts, Radix Angelicae Sinensis 5 15 parts, Rhizoma valerianae latifoliae 1 10 parts, Radix Campylotropis hirtellae 10 20 parts, Radix Cyathulae 5 15 parts, Herba Lycopodii 10 20 parts, Radix Salviae Miltiorrhizae 5 15 parts, Rubus delavayi Franch. 10 20 parts, Radix Cudraniae 10 parts, Rhizoma Drynariae 5 15 parts, Herba Melasmatis arvensis 5 15 parts, 10 20 parts of water Asia wood, oil head grass 1 10 parts, 1 10 parts of Radix Glycyrrhizae, lignum Ormosiae henryi 5 15 parts, Herba Morindae Parvifoliae 10 20 parts, Herba Gynurae bicoloris 1 10 parts, Parathelypteris glanduligera (Kunze) Ching 10 20 parts, Radix Averrhoae Carambolae 10 20 parts.Medicament synergism of the present invention, complementing each other, play the merit of monarch altogether, based on blood circulation promoting and blood stasis dispelling, subduing swelling and detoxicating, be aided with spleen reinforcing nourishing the liver, removing damp-heat, treatment corticosteroid femur head necrosis effect is notable, clinic application and promoting.

Description

Compositions purposes in the medicine of preparation treatment corticosteroid femur head necrosis

The present invention be Application No. 201510066342.8, filing date on February 10th, 2015, The divisional application of the patent of invention entitled " a kind of medicament treating corticosteroid femur head necrosis ".

Technical field

The present invention relates to field of medicaments, relate in particular to one and treat corticosteroid femur head necrosis Medicament.

Background technology

Femur head necrosis is one of refractory pertinacious disease in orthopaedic disease, and wherein hormonal femoral head is bad Extremely (steraid induced Arascular Necrosis of Femoral Head, SANFH) is at stock Occupying sizable ratio in head necrosis, its sickness rate has accounted for atraumatic restorative technique The first.Use hormone can cause SANFH although long-term, a large amount of, but in some disease In treatment, hormonotherapy is again irreplaceable, and this causes SANFH patient populations drastically to increase Add.SANFH has that onset is short, progress is fast, the feature of poor prognosis, and its state of an illness progressively develops To cause irreversible infringement, disability rate is high, all brings huge economy to patient and society And stress, have a strong impact on the quality of life of patient.Therefore, early diagnosis, rational therapy The most important for preventing and treating SANFH.

Chinese medicine thinks that SANFH belongs to traditional medicine " rheumatism involving the bone ", " atrophic debility of bones ", " osteomyelitis ", " blood The stasis of blood " etc. category.Along with the development of Chinese medicine and going deep into of clinical research, SANFH is recognized Knowledge deepens continuously.Although the understanding of its etiology and pathogenesis is not quite similar, emphasizes particularly on different fields by ancient Chinese medicine doctor, But it is summed up and loses support into qi depression to blood stasis, caused by liver and kidney deficiency, the retardance of muscle arteries and veins, skeleton.In additionally, Medicine make simple, external convenient, without invasive, patient is prone to acceptance and has no adverse reaction, The preventing and treating of SANFH has played positive effect.

Summary of the invention

It is an object of the invention to provide a kind of medicament treating corticosteroid femur head necrosis.

In order to realize the purpose of the present invention, the present invention provides one to treat corticosteroid femur head necrosis Medicament, it is made up of the material of following weight portion: Flos Carthami 1-10 part, traumatic injury grass 10-20 Part, Pericarpium syzygii 10-20 part, Radix Angelicae Sinensis 5-15 part, Rhizoma valerianae latifoliae 1-10 part, Radix Campylotropis hirtellae 10-20 Part, Radix Cyathulae 5-15 part, Herba Lycopodii 10-20 part, Radix Salviae Miltiorrhizae 5-15 part, Rubus delavayi Franch. 10-20 Part, Radix Cudraniae 1-0 part, Rhizoma Drynariae 5-15 part, Herba Melasmatis arvensis 5-15 part, water Asia wood 10-20 Part, oil head grass 1-10 part, Radix Glycyrrhizae 1-10 part, lignum Ormosiae henryi 5-15 part, Herba Morindae Parvifoliae 10-20 part, Herba Gynurae bicoloris 1-10 part, Parathelypteris glanduligera (Kunze) Ching 10-20 part, Radix Averrhoae Carambolae 10-20 part.

