CN105434695A - A kind of compound Zhixuening dispersible tablet and preparation method thereof - Google Patents

Abstract

The compound Zhixuening dispersing tablet is prepared with Chinese medicine extract 10-50 wt%, stuffing 10-80 wt%, inner disintegrating agent 5-5 wt%, outer disintegrating agent 5-15 wt%, corrective 0.1-10 wt%, wetting agent 0.1-20 wt% and lubricant 0.05-20 wt%; in the traditional Chinese medicine extract, the raw materials comprise, by weight, 100 portions of pseudo-ginseng, 200 portions of callicarpa bodinieri, 400 portions of purslane, 200 portions of fried sophora japonica, 10-50 portions of crinis carbonisatus and 50-100 portions of ophicalcitum; the preparation method comprises the following specific steps: step 1, pretreating raw materials; step 2, extracting; step 3, preparing a preparation; and 4, packaging. The compound Zhixuening dispersible tablet has the effects of stopping bleeding, reducing swelling and removing blood stasis. [ b ]

Description

A kind of compound Zhixuening dispersible tablet and preparation method thereof

technical field

The invention relates to the technical field of pharmacy, in particular to a compound Zhixuening dispersible tablet and a preparation method thereof.

Background technique

Functional uterine bleeding, referred to as dysfunctional uterine bleeding, is a common gynecological disease. It refers to abnormal uterine bleeding. After examination, no organic diseases of the whole body and reproductive organs were found, but it was caused by dysfunction of the neuroendocrine system. . Manifested as irregular menstrual cycle, heavy menstrual flow, prolonged menstruation or irregular bleeding. Metrorrhagia refers to a woman who is not menstruating and has a large amount of vaginal bleeding, or continuous bleeding, which is also called "metrorrhagia".

Contents of the invention

The object of the present invention is to provide a compound Zhixuening dispersible tablet and a preparation method thereof, which have the effects of hemostasis, detumescence and blood stasis removal. For functional uterine bleeding, metrorrhagia, epistaxis, hemoptysis, hematemesis and other hemorrhagic diseases.

The purpose of the present invention is achieved through the following technical solutions:

A compound Zhixuening dispersible tablet, which is prepared from raw materials according to the following weight percentages: 10-50% of traditional Chinese medicine extract, 10-80% of filler, 5-50% of internally added disintegrating agent, and 5-15% of externally added disintegrating agent %, flavoring agent 0.1-10%, wetting agent 0.1-20%, lubricant 0.05-20%; in the Chinese medicine extract, the raw materials are 100-200 parts by weight of Panax notoginseng, 200 parts of Zizhucao -400 parts, 200-400 parts of purslane, 100-200 parts of fried Sophora japonica, 10-50 parts of blood charcoal, 50-100 parts of stamen.

In the traditional Chinese medicine extract, the raw materials are in preferred parts by weight, 100-120 parts of Panax notoginseng, 350-400 parts of Zizhucao, 350-400 parts of purslane, 100-150 parts of fried Sophora japonica, 30 parts of Xue Yu charcoal -50 parts, stamens 50-80 parts.

In the Chinese medicine extract, the raw materials are 111 parts by weight of Panax notoginseng, 370 parts of Zizhucao, 370 parts of purslane, 148 parts of fried Sophora japonica, 37 parts of blood charcoal, and 74 parts of stamen.

The filler is a mixture of one or more of pregelatinized starch, mannitol, microcrystalline cellulose, sucrose, lactose, sodium chloride, and calcium sulfate; The agent is a mixture of one or more of low-substituted hydroxypropyl cellulose, sodium starch glycolate, croscarmellose sodium, and crospovidone; the flavoring agent is aspartame, stevia One or more of citric acid, sweet orange essence; the wetting agent is water, ethanol solution or a mixture of two; the lubricant is magnesium stearate, One or more of sodium lauryl sulfate, silicon dioxide, and talcum powder.

Described a kind of compound Zhixuening dispersible tablet, the concrete steps of its preparation method are:

Step 1, raw material pretreatment: select high-quality Panax notoginseng, Zizhucao, purslane, fried Sophora japonica, blood residue charcoal, stamens, wash and remove impurities, and set aside;

Step 2. Extraction: Take the above six traditional Chinese medicines, grind Panax notoginseng and Xueyu charcoal into fine powder, and crush stamens. After mixing, add water and boil for 2 hours, then add Zizhucao, purslane, fried Sophora japonica, add water Decoct twice, each time for 2 hours, combine the decoction, filter, and when the filtrate is concentrated under reduced pressure to 70°C, the relative density is 1.24-1.28, and finally dried under reduced pressure at 80°C to obtain the Chinese medicine extract;

Step 3, preparation: crush the Chinese medicine extract into fine powder, pass through an 80-mesh sieve, then add a filler and an internal disintegrant to mix evenly, add a wetting agent, and granulate by fluidized bed granulation technology to obtain the whole After granulation, add additional disintegrating agent, corrective agent, lubricant and mix evenly, and compress into tablets with a tablet machine to make tablets;

Step 4. Packaging: According to the specifications of the photo agent, it is sorted and packaged to make a finished product.

