CN105878189A - Preparation method of tuber fleeceflower stem granules - Google Patents

Abstract

The invention discloses a preparation method of tuber fleeceflower stem granules. The preparation method comprises the following main granulating processes: crushing dry powder of water extract of tuber fleeceflower stem, soluble starch and alpha-lactose, sieving with a No.5 sieve with 80 meshes, and uniformly mixing according to the ratio of 1:0.5:0.5; adding 12% of wetting agent (80% ethanol) for adjusting the humidity, preparing a soft material according to the criterion of agglomerating by pinching and scattering by loosely gripping, and sieving the soft material with a No.1 sieve to obtain wet granules; and then, carrying out forced air drying on the wet granules at 70 DEG C for 1h, and finishing the granules by adopting the No.1 sieve and a No.4 sieve, so as to obtain the tuber fleeceflower stem granules. The prepared tuber fleeceflower stem granules have the advantages of high formability, low water content, low hygroscopicity and good flowability; the appearance and dissolubility of the granules meet the corresponding requirements of the Pharmacopoeia of China; and the granules can be applied to the field of related drugs and health foods, and large-scale mass production can be easily realized.

Description

A kind of preparation method of Caulis Polygoni Multiflori granule

Technical field

The present invention relates to the preparation method of a kind of Caulis Polygoni Multiflori granule, belong to medicine and field of health care food.

Background technology

The Vine of Polygonum Multiflorum is rattan or the leaf bine stem of the perennial draft Plant-Polygonum of overgrowing of Polygonaceae.Theory of Chinese medical science thinks that Caulis Polygoni Multiflori can nourish heart, and calms the nerves, Dredging collateral, dispels the wind, and can treat insomnia, impairment caused by overstrain, hyperhidrosis, blood deficiency general pain, carbuncle, scrofula, the disease such as wind skin ulcer scabies.We also find early-stage Study Caulis Polygoni Multiflori extract can suppress the nucleus formation of interior cutaneous vessel, finds that Caulis Polygoni Multiflori grinds in the suppression pharmacology of angiogenesis, drug effect etc. by literature survey Studying carefully field and be still in the blank stage, therefore Caulis Polygoni Multiflori extract has well in terms of suppression tumor-blood-vessel growth and other and associated angiogenesis disease Potential medical value, but the granule that The Vine of Polygonum Multiflorum is correlated with also does not has ripe preparation method.And Chinese medicine granules is at Chinese medicine decoction and syrup Etc. the novel form grown up on the basis of dosage form, having obvious advantage compared with other dosage forms, it had both maintained decoction and had absorbed fast, effect Feature rapidly, when overcoming again decoction use, decoction is inconvenient, dose is big, be prone to shortcomings such as going mouldy.And its preparation technology be suitable to commercial production, Dosage is little, takes, carries, stores, transports the most more convenient, and therefore development prospect is the best.

Therefore, by substantial amounts of early-stage Study and optimization experiment, the invention discloses the preparation method of a kind of Caulis Polygoni Multiflori granule, for its scale metaplasia Produce and clinical practice provides technical support and reference material.

Summary of the invention

It is an object of the invention to provide a kind of mouldability high, moisture is low, and hygroscopicity is low, good fluidity, and outward appearance and melting all meet Chinese Pharmacopoeia phase The preparation method of the Caulis Polygoni Multiflori granule that should require.Its preparation process operating parameter is---Caulis Polygoni Multiflori extract dry powder: soluble starch: alpha-lactose =1: 0.5: 0.5, wetting agent concentration of alcohol is 80%, and wetting agent ethanol consumption is 12%, and soft material is made in mixing, crosses 10 mesh mesh screens and obtains wet granular, in 70 DEG C of forced air drying 1h, granulate i.e. obtains Caulis Polygoni Multiflori granule.

Detailed description of the invention

Embodiment 1: the preparation of The Vine of Polygonum Multiflorum water extract

Weigh Caulis Polygoni Multiflori medical material, add 12 times of water soaking 60min, decoct 3 times, each 2h, after merging three extracting solution, filtered while hot, decompression It is concentrated into dry powder, obtains The Vine of Polygonum Multiflorum water extract.

Embodiment 2: the preparation method (wet granulation) of Caulis Polygoni Multiflori granule

The flow operations using wet granulation is as follows:

(1) after Caulis Polygoni Multiflori water extract embodiment 1 prepared and adjuvant are pulverized, No. 5 sieves (80 mesh) are crossed, wanting by embodiment 4 optimization experiment Ratio is asked to mix.