Preferably, the medicament for the treatment of corticosteroid femur head necrosis of the present invention is by following weight Part material make: 8 parts of Flos Carthami, traumatic injury grass 12 parts, Pericarpium syzygii 15 parts, Radix Angelicae Sinensis 10 parts, Rhizoma valerianae latifoliae 5 parts, Radix Campylotropis hirtellae 12 parts, Radix Cyathulae 10 parts, Herba Lycopodii 15 parts, Radix Salviae Miltiorrhizae 10 parts, Rubus delavayi Franch. 12 parts, Radix Cudraniae 5 parts, Rhizoma Drynariae 10 parts, Herba Melasmatis arvensis 10 parts, water Asia wood 12 Part, oil head grass 5 parts, 8 parts of Radix Glycyrrhizae, lignum Ormosiae henryi 10 parts, Herba Morindae Parvifoliae 15 parts, Herba Gynurae bicoloris 10 Part, Parathelypteris glanduligera (Kunze) Ching 12 parts, Radix Averrhoae Carambolae 15 parts.

It is highly preferred that described medicament can be tablet, dispersible tablet, capsule, soft capsule or Patch.

The present invention also provides for compositions in the medicine of preparation treatment corticosteroid femur head necrosis Purposes, described compositions is made up of the material of following weight portion: Flos Carthami 1-10 part, traumatic injury grass 10-20 part, Pericarpium syzygii 10-20 part, Radix Angelicae Sinensis 5-15 part, Rhizoma valerianae latifoliae 1-10 part, Radix Campylotropis hirtellae 10-20 part, Radix Cyathulae 5-15 part, Herba Lycopodii 10-20 part, Radix Salviae Miltiorrhizae 5-15 part, Rubus delavayi Franch. 10-20 part, Radix Cudraniae 1-0 part, Rhizoma Drynariae 5-15 part, Herba Melasmatis arvensis 5-15 part, water Asia wood 10-20 part, oil head grass 1-10 part, Radix Glycyrrhizae 1-10 part, lignum Ormosiae henryi 5-15 part, Herba Morindae Parvifoliae 10-20 Part, Herba Gynurae bicoloris 1-10 part, Parathelypteris glanduligera (Kunze) Ching 10-20 part, Radix Averrhoae Carambolae 10-20 part.

Preferably, described compositions is made up of the material of following weight portion: 8 parts of Flos Carthami, traumatic injury Grass 12 parts, Pericarpium syzygii 15 parts, Radix Angelicae Sinensis 10 parts, Rhizoma valerianae latifoliae 5 parts, Radix Campylotropis hirtellae 12 parts, river Radix Achyranthis Bidentatae 10 parts, Herba Lycopodii 15 parts, Radix Salviae Miltiorrhizae 10 parts, Rubus delavayi Franch. 12 parts, Radix Cudraniae 5 parts, Rhizoma Drynariae 10 parts, Herba Melasmatis arvensis 10 parts, water Asia wood 12 parts, oil head grass 5 parts, 8 parts of Radix Glycyrrhizae, Lignum Ormosiae henryi 10 parts, Herba Morindae Parvifoliae 15 parts, Herba Gynurae bicoloris 10 parts, Parathelypteris glanduligera (Kunze) Ching 12 parts, Radix Averrhoae Carambolae 15 Part.

It is highly preferred that described medicine can be tablet, dispersible tablet, capsule, soft capsule or Patch.

In the present compositions, Pericarpium syzygii, Radix Campylotropis hirtellae, traumatic injury grass are monarch drug；Flos Carthami, Radix Angelicae Sinensis, Rhizoma valerianae latifoliae, Radix Cyathulae, Herba Lycopodii, Radix Salviae Miltiorrhizae, Rubus delavayi Franch. are ministerial drug；Radix Cudraniae, bone Broken benefit, Herba Melasmatis arvensis, water Asia wood, oil head grass, lignum Ormosiae henryi, Herba Morindae Parvifoliae, Herba Gynurae bicoloris, Parathelypteris glanduligera (Kunze) Ching, Radix Averrhoae Carambolae is adjuvant drug；Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, for making medicine.

Medicament synergism of the present invention, complement each other, play the merit of monarch altogether, with Blood circulation promoting and blood stasis dispelling, subduing swelling and detoxicating are main, are aided with spleen reinforcing nourishing the liver, removing damp-heat, treat hormonal stock Head necrosis effect is notable, clinic application and popularization.

Detailed description of the invention

The present invention is further illustrated below by embodiment.It should be understood that the reality of the present invention Executing example is for illustrating rather than limitation of the present invention.Essence pair according to the present invention The simple modification that the present invention is carried out broadly falls into the scope of protection of present invention.Unless otherwise saying Bright, otherwise the percent in the present invention is percetage by weight.