In the above-mentioned medicines: Panax notoginseng, dissipating blood stasis to stop bleeding, reducing swelling and relieving pain, used for hemoptysis, vomiting blood, epistaxis, hematochezia, metrorrhagia, traumatic bleeding, tingling pain in chest and abdomen, tumbling and swelling pain, Zizhucao, dispelling blood stasis Hemostasis, swelling and pain relief, for vomiting blood, hemoptysis, epistaxis, blood in the stool, external treatment of traumatic bleeding, purslane, has the effects of clearing away heat and dampness, detoxifying and reducing swelling, reducing inflammation, quenching thirst, diuresis, and treating dysentery with febrile pus and blood, fever Drenching, bloody stranguria, leukorrhagia, carbuncle, swollen sores, erysipelas, scars, blood in the stool, uterine bleeding, has a hemostatic effect, Sophora japonica (stir-fried), has the effects of clearing away heat, cooling blood, hemostasis, and lowering blood pressure, and is effective for vomiting blood and hematuria , hemorrhoids bleeding, wind-heat red eyes, hypertension, hyperlipidemia, cervical lymphatic tuberculosis, hardening of the arteries, blood in the stool, diabetes, retinitis, psoriasis, etc. have significant curative effect, blood remaining charcoal, astringent and hemostasis, chemical Blood stasis, diuresis, used for vomiting blood, hemoptysis, epistaxis, stranguria, hematuria, hematochezia, metrorrhagia, traumatic bleeding, difficulty urinating, stamen stone, removing blood stasis and hemostasis, used for hemoptysis, hematemesis, traumatic bleeding, tumbling pain.

Beneficial effects of the present invention: a compound Zhixuening dispersible tablet of the present invention and its preparation method have the effects of hemostasis, swelling, and blood stasis, and are used for functional uterine bleeding, metrorrhagia, epistaxis, and hemoptysis. Hematemesis and other hemorrhagic diseases; it has good solubility and dispersibility, high dissolution rate, good bioavailability, rapid distribution in the body, stable quality, good taste, easy to take, can be swallowed, chewed, sucked or taken after dispersing with water, more It is suitable for elderly patients or children, and has the advantages of good drug stability, convenient packaging, transportation and storage, and the preparation method is simple and feasible, and is suitable for industrial production.

The process characteristics of the present invention: 1. Scientific selection of raw materials, advanced production technology, and convenient storage and use of the product; 2. The medicinal ingredients in the product are easily absorbed by the human body; 3. Wide source of raw materials, short processing line, and easy processing and manufacturing of the product.

detailed description

Example 1

A compound Zhixuening dispersible tablet, which is prepared from raw materials according to the following weight percentages: 10-50% of traditional Chinese medicine extract, 10-80% of filler, 5-50% of internally added disintegrating agent, and 5-15% of externally added disintegrating agent %, flavoring agent 0.1-10%, wetting agent 0.1-20%, lubricant 0.05-20%; in the Chinese medicine extract, the raw materials are 100-200 parts by weight of Panax notoginseng, 200 parts of Zizhucao -400 parts, 200-400 parts of purslane, 100-200 parts of fried Sophora japonica, 10-50 parts of blood charcoal, 50-100 parts of stamen.

Example 2

In the traditional Chinese medicine extract, the raw materials are in preferred parts by weight, 100-120 parts of Panax notoginseng, 350-400 parts of Zizhucao, 350-400 parts of purslane, 100-150 parts of fried Sophora japonica, 30 parts of Xue Yu charcoal -50 parts, stamens 50-80 parts.

Example 3

In the Chinese medicine extract, the raw materials are 111 parts by weight of Panax notoginseng, 370 parts of Zizhucao, 370 parts of purslane, 148 parts of fried Sophora japonica, 37 parts of blood charcoal, and 74 parts of stamen.

Example 4

The filler is a mixture of one or more of pregelatinized starch, mannitol, microcrystalline cellulose, sucrose, lactose, sodium chloride, and calcium sulfate; The agent is a mixture of one or more of low-substituted hydroxypropyl cellulose, sodium starch glycolate, croscarmellose sodium, and crospovidone; the flavoring agent is aspartame, stevia One or more of citric acid, sweet orange essence; the wetting agent is water, ethanol solution or a mixture of two; the lubricant is magnesium stearate, One or more of sodium lauryl sulfate, silicon dioxide, and talcum powder.

