阅读说明：本技术 一种治疗梗阻性脑积水的中药制剂及其制备方法 (Traditional Chinese medicine preparation for treating obstructive hydrocephalus and preparation method thereof ) 是由 宋虎杰 于 2020-06-23 设计创作，主要内容包括：本发明属于中药制剂技术领域,特别是涉及一种治疗梗阻性脑积水的中药制剂及其制备方法。由以下重量份数的原料组成,川芎120-130份、丹参115-123份、全蝎60-65份、人工麝香0.3-0.5份、穿山甲55-63份、王不留行120-130份、路路通120-125份、车前子118-123份。对梗阻性脑积水治疗有效率高达100％,相比对照组23.33％的有效率具有显著的进步,同时经过统计学检验分析,p＜0.05,试验数据之间有显著差异；并经过采用卡方检验发现试验组与对照组数据不良反应发生率均＜95％,满足安全性评价标准要求。(The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating obstructive hydrocephalus and a preparation method thereof. The traditional Chinese medicine composition comprises, by weight, 130 parts of ligusticum wallichii 120-. The effective rate of the treatment of obstructive hydrocephalus is up to 100%, and the effective rate is remarkably improved compared with that of a control group of 23.33%, meanwhile, through statistical test and analysis, p is less than 0.05, and test data have remarkable difference; and the incidence rate of adverse reactions of the test group and the control group is less than 95 percent by chi-square test, so that the safety evaluation standard requirement is met.)

1. A traditional Chinese medicine preparation for treating obstructive hydrocephalus is characterized by comprising the following components in parts by weight: the traditional Chinese medicine composition comprises, by weight, 130 parts of ligusticum wallichii 120-.

2. The traditional Chinese medicine preparation for treating obstructive hydrocephalus according to claim 1, which is characterized in that: the traditional Chinese medicine composition comprises, by weight, 120 parts of ligusticum wallichii, 115 parts of salvia miltiorrhiza, 60 parts of scorpion, 0.3 part of artificial musk, 55 parts of pangolin, 120 parts of cowherb seed, 120 parts of beautiful sweetgum fruit and 118 parts of plantain seed.

3. The traditional Chinese medicine preparation for treating obstructive hydrocephalus according to claim 1, which is characterized in that: the traditional Chinese medicine composition comprises the following raw materials, by weight, 123 parts of ligusticum wallichii, 113 parts of salvia miltiorrhiza, 61 parts of scorpio, 0.3 part of artificial musk, 61 parts of pangolin, 123 parts of cowherb seed, 123 parts of beautiful sweetgum fruit and 123 parts of plantain seed.

4. The traditional Chinese medicine preparation for treating obstructive hydrocephalus according to claim 1, which is characterized in that: the traditional Chinese medicine composition comprises, by weight, 130 parts of ligusticum wallichii, 123 parts of salvia miltiorrhiza, 65 parts of scorpion, 0.5 part of artificial musk, 63 parts of pangolin scales, 130 parts of cowherb seed, 125 parts of beautiful sweetgum fruit and 123 parts of plantain seed.

5. The traditional Chinese medicine preparation for treating obstructive hydrocephalus according to any one of claims 1 to 4, which is characterized in that: the traditional Chinese medicine preparation for treating obstructive hydrocephalus is one of tablets, capsules or granules.

6. A preparation method of a traditional Chinese medicine preparation for treating obstructive hydrocephalus is characterized by comprising the following steps: comprises the following steps of (1) mixing one third of the weight of rhizoma ligustici wallichii, scorpion and pangolin, drying by blowing at 60 ℃, crushing into fine powder and sieving; (2) mixing the rest two thirds of the weight of the hemlock parsley, the salvia miltiorrhiza, the cowherb seed, the sweetgum fruit and the plantain seed, decocting for 2 times, adding 10 times of water by weight for decocting for 2 hours for the first time, and adding 8 times of water by weight for decocting for 2 hours for the second time; (3) combining the two decocted liquid medicines, filtering, and then concentrating the filtrate at-0.08 to-0.09 MPa and 60 to 70 ℃ until the relative density of the filtrate reaches 1.25 to 1.30 at 60 ℃ to obtain thick paste; (4) adding the fine powder mixture obtained in the step (1) into the clear paste obtained in the step (3), uniformly stirring, adding dextrin and sucrose, uniformly stirring, drying, crushing and sieving; (5) granulating, drying, grading, adding artificial Moschus, mixing, and making into capsule.

Technical Field

The invention belongs to the technical field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine preparation for treating obstructive hydrocephalus and a preparation method thereof.