(2) add 80% ethanol, adjust humidity, be that criterion makes soft material with " hands is pinched agglomerating, gently holds the most scattered ", soft material crossed a sieve and obtains wet Granule.

(3), after wet granular being put in 70 DEG C of forced air drying 1h, use a sieve, No. four sieves to carry out granulate, obtain Caulis Polygoni Multiflori granule.

Embodiment 3: the assessment indicator system of granule

(1) outward appearance

Specifying according to Chinese Pharmacopoeia, conforming particle needs uniformly, and color and luster is consistent, without phenomenons such as the moisture absorption, caking, deliquescence.

(2) mouldability

Using double screen method to measure: to weigh granule, be placed in a sieve, keep level, left and right comes and goes, and sieves while tapping 3 minutes.Take Percentage ratio can not be calculated by No. five sieves and granule and powder that a sieve can be passed through, weighed weight.Unless otherwise specified, according to granulometry Measure, it is impossible to by a sieve and the summations that No. five sieves can be passed through, cannot be greater than the 15% of gross mass

(3) mobility

Using injection method to measure θ angle of repose, be fixed on up and down on iron stand by two funnels, place on the contrary for two jiaos, granule freely falls on funnel, The disc of a diameter of R is formed accumulation body, measures height H, the tan θ=H/R of accumulation body.Angle of repose is the least, and mobility is the best, when θ≤30 ° Time mobility fine, substantially can meet the requirement to mobility in production process during θ≤40 °.

(4) determination of water

Use oven drying method to measure without or contain the medicine of volatile ingredient less: weighing test sample 2～5g, be laid in and be dried to the weighing botle of constant weight, Thickness is less than 5mm, accurately weighed, opens bottle cap and is dried 3h bonnet upper bottle cover at 105 DEG C, and dislocation, in exsiccator, cools down 30min, Accurately weighed, then it is dried 1h at said temperature, cooling is weighed, and being less than 0.02% to double difference of weighing, calculates moisture in test sample Content θ moisture.Before θ moisture=(before m is dried ,-m is dried)/m is dried × 100%

(5) hygroscopicity

Weigh test sample, be laid in and be dried to the weighing botle of constant weight, micrometric measurement, put into bottom and fill the glass desicator of saturated NaCl solution (having balanced 24h, relative humidity 75%), ambient temperatare is put, in 1h, 2h, 4h, 6h, 8h, 24h, 48h, 72h accurate weighing, Calculate the θ moisture absorption of its hydroscopicity, draw the sucting wet curve of humidity 75%.Before θ hydroscopicity=(before the dried-m of m is dried)/m is dried × 100%

Embodiment 4: Caulis Polygoni Multiflori extract and the formulation optimization of adjuvant in wet granulation

Preliminary experiment filters out three kinds of relatively good adjuvants of granulation situation: soluble starch, mannitol, alpha-lactose.By Caulis Polygoni Multiflori extract dry powder with These three kinds of adjuvants carry out proportioning mixing according to the ratio of table 1, according to the step of above-described embodiment 2 wet granulation, prepare three kinds of granules, and by implementing Example 3 carries out many index evaluation respectively, thus the granulating efficiency of screening and assessment binary adjuvant.

The proportioning table of table 1 two end number mixing adjuvant

The formulation optimization experimental result of Caulis Polygoni Multiflori extract and adjuvant is shown in Table 2.Can be seen that prescription 3 uses Caulis Polygoni Multiflori extract dry powder from experimental result: Soluble starch: alpha-lactose=1: the formula of 0.5: 0.5, the grain forming obtained is higher, and moisture is low, and hygroscopicity is low, good fluidity, outward appearance and Melting all meets Chinese Pharmacopoeia corresponding requirements.

The granulation eveluatin result of table 2 binary ratio of adjuvant screening

Claims (2)

1. the preparation method of a Caulis Polygoni Multiflori granule.After it is characterized in that pulverizing the water extract dry powder of Caulis Polygoni Multiflori, soluble starch, alpha-lactose, Cross No. 5 sieves (80 mesh), in 1: 0.5: 0.5 ratio mixing.Add the wetting agent (80% ethanol) of 12%, adjust humidity, with " hands is pinched agglomerating, Gently hold the most scattered " it is that criterion makes soft material, soft material is crossed a sieve and obtains wet granular.Then, after wet granular being put in 70 DEG C of forced air drying 1h, adopt Carry out granulate with a sieve, No. four sieves, obtain Caulis Polygoni Multiflori granule.

The most according to claim 1, its application includes the large-scale production of Caulis Polygoni Multiflori granule.