Example 5

Described a kind of compound Zhixuening dispersible tablet, the concrete steps of its preparation method are:

Step 1, raw material pretreatment: select high-quality Panax notoginseng, Zizhucao, purslane, fried Sophora japonica, blood residue charcoal, stamens, wash and remove impurities, and set aside;

Step 2. Extraction: Take the above six traditional Chinese medicines, grind Panax notoginseng and Xueyu charcoal into fine powder, and crush stamens. After mixing, add water and boil for 2 hours, then add Zizhucao, purslane, fried Sophora japonica, add water Decoct twice, each time for 2 hours, combine the decoction, filter, and when the filtrate is concentrated under reduced pressure to 70°C, the relative density is 1.24-1.28, and finally dried under reduced pressure at 80°C to obtain the Chinese medicine extract;

Step 3, preparation: crush the Chinese medicine extract into fine powder, pass through an 80-mesh sieve, then add a filler and an internal disintegrant to mix evenly, add a wetting agent, and granulate by fluidized bed granulation technology to obtain the whole After granulation, add additional disintegrating agent, corrective agent, lubricant and mix evenly, and compress into tablets with a tablet machine to make tablets;

Step 4. Packaging: According to the specifications of the photo agent, it is sorted and packaged to make a finished product.

Claims (5)

1. the peaceful dispersible tablet of compound hemostatic, it is characterized in that: be prepared from by following percentage by weight by raw material, Chinese medicine extract 10-50%, filler 10-80%, in disintegrating agent 5-50%, additional disintegrating agent 5-15%, correctives 0.1-10%, wetting agent 0.1-20%, lubricant 0.05-20%; In described Chinese medicine extract, raw materials by weight portion, Radix Notoginseng 100-200 part, Folium Callicarpae Formosanae 200-400 part, Herba Portulacae 200-400 part, Flos Sophorae (parched) 100-200 part, Crinis Carbonisatus 10-50 part, Ophicalcitum 50-100 part.

2. the peaceful dispersible tablet of a kind of compound hemostatic according to claim 1, it is characterized in that: in described Chinese medicine extract, preferred weight number pressed by raw material, Radix Notoginseng 100-120 part, Folium Callicarpae Formosanae 350-400 part, Herba Portulacae 350-400 part, Flos Sophorae (parched) 100-150 part, Crinis Carbonisatus 30-50 part, Ophicalcitum 50-80 part.

3. the peaceful dispersible tablet of a kind of compound hemostatic according to claim 1, it is characterized in that: in described Chinese medicine extract, optimum weight number pressed by raw material, Radix Notoginseng 111 parts, Folium Callicarpae Formosanae 370 parts, Herba Portulacae 370 parts, Flos Sophorae (parched) 148 parts, Crinis Carbonisatus 37 parts, Ophicalcitum 74 parts.

4. the peaceful dispersible tablet of a kind of compound hemostatic according to claim 1, is characterized in that: described filler is the mixing of one or more in pregelatinized Starch, mannitol, microcrystalline Cellulose, sucrose, lactose, sodium chloride, calcium sulfate; With the mixing of one or more that disintegrating agent or additional disintegrating agent are in low-substituted hydroxypropyl cellulose, carboxymethylstach sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone in described; Described correctives is the mixing of one or more in aspartame, steviosin, citric acid, orange flavor; Described wetting agent is one or both the mixing in water, alcoholic solution; Described lubricant is the mixing of magnesium stearate, sodium lauryl sulphate, silicon dioxide, Pulvis Talci wherein one or more.

5. the peaceful dispersible tablet of a kind of compound hemostatic according to claim 1-3 any one, is characterized in that: the concrete steps of its preparation method are:

Step 1, pretreatment of raw material: by weight, choose the Radix Notoginseng of high-quality, Folium Callicarpae Formosanae, Herba Portulacae, Flos Sophorae (parched), Crinis Carbonisatus, Ophicalcitum, cleans and remove impurity, for subsequent use;

Step 2, extraction: get above Six-element Chinese medicine, Radix Notoginseng, Crinis carbonisatus powder are broken into fine powder, Ophicalcitum is pulverized, 2 hours are first decocted with water after mixing, add Folium Callicarpae Formosanae, Herba Portulacae, Flos Sophorae (parched) again, decoct with water secondary, each 2 hours, collecting decoction, filter, during filtrate reduced in volume to 70 DEG C, relative density is the clear paste of 1.24 ~ 1.28, last at 80 DEG C of drying under reduced pressure, obtain Chinese medicine extract;

Step 3, preparation: Chinese medicine extract is ground into fine powder, cross 80 mesh sieves, then add filler, in disintegrating agent mix homogeneously, add wetting agent, adopt fluidized bed granulation technology to granulate, after obtained granulate, add additional disintegrating agent, correctives, mix lubricant are even, with tabletting machine, make tablet;

Step 4, packaging: according to tablet format, class wrapping, makes finished product.