Background

Obstructive hydrocephalus refers to the condition that the cerebrospinal fluid circulation is blocked due to the blockage of the cerebrospinal fluid circulation passage at parts above four ventricles (including self pathological changes and outlets in the four ventricles), and the intracranial cerebrospinal fluid accumulates to cause damage to brain tissues, so that mental movement, intelligence level and the like of a patient are influenced, has extremely high disability rate, and is a persistent symptom recognized by the world medical community. In the prior art, no effective traditional Chinese medicine preparation has good curative effect on obstructive hydrocephalus.

Disclosure of Invention

The invention provides a traditional Chinese medicine preparation for treating obstructive hydrocephalus and a preparation method thereof, and solves the technical problem of poor drug effect of an obstructive hydrocephalus preparation in the prior art.

In order to achieve the purpose, one aspect of the embodiment of the invention provides a traditional Chinese medicine preparation for treating obstructive hydrocephalus, which comprises the following raw materials, by weight, 130 parts of ligusticum wallichii 120-.

Furthermore, the traditional Chinese medicine preparation for treating obstructive hydrocephalus is prepared from the following raw materials, by weight, 120 parts of ligusticum wallichii, 115 parts of salvia miltiorrhiza, 60 parts of scorpion, 0.3 part of artificial musk, 55 parts of pangolin, 120 parts of cowherb seed, 120 parts of beautiful sweetgum fruit and 118 parts of plantain seed.

Further, the traditional Chinese medicine preparation for treating obstructive hydrocephalus comprises, by weight, 123 parts of ligusticum wallichii, 113 parts of salvia miltiorrhiza, 61 parts of scorpio, 0.3 part of artificial musk, 61 parts of pangolin, 123 parts of cowherb seed, 123 parts of beautiful sweetgum fruit and 123 parts of plantain seed.

Further, the traditional Chinese medicine preparation for treating obstructive hydrocephalus comprises, by weight, 130 parts of ligusticum wallichii, 123 parts of salvia miltiorrhiza, 65 parts of scorpio, 0.5 part of artificial musk, 63 parts of pangolin, 130 parts of cowherb seed, 125 parts of beautiful sweetgum fruit and 123 parts of plantain seed.

Further, the traditional Chinese medicine preparation for treating obstructive hydrocephalus is one of tablets, capsules or granules.

In another aspect of the embodiment of the invention, a preparation method of a traditional Chinese medicine preparation for treating obstructive hydrocephalus is provided, which comprises the following steps of (1) mixing one third of rhizoma ligustici wallichii, scorpion and pangolin scales by weight, drying by blowing at 60 ℃, crushing into fine powder and sieving; (2) mixing the rest two thirds of the weight of the hemlock parsley, the salvia miltiorrhiza, the cowherb seed, the sweetgum fruit and the plantain seed, decocting for 2 times, adding 10 times of water by weight for decocting for 2 hours for the first time, and adding 8 times of water by weight for decocting for 2 hours for the second time; (3) combining the two decocted liquid medicines, filtering, and then concentrating the filtrate at-0.08 to-0.09 MPa and 60 to 70 ℃ until the relative density of the filtrate reaches 1.25 to 1.30 at 60 ℃ to obtain thick paste; (4) adding the fine powder mixture obtained in the step (1) into the clear paste obtained in the step (3), uniformly stirring, adding dextrin and sucrose, uniformly stirring, drying, crushing and sieving; (5) granulating, drying, grading, adding artificial Moschus, mixing, and making into capsule.

Compared with the prior art, the invention has the beneficial effects that: the traditional Chinese medicine takes ligusticum wallichii and salvia miltiorrhiza as monarch drugs, has the effects of tonifying qi and blood and promoting blood circulation to remove blood stasis, takes scorpion and musk as ministerial drugs, has the effects of removing blood stasis and dredging orifices, and takes pangolin, cowherb, beautiful sweetgum fruit and plantain seed as adjuvant drugs, has the effects of inducing resuscitation, ventilating, dredging channels and inducing diuresis, takes musk as conductant drug, and leads the drugs to be led to the brain orifices. The medicines are combined to lead the brain to be dredged, the channels and collaterals to be dredged, the blood stasis to be removed and the hydrops to be automatically eliminated to recover. Through clinical tests, the effective rate of the traditional Chinese medicine preparation for treating obstructive hydrocephalus is up to 100%, and the traditional Chinese medicine preparation has remarkable progress compared with the effective rate of 23.33% of a control group, and meanwhile, through statistical test and analysis, p is less than 0.05, and test data have remarkable difference; and the incidence rate of adverse reactions of the test group and the control group is less than 95 percent by chi-square test, so that the safety evaluation standard requirement is met.

Drawings

Figure 1 is a CT examination before treatment of a typical case.

Figure 2 is a CT examination after typical case treatment.