The preparation of the medicament of the embodiment present invention

As a example by patch, the preparation technology of the medicament of the present invention is as follows:

(1) traumatic injury grass 120 grams, Pericarpium syzygii 150 grams, Herba Morindae Parvifoliae 150 grams, white hair are weighed Serpentis 120 grams, lignum Ormosiae henryi 100 grams, add 6000 milliliters of water, equipped with in the flask of condensing tube Being heated to reflux 4 hours, filter after being cooled to room temperature, adding ethanol in filtrate to alcohol content is 80 volume %, ambient temperatare filters after putting 24 hours, is evaporated after being reclaimed by the ethanol in filtrate Aqueous solution obtains dry cream 1；

(2) Herba Lycopodii 150 grams, Radix Cudraniae 50 grams, Radix Averrhoae Carambolae 150 grams, Radix Campylotropis hirtellae are weighed 120 grams, adding 6000 milliliters of water, heating was filtered, in filtrate after 1 hour under reflux Add 2mol/L aqueous hydrochloric acid solution regulation pH value to 6.0, be subsequently added Herba Melasmatis arvensis 100 grams, Oil head grass 50 grams, Herba Gynurae bicoloris 100 grams, Radix Cyathulae 100 grams, be heated at reflux mistake after 4 hours Filter, filtrate is evaporated and obtains dry cream 2；

(3) weigh 80 grams of Flos Carthami, Radix Angelicae Sinensis 100 grams, Rhizoma valerianae latifoliae 50 grams, 80 grams of Radix Glycyrrhizae, Radix Salviae Miltiorrhizae 100 grams, Rhizoma Drynariae 100 grams, Rubus delavayi Franch. 120 grams, 120 grams of water Asia wood, add The ethanol water of 5000 milliliter of 85 volume %, is heated at reflux 4 hours, after being cooled to room temperature Filter, be evaporated aqueous solution after being reclaimed by the ethanol in filtrate and obtain dry cream 3；

(4) merge above-mentioned dry cream 1, dry cream 2 and dry cream 3, after pulverizing, add vaseline 400 Gram and lanoline 200 grams, be applied in after stirring on 500 blocks of non-woven fabrics.Every piece of non-woven fabrics length and Wide being 20 centimetres, thickness is 1 centimetre.

The curative effect of the medicament of the experimental example present invention

1 data and method

1.1 physical data

This group corticosteroid femur head necrosis patient totally 60 example, all meets " new Chinese medicine treatment stock The guideline of clinical investigations of bone bland necrosis " in about femur head necrosis diagnosis and treatment advise Model, gets rid of and has clear and definite hip trauma history person and congenital hip developmental disorder person.Staging scale With reference to luxuriant and rich with fragrance card (Ficat) aging schedule.

60 example patients are divided into treatment group 30 example and matched group 30 example.Wherein treatment group male 18 examples, women 12 example；Patient age between 24-51 year, 37.7 years old mean age；Suffer from Sick position list hip 20 example, double hip 10 examples；I phase 5 hip, II phase 18 hip, III phase 11 hip, IV phase 6 hip.Matched group male 20 example, women 10 example；Patient age between 21-53 year, 38.2 years old mean age；Disease sites list hip 22 example, double hip 8 hips；I phase 4 hip, the II phase 16 hips, III phase 12 hip, IV phase 6 hip.Two groups of patients are in the equal nothing of difference of above-mentioned each side Statistical significance (p ＞ 0.05), has comparability.

1.2 observation index

1.2.1 femur head necrosis clinical symptoms, sign scoring

Before treatment and after treatment, with reference to table 1, femur head necrosis clinical symptoms, sign situation are entered Row scoring.

Table 1 femur head necrosis clinical symptoms, sign scalar quantization table

1.2.2 x-ray inspection

Utilize x-ray inspection that articular surface form, joint space and bone structure are observed.This Item checks and is operated by specialist.

1.3 Therapeutic Method

Treatment group uses the patch of the present invention of preparation in embodiment to treat, by 1 piece of patch It is attached to suffer from hip, if single hip then uses 1 piece of patch, if double hip then uses 2 pieces of patches Agent, often hip 1 piece of patch of use is suffered from place, and 2 times/day, 30 days be a course for the treatment of.Matched group takes With XIANLING GUBAO JIAONANG (Guizhou Tongjitang Pharmaceutical Co., Ltd), 3 tablets/time, 2 times/day, 30 It is a course for the treatment of.

1.4 criterion of therapeutical effect

1.4.1 evaluation of clinical curative effect standard

With reference to " guideline of clinical investigations of new Chinese medicine treatment aseptic necrosis of femoral head " system Fixed.Therapeutic index (N) and effective percentage is calculated according to score value of marking for twice before treatment and after treatment.