Detailed Description

The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The terms "first" and "second," and the like, in the description and in the claims of embodiments of the present invention are used for distinguishing between different objects and not for describing a particular order of the objects. For example, the first parameter set and the second parameter set, etc. are used to distinguish different parameter sets, rather than to describe a particular order of parameter sets.

In the description of the embodiments of the present invention, the meaning of "a plurality" means two or more unless otherwise specified. For example, a plurality of elements refers to two elements or more.

The term "and/or" herein is an association relationship describing an associated object, and means that there may be three relationships, for example, a display panel and/or a backlight, which may mean: there are three cases of a display panel alone, a display panel and a backlight at the same time, and a backlight alone. The symbol "/" herein denotes a relationship in which the associated object is or, for example, input/output denotes input or output.

In the embodiments of the present invention, words such as "exemplary" or "for example" are used to mean serving as examples, illustrations or descriptions. Any embodiment or design described as "exemplary" or "e.g.," an embodiment of the present invention is not necessarily to be construed as preferred or advantageous over other embodiments or designs. Rather, use of the word "exemplary" or "such as" is intended to present concepts related in a concrete fashion.

Hydrocephalus belongs to the scope of 'skull-relieving' in traditional Chinese medicine, the cause of skull-relieving is congenital deficiency, acquired malnutrition and disorder after illness, which lead to deficiency of qi and blood, unsmooth blood circulation and obstruction of cerebral collaterals; or pathogenic toxin invades the brain and affects or blocks the blood circulation of the brain orifices; or toxic heat obstructing the brain orifices. Therefore, the key pathogenesis of the disease is that blood stasis blocks collaterals, brain orifices are blocked, water-dampness (fluid) stops accumulation (blockage), the disease belongs to the syndrome of deficiency and marked excess, the deficiency of spleen and kidney is the main cause, the water stasis stops serving as the mark, and the main cause is slow and marked urgent, so the treatment aims at promoting blood circulation to remove blood stasis, dredging orifices and inducing diuresis, the essence is removed firstly, the blood stasis is dissolved, the blood collaterals are unblocked, the brain orifices are opened, and the accumulated water is removed automatically. The traditional Chinese medicine takes ligusticum wallichii and salvia miltiorrhiza as monarch drugs, has the effects of tonifying qi and blood and promoting blood circulation to remove blood stasis, takes scorpion and musk as ministerial drugs, has the effects of removing blood stasis and dredging orifices, and takes pangolin, cowherb, beautiful sweetgum fruit and plantain seed as adjuvant drugs, has the effects of inducing resuscitation, ventilating, dredging channels and inducing diuresis, takes musk as conductant drug, and leads the drugs to be led to the brain orifices. The medicines are combined to lead the brain to be dredged, the channels and collaterals to be dredged, the blood stasis to be removed and the hydrops to be automatically eliminated to recover.

The invention treats obstructive hydrocephalus, suppurative meningitis, tuberculous meningitis and traffic hydrocephalus, arachnoid cyst and brain tumor caused by subarachnoid hemorrhage by using the musk through brain dredging granules for removing blood stasis, inducing diuresis, inducing resuscitation and dredging collaterals, and achieves the aim of improving clinical curative effect.

The embodiment of the invention provides a traditional Chinese medicine preparation for treating obstructive hydrocephalus, which comprises the following raw materials, by weight, 130 parts of ligusticum wallichii, 123 parts of salvia miltiorrhiza 115, 60-65 parts of scorpion, 0.3-0.5 part of artificial musk, 55-63 parts of pangolin scales, 130 parts of cowherb seed, 125 parts of sweetgum fruit and 118 parts of plantain seed.

Clinical data: all cases were from hospitalized children or outpatient children in our hospital, aged 6 months-65 years, with an average age of 2.6 years. Among 120 children, 79 men and 41 women. All cases have been diagnosed as obstruction to hydrocephalus and meet the syndrome type standard of water-stasis.

Diagnostic criteria: (1) and head circumference exceeds the national standard by 2 standard deviations.

(2) Enlargement of fontanel, prolonged retention, tension and fullness or splitting of cranial sutures.

(3) The condition of subbulbar rotation is called "sunset", or "tremor", or "strabismus".

(4) And low intelligence.

(5) Speech retardation, or motor dysplasia, vomiting and convulsions, which are difficult to explain with other diseases.

(6) And the imaging examination proves that the patient has obstructive hydrocephalus.

The disease can be diagnosed by the patients having one of the items (1) to (5) and (6).

The syndrome of traditional Chinese medicine is characterized in that: the syndrome of water stasis may indicate that the infant has a large head and a drop of eyes, such as a sunset, and the movement of both lower limbs is not smooth, or accompanied by strabismus, convulsion, etc. Adults have symptoms of head distension and headache, localized pain, immobility, light day and heavy night, visual deterioration or even blindness, convulsion of limbs, or diseases caused by trauma, bleeding, etc., dark tongue with ecchymosis, and unsmooth or deep and slippery pulse.