Recovery from illness: clinical symptoms, sign disappear or substantially disappear, N >=95%；

Effective: clinical symptoms, sign are obviously improved, N=70%-95%；

Effective: clinical symptoms, sign all take a favorable turn, N=30%-70%；

Invalid: clinical symptoms, sign are not improved or increase the weight of N ＜ 30%.

Wherein,

Score value × 100% before therapeutic index (N)=(score value after score value-treatment before treatment)/treatment

Effective percentage=(recovery from illness+effective+effectively) number of cases/total number of cases × 100%

1.4.2 x-ray checks the standard of curative effect evaluation

This inspection is operated by specialist.The standard of curative effect evaluation is worked out as follows:

Recovery from illness: x-ray shows that recovery is normal；

Effective: x-ray is shown with and is clearly better, substantially close to normally；

Effective: x-ray is shown with improvement；

Invalid: x-ray shows unchanged.

1.5 statistical method

SPSS17.0 statistical software is used to carry out data analysis.Measurement data withRepresent, Use t inspection；Enumeration data uses x²Inspection.Statistically significant with p≤0.05 for difference.

2 results

2.1 clinical symptoms, sign are marked

What before and after two groups of patient treatments, clinical symptoms, sign scoring score value changed is relatively shown in Table 2, Curative effect is shown in Table 3.

The comparison of table 2 clinical symptoms, sign scoring score value change

Note: compare with before treatment, * p < 0.05；Compare with matched group, * * p < 0.05

As can be seen from Table 2, two groups of patients score value not statistically significant (p ＞ before the treatment 0.05), and after treating 30 days, the score value of two groups has declined, and difference has statistics Meaning (p < 0.05), and treatment group relatively matched group decline become apparent from, group difference has statistics Learn meaning (p < 0.05).

Table 3 Clinical efficacy comparison

Note: compare with matched group, * p < 0.05

Table 3 shows, the difference of two groups of patient clinical curative effects is statistically significant (p < 0.05). This shows that treatment group symptom takes a turn for the better and is better than matched group, and the clinical efficacy of the medicament of the present invention is better than celestial being Spirit bone preserves capsule.

2.2 x-ray signs

Before and after two groups of patient treatments, the change of x-ray sign is relatively shown in Table 4.

Table 4 x-ray sign changes

Note: compare with matched group, * p < 0.05

As can be seen from Table 4, the difference in terms of two groups of patient's x-ray signs is statistically significant (p < 0.05), shows that the curative effect of the medicament of the present invention is better than XIANLING GUBAO JIAONANG.

Claims (1)

1. compositions purposes in the medicine of preparation treatment corticosteroid femur head necrosis, it is special Levying and be, described compositions is made by following method:

(1) traumatic injury grass 120 grams, Pericarpium syzygii 150 grams, Herba Morindae Parvifoliae 150 grams, white hair are weighed Serpentis 120 grams, lignum Ormosiae henryi 100 grams, add 6000 milliliters of water, equipped with in the flask of condensing tube Being heated to reflux 4 hours, filter after being cooled to room temperature, adding ethanol in filtrate to alcohol content is 80 volume %, ambient temperatare filters after putting 24 hours, is evaporated after being reclaimed by the ethanol in filtrate Aqueous solution obtains dry cream 1；

(2) Herba Lycopodii 150 grams, Radix Cudraniae 50 grams, Radix Averrhoae Carambolae 150 grams, Radix Campylotropis hirtellae are weighed 120 grams, adding 6000 milliliters of water, heating was filtered, in filtrate after 1 hour under reflux Add 2mol/L aqueous hydrochloric acid solution regulation pH value to 6.0, be subsequently added Herba Melasmatis arvensis 100 grams, Oil head grass 50 grams, Herba Gynurae bicoloris 100 grams, Radix Cyathulae 100 grams, be heated at reflux mistake after 4 hours Filter, filtrate is evaporated and obtains dry cream 2；

(3) weigh 80 grams of Flos Carthami, Radix Angelicae Sinensis 100 grams, Rhizoma valerianae latifoliae 50 grams, 80 grams of Radix Glycyrrhizae, Radix Salviae Miltiorrhizae 100 grams, Rhizoma Drynariae 100 grams, Rubus delavayi Franch. 120 grams, 120 grams of water Asia wood, add The ethanol water of 5000 milliliter of 85 volume %, is heated at reflux 4 hours, after being cooled to room temperature Filter, be evaporated aqueous solution after being reclaimed by the ethanol in filtrate and obtain dry cream 3；

(4) merge above-mentioned dry cream 1, dry cream 2 and dry cream 3, after pulverizing, add vaseline 400 Gram and lanoline 200 grams, be applied in after stirring on 500 blocks of non-woven fabrics.