The main symptoms are: distending pain in the head, localized pain and immobility.

The secondary symptoms are as follows: light day and heavy night, or due to trauma, bleeding, etc., dark tongue with ecchymosis, and unsmooth and wiry or deep and slippery pulse.

There are any two of the major symptoms and two of the minor symptoms.

The treatment method comprises the following steps:

test group, musk deer bone-piercing brain-clearing granules, specification: 5g per bag. 2 bags per day under 8 years old; the preparation is administered 3 bags each day for 3-4 times before meals over 8 years old.

In the control group, the acezamide tablets (specification: 250mg per tablet, control drug manufactured by Beijing Yanjing pharmaceutical factory) are administered with warm boiled water 5-10 mg/kg/time and 2 times/day. During the administration period, 2g of sodium bicarbonate, 1g of sodium citrate, 1g of potassium chloride, 1.5g of magnesium chloride and 1500-2000ml of drinking water can be used together daily to prevent the water electrolyte from being disturbed.

The above two groups of patients are treated every 4 weeks for 1 course. Continuously observing for 3 courses of treatment, wherein the follow-up is carried out once a week in an observation period, and patients with serious adverse reactions should be checked and recorded in time and treated according to symptoms. For those with adverse drug reactions, they should be treated with withdrawal.

The therapeutic effect judgment standard is as follows: the evaluation standard is formulated according to the evaluation standard of clinical efficacy for treating cephalocathartic (hydrocephalus) in the Chinese medical diagnosis and treatment standard and in combination with the evaluation standard of efficacy for obstructive hydrocephalus disease formulated in the national first TCM medical treatment Association.

And (3) healing: clinical symptoms disappear or basically disappear, and physical signs return to normal; the hydrocephalus is reduced by more than 75% by image examination.

The effect is shown: the clinical symptoms and physical signs are obviously improved; the reduction of hydrocephalus by 25-50% is detected by image.

The method has the following advantages: the clinical symptoms are improved, and the physical signs are improved; the reduction of hydrocephalus by 5-25% is detected by image.

And (4) invalidation: clinical symptoms and signs are unchanged or aggravated, and hydrocephalus is reduced by less than 5% in image examination.

The following table shows the results of the efficacy evaluations of the two groups of patients after 3 courses of treatment:

statistical tests show that p is less than 0.05, which indicates that the two groups of data have significant difference.

Safety evaluation criteria:

first-stage: safe and has no adverse reaction; the security index checks for no anomalies.

And (2) second stage: is safe, has mild adverse reaction, and can continue to treat without any treatment; the security index checks for no anomalies.

Third-stage: has safety problem, moderate adverse reaction or slight abnormality in safety index inspection, and can continue to be treated after treatment.

And (4) fourth stage: discontinuation of the test due to severe adverse reactions; or an abnormality is manifested upon checking the safety index.

Whether adverse reactions or safety accidents occur after the two groups of patients receive treatment for 3 courses of treatment is shown in the following table:

the two groups of data are statistically tested, and p is more than 1, which indicates that the two groups of data have no obvious difference. And the incidence rate of adverse reaction of the two groups of data is less than 95 percent by adopting chi-square test.

The effective rate of the test group is 100%, the effective rate of the control group is 23.33%, and the two groups of data p are less than 0.05, which shows that the two groups of data have significant difference, and the traditional Chinese medicine preparation for treating obstructive hydrocephalus has significant treatment effect on obstructive hydrocephalus; no patients in the test group had serious adverse drug reactions. The traditional Chinese medicine preparation for treating obstructive hydrocephalus has good curative effect and reliable safety on obstructive hydrocephalus (water-stasis-combined type).

Typical cases are:

yuan Zhi, female, 16 years old. Initial diagnosis time: 2016, 9, 19 months. The patients are diagnosed with fullness in the head, headache, nausea and weakness of the lower limbs.

Admission diagnosis: obstructive hydrocephalus.

Treatment: the granule is orally administered with warm boiled water before meal, 3 bags per day, 3 times.

Before treatment: the patient has the symptoms of head distension, headache, nausea, weakness of both lower limbs and difficulty in walking. Poor spirit, obvious decline of intelligence of family response patients and slow response. The CT examination result is shown in fig. 1, and the presence of hydrocephalus can be clearly seen.

After treatment: after 6 months of treatment, the headache of the patient disappears, the patient does not have nausea and vomiting, walks normally, and has recovered intelligence, CT examination results are shown in figure 2, and all indexes are examined to recover to be normal. Follow-up was to date free of abnormalities.